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RegenXBio (RGNX)
NASDAQ:RGNX
Rgx-202
Duchenne Muscular Dystrophy
Phase II/III
Recruiting
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
Jan 04, 2023
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RGX-121
Mucopolysaccharidosis Type Ii (Mps Ii)
Phase I/II
Completed
RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome)
Sep 23, 2020
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RGX-121
Mucopolysaccharidosis Type Ii (Mps Ii)
Phase II/III
Active Not Recruiting
CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome)
May 01, 2018
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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 RegenXBio (RGNX) have in its pipeline
RGNX is currently developing the following drugs: Rgx-202, RGX-121, RGX-121. These drug candidates are in various stages of clinical development as the company works toward FDA approval.