The purpose of this study is to determine if intranasal (IN) Ketorolac in combination with oral Prochlorperazine and Diphenhydramine is non-inferior to current migraine management which involves use of intravenous (IV) Ketorolac and oral adjuncts Prochlorperazine and diphenhydramine for reducing pain intensity in children with migraine headaches.
The investigators hypothesize that IN ketorolac combined with these oral adjuncts is non-inferior to IV ketorolac and oral adjuncts in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration.

Start Date01 Jan 2024

Sponsor / Collaborator

Washington University School of Medicine

[+1]

NCT05013437

/ WithdrawnEarly Phase 1IIT

A Pilot Study to Assess Impact of Low Dose Melphalan on Disease Burden Measured by Next Generation Sequencing Before Autologous Hematopoietic Cell Transplant (AHCT) for Multiple Myeloma Patients

The purpose of this study is to see if Multiple Myeloma (MM) cells are sensitive to the chemotherapy used in transplant or not. The main chemotherapy agent utilized in stem cell transplant is melphalan. The study will utilize 1/10 of the dose used in transplant to study sensitivity of the tumor to melphalan. Melphalan is approved by the U.S. Food and Drug Administration (FDA) for transplant for MM patients.

Start Date01 Sep 2023

Sponsor / Collaborator

The Case Comprehensive Cancer Center

NCT06182098

/ Unknown statusNot ApplicableIIT

Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine

The goal of this clinical trial is to compare intravenous (IV) fluids in pediatric patients with migraine. The main questions it aims to answer are:
* Does a large amount of fluids (bolus) improve pain
* Does a large amount of fluids (bolus) reduce admissions to the hospital for migraine Participants will be asked to report their pain and have vital signs checked every 30 minutes for two hours.
Researchers will compare a large amount of fluids (bolus) to a small amount (half maintenance) to see if there is a difference in pain improvement.

Start Date27 Jun 2023

Sponsor / Collaborator

Dayton Children's Hospital

100 Clinical Results associated with Prochlorperazine Edisylate

100 Translational Medicine associated with Prochlorperazine Edisylate

100 Patents (Medical) associated with Prochlorperazine Edisylate

976

Literatures (Medical) associated with Prochlorperazine Edisylate

01 Sep 2025·CHEMICO-BIOLOGICAL INTERACTIONS

Characterization of a gene expression biomarker predictive of hypoxia-inducible factor-1 modulation

Article

Author: Liu, Jie ; Chorley, Brian ; Corton, J Christopher

We describe here a gene expression biomarker that can accurately identify chemicals and genetic conditions that perturb hypoxia-inducible factor-1 (HIF-1), a transcription factor critical for the cellular response to hypoxia involved in the pathophysiology of cancer, inflammation, and ischemia. The HIF-1 biomarker genes were identified from transcript profiles in a variety of human cell lines after hypoxia as well as genetic knockdown of the HIF1A gene. The HIF-1 biomarker of 122 genes was found to be enriched for genes bound by HIF-1 using ChIP-Seq and metabolic pathways regulated by HIF-1 (e.g., gluconeogenesis). Using Ingenuity Pathway Analysis, HIF-1 was the top predicted transcriptional regulator of the genes. The biomarker could identify activation of HIF-1 by overexpression of the HIF1A gene or suppression of the negative regulator, von-Hipple Lindau (VHL) gene; suppression of HIF-1 occurred by inhibition of the expression of HIF1A or the heterodimer partner aryl hydrocarbon receptor nuclear translocator (ARNT). The biomarker was specific for HIF-1 activation, as activation or suppression of the HIF-2 gene was not detected by the biomarker. Using a reference chemical set with 180 positives and 45 negatives, the balanced accuracy of the HIF-1 biomarker to identify activation was 94.1 %. An in-silico screen of a gene expression compendium identified hundreds of potential activators. Eleven of these were selected for verification and all were found to activate HIF-1 biomarker genes in wild-type but not HIF1A-null cells. The HIF-1 biomarker will be a useful tool to identify environmentally relevant chemicals that affect HIF-1 in high-throughput transcriptomics screening studies.

01 Jun 2025·EUROPEAN JOURNAL OF HAEMATOLOGY

Outcomes of Melflufen Treatment in Patients With Relapsed/Refractory Multiple Myeloma

Article

Author: O'Neill, Kathleen ; Richardson, Paul G. ; Patches, Sarah ; Goodrich, Kathryn ; Laubach, Jacob ; Leblebjian, Houry ; Regan, Eileen ; Hossain, Shahrier ; Noonan, Kim ; Mo, Clifton

ABSTRACT:

Objective:

Melphalan flufenamide (melflufen) plus dexamethasone is fully approved in Europe for patients with relapsed/refractory multiple myeloma (RRMM) with ≥ 3 prior lines of therapy. We analyzed the efficacy and safety of melflufen in the real‐world setting.

Methods:

In this retrospective analysis, we examined baseline features, efficacy, and safety outcomes with melflufen plus dexamethasone in a cohort of 12 patients with heavily pre‐treated RRMM at the Dana‐Farber Cancer Institute, USA.

Results:

Patients had received a median of 5.5 prior lines of therapy. Three patients (25%) had extramedullary disease, three (25%) cytogenetically high‐risk features, and five (42%) had received prior autologous stem cell transplantation. The overall response rate was 55% (complete response: three [27%], very good partial response: one [9%], partial response: two [18%] patients). Five patients (42%) had stable disease; one was non‐evaluable. Adverse events (AEs) were mostly hematologic and proved manageable; two patients had Grade 2 infections. Reasons for melflufen discontinuation were progressive disease (42%), drug withdrawal from the United States market (33%), AEs (17%), and sudden death (8%) unrelated to treatment.

Conclusions:

Consistent with clinical trial data, melflufen had an expected safety profile with manageable toxicity and clinically meaningful efficacy in patients with RRMM treated in the real‐world setting.

01 May 2025·PARKINSONISM & RELATED DISORDERS

From Queasy to Rigid - An amendment on the administration of contraindicated antiemetics in hospitalized people with Parkinson's disease

Letter

Author: Sonneborn, Claire ; Yu, Jeryl Ritzi T ; Liao, James ; Popov, Roman ; Hogue, Olivia ; Sperling, Scott A ; Ghosh, Debolina ; Walter, Benjamin L ; Shaffer, Shannon ; Brooks, Anne ; Piccinin, Camila C

News (Medical) associated with Prochlorperazine Edisylate

14 Apr 2026

·www.biospace.com

Neurocrine Biosciences Presents First Real-World Head-to-Head Claims Analysis Demonstrating Greater Treatment Persistence with INGREZZA® (valbenazine) Capsules Compared to AUSTEDO XR

INGREZZA showed higher rates of long-term treatment continuation and lower switching between medications compared to AUSTEDO XR (deutetrabenazine) in a real-world claims analysis among adults with tardive dyskinesia Higher continuation with INGREZZA was observed early in treatment and persisted across a six‑month follow‑up period SAN DIEGO , April 14, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new real-world evidence demonstrating that adult patients with tardive dyskinesia receiving INGREZZA ® (valbenazine) capsules showed higher treatment persistence compared to those on AUSTEDO XR (deutetrabenazine). The findings are being presented at the Academy of Managed Care Pharmacy 2026 Annual Meeting in Nashville. This retrospective, real-world claims analysis is the first published study to directly compare treatment persistence — defined as remaining on therapy without discontinuation or switching medications — between INGREZZA and AUSTEDO XR in matched tardive dyskinesia (TD) patient cohorts. Over a six-month follow-up period, patients treated with INGREZZA demonstrated statistically greater treatment continuation and lower switching rates than those receiving AUSTEDO XR. Differences in treatment persistence emerged early and were sustained throughout the six-month period, highlighting durable treatment continuation patterns. "Treatment discontinuation is common in psychiatric populations, and interruption of VMAT2 inhibitor therapy can lead to recurrence of tardive dyskinesia symptoms, associated increased disease burden and worsened quality of life," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "As the first real-world comparison of treatment persistence between INGREZZA and AUSTEDO XR, these findings highlight a higher persistence pro INGREZZA and provide real-world evidence to inform treatment decision-making in clinical practice." The analysis used IQVIA's U.S. Longitudinal Access and Adjudication Data (LAAD), integrating pharmacy and medical claim information. The study period ranged from September 1, 2022 to March 31, 2025 (30 months), including adult patients with TD who initiated either INGREZZA or AUSTEDO XR between March 1, 2023 and September 30, 2024 (18 months). Eligible patients had ≥1 pharmacy claim during both the 6-month baseline and follow-up periods, ≥1 claim for either INGREZZA or AUSTEDO XR during the selection period and ≥1 claim with a diagnosis of TD during the study period. Ultimately, the analysis included 2,988 eligible patients split between cohorts who started on either INGREZZA (n=1,494) or AUSTEDO XR (n=1,494), using propensity score matching (1:1) to create balanced cohorts accounting for baseline demographics, comorbidities, psychiatric conditions and antipsychotic use. Over the 6-month follow-up period: Significantly more patients persisted with their initial TD therapy in the cohort who started on INGREZZA (55.6%) compared to those who started on AUSTEDO XR (48.1%). Switching to another TD therapy at any time during the follow-up period was significantly less frequent in the INGREZZA cohort (7.7%) compared to AUSTEDO XR (11.2%). The median time to discontinuation or switch from the initial therapy was 129 days for the AUSTEDO XR cohort, while the median was not reached for the INGREZZA cohort (>180 days), indicating significantly longer time to discontinuation or switch. Measure INGREZZA AUSTEDO XR Percent treatment persistence after ≥6 months 55.6%* (830/1,494) 48.1% (718/1,494) Percent of patients that switched from initial therapy † 7.7% ‡ (115/1,494) 11.2% (167/1,494) Median time to treatment discontinuation or switch (days) >180* 129 *Denotes statistically significant result vs. AUSTEDO XR cohort ( p <0.0001). † Includes switching from INGREZZA to AUSTEDO XR or BID, and from AUSTEDO XR to INGREZZA or AUSTEDO BID. ‡ Denotes statistically significant result vs. AUSTEDO XR cohort ( p =0.0012). "Claims-based analyses offer critical insight into treatment patterns for tardive dyskinesia, where staying on therapy is key to controlling symptoms that can disrupt daily life. By applying a robust methodological approach to real-world data, providers can better understand persistence and help inform more effective treatment strategies for patients," said Mercedes Perez-Rodriguez, M.D., Ph.D., Associate Professor of Psychiatry, Icahn School of Medicine at Mount Sinai, New York. Dr. Perez-Rodriguez is a paid consultant of Neurocrine Biosciences, Inc. and has received grant funding from Neurocrine Biosciences, Inc. Findings from this analysis are built on prior clinical evidence demonstrating the impact of INGREZZA on TD symptoms and patient-reported outcomes. In clinical studies, including the Phase 4 KINECT-PRO™ study , treatment with INGREZZA improved TD severity and was associated with meaningful improvements in patient-reported outcomes, including physical, social and emotional functioning. In addition, in the KINECT-PRO study, 57.8% of patients who continued treatment with INGREZZA achieved symptomatic remission after 24 weeks, defined as minimal or no involuntary movements (Abnormal Involuntary Movement Scale [AIMS] score ≤1 in each body region [items 1-7]). Together, the real-world and clinical evidence underscore the importance of sustained treatment of TD and the utility of INGREZZA as a first-line therapy for the condition. Additional presentation at the Academy of Managed Care Pharmacy 2026 Annual Meeting includes: Valbenazine Improves Physical, Social, and Emotional Impacts on the Tardive Dyskinesia Impact Scale (TDIS): Post-Hoc Analyses of KINECT-PRO Data About Tardive Dyskinesia Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. About the KINECT-PRO™ Phase 4 Study The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA ® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT ® 3 and KINECT ® 4 studies. KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). The TDIS is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. About INGREZZA ® (valbenazine) Capsules and INGREZZA ® SPRINKLE (valbenazine) Capsules INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses INGREZZA ®  (valbenazine) capsules or INGREZZA ®  SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions.  Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you: are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation ) . INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you:  have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take,  including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are  sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088. Dosage Forms and Strengths:  INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information , including Boxed Warning, and Medication Guide . About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, psychiatric and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie ) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, INGREZZA and KINECT are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO and TDIS are trademarks of Neurocrine Biosciences, Inc. Third-party trademarks are property of their respective owners. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA, the interpretation and potential relevance of the data described in this press release, including expectations as to how such data may relate to the therapeutic effects and clinical efficacy of INGREZZA, and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0095 04/2026 View original content to download multimedia: SOURCE Neurocrine Biosciences, Inc.

26 Mar 2026

·neurocrine.gcs-web.com

Neurocrine Biosciences Presents First Expert Consensus Recommendations for Tardive Dyskinesia in Long-Term Care Settings

Expert panel establishes structured approach to tardive dyskinesia screening, diagnosis and treatment in long-term care, including use of VMAT2 inhibitors New post-hoc KINECT‑PRO™ analysis in adults aged 65 years and older demonstrates clinically meaningful patient-reported improvements in tardive dyskinesia impact with INGREZZA® (valbenazine) capsules, reinforcing expert panel recommendations SAN DIEGO, March 26, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of the first expert consensus recommendations focused on screening, diagnosis and treatment of tardive dyskinesia among older adults in long-term care settings. Developed through a multidisciplinary Delphi panel, the recommendations address persistent gaps in recognizing and managing tardive dyskinesia in this higher-risk population. Findings were presented at the Society for Post-Acute and Long-Term Care Medical Association (PALTmed) PALTC26 Annual Conference in Anaheim, Calif. The company also presented a first-of-its-kind post-hoc analysis from the KINECT‑PRO™ study demonstrating meaningful improvements in patient‑reported tardive dyskinesia (TD) impact among adults aged 65 years and older treated with INGREZZA® (valbenazine) capsules. This analysis adds to the growing body of evidence supporting the appropriateness, efficacy, tolerability and established safety profile of INGREZZA in this patient population. "To date, there has been limited practical guidance tailored specifically to the screening, diagnosis and treatment of tardive dyskinesia in the long-term care setting," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The consensus recommendations provide structured guidance for clinicians caring for residents in these environments, and the KINECT-PRO findings demonstrate clinically meaningful patient-reported improvements in the impact of tardive dyskinesia with INGREZZA in adults aged 65 years and older. Together, this guidance and evidence help support more informed treatment decisions in this population that may be at higher risk for tardive dyskinesia." Older adults in long-term care are at an elevated risk for TD due to prolonged exposure to dopamine receptor blocking agents, advanced age, polypharmacy and complex comorbidities. Recognition and management may be further complicated in residents who are non-ambulatory, cognitively impaired or unable to reliably report symptoms. The Delphi panel was convened to develop recommendations that reflect this clinical complexity and support a more consistent, structured approach to TD care. "Residents in long-term care settings often present with overlapping medical and psychiatric complexities that can make tardive dyskinesia difficult to consistently recognize and manage," said Amita Patel, M.D., the poster's lead author and psychiatrist at the Joint Township District Memorial Hospital in St. Mary's, Ohio. "Through this process, the panel reached clear consensus on practical, implementable recommendations that support evidence-based diagnosis and appropriate use of VMAT2 inhibitors. These recommendations provide clinicians with a structured framework to guide screening and treatment decisions to help improve outcomes for this especially vulnerable population." Screening and Diagnosing TD in Long-Term Care Settings Requires a Holistic Approach The panel identified key considerations to support routine and consistent TD screening in long-term care settings. These include: Use of the Abnormal Involuntary Movement Scale (AIMS) for screening and assessing TD. Quarterly screening for residents treated with dopamine receptor blocking agents, the primary cause of TD. Regular assessment of the impact of TD on residents' well-being, including feedback from residents, family members, caregivers and the broader care team. Treatment Selection Should Consider Relevant Patient Factors Panelists also reached consensus that TD should be treated with a vesicular monoamine transporter 2 (VMAT2) inhibitor in long-term care settings and identified several treatment-selection factors particularly relevant in these environments. These include: Formulation flexibility for residents who experience dysphagia or difficulty swallowing. Simplified administration, including the availability of a therapeutic starting dose. Consideration of polypharmacy and potential drug-drug interactions. Availability of clinical data in adults aged 65 years and older. These considerations underscore the importance of selecting a therapy with a clinical profile and administration characteristics that align with the needs of long-term care residents. INGREZZA is approved for the treatment of adults with TD and, among approved VMAT2 inhibitors: has been studied extensively in adults aged 65 years and older. is the only VMAT2 inhibitor without a cautious dosing recommendation in this population. is the only treatment that offers a therapeutic dose from day one with no required titration. is available in a sprinkle formulation. has a safety profile in adults aged 65 years and older that is consistent with that observed in patients younger than 65 years of age.* Phase 4 KINECT-PRO Findings Reinforce Significance of Expert Consensus Guidelines A post-hoc analysis of the KINECT-PRO study complements the consensus recommendations by demonstrating the real-world impact of INGREZZA treatment in older adults. KINECT-PRO is the first and only clinical study to specifically evaluate and investigate patient-reported improvement with INGREZZA for TD using multiple validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). In adults aged 65 and older, once-daily INGREZZA was associated with robust patient-reported improvements in TD symptoms, quality of life and functional impairment at Week 24. Patient-reported outcomes also demonstrated reduced social and emotional burden, with improvements in total TDIS scores exceeding the established threshold for clinically meaningful change. Additional presentations at the Society for Post-Acute and Long-Term Care Medical Association (PALTmed) PALTC26 Annual Conference include: Management of Tardive Dyskinesia in Long-Term Care: Application of the 4Ms Framework Physical, Mental, and Socioemotional Functional Improvement Following Valbenazine Treatment in Patients with TD Residing in Long-term Care Settings Valbenazine Treatment for Tardive Dyskinesia in a 64-Year-Old Female Presenting with Nonhealing Wounds due to Truncal Dyskinesias: A Case Report * Safety profiles as demonstrated in a post-hoc analysis from two 48-week studies (KINECT® 3 extension and KINECT® 4). About Tardive Dyskinesia Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. About the KINECT-PRO™ Phase 4 Study The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT® 3 and KINECT® 4 studies. KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). The TDIS is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. About the Tardive Dyskinesia Impact Scale The Tardive Dyskinesia Impact Scale (TDIS™) is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. It was developed by Neurocrine Biosciences from qualitative studies and Phase 3 trials of INGREZZA for the treatment of TD (KINECT® 3 and KINECT® 4) as a comprehensive measure of impact and burden of TD from a patient's perspective. The TDIS consists of 11 questions evaluating physical and socio-emotional impact. Six scales are assessed: mouth/throat, dexterity, mobility, pain, social and emotional. The TDIS allows people with TD to rate how their symptoms affect daily activities and how their uncontrollable movements make them feel. The questionnaire captures relevant information about the impact of TD to provide a more holistic assessment of the condition. Validation of this scale was published in the Journal of Patient-Reported Outcomes. About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you: are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, psychiatric and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO and TDIS are trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA, the interpretation and potential relevance of the data described in this press release, including statements regarding the use and interpretation of the Tardive Dyskinesia Impact Scale (TDIS™), and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0094 03/2026 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-first-expert-consensus-recommendations-for-tardive-dyskinesia-in-long-term-care-settings-302725473.html SOURCE Neurocrine Biosciences, Inc. Neurocrine Biosciences, Inc.  Media: Aimee White, 1-858-354-7865, media@neurocrine.com; Investors: Todd Tushla,1-858-617-7143, ir@neurocrine.com

Phase 3Clinical ResultDrug Approval

15 Jan 2026

·neurocrine.gcs-web.com

Neurocrine Biosciences Presents Head-to-Head INGREZZA® (valbenazine) Capsules Data Demonstrating Higher VMAT2 Target Occupancy Compared to AUSTEDO XR

INGREZZA showed a nearly two-fold higher VMAT2 occupancy, consistent with greater potency when compared to AUSTEDO XR (deutetrabenazine) after a single dose of each treatment VMAT2 occupancy is a key measurement thought to be associated with drug response in involuntary movement disorders, including tardive dyskinesia and Huntington's disease chorea SAN DIEGO, Jan. 15, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of the first head-to-head data comparing vesicular monoamine transporter 2 (VMAT2) target occupancy between INGREZZA® (valbenazine) capsules and AUSTEDO XR (deutetrabenazine) at therapeutic doses. Results from the study confirmed that both compounds engage VMAT2; however, INGREZZA demonstrated significantly higher VMAT2 target occupancy and greater potency. Findings were presented at the American College of Neuropsychopharmacology 64th Annual Meeting taking place January 12-15 in the Bahamas. VMAT2 inhibition is an established target for treatment of hyperkinetic movement disorders, such as tardive dyskinesia (TD) and Huntington's disease (HD) chorea. VMAT2 target occupancy (TO) is a key measurement thought to be associated with the level of drug response in these conditions. Higher VMAT2 occupancy indicates greater engagement of the target, and inhibition of VMAT2 lowers excessive dopamine transmission associated with involuntary movements. "In this head-to-head assessment, INGREZZA demonstrated approximately two-fold higher target occupancy compared with AUSTEDO XR at therapeutic doses," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The significantly higher VMAT2 occupancy observed with INGREZZA adds to the already established differences between VMAT2 inhibitors in pharmacologic and clinical profiles. The high occupancy of INGREZZA may contribute to the robust early and sustained clinical efficacy consistently demonstrated in multiple tardive dyskinesia and Huntington's disease chorea clinical trials." The study used positron emission tomography (PET) imaging to evaluate VMAT2 TO following single doses of either INGREZZA (40 mg or 80 mg) or AUSTEDO XR (24 mg or 48 mg) in eight participants, each completing four PET visits. Using a linear mixed-effects model, the primary TO analysis demonstrated a least squares mean VMAT2 occupancy of approximately 76.5% for INGREZZA compared with approximately 38.3% for AUSTEDO XR at therapeutic doses. Pharmacokinetic exposure modeling and calculated half-maximal effective concentration (EC50) values enabled estimates of steady-state TO with superior VMAT2 engagement at therapeutic doses of INGREZZA compared to AUSTEDO XR. Findings are depicted in the table below: VMAT2 Inhibitor Dose (mg) Estimated Steady-State VMAT2 Occupancy INGREZZA 40 83 % 80 92 % AUSTEDO XR 24 54 % 48 70 % These data are consistent with our integrated understanding of the TO of INGREZZA and drug exposure concentrations observed from INGREZZA in pivotal clinical trials.1,2 The superior target engagement observed with INGREZZA may be related to its single high affinity metabolite, compared with AUSTEDO XR, which generates multiple metabolites, including those with lower VMAT2 affinity. All doses of INGREZZA and AUSTEDO XR were generally well tolerated and consistent with the known safety profile of each compound. Additional presentations at the 2026 American College of Neuropsychopharmacology Annual Meeting: Once-Daily Valbenazine Improves Patient-Reported Quality of Life in Patients From KINECT-PRO™ Who Met a Remission Threshold for Tardive Dyskinesia Potential Change in Disease Burden with Valbenazine in Adults with Huntington's Disease: Post Hoc Analysis of Cognitive- and Emotional-Related HD-HI Items in the KINECT®-HD Trial Osavampator (NBI-1065845/TAK-653) Demonstrates Statistically Significant and Clinically Meaningful Improvements in Depression Severity and is Well Tolerated in Adults with Major Depressive Disorder: Phase 2 SAVITRI Results About Tardive Dyskinesia Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. About Chorea Associated with Huntington's Disease Huntington's disease (HD) is a hereditary progressive neurodegenerative disorder in which the loss of certain neurons within the brain causes motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 and 50 years and worsen over a 10- to 25-year period. Most people with HD experience chorea, an abnormal involuntary movement disorder, characterized by irregular and unpredictable movements. Chorea can affect various body parts and interfere with motor coordination, gait, swallowing and speech. HD is estimated to affect approximately 41,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease. About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you: are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, psychiatric and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, INGREZZA and KINECT are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO and SAVITRI are trademarks of Neurocrine Biosciences, Inc. Third-party trademarks are property of their respective owners. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA, the interpretation and potential relevance of the data described in this press release, including expectations as to how such data may relate to the therapeutic effects and clinical efficacy of INGREZZA, and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. REFERENCES © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0089 01/2026 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-head-to-head-ingrezza-valbenazine-capsules-data-demonstrating-higher-vmat2-target-occupancy-compared-to-austedo-xr-302661800.html SOURCE Neurocrine Biosciences, Inc. Media: Aimee White, 1-858-354-7865, media@neurocrine.com ; Investors: Todd Tushla , 1-858-617-7143 , ir@neurocrine.com

Clinical ResultDrug ApprovalPhase 2ASCO

100 Deals associated with Prochlorperazine Edisylate

External Link

KEGG	Wiki	ATC	Drug Bank
D02609	Prochlorperazine Edisylate	N05AB04	DB00433

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Schizophrenia	United States	GlaxoSmithKline, Inc.	08 Apr 1957

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03367572 (CTgov)	Phase 3	Nausea \| Breast Cancer \| Vomiting	1,363	Quality-of-Life Assessment+Dexamethasone+Netupitant/Palonosetron Hydrochloride (Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone)	xahsslmfmn(cohcsaihdv) = rsihfevxhg jdbdarugfa (qddafjnhxu, 0.155) View more	-	25 Sep 2025
				Quality-of-Life Assessment+Prochlorperazine+Dexamethasone+Netupitant/Palonosetron Hydrochloride (Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo))	xahsslmfmn(cohcsaihdv) = mczcjlukap jdbdarugfa (qddafjnhxu, 0.141) View more
NCT03185130 (I-FiBH, CTgov)	Phase 4	Headache	58	Normal Saline 5mL+Prochlorperazine+Diphenhydramine (Standard Treatment Arm)	mtbcrqevdx(ukkxymvhnr) = bvdvdvotdg ilkpohgbwr (xfdnlsgeun, 29.3) View more	-	06 Jun 2024
				Normal Saline 20mL/kg+Prochlorperazine+Diphenhydramine (Study Arm)	mtbcrqevdx(ukkxymvhnr) = ezxnfjeple ilkpohgbwr (xfdnlsgeun, 31.0) View more
NCT03435003 (CTgov)	Phase 4	Postoperative Nausea and Vomiting \| Vomiting	83	dexmedetomidine+Total intravenous anesthesia+Fentanyl+scopolamine transdermal+Compazine+sugammadex+Reglan+Propofol+Dexamethasone+Ondansetron+Aprepitant 80 mg Oral Capsule (Intervention Arm)	xehcnctosi = atbatrnrkx iiupwbrlfo (ykiwjwxegx, nfglktwucn - sasmmhajpz) View more	-	14 Feb 2024
				Compazine+sugammadex+Reglan+Sevoflurane+Dexamethasone+desflurane+Ondansetron (Control Arm)	xehcnctosi = pujaukexuh iiupwbrlfo (ykiwjwxegx, egnboqirth - wlalzmaxuv) View more
CNS2023	Phase 1/2	Migraine Disorders	17	Normal Saline, Prochlorperazine, Ketorolac	kuhrwypzkp(arvhythoin) = rgqnntvbiq mbrqhiatra (ldfnscjcac ) View more	Positive	01 Oct 2023
NCT01629329 (Migraine, CTgov)	Phase 4	Acute migraine	93	Acetaminophen+Caffeine+Aspirin (Aspirin, Acetaminophen, Caffeine Pills)	jivithntnt(gisvqtopbj) = oqnbmgddwc gqrjssiupu (alqivhecil, jxucdluiod - mnykzcgfok) View more	-	18 Mar 2020
				Prochlorperazine (Prochlorperazine 10mg)	jivithntnt(gisvqtopbj) = nczomqqshf gqrjssiupu (alqivhecil, ggswmpwrlq - gbykanjztf) View more
NCT00543062 (CTgov)	Phase 1	Cardiotoxicity	48	Placebo+Prochlorperazine (Placebo+Inhaled Prochlorperazine 5 mg Crossover Subjects)	bolqgmeony(yorzfsxycr) = scbdyauria wlimzcevsr (lamexbptnd, qqcironovj - jrdzwzijhf)	-	11 Mar 2019
				Placebo+Prochlorperazine (Placebo+Inhaled Prochlorperazine 10 mg Crossover Subjects)	bolqgmeony(yorzfsxycr) = bsaaujqiqy wlimzcevsr (lamexbptnd, frjamonugw - wvvnwtxaej)
NCT02389829 (CTgov)	Phase 4	Acute migraine	127	Hydromorphone (Hydromorphone)	ghmmxkszad = wdyewayyry ekxbrmqbzt (cbknqlrpcx, hsgrdienyd - bjloyztqds) View more	-	06 Jun 2018
				Prochlorperazine+Diphenhydramine (Prochlorperazine)	ghmmxkszad = bimbrsmpci ekxbrmqbzt (cbknqlrpcx, pwqeazipdh - smzeogryvz) View more
NCT02735343 (Pubmed \| Ann Emerg Med)	Phase 3	Headache	54	Prochlorperazine	hdaylzibel(orlixsanai) = udoennpulf tzunnbzvbt (pudqwexkob ) View more	Positive	01 Mar 2018
				Ketamine	hdaylzibel(orlixsanai) = usvcuujqzx tzunnbzvbt (pudqwexkob ) View more
NCT00610428 (CTgov)	Phase 2	Migraine With Aura	75	Staccato Placebo (Inhaled Placebo)	gcdrisgwls = vjljqbqahx jrawzywttd (hdppylcfmw, zywpjlsldi - zikdyfxqje) View more	-	25 Jan 2018
				Prochlorperazine+Staccato (Inhaled PCZ 5 mg)	gcdrisgwls = ozugrjsyod jrawzywttd (hdppylcfmw, tzubedrazs - kapwxsnzxd) View more
NCT00590317 (CTgov)	Phase 2	Nausea and vomiting \| Nausea \| Vomiting	64	Prochlorperazine (Prochlorperazine)	eersupghhs = gkrphalxog yqkaeqauku (isbmuactuo, wrprmwdphs - pnvdztcaqs) View more	-	19 May 2014
				Ondansetron (Ondansetron)	eersupghhs = jlrhxdreyb yqkaeqauku (isbmuactuo, feaphcvyjo - gdwakunhjo) View more

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