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Tinlarebant

Phase 3

Geographic Atrophy | Small molecule | Ophthalmology |Belite Bio, Inc|Last Updated: Jul 23, 2026

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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment429
FDA Designations
BREAKTHROUGH_THERAPYFAST_TRACKORPHAN_DRUGRARE_PEDIATRIC_DISEASE
Clinical trial landscape

Tinlarebant · 5 trials · 6 indications

Phase 3 2Phase 2 1Phase 1 2
NCT05949593Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic AtrophyGeographic Atrophy
ACTIVE NOT_RECRUITING429 Analytics
NCT05244304Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt DiseaseStargardt Disease 1
COMPLETED104 Analytics
PHASE3ACTIVE NOT_RECRUITING
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
Geographic Atrophy
NCT05949593429
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PHASE3COMPLETED
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease
Stargardt Disease 1
NCT05244304104
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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]
To measure change in atrophic lesion size (definitely decreased autofluorescence, DDAF) by fundus autofluorescence (FAF) photography from baseline
Baseline thru month 24
To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy
From baseline to Month 24
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Up to 168 hours

Area under the plasma concentration versus time curve from time 0 to the last time point with quantifiable concentration (AUC0-t)

To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Up to 168 hours

Time of minimal RPB4 levels post-dose (Tmin)

To evaluate systemic and ocular safety and tolerability of tinlarebant.
From baseline to 24 months

To evaluate safety and tolerability of daily dosing of tinlarebant assessed by incidence and/or severity of ocular and non-ocular adverse events.

The optimal dose for Phase 2.
Up to 24 months

To determine optimal dose of tinlarebant administered orally in adolescent patients with Stargardt Disease.

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
To measure the change in retinal thickness assessed by spectral-domain optical coherence tomography (SD-OCT) from baseline
Baseline thru month 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LBS-008, TinlarebantEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
TinlarebantEXPERIMENTAL5 mg tablet taken orally once a day
Cohort 1: 5 mg, fastedACTIVE_COMPARATORA single dose (5 mg) of tinlarebant will be administered to each study participant on study Day 1.
Cohort 2: 10 mg, fastedACTIVE_COMPARATORA single dose (10 mg) of tinlarebant will be administered to each study participant on study Day 1.
Interventions
NameTypeDescription
TinlarebantDRUG5 mg tablet taken orally once a day
PlaceboDRUGPlacebo tablets for tinlarebant 5 mg prepared similarly.
Tinlarebant (LBS-008)DRUGA single dose of Tinlarebant (LBS-008) will be administered to each study participant on study Day 1.
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Eligibility Criteria
Age Range60 Years to 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 KingdomBelgiumGermanyHong KongNetherlandsJapan
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Competitive Landscape -Geographic Atrophy 9 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN2PHASE3Pozelimab, Cemdisiran
Annexon, Inc.ANNX1PHASE3Vonaprument
Belite Bio, Inc. ADRBLTE1PHASE3Tinlarebant
Johnson & JohnsonJNJ1PHASE2JNJ-81201887
AbbVie, Inc.ABBV1PHASE1ABBV-6628, SYFOVRE
Sanofi SA Sponsored ADRSNY1PHASE1SAR446597, Sham Comparator
Ocugen IncOCGN1PHASE1OCU410
Apellis Pharmaceuticals, Inc.APLS1 - Pegcetacoplan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05949593primaryCompletionDate: changed
LOWMay 26, 2026NCT06388083primaryCompletionDate: changed
LOWMay 24, 2026NCT05949593studyFirstPostDate: changed
LOWMay 24, 2026NCT06388083studyFirstPostDate: changed