Apitegromab clinical trials
Also written SRK-015.
How each study uses apitegromab is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Example · made-up studies
Breast cancer · Recruiting: 2 came in, 3 changed
What changed in your saved searches, Oct 31 – Nov 6:
A study of drug A after surgery for early breast cancer
Came in · now Recruiting
Drug B with hormone therapy in advanced breast cancer
Changed
· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
Exercise during chemotherapy
Now Active, not recruiting
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Approvals
The first approval found in each region, with its record
- United States
- 11 Sept 2026 · ISEMBYLD · BLA 761463 (FDA, Drugs@FDA)
- European Union
- Not in EMA's list of EU-wide authorisations
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
Studies by the year they started
6 studies that test it; most in 2019 (1)
| Year | Studies |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 6 · Other 0
Scholar Rock, Inc. (6)
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 1, 1 in phase 3
Studies that test apitegromab, phase 3 first.
- Nov 2026Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of ApitegromabPhase 3 · Scholar Rock, Inc.
Studies
Open first, then newest update. How each study uses apitegromab is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 6
- A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular AtrophyRecruitingPhase 2Scholar Rock, Inc.NCT07047144Written as Apitegromab
- Phase 2 Study Evaluating Apitegromab for the Treatment of FSHDRecruitingPhase 2Scholar Rock, Inc.NCT07435129Written as Apitegromab
- Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of ApitegromabActive, not recruitingPhase 3Scholar Rock, Inc.NCT05626855Written as Apitegromab
- Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or ObeseCompletedPhase 2Scholar Rock, Inc.NCT06445075Written as Apitegromab
- Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or RisdiplamCompletedPhase 3Scholar Rock, Inc.NCT05156320Written as Apitegromab
- An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular AtrophyCompletedPhase 2Scholar Rock, Inc.NCT03921528Written as SRK-015
Codes
What other systems call apitegromab · ClinicalTrials.gg INT001829
- MeSH (NLM) C000722231apitegromabConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) UZ54216N0YAPITEGROMABConfirmed FDA, NLM
- NCI Thesaurus C174923ApitegromabOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000722231 | apitegromab | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | UZ54216N0Y | APITEGROMAB | Confirmed FDA, NLM |
| NCI Thesaurus | C174923 | Apitegromab | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.