A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.

Start Date29 Aug 2025

Sponsor / Collaborator

Neurocrine Biosciences, Inc.

NCT06107829

/ WithdrawnPhase 4IIT

Identification, Assessment, and Treatment of Tardive Dyskinesia With Valbenazine in Adults With Intellectual/Developmental Disabilities and Co-occurring Psychiatric and/or Behavioral Disorders

The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD). The main questions this study aims to answer are:
* Does valbenazine treatment of TD in the previously untreated patient population of adults with IDD produce comparable amelioration of signs of movement disorder as what has historically been reported in adults without IDD?
* Is valbenazine treatment of TD in persons with IDD as safe as what has historically been reported in adults without IDD?
* Does valbenazine treatment improve Quality of Life (QOL) in persons with IDD and TD treated with valbenazine?
* Does valbenazine treatment produce positive change in Activities of Daily Living (ADLs) in persons with IDD and TD?
* Does valbenazine treatment of TD in persons with IDD reduce caregiver burden?
In this study, 25 participants with IDD and TD will undergo valbenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks.
This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to valbenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication.

Start Date01 Jan 2025

Sponsor / Collaborator

University Hospitals Cleveland Medical Center

[+1]

NCT06771323

/ RecruitingPhase 2IIT

Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia

The most common form of idiopathic dystonia is adult-onset cervical dystonia (CD), a focal form of dystonia affecting the muscles of the neck. CD is often associated with pain and limited range of motion, and frequently leads to reduced quality of life and disability. Effective long-term treatment options are extremely limited. Recurring botulinum neurotoxin (BoNT) injections can ease the symptoms of CD, but they frequently provide only partial relief and can be associated with intolerable side effects. Deep brain stimulation can be used to treat more severe cases of CD, but this neurosurgical procedure is invasive, on average only about 50% effective and may lead to serious adverse effects. Novel treatment approaches for CD are desperately needed to alleviate symptoms and improve the quality of life for the many who suffer from this chronic and disabling neurological disorder.

Start Date17 Dec 2024

Sponsor / Collaborator

Virginia Commonwealth University

100 Clinical Results associated with Valbenazine Tosylate

100 Translational Medicine associated with Valbenazine Tosylate

100 Patents (Medical) associated with Valbenazine Tosylate

Literatures (Medical) associated with Valbenazine Tosylate

01 Dec 2025·JOURNAL OF CLINICAL PHARMACOLOGY

Population Pharmacokinetic and Exposure‐Efficacy Analyses of Valbenazine in Patients with Huntington's Disease: Supporting Dose Selection for Chorea Management

Article

Author: Chapel, Sunny ; Loewen, Gordon ; Brar, Satjit ; Nguyen, Hoa Q. ; Kuan, Han‐Yi Steve ; Crass, Ryan L.

Abstract:

Valbenazine improved chorea in individuals with Huntington's disease compared to placebo in a phase 3, placebo‐controlled study (KINECT‐HD). Population pharmacokinetics (PK) and exposure–response (E–R) analyses focused on understanding the PK characteristics of valbenazine and its active metabolite, [+]‐α‐dihydrotetrabenazine ([+]‐α‐HTBZ), and their correlation with clinical efficacy measured by the total maximal chorea (TMC) score. Consistent with previous analyses, a two‐compartmental population PK model adequately described valbenazine and [+]‐α‐HTBZ plasma disposition, generating reliable individual‐predicted exposure levels for sequential E–R analysis. The distributions of individual‐predicted steady‐state exposures of valbenazine and [+]‐α‐HTBZ were found to largely overlap between patients with tardive dyskinesia and those with Huntington's disease (HD) chorea. The relationship between the change from baseline in TMC score and [+]‐α‐HTBZ systemic exposure were effectively characterized by a nonlinear E max model, with negligible impact from selected covariates. The predicted E–R curve closely aligns with the observed data, exhibiting a negative slope that indicates an increasing clinical response with escalating doses of 40, 60, and 80 mg/day. Predicted efficacy appears to reach a plateau at 80 mg once daily (QD), suggesting minimal additional benefit beyond this dosage. Together, results from the population PK model and E–R analyses reinforce the evidence base for valbenazine efficacy in reducing chorea severity, as demonstrated by the notable decrease in TMC scores compared to baseline. They also endorse the selection of dosing regimens ranging from 40 to 80 mg QD for the treatment of chorea in patients with HD.

01 Nov 2025·CTS-Clinical and Translational Science

Valbenazine Sprinkle: An Alternative Formulation of Valbenazine for Oral Administration in Patients With Dysphagia

Article

Author: Brar, Satjit ; Hebert, Mello ; Jimenez, Roland ; Zhang, Hui ; Maynard‐Scott, Jessica ; Rees, Linda ; Mar, Alexander ; Giri, Nagdeep ; Bristow, Ali

ABSTRACT:

Valbenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of tardive dyskinesia and Huntington's chorea. Dysphagia, pill aversion, and fear of swallowing are common in patients with these conditions. A new valbenazine sprinkle capsule, to be swallowed whole or the granule contents sprinkled onto soft food, was developed and approved based on the studies presented here. Study 1 evaluated the stability of valbenazine granules in soft foods. Recovery of valbenazine granules within 2 h after addition to applesauce, pudding, and yogurt was 95.6%–100.2%, indicating acceptable stability. Study 2 was a randomized, open‐label, 2‐cohort, phase 1 study in healthy volunteers. Plasma concentrations of valbenazine and its active metabolite, [+]‐α‐dihydrotetrabenazine ([+]‐α‐HTBZ) were measured serially after a single dose under various conditions. Cohort 1 evaluated bioequivalence between the sprinkle capsule and the original capsule with compacted powder (reference). Pharmacokinetics of valbenazine and [+]‐α‐HTBZ were similar between the whole sprinkle capsule and reference. When granules were sprinkled on applesauce, a lower valbenazine C max and AUC were observed relative to reference; all other parameters were similar. Cohort 2 evaluated food effects on valbenazine granules and found that the pharmacokinetics of valbenazine and [+]‐α‐HTBZ were generally similar between fed and fasted states. Overall results from both cohorts for the 90% CIs of the geometric mean ratios indicated bioequivalence between the whole sprinkle capsule or granules sprinkled on applesauce and reference, with minor exceptions. These findings support that the VMAT2 inhibitor valbenazine can be used with multiple modes of oral administration.

24 Mar 2025·Journal of biomolecular structure & dynamics

Inhibition of respiratory syncytial virus by Daclatasvir and its derivatives: synthesis of computational derivatives as a new drug development

Article

Author: Mitra, Debanjan ; Abdalla, Mohnad ; Afreen, Shagufta ; Das Mohapatra, Pradeep K.

The most common cause of respiratory tract illness in newborns and young children is the respiratory syncytial virus (RSV). There is no approved vaccination or specific antiviral medication for RSV infections. Here, an attempt has been made to explore the potential of currently marketed drugs as well as their probable derivatives to improve the possibility of developing stronger medications against RSV. From the 100 synthetic drug compounds library, the best drug molecule was identified through drug-likeness properties, toxicity, molecular docking and molecular dynamics simulations. Molecular Mechanics Generalized Born Surface Area (MM-GBSA) was also a method that was applied in this study. Daclatasvir showed the highest binding energy and appeared as the best drug to inhibit matrix protein and a fusion protein of RSV. Based on Daclatasvir, 40 computational derivatives were made. D28, D34 and D40 showed far better results than the actual drug. Changes in lipophilicity character increase the binding energy of derivatives. Molecular dynamic simulations showed their non-deviated, non-fluctuated and stable complex formation with target proteins. The high number of amino acid contacts throughout the trajectory increases the stability and effectiveness of derivatives. The key to producing a novel medicine to eradicate RSV is provided by derivatives. Daclatasvir will be employed as a potential RSV inhibitor up until that point.

215

News (Medical) associated with Valbenazine Tosylate

12 Feb 2026

·www.biopharmadive.com

Earnings roundup: Neurocrine slumps, Alnylam battles skeptics and Ascendis eyes a competitor

With quarterly earnings underway, BioPharma Dive is providing a snapshot of some companies results and how theyre being received by investors. Today, were offering insight into the latest numbers from Neurocrine Biosciences, Alnylam Pharmaceuticals and Ascendis Pharma. Neurocrine again disappoints some investorsShares of Neurocrine Biosciences fell by over 10% on Thursday, wiping more than $1 billion in value from the brain-focused biotechnology company.The drop followed a Wednesday afternoon earnings report in which Neurocrine said net product sales in the fourth quarter and 2025 overall totaled $798 million and $2.83 billion. Those figures are respectively 29% and 22% higher year-over-year. Ingrezza, a drug for movement issues associated with Huntington's disease, accounted for more than 80% of overall sales. The remainder mostly came from Crenessity, a treatment approved in 2024 for a rare, genetic condition that can cause life-threatening shortages of crucial hormones.Brian Abrahams, an analyst at RBC Capital Markets, suspects a combination of factors may be concerning some investors. One is Neurocrine's guidance. The company expects that, over the course of this year, net sales from Ingrezza will be in the range of $2.7 billion to $2.8 billion. That might not be as high as shareholders had hoped. Neurocrine executives also recently disclosed plans to spend another $150 million building out the sales teams for those two leading products a decision that could be seen as bad for near-term margins.Additionally, Abrahams noted how some are worried about Crenessitys growth prospects, specifically with regard to the number of new patients starting on the drug. Neurocrine says there are roughly 20,000 people in the U.S. with that rare condition, congenital adrenal hyperplasia, and, across last year, about 2,050 began taking Crenessity. Sales figures indicate the final three months of 2025 averaged fewer starts, at 431, than previous quarters.Even so, Abrahams and his team see the fears as overblown. Though we acknowledge investor consternation around margins and Crenessity launch dynamics could persist ... we believe todays downside reaction will prove to be a compelling buying opportunity, he wrote in a note to clients.Ingrezza looks poised for a major beat, he added, and Crenessity should be fine [as] we have always anticipated some continued slowdown in new patient starts.Overall, we see much growth left in both key franchises, wrote TD Cowen analyst Phil Nadeau in his own client note.Alnylam bitten by its successA similar situation played out with Alnylam Pharmaceuticals. The company, which specializes in so-called RNA interference drugs, gave a preliminary look at fourth-quarter and full-year earnings last month, then released its official report Thursday. It recorded nearly $3 billion across all of 2025 and almost $1 billion over those final three months, reflecting increases of 81% and 121% compared to the same periods the prior year.Despite that performance, Alnylam shares had slipped around 4% by the time trading closed Thursday afternoon.Though the company sells half a dozen drugs, nearly 80% of its product revenue comes from Amvuttra, a treatment for the nerve damage and heart failure associated with a rare disorder known as ATTR. Alnylam has said this disorder, which has a couple subtypes, affects north of a few hundred thousand people worldwide. For 2026, the company expects net product revenue to reach $4.9 billion to $5.3 billion, with Amvuttra and another ATTR medicine, Onpattro, responsible for up to $4.7 billion of that sum.To Paul Matteis, an analyst at Stifel, the main debate among investors is whether Amvuttra can meet or beat this guidance, and whether Alnylam can keep pace finding new patients to get on the drug.Alnylam is somewhat a victim of its own success after two very strong quarters for Amvuttra, Matteis wrote. Yet, while some investors may have wanted even more from the latest earnings, the underlying fundamentals here still seem strong.To that end, Alnylam said Amvuttras approval last spring for those cardiovascular problems tied to ATTR was a primary reason why patient demand for the drug grew roughly 250% in the fourth quarter. The company estimates that, globally, around 80% of patients with this condition, which stiffens the heart and impairs its function, remain undiagnosed.The number of identified patients has, on average, grown 40% annually since 2019, according to Alnylam.There are simply many tailwinds for the mid-to-long term, even if short-term expectations had gotten ahead of themselves, Matteis wrote.Ascendis numbers overshadowed by competitorDenmark-based Ascendis Pharma also provided an early glance at earnings in January. Its full report, out Wednesday, detailed fourth-quarter product revenue of 240 million euros, or about $279 million. Full-year product revenue hit 684 million euros, with 70% coming from Yorvipath, a drug for a rare illness where the body doesnt produce enough of a hormone that regulates vital minerals.The results were in-line with analyst forecasts. Joseph Schwartz, of Leerink Partners, expects Yorvipaths momentum to continue throughout this year, and described Ascendis goal of the drug surpassing $1 billion in revenue as achievable.The companys share price, however, slumped 5% at markets open Thursday. Though the stock would rebound over the following hours, Ascendis earnings appeared to take a back seat to data from a rival.Early that morning, BridgeBio Pharma disclosed positive findings from a late-stage study evaluating one of its most advanced drugs an oral enzyme-blocker named infigratinib as a growth-inducing treatment for achondroplasia, the most common type of dwarfism. Ascendis has been testing a once-weekly injectable therapy in this setting, and could receive approval from the Food and Drug Administration before the end of February.With few surprises in Ascendis results, the update from BridgeBio served as bigger news and reinforced that this oral option creates competition, wrote Li Watsek of Cantor Fitzgerald.Yaron Werber, a TD Cowen analyst who covers Ascendis, acknowledged that BridgeBios drug appears solid, with clean safety. And, if approved, it will likely dominate the achondroplasia market as both an initial and second-line treatment.In Werbers view, the key to Ascendis being able to compete is securing strong data from a Phase 3 study of its TransCon CNP therapy combined with its already approved product for growth hormone deficiency. In earlier testing, Ascendis said this pairing, when used in certain people with achondroplasia, tripled the effectiveness seen when TransCon CNP was used alone.The combination should eventually become the standard-of-care in achondroplasia, Werber wrote. '

Clinical ResultPhase 3Financial StatementDrug Approval

11 Feb 2026

·www.prnewswire.com

Neurocrine Biosciences Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides Financial Expectations for 2026

Total Fourth-Quarter and Full-Year 2025 Net Product Sales of $798.3 Million and $2.83 Billion, Representing Year-Over-Year Growth of 29% and 22%, Respectively INGREZZA® (valbenazine) Full Year 2026 Net Product Sales Guidance of $2.7 - $2.8 Billion SAN DIEGO, Feb. 11, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the fourth quarter ended December 31, 2025. "Our 2025 performance reflects the strength and durability of our commercial business and meaningful progress we are making transforming Neurocrine into a broader, more diversified biopharmaceutical company," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "In 2026, we are focused on delivering strong, sustainable growth for INGREZZA and CRENESSITY® (crinecerfont) while advancing our pipeline anchored by Phase 3 programs, including osavampator in major depressive disorder and direclidine in schizophrenia. We expect this building momentum will create value for all stakeholders as Neurocrine is well positioned to improve the lives of even more patients in the years ahead." Net Product Sales Highlights Total fourth-quarter and full-year 2025 net product sales were $798.3 million and $2.83 billion, reflecting 29% and 22% growth year-over-year, respectively. INGREZZA fourth-quarter and full-year 2025 net product sales were $657.5 million and $2.51 billion, reflecting 7% and 9% growth year-over-year, respectively. Results reflected double-digit prescription volume growth in TRx and NRx driven by strong patient demand, partially offset by a lower net price due to new formulary access investments to support long-term growth. CRENESSITY fourth-quarter and full-year 2025 net product sales were $135.3 million and $301.2 million, reflecting 431 and 2,048 total new patient enrollment start forms, respectively, driven by strong patient demand with over 80% reimbursement coverage for dispensed scripts in the fourth-quarter. Recent Clinical and Corporate Developments Published a landmark narrative review on FDA-approved vesicular monoamine transporter 2 (VMAT2) inhibitors demonstrating the unique profile of INGREZZA in CNS Spectrums. The review highlighted the distinct profile of INGREZZA, including selective VMAT2 targeting, simplified dosing without required titration and robust clinical data across diverse patient populations and concluded that VMAT2 inhibitors are not clinically interchangeable. Presented head-to-head INGREZZA capsules data at the American College of Neuropsychopharmacology 64th Annual Meeting showing a nearly two-fold higher VMAT2 mean target occupancy, consistent with greater potency when compared to AUSTEDO XR (deutetrabenazine) after a single dose. In addition, the lowest approved dose of INGREZZA (40 mg) exhibited higher estimated VMAT2 target occupancy at steady state versus the highest approved dose of AUSTEDO XR (48 mg) at steady state. At Neurocrine's R&D Day in December, provided an update on Neurocrine's R&D engine, which remains on track to deliver multiple first- and best-in-class medicines across an industry-leading neuropsychiatry portfolio, including Phase 3 programs for osavampator in major depressive disorder and direclidine in schizophrenia. Neurocrine remains well-positioned for long-term value creation across core therapeutic areas and announced the strategic expansion and diversification of the corticotropin releasing factor (CRF) platform as a foundation for a new class of medicines targeting metabolic diseases, including obesity. Announced the initiation of a Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD). NBI-1065890 is a next-generation, selective inhibitor of VMAT2. Building on nearly 20 years of deep scientific expertise and experience in VMAT2 inhibition, Neurocrine designed NBI-1065890 to potentially deliver a differentiated profile, including the possibility of longer-acting options for the treatment of TD. Fourth-Quarter and Full-Year 2025 Financial Results Differences in fourth-quarter 2025 GAAP and Non-GAAP operating expenses compared with fourth-quarter 2024 were driven by: Increased R&D expense in support of an expanded and advancing pre-clinical and clinical portfolio including investments in osavampator Phase 3 program in major depressive disorder (MDD) and muscarinic franchise, including the direclidine Phase 3 program as a potential treatment for adults with schizophrenia. Increased SG&A expense including incremental investment in CRENESSITY launch activities and continued investment in INGREZZA. Increased acquired in-process research and development (IPR&D) expense associated with upfront payments for early-stage development candidates license agreements Fourth-quarter 2025 GAAP net income and earnings per share were $153.7 million and $1.48, respectively, compared with $103.1 million and $1.00, respectively, for fourth-quarter 2024. Fourth-quarter 2025 Non-GAAP net income and earnings per share were $194.6 million and $1.88, respectively, compared with $173.4 million and $1.69, respectively, for fourth-quarter 2024. Differences in fourth-quarter 2025 GAAP and Non-GAAP net income compared with fourth-quarter 2024 were primarily driven by: Higher net product sales of $177.1 million Increased operating expenses in support of expanding and advancing R&D portfolio, incremental investment in CRENESSITY launch activities, and continued investment in INGREZZA Increased IPR&D expense associated with upfront payments for early-stage development candidates license agreements At December 31, 2025, the Company had cash, cash equivalents, and marketable securities totaling approximately $2.54 billion. A reconciliation of GAAP to Non-GAAP financial results can be found in Table 3 and Table 4 at the end of this news release. Full-Year 2026 Financial Guidance INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease. R&D guidance reflects the continued advancement of the Company's pre-clinical and clinical portfolio including the Phase 3 programs for osavampator in MDD and direclidine in schizophrenia, and includes approximately $25 million of expense for development milestones related to our in-licensed product candidates. Development milestones are included in R&D guidance once achieved or deemed probable to achieve. Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of approximately $90 million in R&D and $125 million in SG&A, divestiture-related expenses and vacated legacy campus facility costs. Non-cash stock-based compensation expense for performance-based equity awards is included in guidance once the predefined performance-based criteria for vesting is achieved or deemed probable to achieve. IPR&D guidance represents completed collaboration and licensing arrangements. SG&A guidance range reflects expense for ongoing commercial initiatives supporting INGREZZA growth and the launch of CRENESSITY including expansion of sales teams expected to be completed by the end of the first quarter of 2026. Conference Call and Webcast Today at 4:30 PM Eastern Time Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-579-2543 (US) or 785-424-1789 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 4:30 p.m. Eastern Time on Neurocrine Biosciences' website under Investors at . A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. About Neurocrine Biosciences Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neuropsychiatric, neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes U.S. 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) NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA, and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc. Non-GAAP Financial Measures In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following Non-GAAP financial measures: Non-GAAP R&D expense, Non-GAAP SG&A expense, Non-GAAP operating income, Non-GAAP net income and net income per share. When preparing the Non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these Non-GAAP financial measures exclude: non-cash stock-based compensation expense, charges associated with convertible senior notes, vacated legacy campus facility costs, net of sublease income, non-cash amortization expense related to acquired intangible assets, changes in fair value of equity investments, transaction and divestiture-related expenses, changes in foreign currency exchange rates and certain adjustments to income tax expense. These Non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these Non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these Non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a Non-GAAP basis. A reconciliation of these GAAP financial results to Non-GAAP financial results is included in the attached financial information. 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 related to: our business strategy, objectives, and future development plans; the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; successfully launching and commercializing CRENESSITY; our financial and operating performance, including our future revenues, expenses, or profits; our collaborative partnerships; clinical and scientific data updates for our products and product candidates, including observations regarding clinical outcomes, safety, and tolerability; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. 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; risks and uncertainties associated with the commercialization of INGREZZA and CRENESSITY; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates 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; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with our ability to manage the growth of our organization; and other risks described in our periodic reports filed with the Securities and Exchange Commission, including our 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 as required by law. SOURCE Neurocrine Biosciences, Inc. 21% more press release views with Request a Demo

Financial StatementPhase 3Phase 2

26 Jan 2026

·www.prnewswire.com

Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1065890 in Adults with Tardive Dyskinesia

SAN DIEGO, Jan. 26, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD). NBI-1065890 is a next-generation, selective inhibitor of the vesicular monoamine transporter 2 (VMAT2). Building on nearly 20 years of deep scientific expertise and experience in VMAT2 inhibition, Neurocrine designed NBI-1065890 to potentially deliver a differentiated profile, including the possibility of longer-acting options for the treatment of TD. "NBI-'890 is an internally discovered molecule with distinct physical and chemical properties that may allow it to benefit a broader range of patients with tardive dyskinesia," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Advancing this program to a Phase 2 clinical study is key to our strategy to define the future of VMAT2 biology and deliver lasting impact for patients." This Phase 2, randomized, double-blind, placebo-controlled study will enroll approximately 100 adult subjects with TD and will assess the efficacy, safety, and tolerability of NBI-1065890 compared with placebo. The primary efficacy endpoint is change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (sum of Items 1–7) at Week 8. Neurocrine successfully developed and received U.S. Food and Drug Administration approval in 2017 for valbenazine, a selective VMAT2 inhibitor, for use as the first drug ever developed for the treatment of tardive dyskinesia. In 2023, the company received FDA approval for valbenazine as a treatment for chorea associated with Huntington's disease. For more information about the Phase 2 study (NBI-1065890-TD2033), visit ClinicalTrials.gov. 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 NBI-1065890 NBI-1065890, discovered and developed internally at Neurocrine, is a potent, selective and orally bioavailable inhibitor of vesicular monoamine transporter 2 (VMAT2) in clinical development for the treatment of tardive dyskinesia (TD). Inhibition of VMAT2 is expected to provide therapeutic benefit in TD, other hyperkinetic movement disorders, and potentially other CNS disorders where dopaminergic signaling is dysregulated. 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, psychiatric, endocrine 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 and YOU DESERVE BRAVE SCIENCE 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 efficacy and therapeutic potential of NBI-1065890. 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 that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates 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; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; 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 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. © 2026 Neurocrine Biosciences, Inc. All Rights Reserved. SOURCE Neurocrine Biosciences, Inc. 21% more press release views with Request a Demo

Phase 2Drug Approval

100 Deals associated with Valbenazine Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Valbenazine Tosylate	N07XX13	DB11915

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Huntington Disease	United States	Neurocrine Biosciences, Inc.	18 Aug 2023
Tardive Dyskinesia	United States	Neurocrine Biosciences, Inc.	11 Apr 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Choreoathetosis	Phase 3	United States	Neurocrine Biosciences, Inc.	01 Mar 2024
Choreoathetosis	Phase 3	Argentina	Neurocrine Biosciences, Inc.	01 Mar 2024
Choreoathetosis	Phase 3	Australia	Neurocrine Biosciences, Inc.	01 Mar 2024
Choreoathetosis	Phase 3	Belgium	Neurocrine Biosciences, Inc.	01 Mar 2024
Choreoathetosis	Phase 3	Brazil	Neurocrine Biosciences, Inc.	01 Mar 2024
Choreoathetosis	Phase 3	Israel	Neurocrine Biosciences, Inc.	01 Mar 2024
Choreoathetosis	Phase 3	Italy	Neurocrine Biosciences, Inc.	01 Mar 2024
Choreoathetosis	Phase 3	Poland	Neurocrine Biosciences, Inc.	01 Mar 2024
Choreoathetosis	Phase 3	Portugal	Neurocrine Biosciences, Inc.	01 Mar 2024
Choreoathetosis	Phase 3	Spain	Neurocrine Biosciences, Inc.	01 Mar 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05859698 (KINECT-PRO, CTgov)	Phase 4	Bipolar Disorder \| Schizoaffective disorder \| Depressive Disorder, Major ... View more	59	Valbenazine	iekioydgwb(mphuydhiok) = zcgwozouhu vtqibdbwqq (nlwrtcjtap, mjtotzvnqp - iptlptualr) View more	-	16 Jan 2026
Company_Website Manual	Not Applicable	Huntington Disease \| Tardive Dyskinesia	8	INGREZZA	stdbiavyie(gjonqqrjbx) = xqrbyaefym qltnpyyzrm (hhzmgojepk )	Positive	15 Jan 2026
				AUSTEDO XR	stdbiavyie(gjonqqrjbx) = tpormynhvj qltnpyyzrm (hhzmgojepk )
NCT01688037 (KINECT, PRNewswire) Manual	Phase 3	Cerebral Palsy	-	Valbenazine	xguafovlxm(hdaocntlks) = did not meet ipnevkjxvs (ldmdrovvvm ) Not Met View more	Negative	22 Dec 2025
				Placebo
KINECT-HD2 (MDS2025)	Phase 3	Huntington Disease	232	Valbenazine	qbwuubogrr(ueptlqtqtg) = poxrdugron kmwaifikuc (rqwltjznut ) View more	Positive	05 Oct 2025
				Placebo	qbwuubogrr(ueptlqtqtg) = nddvzhfpjt kmwaifikuc (rqwltjznut ) View more
NCT04400331 (KINECT-HD2, MDS2025)	Phase 3	Huntington Disease	154	Valbenazine	fmtwnbsljv(llqmsmyvik) = jmdmlrqtke ojexqoclzc (hljpsmfsve ) View more	Positive	05 Oct 2025
NCT04102579 (KINECT-HD, PRNewswire) Manual	Phase 3	Huntington Disease	128	INGREZZA	cafdqbnszm(khawgmqwvj) = xophqqqwdb uytyceeiqv (rheczfnaue ) View more	Positive	27 Jun 2025
				placebo	cafdqbnszm(khawgmqwvj) = ebdngteusd uytyceeiqv (rheczfnaue ) View more
NCT03891862 (PRNewswire) Manual	Phase 4	Tardive Dyskinesia	-	INGREZZA	ijkgxegumu(rtvllfxpdy) = 8-week: including mobility (change from baseline: -0.27), self-care (-0.28), usual activities (-0.36) and pain/discomfort (-0.34). 16-week: including significant improvements in mobility (placebo-adjusted difference from Week 8: -0.34) and anxiety/depression (-0.38) compared with those receiving placebo. nrztlestcz (fsydhnqgmd ) View more	Positive	16 May 2025
				Placebo
NCT04400331 (KINECT-HD2, AAN2025)	Phase 3	Huntington Disease Maintenance	154	Valbenazine 40 mg	tlcqyngrjj(rdszzwxvbe) = 2.6% wktnmrsbqy (rpuuejhwlz ) View more	Positive	07 Apr 2025
				Valbenazine 80 mg
P10-5.019 (AAN2025)	Not Applicable	Tardive Dyskinesia	164	Valbenazine	vfiyroipue(gmeqgqzdtg) = chypopjhse lljmdfgwpa (hrepuzkifq ) View more	Positive	07 Apr 2025
NCT05859698 (KINECT-PRO, PRNewswire) Manual	Phase 4	Tardive Dyskinesia	59	INGREZZA	trzakhxran(isamabemgx) = 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. xkplbtbkfa (hexdbmxwut ) View more	Positive	27 Feb 2025

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