Drugs / SRP-5051
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | DMD-related muscular dystrophy | 2022-06-23 | “today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on SRP-5051 (vesleteplirsen)” sarepta.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03375255 | Feb 2018 → Aug 2019 | Duchenne muscular dystrophy | Sarepta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03675126 | Dec 2018 → Aug 2021 | Duchenne muscular dystrophy | Sarepta Therapeutics, Inc. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-02-28 | Sarepta Therapeutics, Inc. | Results Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Recent Corporate Developments sarepta.com ↗
Data from Part B of MOMENTUM found that at the higher, target dose, approximately 30 mg/kg dosed every four weeks, SRP-5051 resulted in mean dystrophin expression of 5.17%, and mean exon skipping of 11.11% at 28 weeks (n=20). |
| 2024-01-29 | Sarepta Therapeutics, Inc. | Results Sarepta Therapeutics Announces Positive Data from Part B of MOMENTUM, a Phase 2 Study of SRP-5051 in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 51 sarepta.com ↗
Data from Part B of MOMENTUM found that at the higher, target dose, approximately 30 mg/kg dosed every four weeks, SRP-5051 resulted in mean dystrophin expression of 5.17%, and mean exon skipping of 11.11% at 28 weeks (n=20). |
| 2022-09-06 | Sarepta Therapeutics, Inc. | Regulatory Sarepta Therapeutics Announces That FDA has Lifted its Clinical Hold on SRP-5051 for the Treatment of Duchenne Muscular Dystrophy sarepta.com ↗ |
| 2022-06-23 | Sarepta Therapeutics, Inc. | Regulatory Sarepta Therapeutics Provides Update on SRP-5051 for the Treatment of Duchenne Muscular Dystrophy sarepta.com ↗
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on SRP-5051 (vesleteplirsen), the Company’s next-generation peptide-conjugated phosphorodiamidate morpholino oligomer (PPMO) to treat patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping. |
| 2021-05-03 | Sarepta Therapeutics, Inc. | Results Sarepta Therapeutics Reports Positive Clinical Results from Phase 2 MOMENTUM Study of SRP-5051 in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 51 sarepta.com ↗ |
| 2020-12-07 | Sarepta Therapeutics, Inc. | Results Sarepta Therapeutics Announces Positive Clinical Results from MOMENTUM, a Phase 2 Clinical Trial of SRP-5051 in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 51 sarepta.com ↗ |
| 2017-11-07 | Sarepta Therapeutics, Inc. | Regulatory Sarepta Therapeutics Announces FDA Clearance of IND for the Company’s PPMO Exon 51 Candidate, SRP-5051 sarepta.com ↗
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the Company’s peptide phosphorodiamidate morpholino oligomer (PPMO) exon 51 candidate, SRP-5051. |
All press releases naming this drug 10 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SRP-5051 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03675126 ↗ |
| Route | Intravenous | “administered as an intravenous (IV) infusion” NCT03375255 ↗ |