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Tinlarebant (LBS-008)

Stargardt disease type 1

Manufacturer
Belite Bio
Regulatory submission
NDA submitted June 2026
Last updated
66 sources

Product information and disease descriptionProduct description

Phase of product development

6 evidence topics · 6 sources

Product, sponsor, indication, and FDA orphan status: designation and approval status
FieldSource quotation
Orphan designation“Treatment of Stargardt disease”
Date designated“09/19/2017”
FDA orphan approval status“Not FDA Approved for Orphan Indication”
Regulatory submission: NDA submitted June 2026

“SAN DIEGO, June 12, 2026 (GLOBE NEWSWIRE)” (opens the source at this quote in a new tab)

“completion of its rolling submission of a New Drug Application (NDA)” (opens the source at this quote in a new tab)

FDA acceptance, review designation, and target action date

“accepted and granted Priority Review designation” (opens the source at this quote in a new tab)

“Prescription Drug User Fee Act target action date is February 12, 2027” (opens the source at this quote in a new tab)

Launch: Anticipated in March 2027

“U.S. LAUNCH READINESS” (opens the source at this quote in a new tab)

“Launch” (opens the source at this quote in a new tab)

“March 2027” (opens the source at this quote in a new tab)

Additional regulatory designations

“Breakthrough Therapy Designation” (opens the source at this quote in a new tab)

“Fast Track and Rare Pediatric Disease Designations in the U.S.” (opens the source at this quote in a new tab)

“Orphan Drug Designation in the U.S., Europe, and Japan” (opens the source at this quote in a new tab)

Japan: regulatory submission and expedited review

“submission of a New Drug Application (NDA)” (opens the source at this quote in a new tab)

“Tinlarebant has been designated a SAKIGAKE pharmaceutical product for accelerated review” (opens the source at this quote in a new tab)