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GenSight Biologics SA (DE:G49N)
FRANKFURT:G49N
Gs010, Sham Intravitreal Injection
Leber Hereditary Optic Neuropathy
Phase III
Completed
RESCUE and REVERSE Long-term Follow-up
Jan 15, 2018
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Gene Therapy: Gs030-Dp And Medical Device: Gs030-Md
Non-Syndromic Retinitis Pigmentosa
Phase I/II
Active Not Recruiting
Dose-escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa
Oct 11, 2017
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Gs010
Leber Hereditary Optic Neuropathy
Phase III
Completed
Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year
Sep 19, 2017
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Gs010, Sham Intravitreal Injection
Optic, Atrophy, Hereditary, Leber
Phase III
Completed
Efficacy Study of GS010 for Treatment of Vision Loss From 7 Months to 1 Year From Onset in LHON Due to the ND4 Mutation (REVERSE)
Jan 07, 2016
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Gs010, Sham Intravitreal Injection
Optic, Atrophy, Hereditary, Leber
Phase III
Completed
Efficacy Study of GS010 for the Treatment of Vision Loss up to 6 Months From Onset in LHON Due to the ND4 Mutation
Jan 07, 2016
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Gs010
Leber Hereditary Optic Neuropathy
Phase I/II
Completed
Safety Evaluation of Gene Therapy in Leber Hereditary Optic Neuropathy (LHON) Patients
Feb 13, 2014
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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 GenSight Biologics SA (G49N) have in its pipeline
G49N is currently developing the following drugs: Gs010, Sham Intravitreal Injection, Gene Therapy: Gs030-Dp And Medical Device: Gs030-Md, Gs010. These drug candidates are in various stages of clinical development as the company works toward FDA approval.