Valbenazine Tosylate

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