Apitegromab Clinical Trials (2026): 6 Studies for SMA & Anti-myostatin
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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6 Apitegromab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 4 indications (including SMA & Anti-myostatin) and 640 total planned enrollment. 2 Phase 3 Apitegromab trials and 3 Phase 2 are listed. 2 Apitegromab clinical trials are actively recruiting at 13 U.S. sites across 9 states. Most recent activity: NCT05626855 (May 2029).
Where to Participate: All Apitegromab Trial Sites in the U.S. (13 sites across 9 states)
Every actively recruiting Apitegromabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AZ | Phoenix Children's Hospital | Phoenix85016 | NCT07047144 | Map |
| CA | Children's Hospital of Orange County (CHOC) | Orange92868 | NCT07047144 | Map |
| CA | Stanford Neuroscience Health Center (SNHC) | Palo Alto94304 | NCT07047144 | Map |
| CO | Children's Hospital Colorado | Aurora80045 | NCT07047144 | Map |
| GA | Children's Healthcare of Atlanta | Atlanta30329 | NCT07047144 | Map |
| IA | University of Iowa | Iowa City52242 | NCT07047144 | Map |
| MI | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids49503 | NCT07047144 | Map |
| NC | Atrium Health Wake Forest Baptist | Winston-Salem27157 | NCT07047144 | Map |
| PA | The Children's Hospital of Philadelphia | Philadelphia19104 | NCT07047144 | Map |
| TX | University of Texas Southwestern Medical Center | Dallas75207 | NCT07047144 | Map |
| TX | Neurology Rare Disease Center | Flower Mound75028 | NCT07047144 | Map |
| TX | Cook Children's Medical Center | Fort Worth76104 | NCT07047144 | Map |
| TX | Texas Children's Hospital (TCH)-Clinical Care Center (CCC) | Houston77030 | NCT07047144 | Map |
Apitegromab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | not yet recruiting | no longer available | Total |
|---|---|---|---|---|---|---|
| P2 | 1 | 1 | 1 | 3 | ||
| P3 | 1 | 1 | 2 | |||
| N/A | 1 | 1 |
Recruiting Apitegromab clinical trials (2)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07047144 | OPALA Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy | P2 | Spinal Muscular Atrophy | 52 | Sep 2025 |
| NCT07435129 | Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD | P2 | Facioscapulohumeral Muscular Dystrophy | 60 | Aug 2026 |
Apitegromab clinical trials by indication
Spinal Muscular Atrophy (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05626855 | ONYX | P3 | active not recruiting | Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab |
| NCT07047144 | OPAL | P2 | recruiting | A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy |
| NCT05156320 | SAPPHIRE | P3 | completed | Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam |
Facioscapulohumeral Muscular Dystrophy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07435129 | — | P2 | not yet recruiting | Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD |
Overweight and Obesity (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06445075 | EMBRAZE | P2 | completed | Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese |
SMA (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06877689 | — | N/A | no longer available | EAP of Apitegromab for Patients With Spinal Muscular Atrophy |
Apitegromab pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| ONYX | NCT05626855 | P3 | active not recruiting | Spinal Muscular Atrophy | 238 | — |
| SAPPHIRE | NCT05156320 | P3 | completed | Spinal Muscular Atrophy | 188 | PMID 40818473 |
| OPAL | NCT07047144 | P2 | recruiting | Spinal Muscular Atrophy | 52 | — |
| EMBRAZE | NCT06445075 | P2 | completed | Overweight and Obesity | 102 | — |
All Apitegromab trials (6)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT05626855 | ONYX | Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab | P3 | active not recruiting | 238 | Scholar Rock, Inc. | Apr 2023 |
| NCT07047144 | OPAL | A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy | P2 | recruiting | 52 | Scholar Rock, Inc. | Sep 2025 |
| NCT07435129 | Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD | P2 | not yet recruiting | 60 | Scholar Rock, Inc. | Aug 2026 | |
| NCT06445075 | EMBRAZE | Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese | P2 | completed | 102 | Scholar Rock, Inc. | May 2024 |
| NCT06877689 | EAP of Apitegromab for Patients With Spinal Muscular Atrophy | — | no longer available | 0 | Scholar Rock, Inc. | — | |
| NCT05156320 | SAPPHIRE | Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam | P3 | completed | 188 | Scholar Rock, Inc. | Apr 2022 |
Apitegromab clinical trials: frequently asked questions
- How many Apitegromab clinical trials are there?
- 6 Apitegromab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 1 is actively recruiting participants. 2 are marked completed.
- Are Apitegromab clinical trials recruiting in 2026?
- Yes — 1 Apitegromab trial is actively recruiting in 2026, with 13 U.S. sites across 9 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Apitegromab being studied for?
- Apitegromab is being studied for SMA, Anti-myostatin, Neuromuscular Manifestations, Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 2 and 8 more. The trials are grouped by indication on this page.
- What phase is Apitegromab in?
- Apitegromab clinical trials span 2 Phase 3, 3 Phase 2. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Apitegromab clinical trials?
- The lead sponsor across the most Apitegromab trials is Scholar Rock, Inc.. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Apitegromabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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