Drugs / Garetosmab
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06970405 | May 2025 → Jun 2026 | obesity disorder | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 1 | NCT02943239 | Dec 2016 → Apr 2019 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02870400 | Jul 2016 → Jan 2017 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06299098 | Mar 2024 → May 2026 overdue | obesity disorder | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03710941 | Feb 2019 → Aug 2020 | inclusion body myositis | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT03188666 | Feb 2018 → Sep 2019 | fibrodysplasia ossificans progressiva | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07559513 | Jul 2026 → Dec 2028 expected | fibrodysplasia ossificans progressiva | Regeneron Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05394116 | Nov 2022 → Jul 2025 overdue | fibrodysplasia ossificans progressiva | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04577820 | Oct 2021 → Mar 2022 | fibrodysplasia ossificans progressiva | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT07301450 Background | — | fibrodysplasia ossificans progressiva | Regeneron Pharmaceuticals | Temporarily not available | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-19 | Regeneron Pharmaceuticals | Garetosmab Biologics License Application Accepted for FDA Priority Review for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) regeneron.com ↗ |
| 2025-09-17 | Regeneron Pharmaceuticals | Regeneron Announces Positive Phase 3 Trial in Adults with Ultra-Rare Genetic Disorder Fibrodysplasia Ossificans Progressiva (FOP), Demonstrating that Garetosmab Prevents Greater than 99% of Abnormal Bone Formation regeneron.com ↗ |
| 2020-01-09 | Regeneron Pharmaceuticals | Regeneron Announces Encouraging Garetosmab Phase 2 Results in Patients with Ultra-Rare Debilitating Bone Disease regeneron.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Garetosmab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06299098 ↗ |
| Known as | REGN2477 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03188666 ↗ |
| Action | Inhibit | “Inhibin beta A chain inhibitor” CHEMBL4298176 ↗ |
| Modality | Monoclonal antibody | “Placebo to match garetosmab, is supplied as a liquid solution without the monoclonal antibody (or the protein) and is administered IV.” NCT05394116 ↗ |
| Route | Intravenous | “Intravenously and Subcutaneously Administered REGN2477” NCT02870400 ↗ |
| Route | Subcutaneous | “Intravenously and Subcutaneously Administered REGN2477” NCT02870400 ↗ |
| Target | INHBA | “Inhibin beta A chain inhibitor” CHEMBL4298176 ↗ |