Drugs / Garetosmab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | fibrodysplasia ossificans progressiva | — | “submitted U.S. and EU regulatory applications for garetosmab (an Activin A antibody) in adults with fibrodysplasia ossificans progressiva (FOP).” regeneron.com ↗ |
| Filed | EU (EMA) | — | fibrodysplasia ossificans progressiva | — | “submitted U.S. and EU regulatory applications for garetosmab (an Activin A antibody) in adults with fibrodysplasia ossificans progressiva (FOP).” regeneron.com ↗ |
Trials 9
| 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| Phase 1 | NCT06970405 | May 2025 → Jun 2026 | obesity disorder | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded Stop: Business |
| 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 · 1 met primary | ||||||
| Phase 2 | NCT06299098 | Mar 2024 → Jun 2026 overdue | obesity disorder | Regeneron Pharmaceuticals | Active not recruiting | Met primary |
| Phase 2 | NCT03710941 | Feb 2019 → Aug 2020 | inclusion body myositis | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded |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 | Mixed |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07559513 | Feb 2027 → Jul 2030 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 | Met primary |
| Phase 3 | NCT04577820 | Oct 2021 → Mar 2022 | fibrodysplasia ossificans progressiva | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT07301450 Background | — | fibrodysplasia ossificans progressiva | Regeneron Pharmaceuticals | Temporarily not available | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-08-19 | Regeneron Pharmaceuticals | Regulatory Pasatru™ (garetosmab-grts) First and Only FDA-approved Treatment Demonstrating Reduction in New Heterotopic Ossification (HO) Lesions and Clinician-Assessed Flare-ups in a Placebo-controlled Trial in Adults with Fibrodysplasia Ossificans Progressiva (FOP) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted approval for Pasatru™ (garetosmab-grts) to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). |
| 2026-02-19 | Regeneron Pharmaceuticals | Regulatory Garetosmab Biologics License Application Accepted for FDA Priority Review for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva (FOP). |
| 2025-09-17 | Regeneron Pharmaceuticals | Results Results from Phase 2 COURAGE Trial Demonstrating Potential to Improve Quality of GLP-1 receptor agonist-induced Weight Loss by Preserving Lean Mass, Presented at EASD regeneron.com ↗
Complete 26-week results further demonstrate that combining semaglutide with trevogrumab (anti-GDF8/anti-myostatin) helped prevent about half of semaglutide-induced loss of lean mass, while increasing fat mass loss |
| 2025-09-17 | Regeneron Pharmaceuticals | Results 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 ↗
At 56 weeks, both doses of garetosmab, 3 mg/kg and 10 mg/kg, were highly efficacious in reducing the number of new bone lesions (heterotopic ossification, or HO lesions) as compared to placebo, demonstrating a 94% and 90% reduction, respectively. |
| 2025-08-01 | Regeneron Pharmaceuticals | Results Regeneron Reports Second Quarter 2025 Financial and Operating Results regeneron.com ↗
The Company announced interim 26-week results from the ongoing Phase 2 COURAGE trial investigating combinations of semaglutide and trevogrumab (myostatin antibody) with or without garetosmab (Activin A antibody) for the treatment of obesity. |
| 2025-06-02 | Regeneron Pharmaceuticals | Results Interim Results from Ongoing Phase 2 COURAGE Trial Confirm Potential to Improve the Quality of Semaglutide (GLP-1 receptor agonist)-induced Weight Loss by Preserving Lean Mass regeneron.com ↗
The trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab helped preserve lean mass while increasing loss of fat mass. |
| 2020-01-09 | Regeneron Pharmaceuticals | Results Regeneron Announces Encouraging Garetosmab Phase 2 Results in Patients with Ultra-Rare Debilitating Bone Disease regeneron.com ↗
Patient-reported flare-ups were reduced by 50% (nominal p=0.03). |
All press releases naming this drug 7 releases
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 NCT05394116 ↗ |
| Known as | REGN2477 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02870400 ↗ |
| 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 ↗ |