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

890

Literatures (Medical) associated with Prochlorperazine Edisylate

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

01 Apr 2025·Chemical Biology & Drug Design

Natural Pangenotypic Hepatitis C Virus Preventives‐ a Hope With Terfenadine

Article

Author: Giri, Kalyan ; Irfan, M. D. ; Mukhopadhyay, Aparna ; Chaudhuri, Dwaipayan ; Singh, Maitri

ABSTRACT:

Hepatitis C viral infections are a leading cause of long‐term liver disease and hepatocellular cancer in drug addicts and other at‐risk people, including those who require frequent blood transfusions. Current drug treatments are expensive and have numerous side effects; hence, more affordable treatment plans are required. Furthermore, there are not any preventives in the market. HCV comes in 8 genotypes, and the prevalence of genotypes varies worldwide. Hence, affordable, pangenotypic preventives are needed. In this study, we selected 83 natural compounds that have been shown to have anti‐HCV properties. In silico screening was done via docking assays to check whether any of these compounds could potentially bind to the receptor interaction site of surface protein‐E2 of genotypes 1a, 1b, 2a, 3a, and 3b. From the binding energies, five compounds were selected that exhibited pangenotypic effects. MD simulation was conducted on these compounds to assess their interaction properties. ADME properties and further drug likeliness revealed one of the compounds, Terfenadine, to be similar to an anti‐allergy drug, Fexofenadine. To assess in vitro validation, a binding assay was set up using E2‐GFP expressed in HEK293T cells with the primary receptor CD81. It was observed that Terfenadine (used as the derivative Fexofenadine) could inhibit an interaction between CD81 and E2. We conclude that there is potential for Terfenadine/fexofenadine to be effective as a preventive against the HCV genotypes 1a, 1b, 2a, 3a, and 3b. Further clinical validation is required to confirm these findings.

News (Medical) associated with Prochlorperazine Edisylate

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

20 Nov 2025

·neurocrine.gcs-web.com

Neurocrine Biosciences Announces Publication of Landmark Narrative Review on FDA-Approved VMAT2 Inhibitors Demonstrating Unique Profile of INGREZZA® (valbenazine) Capsules

Published, peer-reviewed narrative review in CNS Spectrums compiles pharmacologic, pharmacokinetic and clinical data of VMAT2 inhibitors to highlight important differences between treatments Review presents distinctive profile of INGREZZA, including selective VMAT2 targeting, simplified dosing without required titration and robust clinical data across diverse patient populations and concludes that VMAT2 inhibitors are not clinically interchangeable Publication provides a comprehensive resource containing clinical study results, safety profiles and use considerations to support treatment decisions SAN DIEGO, Nov. 20, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the publication of a comprehensive peer-reviewed narrative review that consolidates pharmacologic, pharmacokinetic and more than a decade of clinical research on two FDA-approved vesicular monoamine transporter 2 (VMAT2) inhibitors – INGREZZA® (valbenazine) capsules and deutetrabenazine – for the treatment of tardive dyskinesia. Among key insights, the review highlights the distinct profiles of VMAT2 inhibitors approved for tardive dyskinesia and presents unique attributes of INGREZZA: selectivity to VMAT2, a therapeutic response at the lowest available 40 mg dose and data across a wide range of patient populations. VMAT2 Inhibitors for the Treatment of Tardive Dyskinesia: A Narrative Review has been published in CNS Spectrums. "This inclusive resource will help inform healthcare providers to further understand the differences between the two available VMAT2 inhibitors for tardive dyskinesia, with the goal of supporting optimal treatment decisions for each patient," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The review findings highlight how these distinctions can carry meaningful clinical implications for drug selection, emphasizing that appropriate treatment depends on understanding each medication's unique mechanism, safety profile and dosing requirements. Notably, this includes the distinctive profile of INGREZZA with no-titration dosing and comprehensive clinical evidence." Authored by experts in psychiatry and neurology, the review highlights key differences between the two drugs. It reinforces that although both act on VMAT2, they are not interchangeable and have distinct pharmacologic, dosing and clinical profiles. Results from double-blind, placebo-controlled clinical trials, post-hoc analyses and long-term studies for each VMAT2 inhibitor are presented in the review article. Key takeaways related to INGREZZA: Pharmacology: The review notes that both approved treatments for tardive dyskinesia (TD) target inhibition of the VMAT2 receptor, while establishing the metabolism of INGREZZA to a single potent metabolite with high affinity for VMAT2 and no off-target receptor activity. Dosing and formulations: Approved VMAT2 inhibitors for TD differ in dosing and available formulations, and those considerations are highlighted throughout this review. The review also covers dosing considerations with concomitant medications and special/relevant populations (e.g., elderly, hepatic impairment). Clinical trials, post-hoc analyses and long-term studies: Results from double-blind, placebo-controlled clinical trials are presented in the review manuscript, along with post-hoc analyses that provide important context and clinical relevance for practitioners. The publication presents the extensive clinical development program of INGREZZA across diverse patient populations. As TD is a chronic condition requiring ongoing treatment, long-term study findings presented provide evidence of clinically meaningful and sustained efficacy in treating TD with INGREZZA and demonstrate a consistent tolerability profile over years of treatment across multiple studies. A supplemental reference guide accompanying the manuscript provides data on pharmacokinetics, dosing considerations, drug interactions and clinical findings to further educate on approved VMAT2 inhibitors for TD. 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 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 neuroscience-focused, 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, neuroendocrine and neuropsychiatric 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 and INGREZZA are registered 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 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 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. © 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0088 11/2025 View original content to download multimedia:https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-publication-of-landmark-narrative-review-on-fda-approved-vmat2-inhibitors-demonstrating-unique-profile-of-ingrezza-valbenazine-capsules-302620990.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

Drug Approval

27 Feb 2025

·www.prnewswire.com

Neurocrine Biosciences Reports Patient-Reported Outcome Data from KINECT-PRO™ Study for INGREZZA® (valbenazine) Capsules in Tardive Dyskinesia: Significant and Clinically Meaningful Improvements in Functionality and Quality of Life Measures

SAN DIEGO, Feb. 27, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line data from a Phase 4 study, KINECT-PRO™, demonstrating clinically meaningful and sustained effects of INGREZZA® (valbenazine) capsules on the physical, social and emotional impacts experienced by patients living with tardive dyskinesia (TD), irrespective of TD severity or underlying psychiatric condition. KINECT-PRO is the first study to show patient-reported impact of a vesicular monoamine transporter 2 inhibitor, specifically INGREZZA, on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale used to evaluate the physical, social and emotional impact of involuntary movements. These patient-reported outcome measures provide a more complete perspective on a patient's experience of living with TD and the broad range of improvements that occurred following treatment with INGREZZA. The results of KINECT-PRO will be shared at upcoming scientific conferences. "Tardive dyskinesia can significantly impact many aspects of patients' lives, including daily activities, work or school attendance and social interactions," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "The data from the KINECT-PRO trial, which was designed to follow typical clinical practice, show that patients and clinicians observed substantial reduction in the impact and severity of TD, as well as improvement in overall quality of life with use of INGREZZA. Importantly, patients reported significant improvements across measures regardless of their underlying psychiatric conditions or the baseline severity of their TD involuntary movement symptoms." Fifty-nine patients were enrolled in the KINECT-PRO study and received once-daily INGREZZA (40 mg, 60 mg or 80 mg) for up to 24 weeks. Fifty-two patients completed the Week 24 visit. There were comparable numbers of patients across TD severity (mild vs. moderate/severe) and underlying psychiatric condition subgroups (schizophrenia or schizoaffective disorder vs. bipolar disorder or major depression). The primary objective of the KINECT-PRO study was to evaluate changes in patient-reported physical and socio-emotional impacts of TD, changes in a person's work, family, social life and overall sense of health and well-being during INGREZZA treatment. These outcomes were measured at Weeks 4, 8, 16 and 24 by the Tardive Dyskinesia Impact Scale (TDIS), the Sheehan Disability Scale (SDS) and the EQ Visual Analogue Scale (EQ-VAS), respectively. The secondary objective was to evaluate clinician- and patient-reported changes in TD severity as measured by the Abnormal Involuntary Movement Scale (AIMS), the Patient Global Impression of Change–TD (PGI-C) and Clinical Global Impression of Severity–TD (CGI-TD-S). Results showed significant and sustained improvements from baseline in all three patient-reported outcome measures, including patients with either mild or moderate/severe TD, with improvements observed as early as four weeks at the lowest dose (40 mg). AIMS scores also showed sustained reductions in involuntary movements, regardless of TD severity or underlying psychiatric condition. In the study, safety and tolerability of treatment was consistent with the known profile of INGREZZA, with no new concerns identified. 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. About the Tardive Dyskinesia Impact Scale (TDIS) The Tardive Dyskinesia Impact Scale (TDIS) is a novel, psychometrically validated patient-reported outcome measure in TD. 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 domains 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 Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, 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 severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. 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 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 neuroscience-focused, 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, neuroendocrine and neuropsychiatric 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 LinkedIn, X and Facebook. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered 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 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 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, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0047 02/2025 SOURCE Neurocrine Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug ApprovalPhase 2

100 Deals associated with Prochlorperazine Edisylate

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KEGG	Wiki	ATC	Drug Bank
D02609	Prochlorperazine Edisylate	N05AB04	DB00433

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

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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)	claysuggdf(woxcqwbpns) = ifwmesvsob sjfqakfvsd (tnqppdqtth, 0.155) View more	-	25 Sep 2025
				Quality-of-Life Assessment+Prochlorperazine+Dexamethasone+Netupitant/Palonosetron Hydrochloride (Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo))	claysuggdf(woxcqwbpns) = qgysavycbk sjfqakfvsd (tnqppdqtth, 0.141) View more
NCT03185130 (I-FiBH, CTgov)	Phase 4	Headache	58	Normal Saline 5mL+Prochlorperazine+Diphenhydramine (Standard Treatment Arm)	wutwrxrwak(lcdzdbvraw) = zitezfparh bxlfwlfily (bgsyadiwmo, 29.3) View more	-	06 Jun 2024
				Normal Saline 20mL/kg+Prochlorperazine+Diphenhydramine (Study Arm)	wutwrxrwak(lcdzdbvraw) = pbdmiwpdti bxlfwlfily (bgsyadiwmo, 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)	hhpuqwifqg = bywusrdruf hfpvserlnj (dtksmrehkp, ppbllicqfp - ikxsivdagp) View more	-	14 Feb 2024
				Compazine+sugammadex+Reglan+Sevoflurane+Dexamethasone+desflurane+Ondansetron (Control Arm)	hhpuqwifqg = knkezpwckb hfpvserlnj (dtksmrehkp, wufjtlcnrf - ywywejntui) View more
CNS2023	Phase 1/2	Migraine Disorders	17	Normal Saline, Prochlorperazine, Ketorolac	xpetvquudx(ikdzymolqr) = ileinrbred glnppmsemz (esadyimnrt ) View more	Positive	01 Oct 2023
NCT01629329 (Migraine, CTgov)	Phase 4	Acute migraine	93	Acetaminophen+Caffeine+Aspirin (Aspirin, Acetaminophen, Caffeine Pills)	lrphunfdug(mxvtsttvoi) = gilmmydeba tqaeskgokr (ewjkztdlri, xiudfewepn - nwvyccaarz) View more	-	18 Mar 2020
				Prochlorperazine (Prochlorperazine 10mg)	lrphunfdug(mxvtsttvoi) = figabrtggg tqaeskgokr (ewjkztdlri, hzghhgwkis - mmattyejrv) View more
NCT00543062 (CTgov)	Phase 1	Cardiotoxicity	48	Placebo+Prochlorperazine (Placebo+Inhaled Prochlorperazine 5 mg Crossover Subjects)	htvoujoori(ueaneyndnn) = ipiampqgsf jkzxkzhpin (srjumbgjom, kdcexupoas - kwmrndtvji)	-	11 Mar 2019
				Placebo+Prochlorperazine (Placebo+Inhaled Prochlorperazine 10 mg Crossover Subjects)	htvoujoori(ueaneyndnn) = iltblfaqds jkzxkzhpin (srjumbgjom, luavohmvrh - ygeiognjar)
NCT02389829 (CTgov)	Phase 4	Acute migraine	127	Hydromorphone (Hydromorphone)	tvaifptozp = oguirxwmyq dzokbsgmlr (xdamljpeab, hdcunermmw - aivwlqnwrx) View more	-	06 Jun 2018
				Prochlorperazine+Diphenhydramine (Prochlorperazine)	tvaifptozp = orczvqkfeq dzokbsgmlr (xdamljpeab, tvnzcpjrxj - kfvcdhyssd) View more
NCT02735343 (Pubmed \| Ann Emerg Med)	Phase 3	Headache	54	Prochlorperazine	gppexqmxzd(jyqokwtjlb) = nqyptramzr znybayhqxr (ydbvuxyhhd ) View more	Positive	01 Mar 2018
				Ketamine	gppexqmxzd(jyqokwtjlb) = uelfxrjmka znybayhqxr (ydbvuxyhhd ) View more
NCT00610428 (CTgov)	Phase 2	Migraine With Aura	75	Staccato Placebo (Inhaled Placebo)	xhpzojypbi = mipfwplmqi pztkslydvv (mlwhhzwxjc, mubexeddkm - xltctmkkwj) View more	-	25 Jan 2018
				Prochlorperazine+Staccato (Inhaled PCZ 5 mg)	xhpzojypbi = cjdtfegwqs pztkslydvv (mlwhhzwxjc, xhvdttkdea - ndrwafpgme) View more
NCT00590317 (CTgov)	Phase 2	Nausea and vomiting \| Nausea \| Vomiting	64	Prochlorperazine (Prochlorperazine)	gtitpiydzq = wikmvectpm cusksysrsl (bbtfdgmgmz, vufanexfsv - fxhpnidgwm) View more	-	19 May 2014
				Ondansetron (Ondansetron)	gtitpiydzq = orlojuxwlz cusksysrsl (bbtfdgmgmz, eoqtrbidju - atcfdqxghh) View more

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