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Also known as DYNE-101, zeleciment basivarsen (DYNE-101)
Zeleciment basivarsen · 2 trials · 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. |
| MAD Cohort: Placebo-Controlled Period: DYNE-101 | EXPERIMENTAL | Participants will be randomized to receive ascending doses of DYNE-101, once every 4 weeks (Q4W) or once every 8 weeks (Q8W) for up to 24 weeks. |
| MAD Cohort: Placebo-Controlled Period: Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive DYNE-101 matching placebo, Q4W or Q8W for up to 24 weeks. |
| MAD Cohort: Treatment Period: DYNE-101 | EXPERIMENTAL | Participants who receive DYNE-101 in Placebo-Controlled Period will continue to receive DYNE-101, Q4W or Q8W for up to 24 weeks. Participants who receive placebo in Placebo-Controlled Period will receive DYNE-101, Q4W or Q8W for up to 24 weeks. |
| MAD Cohort: Long-Term Extension Period: DYNE-101 | EXPERIMENTAL | Participants will receive DYNE-101, Q4W or Q8W for up to 168 weeks. |
| Dose Expansion Cohort: Placebo-Controlled Period: DYNE-101 | EXPERIMENTAL | Participants will receive DYNE-101, Q8W for up to 24 weeks. |
| Dose Expansion Cohort: Placebo-Controlled Period: Placebo | EXPERIMENTAL | Participants will receive DYNE-101 matching placebo, Q8W for up to 24 weeks. |
| Dose Expansion Cohort: Treatment Period: DYNE-101 | EXPERIMENTAL | Participants who receive DYNE-101 in Placebo-Controlled Period will continue to receive DYNE-101, Q8W for up to 24 weeks. Participants who receive placebo in Placebo-Controlled Period will receive DYNE-101, Q8W for up to 24 weeks. |
| Dose Expansion Cohort: Long-Term Extension Period: DYNE-101 | EXPERIMENTAL | Participants will receive DYNE-101, Q8W for up to 168 weeks. |
| Name | Type | Description |
|---|---|---|
| zeleciment basivarsen (DYNE-101) | DRUG | Administered by IV infusion |
| Placebo | DRUG | Administered by IV infusion |
| DYNE-101 | 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, also known as DYNE-101, is an investigational small molecule being developed 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 targets the DMPK gene, which is associated with Myotonic Dystrophy Type 1. By targeting DMPK, the drug aims to address the underlying cause of the disease. It is being studied in a Phase 3 clinical trial for its efficacy and safety in patients with DM1.
Zeleciment basivarsen is being developed by Dyne Therapeutics, Inc., a biopharmaceutical company. The company is conducting a Phase 3 clinical trial to evaluate the drug's efficacy, safety, and tolerability in participants with Myotonic Dystrophy Type 1.
Zeleciment basivarsen is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is recruiting participants to assess its effects in Myotonic Dystrophy Type 1.
Zeleciment basivarsen is being studied in a Phase 3 clinical trial with the identifier NCT07486934. This randomized, double-blind, placebo-controlled trial is recruiting approximately 150 participants with Myotonic Dystrophy Type 1 across multiple countries, including the United States, Australia, and several European and Asian 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. It is currently in Phase 3 clinical trials.