• Organizations: Belite Bio
FDA accepts Belite's tinlarebant NDA for Stargardt
Pipeline

FDA accepts Belite's tinlarebant NDA for Stargardt

Federal agency also grants priority review for the once-daily oral therapeutic, establishing a PDUFA target action date for Feb. 12, 2027.
Belite Bio presents updated phase 3 data on oral tinlarebant for Stargardt
Pipeline

Belite Bio presents updated phase 3 data on oral tinlarebant for Stargardt

Findings released at ASRS highlight an 80% reduction in key protein implicated in Stargardt disease after 2 years.
Belite Bio completes rolling NDA submission of oral tinlarebant for Stargardt
Pipeline

Belite Bio completes rolling NDA submission of oral tinlarebant for Stargardt

Next up: a 60-day review period ahead of a potential PDUFA target action date assignment; could become the first FDA-approved treatment for Stargardt.
Belite Bio begins rolling NDA submission of oral tinlarebant for Stargardt
Pipeline

Belite Bio begins rolling NDA submission of oral tinlarebant for Stargardt

Full submission planned for Q2 2026, once-daily tablet has potential to become the first-ever treatment approved for this patient base. 
Belite Bio reports phase 3 topline data on oral tinlarebant for Stargardt disease
Pipeline

Belite Bio reports phase 3 topline data on oral tinlarebant for Stargardt disease

DRAGON study is evaluating the once-daily tablet for reducing lesion growth among adolescent patients over a 24-month period.
Belite Bio concludes enrollment for phase 3 GA trial on oral tinlarebant
Pipeline

Belite Bio concludes enrollment for phase 3 GA trial on oral tinlarebant

Also under clinical development for Stargardt disease, the once-daily tablet is under evaluation for its efficacy in slowing atrophic lesion growth.