Tinlarebant
An investigational treatment for Stargardt Disease and Geographic Atrophy.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Tinlarebant wherever you encounter it, plus the key facts at a glance.
- Generic name
- Tinlarebant
- Development code
- LBS-008
- Drug class
- RBP4 antagonist (small molecule)
- Manufacturer
- Belite Bio
- How it's taken
- Tablet by mouth once daily, under FDA review
An investigational once-daily pill from Belite Bio for Stargardt disease type 1, an inherited disease that damages the center of the retina.
- The FDA accepted Belite's application under priority review with a target decision date of February 12, 2027[4].
- In the Phase 3 DRAGON trial of 104 people aged 12 to 20, Belite reported that the areas where retinal cells had died grew 35.7% more slowly on tinlarebant than on placebo over 24 months[1].
- No drug is FDA approved for Stargardt disease[15].
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Where Tinlarebant fits
Tinlarebant would be the first FDA-approved medicine for Stargardt disease type 1 if the FDA approves it, and a decision is due by February 12, 2027[4].
- Stargardt care today is supportive, and the National Eye Institute lists low vision aids, vision rehabilitation, sunglasses and a hat outdoors, and avoiding vitamin A supplements above the recommended daily amount[15].
- Gildeuretinol, another oral drug aimed at vitamin A in the eye, was tested in the TEASE-1 trial published in JAMA Ophthalmology in October 2026, and gildeuretinol is not FDA approved either[13].
- Tinlarebant and gildeuretinol have not been compared in the same trial, and the 2 trials enrolled people of different ages, mostly adults aged 18 to 60 in TEASE-1 and 12 to 20 in DRAGON.
- DRAGON measured how fast damaged areas of the retina grew, and visual acuity changed little in either group over 24 months[1].
- A person with Stargardt disease can ask a retina specialist whether slower lesion growth is likely to matter for their own vision, and how the reported vision side effects might affect night driving or school.
How Tinlarebant works
Vitamin A (retinol) travels from the liver to the eye on a carrier protein called RBP4, and the retina turns it into the chemicals it uses to sense light[7]. In Stargardt disease, changes in the ABCA4 gene stop the retina from clearing byproducts of that process, which build up as a fatty yellow pigment called lipofuscin in cells beneath the macula, the center of the retina, and eventually kill retinal cells[14].
Tinlarebant blocks RBP4, which lowers how much retinol reaches the eye and, according to Belite, slows the formation of the toxic byproducts called bisretinoids[7]. In DRAGON, blood RBP4 levels fell by about 80% on average[1].
Clinical trial results
DRAGON (NCT05244304) was a 24-month, double-masked Phase 3 trial in 104 people aged 12 to 20 with Stargardt disease type 1, randomized 2 to 1 to tinlarebant (69) or placebo (35)[1][8]. Its main measure was how fast lesions of definitely decreased autofluorescence, the dark areas on an eye scan where retinal cells have died, grew in the study eye.
Belite reported that they grew 35.7% more slowly on tinlarebant (p=0.0033), 33.6% more slowly in the other eye (p=0.041), and that visual acuity changed little in either group over 24 months, which Belite says matches the disease's usual course[1]. Full DRAGON results have not been published in a peer-reviewed journal. DRAGON II (NCT06388083), a Phase 2/3 trial in adolescents that includes Japanese participants, has finished enrolling[4][9].
PHOENIX (NCT05949593) is a 24-month Phase 3 trial in geographic atrophy, an advanced form of dry age-related macular degeneration; Belite says it enrolled 530 people, while ClinicalTrials.gov still lists an estimate of 429, and no results have been reported[4][10]. An earlier Phase 1b/2 study (NCT05266014) tested doses in adolescents and followed them for 2 years[11].
Main registered trial: NCT05244304 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Side effects and safety
Tinlarebant has no FDA label, so its official side effects and warnings are not set. Belite reported that the most common drug-related eye side effects in DRAGON were xanthopsia, a yellow tint to vision, and delayed dark adaptation, meaning the eyes take longer to adjust in dim light. Most cases of these and of night vision trouble were mild, and most went away during the trial.
Headache was the most common drug-related side effect outside the eye. Belite reported 4 treatment-related discontinuations, and none for side effects outside the eye[1]. Belite has not published a rate for each side effect or a count of serious adverse events.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Tinlarebant
In DRAGON, tinlarebant was taken as a 5mg tablet by mouth once a day[1][8]. A study in healthy adults found that food and the acid reducer omeprazole did not change drug levels much. In the same study itraconazole, a strong CYP3A inhibitor, raised exposure about 2.4 times, and rifampin, a strong CYP3A inducer, cut exposure by about 80%[12]. The FDA has not approved a label, so the final dose and drug interaction instructions are not set.
Development history
Belite Bio reported DRAGON's topline results on December 1, 2025[1]. The company began a rolling application to the FDA on April 21, 2026, under Breakthrough Therapy designation, and completed it on June 12, 2026[2][3]. The FDA accepted the application under priority review with a target action date of February 12, 2027[4]. Belite announced on September 8, 2026 that it had filed in Japan under Sakigake, a fast review pathway[5], and on October 14, 2026 it filed in Singapore, the UK and Switzerland through the Access Consortium[6].
Tinlarebant also holds Fast Track, Rare Pediatric Disease and Orphan Drug designations in the US[3]. The FDA had not announced a decision as of November 7, 2026.
Explore Stargardt Disease and Geographic Atrophy trials
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Common questions about Tinlarebant
▸What is Tinlarebant?
An investigational once-daily pill from Belite Bio for Stargardt disease type 1, an inherited disease that damages the center of the retina. The FDA accepted Belite's application under priority review with a target decision date of February 12, 2027[4]. In the Phase 3 DRAGON trial of 104 people aged 12 to 20, Belite reported that the areas where retinal cells had died grew 35.7% more slowly on tinlarebant than on placebo over 24 months[1]. No drug is FDA approved for Stargardt disease[15].
▸How does Tinlarebant work?
Vitamin A (retinol) travels from the liver to the eye on a carrier protein called RBP4, and the retina turns it into the chemicals it uses to sense light[7]. In Stargardt disease, changes in the ABCA4 gene stop the retina from clearing byproducts of that process, which build up as a fatty yellow pigment called lipofuscin in cells beneath the macula, the center of the retina, and eventually kill retinal cells[14]. Tinlarebant blocks RBP4, which lowers how much retinol reaches the eye and, according to Belite, slows the formation of the toxic byproducts called bisretinoids[7]. In DRAGON, blood RBP4 levels fell by about 80% on average[1].
▸What are the side effects of Tinlarebant?
Tinlarebant has no FDA label, so its official side effects and warnings are not set. Belite reported that the most common drug-related eye side effects in DRAGON were xanthopsia, a yellow tint to vision, and delayed dark adaptation, meaning the eyes take longer to adjust in dim light. Most cases of these and of night vision trouble were mild, and most went away during the trial. Headache was the most common drug-related side effect outside the eye. Belite reported 4 treatment-related discontinuations, and none for side effects outside the eye[1]. Belite has not published a rate for each side effect or a count of serious adverse events.
▸How is Tinlarebant taken?
In DRAGON, tinlarebant was taken as a 5mg tablet by mouth once a day[1][8]. A study in healthy adults found that food and the acid reducer omeprazole did not change drug levels much. In the same study itraconazole, a strong CYP3A inhibitor, raised exposure about 2.4 times, and rifampin, a strong CYP3A inducer, cut exposure by about 80%[12]. The FDA has not approved a label, so the final dose and drug interaction instructions are not set.
▸Is Tinlarebant FDA approved?
Not yet. Tinlarebant is under FDA review for Stargardt Disease and Geographic Atrophy; Belite Bio has filed an application and a decision is due February 12, 2027. The FDA calendar page tracks the outcome.
▸Is tinlarebant FDA approved for Stargardt disease?
No. The FDA is reviewing tinlarebant, with a target decision date of February 12, 2027.
Review: The FDA accepted Belite Bio's application under priority review.
Designations: Breakthrough Therapy, Fast Track, Rare Pediatric Disease and Orphan Drug in the US.
Other countries: Belite has filed in Japan, Singapore, the UK and Switzerland, and no country has approved it yet.
Source: Belite Bio releases of August 12 and September 8, 2026; Belite Bio Japan release of October 23, 2026
▸What did the DRAGON trial show for tinlarebant?
Belite reported that areas of dead retinal cells grew 35.7% more slowly on tinlarebant than on placebo over 24 months.
Who took part: 104 people aged 12 to 20 with Stargardt disease type 1.
Other eye: Lesions grew 33.6% more slowly in the second eye.
Vision: Visual acuity changed little in either group over 24 months.
Publication: Full results are not yet in a peer-reviewed journal.
Source: Belite Bio topline release, December 1, 2025; ClinicalTrials.gov NCT05244304
▸What are the side effects of tinlarebant?
The most common drug-related eye side effects in DRAGON were a yellow tint to vision and slower adjustment to the dark.
Severity: Most cases were mild, and most went away during the trial.
Outside the eye: Headache was the most common drug-related side effect.
Stopping: Belite reported 4 treatment-related discontinuations.
Not published: Rates for each side effect.
Source: Belite Bio topline release, December 1, 2025
▸How is tinlarebant taken?
In its trials tinlarebant was a 5mg tablet taken by mouth once a day.
Food: A study in healthy adults found food did not change drug levels much.
Interactions: In that study itraconazole, a strong CYP3A inhibitor, raised tinlarebant exposure about 2.4 times, and rifampin, a strong CYP3A inducer, cut it by about 80%.
Label: No FDA label exists yet, so final instructions are not set.
Source: Belite Bio topline release, December 1, 2025; Polasek et al., Clin Pharmacol Drug Dev 2026
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Belite Bio via GlobeNewswire (BioSpace copy) · 2025-12-01. 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. https://www.biospace.com/press-releases/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
- Belite Bio via GlobeNewswire (BioSpace copy) · 2026-04-21. 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. https://www.biospace.com/press-releases/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
- Belite Bio via GlobeNewswire (BioSpace copy) · 2026-06-12. 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. https://www.biospace.com/press-releases/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
- Belite Bio via GlobeNewswire (BioSpace copy) · 2026-08-12. Belite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate Update. https://www.biospace.com/press-releases/belite-bio-reports-unaudited-second-quarter-2026-financial-results-and-provides-a-corporate-update
- Belite Bio via GlobeNewswire (BioSpace copy) · 2026-09-08. 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. https://www.biospace.com/press-releases/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
- Belite Bio Japan via PR TIMES · 2026-10-23. 米国Belite Bio社、「スタルガルト病1型」治療薬候補Tinlarebantについて、Access Consortiumを通じてシンガポール・英国・スイスで製造販売承認を申請. https://prtimes.jp/main/html/rd/p/000000010.000187061.html
- Belite Bio. Product 008 | Belite Bio. https://belitebio.com/product-008/
- ClinicalTrials.gov. Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease. https://clinicaltrials.gov/study/NCT05244304
- ClinicalTrials.gov. A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease. https://clinicaltrials.gov/study/NCT06388083
- ClinicalTrials.gov. Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy. https://clinicaltrials.gov/study/NCT05949593
- ClinicalTrials.gov. This is a Dose-finding Study Followed by 2-year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Adolescent Subjects With Stargardt Disease. https://clinicaltrials.gov/study/NCT05266014
- Clinical Pharmacology in Drug Development · 2026-01. Effects of Gastric Acid Suppression, Cytochrome P4503A Inhibition and Induction, and Food on the Pharmacokinetics of Tinlarebant in Healthy Adults. https://pubmed.ncbi.nlm.nih.gov/41545331/
- JAMA Ophthalmology · 2026-10-01. Safety and Effects of Gildeuretinol Acetate on Retinal Atrophic Lesions in Stargardt Disease: The TEASE-1 Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/42690655/
- MedlinePlus, National Library of Medicine. Stargardt macular degeneration: MedlinePlus Genetics. https://medlineplus.gov/genetics/condition/stargardt-macular-degeneration/
- National Eye Institute · 2024-12-04. Stargardt Disease | National Eye Institute. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/stargardt-disease