DYNE-101

Phase 3Small molecule

DDyne Therapeutics

DYNE-101 is one of 3 small molecule programs targeting Myotonic Dystrophy Type 1 (DM1). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Myotonic Dystrophy Type 1 (DM1)Recruiting

Myotonic Dystrophy Type 1Recruiting

Myotonic Dystrophy Type 1 (DM1)Phase 3

Recruiting

Myotonic Dystrophy Type 1Phase 3

Recruiting

Competition

Competitive Landscape

4 competitors in Myotonic Dystrophy Type 1

#DrugCompanyPhaseTrials

DYNE-101

DDyne Therapeutics

Phase 3

1 2

PGN-EDODM1

PPepGen Inc

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2029

Phase 3Recruiting

Myotonic Dystrophy Type 1 (DM1)

NCT07486934

Q3 2029

Phase 1/2Recruiting

Myotonic Dystrophy Type 1

NCT05481879

Clinical

Trials by Indication[1]

Myotonic Dystrophy Type 11 trial

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

Recruiting·DDyne Therapeutics·Phase 1/2·NCT05481879·116 enrolled

Myotonic Dystrophy Type 1 (DM1)1 trial

A Phase 3, Randomized, Double-Blind, 48-Week Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1

Recruiting·DDyne Therapeutics·Phase 3·NCT07486934·150 enrolled

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for DYNE-101. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — DYNE-101 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for DYNE-101. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Dyne Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDyne Therapeutics

DYNE-101

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2029

Q3 2029

Trials by Indication[1]

Myotonic Dystrophy Type 11 trial

Myotonic Dystrophy Type 1 (DM1)1 trial

References

Drug Info

Quick Facts

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