Drugs / VHX-896
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BYSANTI | — | 2026-02-20 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06494397 | Jul → Oct 2024 | bipolar I disorder, schizophrenia | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT06803290 | Jun → Dec 2022 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06830044 | Mar 2025 → Mar 2028 expected | major depressive disorder | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-02-20 | Vanda Pharmaceuticals | Regulatory 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 vandapharma.com ↗
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. |
| 2025-05-07 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results vandapharma.com ↗
Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 |
| 2025-05-05 | Vanda Pharmaceuticals | Regulatory Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026 vandapharma.com ↗
The FDA has set February 21, 2026 as the target date for decision on this application. |
| 2025-03-31 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today 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. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-20 | Vanda Pharmaceuticals | 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 vandapharma.com ↗ |
| 2025-05-07 | Vanda Pharmaceuticals | Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results vandapharma.com ↗ |
| 2025-05-05 | Vanda Pharmaceuticals | Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026 vandapharma.com ↗ |
| 2025-03-31 | Vanda Pharmaceuticals | Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia vandapharma.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VHX-896 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06494397 ↗ |
| Known as | Milsaperidone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06830044 ↗ |
| Route | Oral | “oral tablet” NCT06494397 ↗ |