Drugs / Sevasemten
Sevasemten
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06916897 | Jan → Feb 2025 | — | Edgewise Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05730842 | Jan → Apr 2023 | atrophic muscular disease, muscular dystrophy | Edgewise Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05492734 | Aug 2022 | muscular dystrophy | Edgewise Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05160415 | Dec 2021 → Mar 2024 | Becker muscular dystrophy | Edgewise Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04585464 | Oct 2020 → Nov 2021 | Becker muscular dystrophy | Edgewise Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT06100887 | Mar 2024 → Mar 2027 expected | Duchenne muscular dystrophy | Edgewise Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06066580 | Nov 2023 → Feb 2031 expected | Becker muscular dystrophy | Edgewise Therapeutics, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT05291091 | Nov 2022 → Sep 2026 | Becker muscular dystrophy | Edgewise Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT05540860 | Oct 2022 → Jan 2027 expected | Duchenne muscular dystrophy | Edgewise Therapeutics, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-05-07 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Reports First Quarter 2026 Financial Results and Advances Clinical Programs in Muscular Dystrophy and Cardiovascular Indications edgewisetx.com ↗
For the first time with an investigational agent, we have generated long-term data showing that people with Becker remain stable despite a disease that typically leads to significant functional decline, |
| 2026-03-10 | Edgewise Therapeutics, Inc. | Results Edgewise Announces Positive Long-Term Sevasemten Data Demonstrating Sustained Functional Stabilization in Becker Muscular Dystrophy Through 3.5 Years of Follow-Up edgewisetx.com ↗
The data show participants on sevasemten experienced stabilization of function over 3.5 years in marked contrast to the functional decline expected from Becker natural history data. |
| 2025-10-02 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics to Present on Sevasemten for Becker and Duchenne Muscular Dystrophies at the 30th International Annual Congress of the World Muscle Society edgewisetx.com ↗
Importantly, the presentations will include a compilation of long-term data of sevasemten in Becker demonstrating sustained disease stabilization compared to natural history. |
| 2025-06-26 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Reports Positive Results on Sevasemten Program for Becker and Duchenne Muscular Dystrophies edgewisetx.com ↗
The MESA data demonstrated sustained disease stabilization, reinforcing prior ARCH and CANYON findings. |
| 2025-03-11 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics to Present on Sevasemten for the Treatment of Becker Muscular Dystrophy at the 2025 MDA Clinical and Scientific Conference edgewisetx.com ↗
CANYON trial results: Sevasemten, an investigational fast skeletal myosin inhibitor, reduced muscle damage biomarkers and stabilized function in BMD |
| 2024-12-16 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Announces Positive Topline Results from the CANYON Phase 2 Trial of Sevasemten in Individuals with Becker Muscular Dystrophy (Becker) edgewisetx.com ↗
Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced positive topline results from the Phase 2 CANYON trial of sevasemten in individuals with Becker muscular dystrophy. |
| 2024-04-23 | Edgewise Therapeutics, Inc. | Regulatory Edgewise Receives European Medicines Agency (EMA) Orphan Drug Designations for Sevasemten (EDG-5506) for the Treatment of Becker and Duchenne Muscular Dystrophies edgewisetx.com ↗
Edgewise Receives European Medicines Agency (EMA) Orphan Drug Designations for Sevasemten (EDG-5506) for the Treatment of Becker and Duchenne Muscular Dystrophies |
| 2024-04-15 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Announces Positive Two-Year Topline Results from the ARCH Open Label Trial of Sevasemten (EDG-5506) in Adults with Becker Muscular Dystrophy (Becker) edgewisetx.com ↗
Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced positive two-year topline results from the ARCH trial. |
| 2024-02-13 | Edgewise Therapeutics, Inc. | Regulatory Edgewise Receives U.S. FDA Fast Track Designation for EDG-5506 for the Treatment of Duchenne Muscular Dystrophy (Duchenne) edgewisetx.com ↗
Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne. |
| 2023-11-30 | Edgewise Therapeutics, Inc. | Regulatory Edgewise Receives Orphan Drug and Rare Pediatric Disease Designations for Its Muscular Dystrophy Program from FDA edgewisetx.com ↗
today announced that the U.S. Food & Drug Administration (FDA) has granted EDG-5506 Orphan Drug Designation (ODD) for the treatment of Duchenne muscular dystrophy (Duchenne) and Becker muscular dystrophy (Becker) and Rare Pediatric Disease Designation (RPDD) for the treatment of Duchenne. |
| 2023-06-26 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Announces Positive 12-Month Topline Results from the ARCH Open Label Study of EDG-5506 in Adults with Becker Muscular Dystrophy (BMD) edgewisetx.com ↗
EDG-5506 was well-tolerated in all participants with no discontinuations or dose reductions due to adverse events. |
| 2023-03-30 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Announces Journal of Clinical Investigation Publication of Key Preclinical Data Linking Modulation of Fast Skeletal Muscle Contraction to Protection of Skeletal Muscle in Models of Duchenne Muscular Dystrophy (DMD) edgewisetx.com ↗
“This article illuminates the biology behind EDG-5506, demonstrating that modulation of fast skeletal muscle contraction protects against muscle injury, degeneration and fibrosis in models of DMD,” said Alan Russell, Ph.D., Chief Scientific Officer of Edgewise and senior author of the article. |
| 2022-10-13 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Announces Positive 6-Month Interim Results from the ARCH Open Label Study of EDG-5506 in Adults with Becker Muscular Dystrophy (BMD) edgewisetx.com ↗
The Company is reporting data at the end of 6 months of treatment with EDG-5506. |
| 2022-09-11 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Announces Positive 4-Month Interim Results from the ARCH Open Label Study of EDG-5506 in Adults with Becker Muscular Dystrophy (BMD) edgewisetx.com ↗
EDG-5506 was well-tolerated in all participants with no discontinuations or dose reductions. |
| 2022-09-07 | Edgewise Therapeutics, Inc. | Regulatory Edgewise Therapeutics Announces FDA Authorization for Phase 2 Clinical Trial of EDG-5506 for the Treatment of Duchenne Muscular Dystrophy (DMD) edgewisetx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has authorized a clinical trial of EDG-5506 in children with DMD. |
| 2022-06-20 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Announces Positive 2-Month Interim Results from the ARCH Open Label Study of EDG-5506 in Adults with Becker Muscular Dystrophy (BMD) edgewisetx.com ↗
EDG-5506 was well-tolerated with no discontinuations or dose reductions. |
| 2022-01-05 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Announces Positive Topline Results From the EDG-5506 Phase 1b Clinical Trial in Adults With Becker Muscular Dystrophy (BMD) edgewisetx.com ↗ |
| 2021-10-28 | Edgewise Therapeutics, Inc. | Results Edgewise Therapeutics Announces Positive Topline Results from the EDG-5506 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers (HVs) and Doses First Becker Muscular Dystrophy (BMD) Patients edgewisetx.com ↗
We are extremely encouraged by these multiple ascending dose data, which clearly demonstrate high levels of target engagement with a well-tolerated dosing regimen. |
| 2021-08-16 | Edgewise Therapeutics, Inc. | Regulatory Edgewise Receives U.S. FDA Fast Track Designation for EDG-5506 for the Treatment of Individuals with Becker Muscular Dystrophy (BMD) edgewisetx.com ↗
Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of individuals with BMD. |
All press releases naming this drug 35 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sevasemten | “Sevasemten (EDG-5506) is an orally administered,” PMID 40452637 ↗ Jun 2025 |
| Known as | EDG-005506 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314486 ↗ |
| Known as | EDG-5506 | “The ARCH study was an open-label, single-center, Phase 1b study of sevasemtem (EDG-5506) to assess the safety and pharmacokinetics (PK) of sevasemten in adults with Becker...” NCT05160415 ↗4“A study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON).” NCT05291091 ↗ “Sevasemten (EDG-5506) is an orally administered,” PMID 40452637 ↗ Jun 2025 |
| Action | Inhibit | “by inhibiting fast myosin ATPase” PMID 40452637 ↗ Jun 2025 |
| Modality | Small molecule | “investigational small molecule” PMID 40452637 ↗ Jun 2025 |
| Route | Oral | “Sevasemten (EDG-5506) is an orally administered” PMID 40452637 ↗ Jun 2025 |