Clinical TrialJun 29, 2026, 04:27 PM
Gain Therapeutics' GT-02287 IND Authorized by FDA for Phase 2 Parkinson's
AI Summary
Gain Therapeutics announced that the U.S. Food and Drug Administration (FDA) has authorized its Investigational New Drug (IND) application for GT-02287. This decision allows the company to initiate Phase 2 clinical development of GT-02287 in the U.S. for Parkinson's disease, including cases with or without a GBA1 mutation. The Phase 2 study is expected to commence during the third quarter of 2026, enrolling participants across sites in the United States, Australia, and Europe.
Key Highlights
- FDA authorized Investigational New Drug (IND) application for GT-02287.
- Authorization allows initiation of Phase 2 clinical development in the U.S.
- GT-02287 targets Parkinson's disease with or without a GBA1 mutation.
- Phase 2 study is anticipated to begin in the third quarter of 2026.
- Phase 1a and 1b studies of GT-02287 were previously conducted in Australia.
- Phase 2a study will enroll participants in the U.S., Australia, and Europe.
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