Tinlarebant
BELITE BIO, INC BLTE · Stargardt Disease 1; Geographic Atrophy; STGD1
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
3
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- BELITE BIO, INC BLTE Source: Company record for BELITE BIO, INC (opens in a new tab)
- Indications
- Stargardt Disease 1; Geographic Atrophy; STGD1 Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 31 Jul 20241 linked trial
- Phase 3 Current stageFirst trial start 28 Mar 20223 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Tinlarebant. Editors add each one with its source.
Filed application
No filed application is on record for Tinlarebant. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Tinlarebant.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06388083ClinicalTrials.gov record for NCT06388083 (opens in a new tab)DRAGON II | A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease | Phase 2/3 | Active, not recruiting | 60 (estimated) | Feb 2028 (estimated) | No |
| NCT05949593ClinicalTrials.gov record for NCT05949593 (opens in a new tab)PHOENIX | Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy | Phase 3 | Active, not recruiting | 429 (estimated) | 30 Jun 2027 (estimated) | No |
| NCT05244304ClinicalTrials.gov record for NCT05244304 (opens in a new tab)DRAGON | Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease | Phase 3 | Completed | 104 (actual) | 4 Aug 2025 (actual) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Tinlarebant.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT06388083 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05949593 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05244304 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.