US EditionVanda Surges as FDA Approves Bysanti for Bipolar Disorder, Schizophrenia
BYSANTI offers a new first-line atypical antipsychotic option for bipolar I and schizophrenia with a safety profile supported by over 100,000 patient-years of clinical experience.
- Vanda said the FDA approved BYSANTI on Feb. 20, 2026, with commercial availability expected in Q3 2026.
- BYSANTI is a new chemical entity that rapidly interconverts to iloperidone, yielding dual active molecules that antagonize dopamine D2, serotonin 5‑HT2A, and alpha1‑adrenergic receptors.
- The FDA‑approved prescribing information lists a boxed WARNING about increased mortality in elderly patients with dementia‑related psychosis and risks of QTc interval prolongation with torsade de pointes; common schizophrenia adverse reactions include dizziness and weight gain, while bipolar mania adverse reactions include tachycardia and somnolence.
- As Vanda scores a second approval, BYSANTI marketing exclusivity and US patents extend protection until 2044, reaching roughly 10 million with bipolar I disorder and about 2.8 million with schizophrenia.
- BYSANTI is currently being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder with study completion expected this year; prescribing guidance recommends CYP2D6 genetic testing and dose reductions with strong CYP2D6 or CYP3A4 inhibitors.
42 Articles
42 Articles
LoudounTimes.com
Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Opening New Horizons in Psychiatric Innovation
WASHINGTON, Feb. 20, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved BYSANTI™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated…
Vanda gets FDA approval for ‘franchise-extending’ antipsychotic
The FDA approved Vanda Pharmaceuticals’ drug Bysanti for schizophrenia and for the acute treatment of manic or mixed episodes related to bipolar I disorder. Bysanti is an active metabolite of Vanda’s currently approved atypical antipsychotic ...
Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia
WASHINGTON, Feb. 20, 2026 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved BYSANTI (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. BYSANTI is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics. In cl…
Coverage Details
Bias Distribution
- 63% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
