Sevasemten
An investigational treatment for Becker Muscular Dystrophy and Duchenne Muscular Dystrophy.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Sevasemten wherever you encounter it, plus the key facts at a glance.
- Generic name
- Sevasemten
- Development code
- EDG-5506
- Drug class
- Fast skeletal muscle myosin inhibitor
- Manufacturer
- Servier (developed by Edgewise Therapeutics)
- How it's taken
- Pill once a day, in studies only
An investigational once-daily pill for Becker and Duchenne muscular dystrophy.
On November 3, 2026, Servier, which bought sevasemten from Edgewise Therapeutics in July 2026, reported that the pivotal GRAND CANYON study in Becker did not meet its main goal [1] [2] or its secondary goals [1]. It is not approved anywhere, and Servier has said only that it is analyzing the full data and will present results later.
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How Sevasemten works
In Becker and Duchenne muscular dystrophy, muscle fibers lack enough working dystrophin, the protein that helps them withstand the force of contracting. Sevasemten partly slows fast skeletal muscle myosin, the motor protein that powers fast-twitch muscle fibers, and Edgewise designed it to limit the exaggerated muscle damage caused by the loss of working dystrophin [8]. In early studies it lowered blood markers of muscle injury such as creatine kinase (CK) and fast skeletal troponin I [9] [5].
Clinical trial results
GRAND CANYON was the pivotal 18-month, placebo-controlled study of sevasemten in 175 people with Becker, run as a cohort inside a study ClinicalTrials.gov registers as Phase 2 (NCT05291091). Its main measure was the change in the North Star Ambulatory Assessment (NSAA), a test of walking, standing and climbing [14] [4]. ClinicalTrials.gov lists the study as completed [14].
Servier reported on November 3, 2026 that it did not meet that goal or its secondary goals, that the results do not line up with some earlier findings, and that it is analyzing the full data and will present full results later. Servier has not published the numbers [1]. STAT reported the same day that the study missed its goal [2].
The earlier CANYON cohort of 40 adults met its main goal, a 28% average drop in CK against placebo over months 6 to 12, while the NSAA difference after 12 months, 1.1 points favoring sevasemten, was not statistically significant, meaning it could have been chance [5].
In Duchenne, the Phase 2 LYNX study (NCT05540860, 76 boys aged 4 to 9) and FOX study (NCT06100887, 43 boys previously treated with gene therapy) are no longer enrolling, with primary completion estimated in 2027 [16] [17]. The MESA extension (NCT06066580) continues by invitation only for people with Becker from the earlier Becker studies [15]. No sevasemten study is recruiting new participants.
Main registered trial: NCT05291091 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Side effects and safety
Servier said GRAND CANYON showed a continued favorable safety and tolerability profile, without giving rates [1]. In a Phase 1 study of up to 14 days in 97 healthy volunteers and 7 adults with Becker, no one had a serious side effect or stopped because of one, and the most common side effects were dizziness and sleepiness [9]. In the ARCH study of 12 adults, all side effects were mild or moderate, with no serious side effects [10].
In a study in healthy volunteers, traces of the drug and its breakdown products left the blood slowly, over about 2 to 3 weeks [11]. No clinical hold has been reported.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Sevasemten
A tablet taken by mouth once a day. Adults in CANYON and GRAND CANYON took 10mg, and adolescents in CANYON took 5mg or 12.5mg [14]; the ARCH study also used 15mg and 20mg [10]. Edgewise said in June 2025 that LYNX identified 10mg as the dose to test in a Duchenne Phase 3 [6]. A study by Edgewise scientists found a high-fat meal raised total exposure in the blood by 20-38% while peak levels stayed about the same, which the authors said supports taking it with or without food [12]. Sevasemten is available only to people already enrolled in its studies.
Development history
Edgewise Therapeutics developed sevasemten. The FDA granted orphan drug and Fast Track designations for both Becker and Duchenne, and rare pediatric disease designation for Duchenne [4]; the European Medicines Agency granted orphan designations for both [4] [13]. In June 2025 Edgewise said the FDA viewed CANYON alone as insufficient for accelerated approval, a faster path based on an early marker rather than a functional result, and supported GRAND CANYON as a possible single study for approval [6].
Edgewise had planned a Becker filing in the first half of 2027 [7]. Edgewise announced on June 1, 2026 that Servier would buy sevasemten for $1.55 billion upfront plus up to $1.1 billion in milestones [3], and the sale closed on July 13, 2026 [4]. After the November 3, 2026 result, Servier has not announced a filing plan or the future of the Duchenne studies.
Explore Becker Muscular Dystrophy and Duchenne Muscular Dystrophy trials
Other Becker Muscular Dystrophy & Duchenne Muscular Dystrophy treatments
Common questions about Sevasemten
▸What is Sevasemten?
An investigational once-daily pill for Becker and Duchenne muscular dystrophy. On November 3, 2026, Servier, which bought sevasemten from Edgewise Therapeutics in July 2026, reported that the pivotal GRAND CANYON study in Becker did not meet its main goal [1] [2] or its secondary goals [1]. It is not approved anywhere, and Servier has said only that it is analyzing the full data and will present results later.
▸How does Sevasemten work?
In Becker and Duchenne muscular dystrophy, muscle fibers lack enough working dystrophin, the protein that helps them withstand the force of contracting. Sevasemten partly slows fast skeletal muscle myosin, the motor protein that powers fast-twitch muscle fibers, and Edgewise designed it to limit the exaggerated muscle damage caused by the loss of working dystrophin [8]. In early studies it lowered blood markers of muscle injury such as creatine kinase (CK) and fast skeletal troponin I [9] [5].
▸What are the side effects of Sevasemten?
Servier said GRAND CANYON showed a continued favorable safety and tolerability profile, without giving rates [1]. In a Phase 1 study of up to 14 days in 97 healthy volunteers and 7 adults with Becker, no one had a serious side effect or stopped because of one, and the most common side effects were dizziness and sleepiness [9]. In the ARCH study of 12 adults, all side effects were mild or moderate, with no serious side effects [10]. In a study in healthy volunteers, traces of the drug and its breakdown products left the blood slowly, over about 2 to 3 weeks [11]. No clinical hold has been reported.
▸How is Sevasemten taken?
A tablet taken by mouth once a day. Adults in CANYON and GRAND CANYON took 10mg, and adolescents in CANYON took 5mg or 12.5mg [14]; the ARCH study also used 15mg and 20mg [10]. Edgewise said in June 2025 that LYNX identified 10mg as the dose to test in a Duchenne Phase 3 [6]. A study by Edgewise scientists found a high-fat meal raised total exposure in the blood by 20-38% while peak levels stayed about the same, which the authors said supports taking it with or without food [12]. Sevasemten is available only to people already enrolled in its studies.
▸Is Sevasemten FDA approved?
Sevasemten is currently in phase 2 clinical trials for Becker Muscular Dystrophy and Duchenne Muscular Dystrophy. It has not yet received FDA approval.
▸Did sevasemten work in the GRAND CANYON trial for Becker muscular dystrophy?
No. Servier reported on November 3, 2026 that GRAND CANYON did not meet its main goal or its secondary goals.
Main goal: the change in the North Star Ambulatory Assessment over 18 months, compared with placebo.
Numbers: not yet published; Servier says full results will be presented later.
Safety: Servier described a continued favorable safety and tolerability profile.
Source: Servier release, November 3, 2026; STAT, November 3, 2026.
▸Is sevasemten FDA approved?
No. Sevasemten is investigational and not approved anywhere.
Filing: Edgewise had planned a Becker application in the first half of 2027, and Servier has not announced a plan since the GRAND CANYON result.
Source: Edgewise release, February 26, 2026; Servier release, November 3, 2026.
▸Who makes sevasemten now?
Servier. It bought sevasemten from Edgewise Therapeutics in a sale that closed on July 13, 2026.
What Servier got: all rights, including the regulatory filings and clinical data.
Registry: ClinicalTrials.gov records still list Edgewise as the sponsor.
Source: Edgewise release, July 13, 2026; ClinicalTrials.gov NCT05291091.
▸Can someone with Becker or Duchenne join a sevasemten study now?
Not right now. No sevasemten study is recruiting new participants.
MESA: an extension open by invitation only to people with Becker who took part in earlier Becker studies.
Duchenne: the LYNX and FOX studies are no longer enrolling.
Next step: a neuromuscular specialist can point to other Becker and Duchenne trials that are open.
Source: ClinicalTrials.gov NCT06066580, NCT05540860 and NCT06100887.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Servier · 2026-11-03. Servier Announces Topline Pivotal Results for Sevasemten in Becker Muscular Dystrophy. https://servier.com/en/newsroom/topline-pivotal-results-sevasemten-becker/
- STAT (Jason Mast) · 2026-11-03. Servier's $1.55 billion muscular dystrophy drug fails first major test. https://www.statnews.com/2026/11/03/becker-muscular-dystrophy-servier-edgewise-sevasemten-fail/
- STAT · 2026-06-01. Servier to buy Edgewise Therapeutics' muscular dystrophy drug. https://www.statnews.com/2026/06/01/servier-edgewise-therapeutics-muscular-dystrophy-drug-sevasemten/
- Edgewise Therapeutics (BioSpace wire copy) · 2026-07-13. Edgewise Therapeutics Completes Sale of Sevasemten for Up to $2.65 Billion, Strengthening Balance Sheet and Centering Company Focus on Cardiovascular Pipeline. https://www.biospace.com/press-releases/edgewise-therapeutics-completes-sale-of-sevasemten-for-up-to-2-65-billion-strengthening-balance-sheet-and-centering-company-focus-on-cardiovascular-pipeline
- Edgewise Therapeutics · 2024-12-16. Edgewise Therapeutics Announces Positive Topline Results from the CANYON Phase 2 Trial of Sevasemten in Individuals with Becker Muscular Dystrophy (Becker). https://investors.edgewisetx.com/news/news-details/2024/Edgewise-Therapeutics-Announces-Positive-Topline-Results-from-the-CANYON-Phase-2-Trial-of-Sevasemten-in-Individuals-with-Becker-Muscular-Dystrophy-Becker/default.aspx
- Edgewise Therapeutics · 2025-06-26. Edgewise Therapeutics reports positive results on sevasemten program for Becker and Duchenne muscular dystrophies. https://investors.edgewisetx.com/news/news-details/2025/Edgewise-Therapeutics-Reports-Positive-Results-on-Sevasemten-Program-for-Becker-and-Duchenne-Muscular-Dystrophies/default.aspx
- Edgewise Therapeutics (BioSpace wire copy) · 2026-02-26. Edgewise Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results with Strong Progress Across Muscular Dystrophy and Cardiovascular Programs. https://www.biospace.com/press-releases/edgewise-therapeutics-reports-fourth-quarter-and-full-year-2025-financial-results-with-strong-progress-across-muscular-dystrophy-and-cardiovascular-programs
- Edgewise Therapeutics · 2026-03-03. Edgewise Therapeutics to present on sevasemten for the treatment of Becker muscular dystrophy at the 2026 MDA Clinical and Scientific Conference. https://investors.edgewisetx.com/news/news-details/2026/Edgewise-Therapeutics-to-Present-on-Sevasemten-for-the-Treatment-of-Becker-Muscular-Dystrophy-at-the-2026-MDA-Clinical-and-Scientific-Conference/default.aspx
- Muscle & Nerve · 2025-09. A Phase 1, Double-Blind, Placebo-Controlled Trial of Sevasemten (EDG-5506), a Selective Modulator of Fast Skeletal Muscle Contraction, in Healthy Volunteers and Adults With Becker Muscular Dystrophy. https://pubmed.ncbi.nlm.nih.gov/40452637/
- eBioMedicine · 2026-07. Effects of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults with Becker muscular dystrophy: results of a phase 1b, open-label study. https://pubmed.ncbi.nlm.nih.gov/42308588/
- Journal of Clinical Pharmacology · 2026-07. Human Disposition, Metabolism, and Excretion of Sevasemten (EDG-5506), a Selective Modulator of Fast Myosin in Healthy Volunteers. https://pubmed.ncbi.nlm.nih.gov/42394192/
- Clinical and Translational Science · 2026-11. Phase 1 Evaluation of the Pharmacokinetics of Sevasemten (EDG-5506) for Potential Food Effect and Drug-Drug Interaction With a CYP3A4 Moderate Inhibitor. https://pubmed.ncbi.nlm.nih.gov/42974700/
- European Medicines Agency · 2024-03-21. EU/3/24/2907 - orphan designation for treatment of Becker muscular dystrophy. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-24-2907
- ClinicalTrials.gov. Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON). https://clinicaltrials.gov/study/NCT05291091
- ClinicalTrials.gov. Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy (MESA). https://clinicaltrials.gov/study/NCT06066580
- ClinicalTrials.gov. A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX). https://clinicaltrials.gov/study/NCT05540860
- ClinicalTrials.gov. Phase 2 Study of EDG-5506 in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy (FOX). https://clinicaltrials.gov/study/NCT06100887