Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as zeleciment basivarsen (DYNE-101)
zeleciment basivarsen · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| Placebo-Controlled Period: DYNE-101 | EXPERIMENTAL | Participants will be randomized to receive DYNE-101, once every 8 weeks (Q8W) for up to 48 weeks. |
| Placebo-Controlled Period: Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive DYNE-101 matching placebo, Q8W for up to 48 weeks. |
| Long-Term Extension Period: DYNE-101 | EXPERIMENTAL | Participants who receive DYNE-101 in Placebo-Controlled Period will continue to received DYNE-101, Q8W for up to 24 weeks. Participants who received placebo in Placebo-Controlled Period will receive DYNE-101, Q8W for up to 24 weeks. |
| Name | Type | Description |
|---|---|---|
| zeleciment basivarsen (DYNE-101) | DRUG | Administered by IV infusion |
| Placebo | DRUG | Administered by IV infusion |
Inclusion Criteria: * Diagnosis of DM1 confirmed by molecular genetics with trinucleotide repeat size greater than (\>) 100. Historical results from clinical testing are acceptable. * Able to walk 10 meters and complete 5 times sit to stand independently (inserts or supports that don't go above the...
Zeleciment basivarsen is an investigational drug being studied for the treatment of Myotonic Dystrophy Type 1 (DM1), a rare genetic disorder. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Zeleciment basivarsen is being developed by Dyne Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DYN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Myotonic Dystrophy Type 1.
Zeleciment basivarsen is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The ongoing Phase 3 trial is designed to assess its efficacy, safety, and tolerability in participants with Myotonic Dystrophy Type 1.
Zeleciment basivarsen is being evaluated in a Phase 3 clinical trial with the identifier NCT07486934. This randomized, double-blind, placebo-controlled study is recruiting approximately 150 participants with Myotonic Dystrophy Type 1 across multiple countries, including the United States, Australia, and several European nations.
Yes, zeleciment basivarsen is also known as DYNE-101. Both names refer to the same investigational drug being developed by Dyne Therapeutics for the treatment of Myotonic Dystrophy Type 1. The drug is currently in Phase 3 clinical trials.