Tinlarebant
Tinlarebant is an oral RBP4 inhibitor developed by Belite Bio for Stargardt disease and geographic atrophy. The next event is the FDA decision on Tinlarebant, on Feb 12, 2027 (source).
- Also known as
- LBS-008
- Company
- Belite Bio (BLTE) · Developer
- How it works
- RBP4 inhibitor
- Approved
- Not approved in any market we track
Development by disease
| Stargardt disease | Filed |
Upcoming events
Firm dates · a specific day set by the company or regulator
Later
- Feb 12in 122 daysTinlarebant · FDA decision · Stargardt disease (STGD1)
Past results and milestones
- Aug 11, 2026FDA accepted the NDA for tinlarebant on August 11, 2026 and granted Priority Review designation, with PDUFA target action date set for February 12, 2027. Source
- Jun 12, 2026Rolling NDA submission for tinlarebant completed on June 12, 2026. Application initiated in April 2026 under BTD and submitted to FDA; 60-day review period underway with PDUFA target action date to follow upon FDA acceptance. Source
- Dec 1, 2025The Phase 3 DRAGON trial met its primary endpoint: tinlarebant achieved a statistically significant 36% reduction in macular lesion growth rate versus placebo (p=0.0033), measured by DDAF in adolescents with STGD1. A post-hoc analysis demonstrated p=0.0001. Source
- May 21, 2025The FDA granted Breakthrough Therapy Designation for tinlarebant for the treatment of Stargardt disease (STGD1), based on interim Phase 3 DRAGON trial data demonstrating efficacy and a favorable safety profile. Source