RegulatoryMay 18, 2026, 04:02 PM
Belite Bio's Tinlarebant Gets Swiss Orphan Drug Status for STGD1
AI Summary
Belite Bio announced that Swissmedic granted orphan drug status to tinlarebant for Stargardt disease (STGD1), a rare inherited retinal disorder with no approved treatments. This follows positive Phase 3 DRAGON trial results, where tinlarebant showed a 35.7% reduction in retinal lesion growth. The company has also initiated a rolling NDA submission with the U.S. FDA, expected to complete in Q2 2026, and tinlarebant holds multiple other designations globally.
Key Highlights
- Belite Bio's tinlarebant received Swissmedic Orphan Drug Status for Stargardt disease.
- Tinlarebant demonstrated a 35.7% reduction in retinal lesion growth rate in Phase 3 DRAGON trial.
- Company initiated rolling NDA submission with U.S. FDA, expected to complete in 2Q 2026.
- Swiss ODS provides 15 years of document protection and accelerated review timelines.
- Tinlarebant previously received Breakthrough Therapy, Fast Track, Rare Pediatric Disease Designations in U.S.
- Orphan Drug Designation also granted in U.S., Europe, and Japan.
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