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PepGen Inc. (PEPG)
NASDAQ:PEPG
Pgn-Edodm1
Myotonic Dystrophy 1
Phase II
Not Yet Recruiting
An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
Oct 22, 2025
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Iv Infusion
Duchenne Muscular Dystrophy (Dmd)
Phase II
Withdrawn
A Study of PGN-EDO51 or Placebo in People With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment
Feb 13, 2025
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Pgn-Edodm1
Myotonic Dystrophy 1
Phase II
Recruiting
A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1
Oct 22, 2024
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Pgn-Edodm1 For Infusion
Myotonic Dystrophy 1
Phase I
Active Not Recruiting
Safety, Tolerability, PK, and PD Study of PGN-EDODM1 in Participants With Myotonic Dystrophy Type 1
Dec 05, 2023
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Pgn-Edo51
Duchenne Muscular Dystrophy
Phase II
Terminated
A Study Of PGN-EDO51 In Participants With Duchenne Muscular Dystrophy Amenable To Exon 51-Skipping Treatment
Sep 29, 2023
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does PepGen Inc. (PEPG) have in its pipeline
PEPG is currently developing the following drugs: Pgn-Edodm1, Iv Infusion, Pgn-Edodm1. These drug candidates are in various stages of clinical development as the company works toward FDA approval.