Drugs / Tinlarebant
Tinlarebant
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diffuse secondary choroid atrophy 4 milestones | |||||
| Filed | China (NMPA) | — | diffuse secondary choroid atrophy | 2023-10-17 | “submission to the National Medical Products Administration (NMPA) to initiate the Phase 3 clinical trial of Tinlarebant in GA” belitebio.com ↗ |
| Filed | Other | — | diffuse secondary choroid atrophy | 2023-10-06 | “submission to Swissmedic to initiate the Phase 3 clinical trial of Tinlarebant in GA (the PHOENIX study)” belitebio.com ↗ |
| Filed | EU (EMA) | — | diffuse secondary choroid atrophy | 2023-09-20 | “submission of the Clinical Trial Application to the European Medicines Agency (EMA) to initiate the Phase 3 clinical trial of Tinlarebant in GA” belitebio.com ↗ |
| Filed | UK (MHRA) | — | diffuse secondary choroid atrophy | 2023-09-01 | “submission to the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate the Phase 3 clinical trial of Tinlarebant in GA” belitebio.com ↗ |
| Filed Stargardt disease 5 4 milestones | |||||
| Filed | China (NMPA) | — | Stargardt disease 5 | 2025-10-15 | “China’s NMPA has agreed to accept New Drug Application with priority review for Tinlarebant for the treatment of Stargardt disease” belitebio.com ↗ |
| Filed | UK (MHRA) | — | Stargardt disease 5 | 2024-04-18 | “submission to the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate the Phase 2/3 portion of the DRAGON II clinical trial in the United Kingdom” belitebio.com ↗ |
| Filed | US (FDA) | — | Stargardt disease 5 | 2024-03-25 | “submission to the FDA to initiate the Phase 2/3 portion of the DRAGON II clinical trial in the U.S.” belitebio.com ↗ |
| Filed | Japan (PMDA) | — | Stargardt disease 5 | 2024-03-22 | “submission to the Pharmaceuticals and Medical Devices Agency (PMDA) to initiate a clinical trial of Tinlarebant in adolescent STGD1 in Japan (“DRAGON II”)” belitebio.com ↗ |
| Filed Indication not stated 3 milestones | |||||
| Filed | Japan (PMDA) | — | Stargardt disease type 1 | 2026-09-08 | “submission of a New Drug Application (NDA) to the Ministry of Health, Labour, and Welfare (MHLW) in Japan for tinlarebant in Stargardt disease type 1 (STGD1)” belitebio.com ↗ |
| Filed | US (FDA) | — | Stargardt disease type 1 | 2026-06-12 | “today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant” belitebio.com ↗ |
| Filed | US (FDA) | — | Stargardt disease type 1 | 2026-04-21 | “it has initiated a rolling submission of an New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant” belitebio.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04005807 | Jul → Dec 2019 | — | Belite Bio, Inc | Completed | No outcome recorded |
| Phase 1 | NCT03735810 | Nov 2018 → Sep 2019 | — | RBP4 Pty Ltd | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05266014 | Mar 2021 → Aug 2023 | Stargardt disease | RBP4 Pty Ltd | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06388083 | Jul 2024 → Feb 2028 expected | Stargardt disease | Belite Bio, Inc | Active not recruiting | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05949593 | Jul 2023 → Jun 2027 expected | diffuse secondary choroid atrophy | Belite Bio, Inc | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05244304 | Mar 2022 → Aug 2025 | Stargardt disease | Belite Bio, Inc | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05667688 Comparator | Nov 2022 → Jan 2023 | dry age related macular degeneration | RBP4 Pty Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 54
| Date | Issuer | Release |
|---|---|---|
| 2026-09-08 | Belite Bio, Inc | Regulatory Belite Bio Announces Submission of New Drug Application to the Ministry of Health, Labour, and Welfare in Japan under the Sakigake Designation System for Tinlarebant for the Treatment of Stargardt Disease Type 1 belitebio.com ↗
Tinlarebant has been designated a SAKIGAKE pharmaceutical product for accelerated review and the NDA in Japan was filed side-by-side with the United States NDA to enable simultaneous early access for patients in both regions. |
| 2026-08-11 | Belite Bio, Inc | Regulatory Belite Bio Announces U.S. Food and Drug Administration Acceptance and Priority Review of New Drug Application for Tinlarebant for the Treatment of Stargardt Disease Type 1 belitebio.com ↗ |
| 2026-07-20 | Belite Bio, Inc | Results Belite Bio Announces Oral Presentation at the ASRS Annual Meeting Featuring Additional Positive Secondary Endpoint Data from the Phase 3 Trial of Tinlarebant in Stargardt Disease Type 1 belitebio.com ↗
Notably, the presentation reported that quantitative autofluorescence (qAF), a marker of toxic bisretinoid accumulation, showed a marked divergence between treatment groups. |
| 2026-06-12 | Belite Bio, Inc | Regulatory Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1 belitebio.com ↗
The rolling NDA was initiated in April 2026 and was submitted under Breakthrough Therapy Designation (BTD), which was granted by the FDA due to the high unmet need among patients living with STGD1. |
| 2026-05-18 | Belite Bio, Inc | Regulatory Belite Bio Receives Orphan Drug Status for Tinlarebant in Stargardt Disease in Switzerland belitebio.com ↗
the Swiss Agency for Therapeutic Products (Swissmedic) has granted tinlarebant, the Company’s lead product candidate, orphan drug status (ODS) for the treatment of Stargardt disease (STGD1), a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. |
| 2026-04-21 | Belite Bio, Inc | Regulatory Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease belitebio.com ↗ |
| 2025-12-01 | Belite Bio, Inc | Results New Hope for People Living with a Disease Once Deemed Untreatable: Belite Bio Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents with Stargardt Disease belitebio.com ↗
Tinlarebant met the primary efficacy endpoint, demonstrating clinical benefit by significantly reducing the lesion growth rate by 36% compared to placebo, as measured by retinal imaging |
| 2025-11-02 | Belite Bio, Inc | Regulatory Belite Bio Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant belitebio.com ↗ |
| 2025-10-15 | Belite Bio, Inc | Regulatory Belite Bio Announces China NMPA Agrees to New Drug Application with Priority Review based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant belitebio.com ↗
Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has agreed to accept the New Drug Application (NDA) with priority review for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial. |
| 2025-05-21 | Belite Bio, Inc | Regulatory Belite Bio Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt Disease belitebio.com ↗ |
| 2025-02-27 | Belite Bio, Inc | Results Belite Bio Announces Interim Analysis Results from the Pivotal Global Phase 3 DRAGON trial of Tinlarebant in Adolescent Stargardt Disease Subjects belitebio.com ↗
An independent Data Safety Monitoring Board (DSMB) for the Phase 3 DRAGON trial recommends trial continuation without any modifications, maintaining the sample size at 104 subjects following a planned interim efficacy analysis; trial completion expected by Q4 2025 (including a three-month follow-up period) |
| 2024-06-18 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate a Second Stargardt Disease Clinical Trial in the United Kingdom belitebio.com ↗
today announces the Medicines and Healthcare products Regulatory Agency (MHRA) approval for a second clinical trial of Tinlarebant in adolescent STGD1 in the United Kingdom (“DRAGON II”). |
| 2024-06-12 | Belite Bio, Inc | Regulatory Belite Bio Receives Sakigake (Pioneer Drug) Designation of Tinlarebant for Stargardt Disease in Japan belitebio.com ↗ |
| 2024-05-06 | Belite Bio, Inc | Results Belite Bio Presents Additional Analysis from Phase 2 Study of Tinlarebant in Stargardt Disease at the ARVO Annual Meeting belitebio.com ↗
Additional analysis of visual acuity loss, genotypic profiles, and retinal imaging data from a 24-month Phase 2 trial of Tinlarebant in adolescent Stargardt disease patients provides further support for the potential of Tinlarebant to slow and potentially halt lesion growth |
| 2024-05-01 | Belite Bio, Inc | Results Belite Bio Announces Presentation at the Association for Research in Vision and Ophthalmology 2024 Annual Meeting belitebio.com ↗
Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar baseline characteristics (aged ≤18 years) (p<0.001) |
| 2024-04-18 | Belite Bio, Inc | Regulatory Belite Bio Announces MHRA Submission of Tinlarebant for Stargardt Disease Clinical Trial in the United Kingdom belitebio.com ↗ |
| 2024-03-25 | Belite Bio, Inc | Regulatory Belite Bio Submits US IND Amendment to Initiate a Phase 2/3 Clinical Trial of Tinlarebant in Stargardt Disease belitebio.com ↗ |
| 2024-03-22 | Belite Bio, Inc | Regulatory Belite Bio Announces PMDA Submission of Tinlarebant for Stargardt Disease Clinical Trial in Japan belitebio.com ↗
today announces its submission to the Pharmaceuticals and Medical Devices Agency (PMDA) to initiate a clinical trial of Tinlarebant in adolescent STGD1 in Japan (“DRAGON II”). |
| 2024-02-05 | Belite Bio, Inc | Regulatory Belite Bio Receives EMA Approval to Initiate Tinlarebant Phase 3 Clinical Trial for GA in France and Czech Republic belitebio.com ↗
today announces EMA approval for the Phase 3 clinical trial of Tinlarebant for Geographic Atrophy, or the PHOENIX study, in France and Czech Republic. |
| 2023-12-27 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate Tinlarebant Phase 3 Clinical Trial for GA in China belitebio.com ↗ |
| 2023-12-10 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate Tinlarebant Phase 3 Clinical Trial for GA in Switzerland belitebio.com ↗ |
| 2023-11-15 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate Tinlarebant Phase 3 Clinical Trial for GA in the UK belitebio.com ↗
today announces the approval from the Medicines and Healthcare products Regulatory Agency (MHRA) of United Kingdom (UK) for the Phase 3 clinical trial of Tinlarebant in Geographic Atrophy, or the PHOENIX study. |
| 2023-11-06 | Belite Bio, Inc | Results Belite Bio Presents Results from a 24-month, Phase 2 Study of Tinlarebant in Childhood-onset Stargardt Disease at the AAO Annual Meeting belitebio.com ↗ |
| 2023-10-17 | Belite Bio, Inc | Regulatory Belite Bio Announces NMPA Submission for Tinlarebant Phase 3 GA Clinical Trial in China belitebio.com ↗ |
| 2023-10-06 | Belite Bio, Inc | Regulatory Belite Bio Announces Submission to Swissmedic for Tinlarebant Phase 3 GA Clinical Trial in Switzerland belitebio.com ↗
Belite Bio , Inc (NASDAQ: BLTE), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs, today announces its submission to Swissmedic to initiate the Phase 3 clinical trial of Tinlarebant in GA (the PHOENIX study) in Switzerland. |
| 2023-09-20 | Belite Bio, Inc | Regulatory Belite Bio Announces EMA Submission for Tinlarebant Phase 3 GA Clinical Trial in the EU belitebio.com ↗ |
| 2023-09-01 | Belite Bio, Inc | Regulatory Belite Bio Announces MHRA Submission for Tinlarebant Phase 3 GA Clinical Trial in United Kingdom belitebio.com ↗
today announces its submission to the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate the Phase 3 clinical trial of Tinlarebant in GA (the PHOENIX study) in the United Kingdom. |
| 2023-08-04 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate Tinlarebant (LBS-008) Phase 3 Clinical Trial for GA in Australia belitebio.com ↗ |
| 2023-07-17 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate Tinlarebant (LBS-008) Phase 3 Clinical Trial for GA in Taiwan belitebio.com ↗
today announces the approval from the Taiwan Food and Drug Administration (TFDA) to initiate the Phase 3 clinical trial of Tinlarebant for Geographic Atrophy, or the PHOENIX study, in Taiwan. |
| 2023-07-06 | Belite Bio, Inc | Regulatory Belite Bio Announces TFDA Submission for Tinlarebant Phase 3 GA Clinical Trial in Taiwan belitebio.com ↗ |
| 2023-06-13 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate Tinlarebant (LBS-008) Phase 3 Clinical Trial for Stargardt Disease in South Korea belitebio.com ↗
today announces the approval of a Clinical Trial Application to the Ministry of Food and Drug Safety (MFDS) to initiate the Phase 3 clinical trial of Tinlarebant (aka LBS-008) for STGD1, or the DRAGO study, in the Republic of Korea. |
| 2023-04-25 | Belite Bio, Inc | Results Belite Bio Presented 18-Month Interim Data from a 24-Month Phase 2 Study of Tinlarebant in Adolescent Stargardt Disease at the 2023 ARVO Meeting belitebio.com ↗
It is great to observe that the 18-month interim data showed a consistent safety profile in patients treated with Tinlarebant, |
| 2023-03-08 | Belite Bio, Inc | Regulatory Belite Bio announces submission of Clinical Trial Application for Phase 3 Stargardt Disease study of Tinlarebant (LBS-008) in South Korea belitebio.com ↗ |
| 2023-01-31 | Belite Bio, Inc | Regulatory Belite Bio Submits IND Amendment to Initiate Phase 3 Clinical Trial of Tinlarebant (LBS-008) in Advanced Dry AMD belitebio.com ↗ |
| 2023-01-11 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate Tinlarebant (LBS-008) Phase 3 Clinical Trial for Stargardt Disease in the Netherlands belitebio.com ↗
today announces the approval from The Central Committee on Research Involving Human Subjects to initiate the Phase 3 clinical trial of Tinlarebant (aka LBS-008) for STGD1 in the Netherlands. |
| 2023-01-05 | Belite Bio, Inc | Regulatory Belite Bio announces submission of Clinical Trial Application for Netherlands Phase 3 study of Tinlarebant (LBS-008) belitebio.com ↗
today announces the submission of a Clinical Trial Application to The Central Committee on Research Involving Human Subjects to initiate a Phase 3 clinical trial of Tinlarebant (a/k/a LBS-008) in the Netherlands. |
| 2022-11-14 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate LBS-008 Phase 1b Clinical Trial for Elderly Subjects in Australia belitebio.com ↗
today announced the approval from Bellberry Human Research Ethics Committee to initiate the Phase 1b clinical trial of Tinlarebant in Australia. |
| 2022-11-09 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate LBS-008 Phase 3 Clinical Trial in France belitebio.com ↗
today announced the approval from The National Agency for the Safety of Medicines and Health Products (L’Agence nationale de sécurité du médicament et des produits de santé, ANSM) of France to initiate the Phase 3 clinical trial of Tinlarebant in France. |
| 2022-10-01 | Belite Bio, Inc | Results Belite Bio Presented 12-Month Interim Results of LBS-008 Phase 1b/2 Study in Adolescent Stargardt Disease at AAO Annual Meeting 2022 belitebio.com ↗
LBS-008 (aka Tinlarebant) was safe and well tolerated in adolescent Stargardt Disease (STGD1) subjects at 12-month time point |
| 2022-09-16 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval of LBS-008 Phase 3 Clinical Trial in China belitebio.com ↗ |
| 2022-08-09 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate LBS-008 Phase 3 Clinical Trial in Germany belitebio.com ↗ |
| 2022-08-08 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval of LBS-008 Phase 3 Clinical Trial in Belgium belitebio.com ↗
The trial will initiate after FAMHP requested protocol amendment that is specific to Belgium. |
| 2022-07-19 | Belite Bio, Inc | Regulatory Belite Bio Submits Investigational New Drug (IND) Application to FDA for Approval to Proceed with LBS-008 Phase 3 Clinical Trial for the Treatment of Stargardt Disease belitebio.com ↗ |
| 2022-06-24 | Belite Bio, Inc | Regulatory Belite Bio announces submission of Clinical Trial Registration for China Phase 3 study of LBS-008 belitebio.com ↗
today announces the submission of a Clinical Trial Registration to National Medical Product Administration (NMPA) of China to initiate a Phase 3 clinical trial of LBS-008. |
| 2022-06-20 | Belite Bio, Inc | Regulatory Belite Bio Receives Approval to Initiate LBS-008 Phase 3 Study at CERA Clinical Trial Site in Australia belitebio.com ↗
Belite Bio , Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a San Diego based clinical stage biopharmaceutical drug development company targeting untreatable eye diseases, today announced the approval to initiate the Phase 3 clinical trial of LBS-008 at Centre for Eye Research Australia (CERA), a clinical trial site in Melbourne, Australia. |
| 2022-06-09 | Belite Bio, Inc | Regulatory Belite Bio announces submission of Clinical Trial Application for Belgium Phase 3 study of LBS-008 belitebio.com ↗ |
| 2022-05-05 | Belite Bio, Inc | Results Belite Bio Presented Interim Results of LBS-008 Phase 1b/2 Study in Adolescent STGD1 at ARVO Annual Meeting 2022 belitebio.com ↗ |
| 2022-05-03 | Belite Bio, Inc | Regulatory Belite Bio Receives FDA Fast Track Designation For LBS-008 belitebio.com ↗
today announced that LBS-008, an orally administered tablet, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of STGD1. |
| 2019-04-24 | Lin BioScience, Inc | Regulatory Belite Bio Announces FDA Approval of Investigational New Drug (IND) for Phase 1 Clinical Trial of LBS-008 to Treat Macular Degeneration and Stargardt Disease linbioscience.com ↗ |
| 2019-04-24 | Belite Bio, Inc | Regulatory Belite Bio Announces FDA Approval of Investigational New Drug (IND) for Phase 1 Clinical Trial of LBS-008 to Treat Macular Degeneration and Stargardt Disease belitebio.com ↗ |
| 2018-09-18 | Lin BioScience, Inc | Regulatory FDA Grants Lin BioScience Rare Pediatric Disease Status for LBS-008 to Treat Stargardt Disease linbioscience.com ↗
Lin BioScience, a drug development company targeting untreatable conditions in oncology, ophthalmology and metabolic diseases, announced today that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to LBS-008, a first-in-class oral therapy for the treatment of Stargardt Disease. |
| 2018-09-17 | Belite Bio, Inc | Regulatory FDA Grants Lin BioScience (Now Belite Bio™) Rare Pediatric Disease Status for LBS-008 to Treat Stargardt Disease belitebio.com ↗
San Diego Lin BioScience (now Belite Bio™), a drug development company targeting untreatable conditions in oncology, ophthalmology and metabolic diseases, announced today that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to LBS-008 , a first-in-class oral therapy for the treatment of Stargardt Disease. |
| 2018-06-28 | Lin BioScience, Inc | Regulatory Lin BioScience Receives EMA Orphan Drug Status for LBS-008 for the Treatment of Stargardt Disease linbioscience.com ↗
Lin BioScience, a drug development company targeting untreatable conditions in oncology, ophthalmology and metabolic diseases, announced today that the European Medicines Agency has granted orphan drug designation to LBS-008, a first-in-class oral therapy for the treatment of Stargardt Disease. |
| 2017-10-30 | Lin BioScience, Inc | Regulatory Lin BioScience Receives US FDA Orphan Drug Status for LBS-008 for the Treatment of Stargardt Disease linbioscience.com ↗ |
All press releases naming this drug 75 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tinlarebant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06388083 ↗ |
| Known as | BPN-14967 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04005807 ↗ |
| Known as | LBS-008 | “This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of...” NCT05949593 ↗2“Tinlarebant (previously called LBS-008) is being developed as an oral treatment to slow or halt the progression of dry age-related macular degeneration (AMD)” NCT05667688 ↗ |
| Modality | Small molecule | — CHEMBL3967849 ↗ |
| Route | Oral | “LBS-008 oral capsules” NCT03735810 ↗ |