Scholar Rock Holding Corp (SRRK)
NASDAQ:SRRK
Apitegromab, Srk-015
Fshd, Facioscapulohumeral Muscular Dystrophy
Phase II
Not Yet Recruiting
Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD
Feb 10, 2026
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Nusinersen, Apitegromab, Risdiplam
Spinal Muscular Atrophy Type 3, Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 2, Sma, Neuromuscular Manifestations, Anti-Myostatin
Phase II
Recruiting
A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy
Apr 16, 2025
Tirzepatide, Apitegromab
Overweight And Obesity
Phase II
Completed
Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese
May 22, 2024
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Apitegromab
Atrophy, Muscular Atrophy, Spinal, Muscular Atrophy, Neuromuscular Diseases, Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3, Anti-Myostatin, Neuromuscular Manifestations, Sma, Spinal Muscular Atrophy Type 2
Phase III
Active Not Recruiting
Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab
Nov 07, 2022
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Apitegromab
Spinal Muscular Atrophy Type 2, Spinal Muscular Atrophy, Sma, Neuromuscular Manifestations, Anti-Myostatin, Spinal Muscular Atrophy Type 3, Muscular Atrophy, Neuromuscular Diseases, Atrophy, Muscular Atrophy, Spinal
Phase III
Completed
Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam
Dec 01, 2021
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Srk-181, Anti-Pd-1 Antibody Therapy
Cancer
Phase I
Completed
SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)
Feb 25, 2020
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Srk-015
Sma, Neuromuscular Manifestations, Muscular Atrophy, Spinal, Atrophy, Neuromuscular Diseases, Muscular Atrophy, Spinal Muscular Atrophy Type 3, Spinal Muscular Atrophy Type 2, Spinal Muscular Atrophy
Phase II
Completed
An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy
Apr 16, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Scholar Rock Holding Corp (SRRK) have in its pipeline
SRRK is currently developing the following drugs: Apitegromab, Srk-015, Nusinersen, Apitegromab, Risdiplam, Tirzepatide, Apitegromab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.