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Design Therapeutics (DSGN)
NASDAQ:DSGN
Dt-168
Fuchs Endothelial Corneal Dystrophy, Fuchs
Phase II
Recruiting
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
May 20, 2025
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Dt-216P2
Friedreich Ataxia
Phase I/II
Recruiting
A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia
Feb 25, 2025
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Saline, Dt-216P2
Friedreich Ataxia
Phase I
Not Yet Recruiting
A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants
Jan 06, 2025
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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 Design Therapeutics (DSGN) have in its pipeline
DSGN is currently developing the following drugs: Dt-168, Dt-216P2, Saline, Dt-216P2. These drug candidates are in various stages of clinical development as the company works toward FDA approval.