Currently Enrolling Trials
Ingrezza (valbenazine) - 2 indications
- for the treatment of tardive dyskinesia; approved April 2017
- for the treatment of chorea associated with Huntington’s disease; approved August of 2023
Scroll down for more information on each indication:
Ingrezza (valbenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor.
Ingrezza is specifically indicated for:
- the treatment of adults with tardive dyskinesia
- the treatment of adults with chorea associated with Huntington’s disease
Ingrezza is supplied as a capsule for oral administration. Scroll down for dosing/administration for each indication.
Mechanism of Action
The mechanism of action of valbenazine for the treatment of tardive dyskinesia and chorea in patients with Huntington’s disease is unclear, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.
Adverse effects associated with the use of Ingrezza for tardive dyskinesia may include, but are not limited to, the following:
Adverse effects associated with the use of Ingrezza for chorea associated with Huntington’s disease may include, but are not limited to, the following:
The Ingrezza drug label comes with the following Black Box Warning: Ingrezza Increases the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Balance risks of depression, and suicidal ideation and behavior with the clinical need for treatment of chorea when considering the use of Ingrezza. Monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. 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. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation.
Indication 1 - tardive dyskinesia
approved April of 2017
The initial dose is 40 mg once daily. After one week, increase the dose to the recommended dose of 80 mg once daily. Continuation of 40 mg once daily may be considered for some patients. Administer Ingrezza orally with or without food. Please see drug label for specific dose modifications.
Indication 2 - chorea associated with Huntington’s disease
approved August of 2023
The initial dosage is 40 mg once daily. Increase the dose in 20 mg increments every two weeks to the recommended dosage of 80 mg once daily. A dosage of 40 mg or 60 mg once daily may be considered depending on response and tolerability
FDA approval for chorea associated with Huntington’s disease was based on data from two clinical studies conducted in collaboration with the Huntington Study Group (HSG), including the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 open-label extension trial. KINECT-HD, a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of Ingrezza, met its primary endpoint of least squares mean (LSM) change in chorea severity using the Total Maximal Chorea (TMC) score of the Unified Huntington's Disease Rating Scale (UHDRS) from screening period baseline to maintenance period (average of Weeks 10 and 12), demonstrating a statistically significant greater improvement in TMC score with Ingrezza versus placebo.
Ingrezza demonstrated a three-times greater improvement in chorea severity compared to placebo, with a 4.6-point improvement seen with Ingrezza versus a 1.4-point improvement with placebo in the chorea severity score from the start to the end of the 12-week clinical study. Ingrezza reduced chorea severity by about 40 percent from baseline to maintenance and nearly half of patients saw a more than 40 percent reduction in HD chorea severity by Week 12. Fifty-three percent of patients and 43 percent of healthcare professionals reported overall HD chorea symptoms were "very much improved" or "much improved" at Week 12.