The first and only study to measure patient-reported TD impact using multiple validated scales
Data on file. Neurocrine Biosciences, Inc.
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FOR ADULTS WITH TARDIVE DYSKINESIA (TD)
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Achieving Remission with INGREZZA
Rapid and robust efficacy at Week 6 with most seeing a response as early as Week 21-3,*
59% of patients reached symptomatic remission at Week 484,†
Patients reported improvements in TD impact on daily life at Week 245,‡
†Post hoc analysis from open-label KINECT® 4. 59% of completers (n/N=61/103) achieved remission at Week 48. Symptomatic remission was defined as a score of 0 ("none") or 1 ("minimal or near normal") on each AIMS item 1–7 at Week 48. Results are descriptive.
RAPID REDUCTIONS
at 6 weeks with most seeing a response as early as 2 weeks1,3,*
DAILY FUNCTIONING IMPROVEMENTS
reported by patients in 24 weeks5,‡
SYMPTOMATIC REMISSION
reached at 48 weeks4,†
PROVEN ACROSS THE WIDEST RANGE OF PATIENTS1
80 mg significantly reduced AIMS total score by –3.2 (N=79) vs –0.1 (N=76) for placebo from baseline to Week 6 in KINECT 3. P≤0.001 vs placebo; adjusted for multiplicity. At Week 2, ~52% of patients (n/N=41/79) on INGREZZA 80 mg had a ≥2-point decrease from baseline in AIMS total score.
Post hoc analysis from open-label KINECT 4. 59% of completers (n/N=61/103) achieved remission at Week 48. Symptomatic remission was defined as a score of 0 ("none") or 1 ("minimal or near normal") on each AIMS item 1–7 at Week 48. Results are descriptive.
Based on patient-reported improvement on the Tardive Dyskinesia Impact Scale from baseline to Week 24 in open-label KINECT-PRO™. No prespecified inferential statistical testing was conducted. Results are descriptive.
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References: 1. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc. 2. Data on file. Neurocrine Biosciences, Inc. 3. Hauser RA, Factor SA, Marder SR, et al. KINECT® 3: a phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J Psychiatry. 2017;174(5):476-484. 4. Cutler AJ, Bahroo L, Zhang H, et al. Clinically Meaningful Improvements and Symptomatic Remission With Once-Daily Valbenazine in Adults With Tardive Dyskinesia. Poster presented at Psych Congress Elevate; June 3-6, 2026; Las Vegas, NV. 5. Parameswaran A, Perez-Rodriguez MM, Farber R, et al. Valbenazine Improves Physical, Social, and Emotional Impacts on the Tardive Dyskinesia Impact Scale (TDIS™): Post Hoc Analyses of KINECT-PRO™ Data. Poster presented at the Professional Society for Health Economics and Outcomes Research Annual Meeting; May 17-20, 2026; Philadelphia, PA. 6. Data on file as of Q3 2024. Neurocrine Biosciences, Inc.
Important Information
INDICATION & USAGE
INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.
IMPORTANT SAFETY INFORMATION
Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.
CONTRAINDICATIONS
INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in patients after taking the first or subsequent doses of INGREZZA. Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE.
Somnolence and Sedation
INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA or INGREZZA SPRINKLE.
QT Prolongation
INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA and INGREZZA SPRINKLE should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
Neuroleptic Malignant Syndrome
A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including INGREZZA. The management of NMS should include immediate discontinuation of INGREZZA or INGREZZA SPRINKLE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If treatment with INGREZZA or INGREZZA SPRINKLE is needed after recovery from NMS, patients should be monitored for signs of recurrence.
Parkinsonism
INGREZZA and INGREZZA SPRINKLE may cause parkinsonism. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA or INGREZZA SPRINKLE treatment in patients who develop clinically significant parkinson-like signs or symptoms.
ADVERSE REACTIONS
The most common adverse reaction in patients with tardive dyskinesia (≥5% and twice the rate of placebo) is somnolence.
The most common adverse reactions in patients with chorea associated with Huntington’s disease (≥5% and twice the rate of placebo) are somnolence/lethargy/sedation, urticaria, rash, and insomnia.
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.
Important Information
INDICATION & USAGE
INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.
Important Safety Information
Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA, can increase the risk of depression and suicidal thoughts and
Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.