Bysanti (milsaperidone) / Vanda - LARVOL DELTA

Vanda Pharmaceuticals…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 (PRNewswire) - "In clinical studies BYSANTI demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum enabling it to leverage well-established knowledge of efficacy and safety derived from a rich clinical development program and more than 100,000 patient-years of real-world experience with Fanapt (iloperidone)....Vanda anticipates commercial availability of BYSANTI in Q3 of 2026."

FDA approval • Launch US • Bipolar Disorder • Schizophrenia

Bysanti (milsaperidone) New Drug Application (NDA) for bipolar I disorder and schizophrenia is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2026. (PRNewswire)

PDUFA • Bipolar Disorder • Schizophrenia

Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Vanda Pharmaceuticals | Not yet recruiting ➔ Completed

Trial completion • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Vanda Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Vanda Announces Bysanti NDA Filing; FDA Decision Expected in Early 2026 (PRNewswire) - "Vanda Pharmaceuticals Inc...announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application."

FDA filing • PDUFA • Bipolar Disorder • Schizophrenia

Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and Schizophrenia (PRNewswire) - "Vanda Pharmaceuticals Inc...announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti....If approved, Bysanti could be available for sale in the US in 2026. Exclusivity, including pending patent applications, could extend into the 2040s. Additionally, Vanda initiated a Phase III clinical study for Bysanti as a once-daily adjunctive treatment for major depressive disorder (MDD) in the fourth quarter of 2024. Results are expected in 2026."

FDA filing • Launch US • P3 data • Bipolar Disorder • Schizophrenia

Evaluation of Efficacy and Safety of Milsaperidone As Adjunctive Therapy in Patients with Major Depressive Disorder (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Vanda Pharmaceuticals

New P3 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - 'Bysanti (milsaperidone): Vanda expects to submit a New Drug Application (NDA) for Bysanti to the U.S. Food and Drug Administration (FDA) for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025. Exclusivity, including pending patent applications, could extend into the 2040s. Vanda initiated a Phase III clinical study for Bysanti as a once-daily adjunctive treatment for major depressive disorder (MDD) in the fourth quarter of 2024. Results are expected in 2026."

FDA filing • New trial • P3 data • Bipolar Disorder • CNS Disorders • Major Depressive Disorder • Schizophrenia

Food Effect Study of VHX-896 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Vanda Pharmaceuticals

New P1 trial

Vanda Pharmaceuticals Reports Second Quarter 2024 Financial Results (PRNewswire) - "Financial Highlights: Second Quarter of 2024:...PONVORY net product sales were $8.6 million in the second quarter of 2024, an increase of 26% compared to $6.8 million in the first quarter of 2024...First Six Months of 2024:...PONVORY net product sales were $15.4 million in the first six months of 2024."

Sales • CNS Disorders • Multiple Sclerosis

Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Vanda Pharmaceuticals

New P1 trial • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia