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Tinlarebant

Phase 3

Geographic Atrophy | Small molecule | Other |Belite Bio, Inc|Last Updated: Jan 7, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment429
FDA Designations
BREAKTHROUGH_THERAPYFAST_TRACKORPHAN_DRUGRARE_PEDIATRIC_DISEASE
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05949593Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic AtrophyPHASE3 ACTIVE NOT_RECRUITING 429Jul 27, 2023Aug 31, 2027Jan 7, 202649 United States, Australia +6
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Study Endpoints
Primary Endpoints
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
From baseline to Month 24]
Secondary Endpoints
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale
From baseline to Month 24
To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)
From baseline to Month 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LBS-008, TinlarebantEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
TinlarebantDRUG5 mg tablet taken orally once a day
PlaceboDRUGPlacebo tablets for tinlarebant 5 mg prepared similarly.
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Eligibility Criteria
Age Range60 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes. * Minimum BCVA is required in the study eye Exclusion Criteria: * The presence of diabetic macular edema or macular disease in either eye. * Diabetic retinopathy more advanced than mild n...

Countries:United StatesAustraliaChinaCzechiaFranceSwitzerlandTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05949593primaryCompletionDate: changed
LOWMay 24, 2026NCT05949593studyFirstPostDate: changed