Ingrezza
Neurology· 140 cited findings· 2 source documents
Company: NEUROCRINE
What the regulatory reviews say
Ingrezza (valbenazine) was approved on April 09, 2020, for the treatment of adults with tardive dyskinesia. The initial dosage is 40 mg once daily, with a recommended dosage of 80 mg once daily. For patients with moderate or severe hepatic impairment, known CYP2D6 poor metabolizers, or those taking strong CYP3A4 or CYP2D6 inhibitors, the recommended dosage is 40 mg once daily.
In placebo-controlled studies involving 445 patients aged 26 to 84 years (mean age 56 years), somnolence was reported in 10.9% of Ingrezza patients compared to 4.2% in placebo. Parkinson-like adverse events occurred in 3% of Ingrezza patients versus <1% in placebo. Discontinuation due to adverse reactions was 3% for Ingrezza and 2% for placebo. Headache incidence was 3.4%, anticholinergic effects 5.4%, and balance disorders/fall 4.1% in Ingrezza patients.
Key figures — cited to the source page
| Recommended dosage | 80 mg once daily | NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022), p.9 |
| Recommended dosage for moderate or severe hepatic impairment | 40 mg once daily | NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022), p.9 |
| Somnolence incidence (INGREZZA) | 10.9 % | NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022), p.12 |
| Somnolence incidence (placebo) | 4.2 % | NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022), p.12 |
| Incidence of parkinson-like adverse events (INGREZZA) | 3 % | NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022), p.11 |
| Incidence of parkinson-like adverse events (placebo) | <1 % | NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022), p.11 |
| Discontinuation due to adverse reactions (INGREZZA) | 3 % | NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022), p.12 |
| Approval Date | April 09, 2020 | NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022), p.1 |
Source documents
Explore the full evidence
All 140 cited findings for Ingrezza — searchable, comparable and answerable in plain language — are in the Neurology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.