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Tinlarebant

Research only

Stargardt disease type 1

Published evidence

2 publications0 exact-program2 related2 context / correction notes

Review publications

Program details

Sponsor reports NDA acceptance for tinlarebant in Stargardt disease and a February 12, 2027 FDA target.

Program names
tinlarebant / LBS-008
Modality
Small molecule
Indication
Stargardt disease type 1
Associated trial
NCT05244304
FDA target
February 12, 2027Date-only guidance; not a trading cutoff.

Publications 2

Evidence is grouped by its relationship to this program.

Search PubMed

Publication notes explain the evidence behind this program. PubMed / NCBI data notice

Coverage & interpretation
  • The bounded query did not identify a DRAGON Stargardt efficacy publication.
  • Selected papers cover healthy-volunteer pharmacokinetics and preclinical mechanism.

No exact-program publication is linked here yet. Follow the registry and PubMed sources to explore further.

Same compound & related evidence

2 records
Same compoundhuman clinicalPMID 41545331

Effects of Gastric Acid Suppression, Cytochrome P4503A Inhibition and Induction, and Food on the Pharmacokinetics of Tinlarebant in Healthy Adults.

Clinical pharmacology in drug development · 2026-01

A healthy-adult crossover study assessed food, acid suppression and CYP3A interactions with oral tinlarebant. Food and omeprazole had limited exposure effects, while CYP3A inhibition or induction changed exposure. This is interaction evidence, not retinal efficacy evidence.

Program relevance

Tinlarebant pharmacokinetics in healthy adults, not the DRAGON Stargardt efficacy trial.

Formulation / population: Oral tinlarebant in healthy-adult drug-interaction and food-effect studies.

  • Healthy volunteers; no Stargardt efficacy outcome.

Journal Article / Randomized Controlled Trial / Research Support, Non-U.S. Gov't

Same compoundpreclinicalPMID 42810809

Structural and biochemical basis for retinol-binding protein 4 antagonism by tinlarebant.

British journal of pharmacology · 2026-09-29

Protein assays, crystallography and mouse experiments examined how tinlarebant binds RBP4 and disrupts its association with transthyretin. The study describes a mechanism for lowering circulating RBP4; it is preclinical evidence.

Program relevance

Mechanistic experiments directly test tinlarebant, but do not report human Stargardt outcomes.

Formulation / population: Tinlarebant studied in purified-protein assays and mice.

  • Protein and animal experiments; not a clinical efficacy trial.

Journal Article

Sources

Publication and retrieval dates are shown separately. Market rules determine which evidence can resolve an outcome.

sponsor-releasebelitebio.gcs-web.com
Sponsor reports NDA acceptance for tinlarebant in Stargardt disease and a February 12, 2027 FDA target.
Published
Aug 11, 2026
Retrieved
2026-10-30 02:09:48 UTC
sponsor-programbelitebio.com
Sponsor describes tinlarebant as an oral small-molecule RBP4 antagonist.
Published
Not supplied
Retrieved
2026-10-30 02:09:48 UTC
clinical-trial-registryclinicaltrials.gov
Registry identifies the associated compound, condition and sponsor; trial completion is separate from FDA action.
Published
Not supplied
Retrieved
2026-10-30 02:09:48 UTC

Research identity and publications do not establish regulatory approval, clinical suitability or an executable market. Read the limits