Dyne Therapeutics

Dyne Therapeutics works on 3 rare diseases tracked on Trial Friend, including Duchenne Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy, with 7 recruiting clinical trials.

Dyne Therapeutics develops targeted muscle therapies using its FORCE platform, which conjugates antisense oligonucleotides to anti-transferrin receptor 1 (TfR1) antibody fragments for direct muscle and CNS delivery. The lead program DYNE-101 (zeleciment basivarsen) is in Phase 1/2 (ACHIEVE trial) for myotonic dystrophy type 1, with FDA Breakthrough Therapy and Fast Track designations. DYNE-251 targets Duchenne muscular dystrophy using exon-skipping.

Type
Rare Disease Specialist
Ticker
DYN
Headquarters
Waltham, United States
Founded
2017
7
Active Rare Disease Trials
3
Rare Diseases in Portfolio
9
Years Active
FDA decision ahead
The FDA is due to decide on Zeleciment rostudirsen for Duchenne muscular dystrophy (exon 51 skipping) by January 21, 2027.
See all upcoming rare disease FDA decisions →

Focus areas at Dyne Therapeutics

As a rare disease specialist, Dyne Therapeutics has active clinical trial programs and drug development efforts across 3 rare diseases, including Duchenne Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Myotonic Dystrophy. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows all active and recruiting studies sponsored by Dyne Therapeutics, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Dyne Therapeutics is headquartered in Waltham, United States, founded in 2017, publicly traded under the ticker symbol DYN. The company dedicates its research and development resources exclusively to rare and orphan diseases, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Dyne Therapeutics Drug Pipeline

Dyne Therapeutics has 7 active clinical trials across 3 development stages, with 7 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Dyne Therapeutics's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Dyne Therapeutics's pipeline
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2
Phase 22 trials
2
Phase 32 trials
3
Other3 trials
DM1+4 more
Recruiting
Recruiting

Dyne Therapeutics Clinical Trials (7)

Active and recruiting clinical trials sponsored by Dyne Therapeutics, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Dyne Therapeutics's trials
Type your own question with a little about your situation, and get an answer with sources.
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RECRUITINGPHASE3Recently updatedNCT07486934

Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1

Intervention: zeleciment basivarsen (DYNE-101), Placebo

The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment basivarsen (DYNE-101) for the treatment of myotonic dystrophy 1 (DM1).

Ages 16 Years+39 locations
View full study
ACTIVE NOT RECRUITINGPHASE1, PHASE2Recently updatedNCT05481879

Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1

Intervention: DYNE-101, Placebo

The primary purpose of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of DYNE-101 administered to participants with Myotonic Dystrophy Type 1 (DM1). The study consists of 4 periods: A Screening Period (up to 8 weeks), a Placebo-Controlled Period (24 weeks), a Treatment Period (24 weeks) and a Long-Term Extension (LTE) Period (208 weeks) in both multiple-ascending dose (MAD) and dose expansion cohorts.

Ages 18 Years - 65 Years20 locations
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ACTIVE NOT RECRUITINGRecently updatedNCT03458832

Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD

Intervention: FSHD-specific functional rating scale, Electrical Impedance Myography

The primary cause of facioscapulohumeral muscular dystrophy (FSHD), a common adult-onset dystrophy, was recently discovered identifying targets for therapy. As multiple drug companies pursue treatments for FSHD, there is an urgent need to define the clinical trial strategies which will hasten drug development, including creating disease-relevant outcome measures and optimizing inclusion criteria. This proposal will develop two new outcome measures (FSHD-COM and EIM) and optimize eligibility criteria by testing 320 patients across 14 international sites over a period of 24 months.

Ages 18 Years - 75 Years14 locations
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RECRUITINGRecently updatedNCT07700225

Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1) Extension

Myotonic Dystrophy type 1 (DM1) is an autosomal dominant multisystemic disorder that causes progressive disability and shortened life expectancy. It is characterized by progressive weakness and myotonia, which preferentially affects the craniofacial, hand, and distal leg muscles. Many patients also experience difficulties with cognition, cardiac arrhythmias, respiratory failure, or cataracts. Currently there is no treatment to slow progression or reverse the symptoms.

Ages 18 Years - 70 Years1 location
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ACTIVE NOT RECRUITINGPHASE1, PHASE2Recently updatedNCT05524883

Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-251 in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

Intervention: DYNE-251, Placebo

The primary purpose of this study is to evaluate the safety, tolerability, and dystrophin protein levels in muscle tissue following multiple intravenous (IV) doses of DYNE-251 in participants with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The study consists of 3 periods: a multiple-ascending dose (MAD) / placebo-controlled period (24 weeks), an open-label period (24 weeks) and a long-term extension (LTE) period (288 weeks).

Ages 4 Years - 16 Years30 locations
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RECRUITINGPHASE3Updated a few months agoNCT07608432

Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)

Intervention: Zeleciment Rostudirsen (DYNE-251), Placebo

Duchenne Muscular Dystrophy (DMD)Muscular Dystrophy, DuchenneMuscular Dystrophy (DMD)DMDMuscular Dystrophies

The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment rostudirsen (DYNE-251) administered intravenously (IV) every 4 weeks to ambulatory Duchenne muscular dystrophy (DMD) participants, 4 to 18 years of age, with dystrophin mutations amenable to exon 51 skipping.

Ages 4 Years - 18 Years1 location
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RECRUITINGUpdated a few months agoNCT04635891

Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)

The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD. Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) will have approximately 450 FSHD participants followed for a minimum of 3 years. A subset of MOVE FSHD participants, approximately 200, will participate in the MOVE+ sub-study which includes whole body MRI and reachable workspace, as well as optional muscle biopsy and wearable device (US participants only).

Ages not specified21 locations
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FDA-Approved Drugs

No FDA-approved drugs found for this company at this time.

Dyne Therapeutics Trial Locations

Dyne Therapeutics clinical trials are running at 126 sites in 16 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
56▼
United Kingdom
12▼
Italy
10▼
France
9▼
Germany
7▼
Belgium
5▼
Japan
5▼
Canada
5▼
Australia
4▼
Netherlands
4▼
Spain
3▼
Denmark
2▼

Rare Disease Focus Areas (3)

Diseases targeted by Dyne Therapeutics's clinical trial and drug development programs

Patient Resources

Organizations and resources related to Dyne Therapeutics's rare disease focus areas

Frequently Asked Questions About Dyne Therapeutics

Common questions about Dyne Therapeutics's rare disease programs, clinical trials, and treatments.