Product Description
Tinlarebant as an oral daily treatment to target RBP4 (retinol binding protein 4), disrupting vitamin A (retinol) binding to RBP4 (Sourced from: )
Mechanisms of Action: RBP4 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Breakthrough Therapy - Stargardt DiseaseFast Track - Stargardt Disease *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: RBP4
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belgium, China, Czech Republic, France, Germany, Hong Kong, Japan, Netherlands, Switzerland, Taiwan, United Kingdom, United States
Active Clinical Trial Count: 9
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Belite Bio presented P3 Stargardt Disease results on 2025-02-27 for Tinlarebant
- Clinical Outcomes Reported - Belite Bio presented P2 Stargardt Disease results on 2024-10-19 for Tinlarebant
- Clinical Outcomes Reported - Belite Bio presented P2 Stargardt Disease results on 2024-05-06 for Tinlarebant
Highest Development Phases
Phase 3: Geographic Atrophy|Macular Degeneration|Stargardt Disease
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05244304 |
DRAGON | P3 |
Completed |
Macular Degeneration|Stargardt Disease |
2025-08-04 |
3% |
2025-11-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-503931-17-00 |
LBS-008-CT05 | P3 |
Recruiting |
Geographic Atrophy |
2025-11-25 |
2025-05-02 |
Treatments |
|
ACTRN12623001328662 |
ACTRN12623001328662 | P2 |
Active, not recruiting |
Stargardt Disease |
2024-04-22 |
2025-07-26 |
Treatments |
|
NCT05266014 |
LBS-008-CT02 | P2 |
Completed |
Stargardt Disease|Macular Degeneration |
2023-08-15 |
50% |
2024-04-13 |
|
NCT06388083 |
DRAGON II | P3 |
Recruiting |
Stargardt Disease |
2027-12-01 |
9% |
2025-08-29 |
|
NCT05949593 |
PHOENIX | P3 |
Recruiting |
Geographic Atrophy |
2027-08-31 |
9% |
2023-09-29 |
|
ACTRN12624000031561 |
ACTRN12624000031561 | P1 |
Completed |
Geographic Atrophy |
2024-05-31 |
2025-07-26 |
Treatments |
|
2024-513483-26-00 |
LBS-008-CT03 | P3 |
Active, not recruiting |
Stargardt Disease |
2025-09-19 |
2025-05-02 |
Treatments |
|
NCT05667688 |
LBS-008-CT06 | P1 |
Completed |
Macular Degeneration |
2023-01-04 |
23% |
2023-02-24 |
Primary Endpoints |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/03/2025 |
News Article |
Belite Bio to Host Webcast on November 10, 2025, to Discuss Third Quarter 2025 Financial Results |
|
10/29/2025 |
News Article |
Belite Bio to Participate in the Deutsche Bank ADR Virtual Investor Conference |
|
10/29/2025 |
News Article |
Belite Bio to Present at the dbVIC - Deutsche Bank ADR Virtual Investor Conference November 4th |
|
10/16/2025 |
News Article |
Belite Bio to Participate in the 2025 Maxim Growth Summit |
|
07/19/2023 |
PubMed |
Analysis of Retinol Binding Protein 4 and ABCA4 Gene Variation in Non-Neovascular Age-Related Macular Degeneration. |
|
12/15/2021 |
PubMed |
Retinol binding protein 4 antagonists and protein synthesis inhibitors: Potential for therapeutic development. |