Drugs / varegacestat
varegacestat
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | desmoid tumor caused by somatic mutation | 2026-04-29 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for varegacestat” immunome.com ↗ “In April 2026, Immunome submitted an NDA to the U.S. FDA for varegacestat for the treatment of adults with desmoid tumors.” immunome.com ↗ “Immunome submitted an NDA for varegacestat to the FDA in April 2026.” immunome.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06841315 | Mar → Nov 2025 | — | Immunome, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06845852 | Feb → Mar 2025 | — | Immunome, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06855264 | Feb → Apr 2025 | — | Immunome, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06677996 | Nov → Dec 2024 | — | Immunome, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01986218 | Nov 2013 → Mar 2016 | cancer of unknown primary site | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04871282 | Sep 2021 → Dec 2025 overdue | desmoid tumor | Immunome, Inc. | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-08-11 | Immunome, Inc. | Regulatory Immunome Reports Second Quarter 2026 Financial Results and Provides Business Update immunome.com ↗
Varegacestat PDUFA target action date set for April 28, 2027, following U.S. FDA acceptance of New Drug Application (NDA) for adults with desmoid tumors |
| 2026-07-08 | Immunome, Inc. | Regulatory Immunome Announces U.S. FDA Acceptance of New Drug Application for Varegacestat for the Treatment of Adults with Desmoid Tumors immunome.com ↗
today announced the U.S. Food and Drug Administration (FDA or the Agency) has accepted its New Drug Application (NDA) for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), for the treatment of adults with desmoid tumors. |
| 2026-05-30 | Immunome, Inc. | Results Immunome Announces Detailed Phase 3 RINGSIDE Data for Varegacestat in Adults with Progressing Desmoid Tumors at the 2026 ASCO Annual Meeting immunome.com ↗
today announced detailed efficacy and safety results from RINGSIDE, the global, randomized, double-blind, placebo-controlled Phase 3 trial of varegacestat in patients with progressing desmoid tumors. |
| 2026-04-29 | Immunome, Inc. | Regulatory Immunome Announces Submission of New Drug Application to U.S. FDA for Varegacestat for the Treatment of Adults with Desmoid Tumors immunome.com ↗
today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for varegacestat |
| 2025-12-15 | Immunome, Inc. | Results Immunome Announces Positive Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors immunome.com ↗ |
All press releases naming this drug 10 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | varegacestat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06841315 ↗ |
| Known as | AL102 | “A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants” NCT06677996 ↗ |
| Known as | BMS-986115 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01986218 ↗ |
| Action | Inhibit | “BMS-986115 (Notch Inhibitor)” NCT01986218 ↗ |
| Modality | Small molecule | — CHEMBL3911164 ↗ |
| Route | Oral | “Single oral dose of varegacestat administered on study day 1” NCT06841315 ↗ |