Drug research

Tinlarebant

Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.

Drug identity checked against registry records

Also recorded as LBS-008

A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.

Included trials

Trial	Sponsor	Phase	Status	Primary completion
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt DiseaseNCT05244304	BLTE	Phase 3	Completed	2025-08-04Actual
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic AtrophyNCT05949593	BLTE	Phase 3	Active not recruiting	2027-06-30Estimated
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt DiseaseNCT06388083	BLTE	Phase 2, Phase 3	Active not recruiting	2028-02Estimated

Date as reported	Drug / company	Event	Condition	Evidence
2027-02-12Day	TinlarebantBelite Bio, Inc · BLTE	Company-disclosed PDUFA goal date	Stargardt disease type 1	Open original source Read source excerpt U.S. Food and Drug Administration accepted the New Drug Application with Priority Review for tinlarebant for the treatment of Stargardt disease type 1; Prescription Drug User Fee Act target action date of February 12, 2027 First seen: 26 Sep 2026 · Evidence last checked: 26 Sep 2026