Last reviewed 2026-04-20 · How we verify

Ingrezza (valbenazine)

Valbenazine (Ingrezza), marketed by Neurocrine, is the first FDA-approved drug for the treatment of tardive dyskinesia, a condition characterized by involuntary movements. Its key strength lies in being the only approved therapy specifically for this indication, providing a unique market position. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.

At a glance

Approved indications

• Tardive Dyskinesia
• Chorea Associated with Huntington’s Disease

Boxed warnings

• WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of INGREZZA or INGREZZA SPRINKLE must balance the risks of depression and suicidal ideation and behavior 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. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease [see Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. • Increases the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease ( 5.1 ) • Balance risks of depression, and suicidal ideation and behavior with the clinical need for treatment of chorea when considering the use of INGREZZA or INGREZZA SPRINKLE ( 5.1 ) • Monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior ( 5.1 ) • Inform patients, 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 ( 5.1 ) • Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ( 5.1 )

Common side effects

• Somnolence (somnolence, fatigue, sedation)
• Anticholinergic effects (dry mouth, constipation, disturbance in attention, vision blurred, urinary retention)
• Balance disorders/fall (fall, gait disturbance, dizziness, balance disorder)
• Headache
• Akathisia (akathisia, restlessness)
• Vomiting
• Nausea
• Arthralgia

Drug interactions

• Monoamine Oxidase Inhibitors (MAOIs)
• Strong CYP3A4 Inhibitors
• Strong CYP2D6 Inhibitors
• Strong CYP3A4 Inducers

Key clinical trials

• Open-Label Rollover Study for Continuing NBI-98854 Administration for the Treatment of Pediatric Subjects With Tourette Syndrome (Phase 2)
• A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy (Phase 3)
• A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective D (Phase 2)
• Valbenazine in Obsessive-compulsive Disorder: A Randomized Double-blind Placebo-controlled Crossover Trial (Phase 2)
• A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Adult Subjects With Tourette Syndrome (Phase 2)
• A Phase 1b, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome (Phase 1)
• A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects With Schizophrenia (Phase 3)
• A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia (Phase 3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Ingrezza CI brief — competitive landscape report
• Ingrezza updates RSS · CI watch RSS
• Neurocrine portfolio CI