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PGN-EDODM1 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| PGN-EDODM1 | EXPERIMENTAL | Participants will receive doses of PGN-EDODM1 once every 4 weeks (Q4W) |
| Placebo | PLACEBO_COMPARATOR | Participants randomized to the placebo arm will receive doses of saline (0.9% NaCl), once every 4 weeks (Q4W) for 12 weeks |
| Name | Type | Description |
|---|---|---|
| PGN-EDODM1 | DRUG | Administered by intravenous (IV) infusion |
| Placebo | OTHER | Administered by intravenous (IV) infusion |
Inclusion Criteria: * Participant has completed a prior study with PGN-EDODM1 Exclusion Criteria: * Abnormal laboratory tests at screening considered clinically significant by the Investigator * Use of an investigational drug (other than PGN-EDODM1), device, or product, within 30 days or 5 half-l...
PGN-EDODM1 is an investigational small molecule being developed for the treatment of Myotonic Dystrophy 1, a rare genetic disorder. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in clinical trials to evaluate its safety and efficacy in people with this condition.
PGN-EDODM1 is being developed by PepGen Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug for the treatment of Myotonic Dystrophy 1. PepGen Inc. is publicly traded under the ticker symbol PEPG.
PGN-EDODM1 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received FDA designations including Orphan Drug, Fast Track, and Rare Pediatric Disease, which are intended to facilitate its development and review.
PGN-EDODM1 is being studied in two Phase 2 clinical trials. The first trial, NCT06667453, is a randomized, double-blind, placebo-controlled study enrolling 24 participants with Myotonic Dystrophy 1 in Canada, New Zealand, South Korea, and the United Kingdom. The second trial, NCT07220603, is an open-label extension study enrolling 48 participants in Canada.
No, PGN-EDODM1 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for the treatment of Myotonic Dystrophy 1. The drug has received FDA designations including Orphan Drug, Fast Track, and Rare Pediatric Disease, but these designations do not indicate approval.