Apitegromab clinical trials
Apitegromab is named as an intervention in 3 current clinical trials in our USA, UK, France, Spain, Italy, Netherlands, Belgium, Germany and Poland registers. 2 are recruiting patients now. The most common phase is Phase 2. The lead sponsor is Scholar Rock, Inc. The most-studied condition is Spinal Muscular Atrophy. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Apitegromab is approved
All regulators →Of the three regulators tracked here, the first to approve Apitegromab was the US, on 11 Sep 2026.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
How Apitegromab works
All drug targets →- Growth/differentiation factor 8 inhibitor InhibitorTarget: MSTN myostatinChEMBL only
- Proximal spinal muscular atrophyPhase 3
- Spinal muscular atrophyPhase 3
- OverweightPhase 2
- Facioscapulohumeral muscular dystrophyPhase 2
- Obesity disorderPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4594326, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 11180, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Apitegromab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Apitegromab
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy
NCT07047144 · Spinal Muscular Atrophy, SMA, Spinal Muscular Atrophy Type 2
|
Phase 2 | Recruiting | Scholar Rock, Inc | UK, USA, France, Spain, Italy, Netherlands, Belgium |
|
Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD
NCT07435129 · Facioscapulohumeral Muscular Dystrophy, FSHD
|
Phase 2 | Recruiting | Scholar Rock, Inc | USA |
|
Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab
NCT05626855 · Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3, Spinal Muscular Atrophy Type 2
|
Phase 3 | Active, closed | Scholar Rock, Inc | UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Apitegromab in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Apitegromab. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study Evaluating the Efficacy and Safety of Apitegromab in Participants With Facioscapulohumeral Muscular Dystrophy (FORGE)
2026-525204-10-00 · CTIS ↗ · Musculoskeletal Diseases
|
Phase 2 | Authorised | Scholar Rock Inc | Italy, Spain |
Conditions studied with Apitegromab
6 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Scholar Rock, Inc | 3 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Apitegromab trials
How many clinical trials are testing Apitegromab?
3 current trials in our USA, UK, France, Spain, Italy, Netherlands, Belgium, Germany and Poland registers name Apitegromab (also registered as SRK-015) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Apitegromab trials recruiting patients?
Yes. 2 of the 3 trials are recruiting: 2 with sites in USA, 1 with sites in UK, 1 with sites in France, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in Netherlands and 1 with sites in Belgium. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Apitegromab clinical trials?
The lead sponsor is Scholar Rock, Inc. The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Apitegromab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Apitegromab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Apitegromab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.