Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tinlarebant · 5 trials · 6 indications
Area under the plasma concentration versus time curve from time 0 to the last time point with quantifiable concentration (AUC0-t)
Time of minimal RPB4 levels post-dose (Tmin)
To evaluate safety and tolerability of daily dosing of tinlarebant assessed by incidence and/or severity of ocular and non-ocular adverse events.
To determine optimal dose of tinlarebant administered orally in adolescent patients with Stargardt Disease.
| Arm | Type | Description |
|---|---|---|
| LBS-008, Tinlarebant | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Tinlarebant | EXPERIMENTAL | 5 mg tablet taken orally once a day |
| Cohort 1: 5 mg, fasted | ACTIVE_COMPARATOR | A single dose (5 mg) of tinlarebant will be administered to each study participant on study Day 1. |
| Cohort 2: 10 mg, fasted | ACTIVE_COMPARATOR | A single dose (10 mg) of tinlarebant will be administered to each study participant on study Day 1. |
| Name | Type | Description |
|---|---|---|
| Tinlarebant | DRUG | 5 mg tablet taken orally once a day |
| Placebo | DRUG | Placebo tablets for tinlarebant 5 mg prepared similarly. |
| Tinlarebant (LBS-008) | DRUG | A single dose of Tinlarebant (LBS-008) will be administered to each study participant on study Day 1. |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
Tinlarebant is an investigational small molecule being developed for Stargardt Disease 1 (STGD1) and Geographic Atrophy, both of which are ophthalmologic conditions. It is also being studied in healthy volunteers for pharmacokinetic and pharmacodynamic purposes. Tinlarebant is currently in Phase 3 clinical development for these indications.
Tinlarebant is a small molecule therapeutic being developed by Belite Bio, Inc. It is designed to target the underlying pathophysiology of Stargardt Disease and Geographic Atrophy, though the specific molecular target has not been disclosed in available information. The drug is being evaluated for its ability to slow disease progression in these retinal conditions.
Tinlarebant is being developed by Belite Bio, Inc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol BLTE. The company is conducting clinical trials to evaluate the safety and efficacy of Tinlarebant for the treatment of Stargardt Disease and Geographic Atrophy.
Tinlarebant is currently in Phase 3 clinical development for Stargardt Disease and Geographic Atrophy. It has received several FDA designations including Breakthrough Therapy, Fast Track, Orphan Drug, Rare Pediatric Disease, and Priority Review. The drug is investigational and has not yet been approved by regulatory authorities.
Tinlarebant has been studied in several clinical trials. NCT05244304 is a completed Phase 3 trial in adolescent Stargardt Disease. NCT05667688 is a completed Phase 1 trial in healthy volunteers. NCT05949593 is an active Phase 3 trial in Geographic Atrophy. NCT06388083 is an active Phase 2/3 trial in Stargardt Disease.
Tinlarebant is not FDA approved. It is an investigational drug currently in Phase 3 clinical trials for Stargardt Disease and Geographic Atrophy. The drug has received FDA designations including Breakthrough Therapy, Fast Track, Orphan Drug, Rare Pediatric Disease, and Priority Review, which facilitate its development and review process.