USFDAJul 8, 2026, 07:01 AM
OKYO Pharma gets FDA alignment for single-trial Phase 3 urcosimod
AI Summary
OKYO Pharma announced positive feedback from its U.S. Food and Drug Administration (FDA) Type D meeting, validating the regulatory and clinical path forward for urcosimod. The FDA's alignment on a single-dose Phase 3 study design and potential single-trial registration pathway significantly de-risks and accelerates the development program. The company unveiled the NEPTUNE global trial, which will enroll approximately 111 subjects, and plans to seek FDA Breakthrough Therapy Designation for urcosimod, which already holds Fast Track designation.
Key Highlights
- FDA provided positive feedback on Type D meeting for urcosimod.
- FDA alignment on single-dose Phase 3 study design for urcosimod.
- Potential single-trial registration pathway for urcosimod.
- Company unveils NEPTUNE, a global Phase 3 trial in US and Europe.
- NEPTUNE trial to enroll approximately 111 subjects with 2:1 randomization.
- Company plans to seek FDA Breakthrough Therapy Designation (BTD).
- Urcosimod already has FDA Fast Track designation.
- Global Phase 3 pivotal trial for urcosimod to start in H2 this year.
Price Impact
More from OKYO