Evicenter
P&T meetings

Tinlarebant (LBS-008)

Stargardt disease type 1

Manufacturer
Belite Bio
Regulatory submission
NDA submitted June 2026
Last updated
66 sources

Company-reported prevalence

Tinlarebant

Overview

FieldValue
DrugTinlarebant (LBS-008)
IndicationStargardt disease type 1
DiseaseStargardt disease type 1 (STGD1), ABCA4-associated
CompanyBelite Bio, Inc. (worldwide rights); RBP4 antagonist patent portfolio exclusively licensed worldwide from Columbia University
Documents searchedCorporate website, home and tinlarebant (LBS-008) product pages (accessed October 2026); Form 20-F for 2025 (March 2026); press releases, January 2023 to October 2026; company presentation (August 2026); Commercial Day presentation (September 2026)
Data as ofOctober 14, 2026
Prepared byAI research agent (Claude); not yet reviewed by a person

Company statements of prevalence

United States

Number affected: Belite Bio press release, August 2026

“STGD1, a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss and affects an estimated 53,000 people in the U.S. alone.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) press release, FDA acceptance of the new drug application, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Number affected: Belite Bio Commercial Day presentation, September 2026

“~53,000 Estimated Prevalent STGD1 population in the U.S.” (opens the source at this quote in a new tab)

Cited source: 2.2 Mata 2025

Belite Bio (2026) Commercial Day presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 45 of 56 (opens in a new tab)

Number diagnosed: Belite Bio Commercial Day presentation, September 2026

“~20,000 Estimated Clinically diagnosed STGD1 patients in the U.S. since 2016” (opens the source at this quote in a new tab)

Cited source: 2.3 Verana Health, undated

Belite Bio (2026) Commercial Day presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 45 of 56 (opens in a new tab)

Number affected: Belite Bio Form 20-F for 2025, March 2026

“The estimated patient population is approximately 53,000 in the United States” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) Form 20-F for 2025, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Number affected (adults and children): Belite Bio Form 20-F for 2025, March 2026

“It is estimated that approximately between 47,000 and 59,000 US citizens are affected by STGD1; this estimate includes both adults and children.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) Form 20-F for 2025, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Number affected: Belite Bio website, October 2026

“Based on this estimate, approximately 30,000 US citizens are affected by STGD1.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) website, tinlarebant (LBS-008) page, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Europe

No evidence found.

Global

No evidence found.

Other countries and regions

Number affected: Belite Bio press release, September 2026

“STGD1 affects an estimated 9,500 people in Japan alone” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) press release, new drug application in Japan, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Number affected (China): Belite Bio Form 20-F for 2025, March 2026

“approximately 109,000 in China” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) Form 20-F for 2025, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Number affected (Europe, Australia, China, Japan, and the United States): Belite Bio Commercial Day presentation, September 2026

“Estimated Patient Population Sizes of STGD1” (opens the source at this quote in a new tab)

“Europe Australia China Japan United States” (opens the source at this quote in a new tab)

“High Estimate 115,345 4,141 122,135 10,777 59,235 Low Estimate 95,517 3,429 94,940 8,377 46,767” (opens the source at this quote in a new tab)

Cited source: 2.2 Mata 2025

Belite Bio (2026) Commercial Day presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 42 of 56 (opens in a new tab)

Geography not stated

Prevalence: Belite Bio Form 20-F for 2025, March 2026

“STGD1 is the most common inherited retinal dystrophy, with an average prevalence rate of approximately 1:8,800 based on a weighted population proportion calculation.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) Form 20-F for 2025, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Prevalence: Belite Bio company presentation, August 2026

“1 in 8,800” (opens the source at this quote in a new tab)

“The most common inherited macular dystrophy” (opens the source at this quote in a new tab)

Cited source: 2.1 Hanany 2020; 2.2 Mata 2025

Belite Bio (2026) company presentation, August 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 6 of 32 (opens in a new tab)

Prevalence (people of European descent): Belite Bio Form 20-F for 2025, March 2026

“The prevalence of STGD1 is estimated to be between 1:7,800 and 1:6,400 in people of European descent.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) Form 20-F for 2025, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Prevalence (East Asian and South Asian people): Belite Bio Form 20-F for 2025, March 2026

“Although comprehensive epidemiological data on the prevalence of STGD1 for other populations is not available, estimates from genetic databases show a prevalence of about 1:15,000 to 1:11,500 in East-Asians and about 1:11,500 to 1:10,500 in South Asians.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) Form 20-F for 2025, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Prevalence (ABCA4 genetic prevalence): Belite Bio Commercial Day presentation, September 2026

“ABCA4 frequency: ~1 in 6,578” (opens the source at this quote in a new tab)

Cited source: 2.1 Hanany 2020

Belite Bio (2026) Commercial Day presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 43 of 56 (opens in a new tab)

Prevalence: Belite Bio website, October 2026

“The prevalence rate of STGD1 is estimated to be 1 in 10,000 people.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Belite Bio (2026) website, tinlarebant (LBS-008) page, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Sources the company cites

Hanany 2020

Reference as the company lists it, company presentation, August 2026

“(1) Hanany M, Rivolta C, Sharon D (2020) Proc Natl Acad Sci U S A. 117(5):2710-2716.” (opens the source at this quote in a new tab)

Belite Bio (2026) company presentation, August 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 6 of 32 (opens in a new tab)

Reference as the company lists it, Commercial Day presentation, September 2026

“(Hanany M, Rivolta C, Sharon D, PNAS 2020)” (opens the source at this quote in a new tab)

Belite Bio (2026) Commercial Day presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 43 of 56 (opens in a new tab)

Passage carrying the figure

“our analysis revealed that ABCA4 mutations result in a GP of STGD cases corresponding to 1:6,578 individuals” (opens the source at this quote in a new tab)

Hanany 2020, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Mata 2025

Reference as the company lists it, company presentation, August 2026

“(2) Mata NL et al. (2025) Ophthalmic Res. 68(1):555-572.” (opens the source at this quote in a new tab)

Belite Bio (2026) company presentation, August 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 6 of 32 (opens in a new tab)

Reference as the company lists it, Commercial Day presentation, September 2026

“Mata NL, Weng S, Michaelides M, Charbel Issa P, Quinodoz M, Rivolta C, Scholl HPN. Bisretinoids as a Source of Early Photoreceptor Pathology in Stargardt Disease. Ophthalmic Res. 2025;68(1):555-572.” (opens the source at this quote in a new tab)

Belite Bio (2026) Commercial Day presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 42 of 56 (opens in a new tab)

Passage carrying the nearest figure

“The prevalence of STGD1 is often reported to be 1 in 8,000 to 1 in 10,000.” (opens the source at this quote in a new tab)

“For the USA, the breakdown of genetic populations is shown in Table 3 and allows estimation of the number of affected patients to be between 47,000 and 59,000.” (opens the source at this quote in a new tab)

“For both Europe and China, the estimated affected patient number is likely larger than 100,000.” (opens the source at this quote in a new tab)

“Japan East Asian 124,500,000 8,377 10,777” (opens the source at this quote in a new tab)

“USA Mixed 334,900,000 46,767 59,235” (opens the source at this quote in a new tab)

Mata 2025, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Verana health, undated

Reference as the company lists it

“Clinically diagnosed estimates sourced via Verana Health / IRIS registry” (opens the source at this quote in a new tab)

Belite Bio (2026) Commercial Day presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 45 of 56 (opens in a new tab)

Passage carrying the figure

Not quoted: A registry database that a licensed user must query; the presentation names no published report of the figure.

References

  1. Belite Bio (2026) Commercial Day presentation, September 2026 (opens in a new tab)
  2. Belite Bio (2026) company presentation, August 2026 (opens in a new tab)
  3. Belite Bio (2026) Form 20-F for 2025 (opens in a new tab)
  4. Belite Bio (2026) press release, FDA acceptance of the new drug application (opens in a new tab)
  5. Belite Bio (2026) press release, new drug application in Japan (opens in a new tab)
  6. Belite Bio (2026) website, tinlarebant (LBS-008) page (opens in a new tab)
  7. Hanany 2020 (opens in a new tab)
  8. Mata 2025 (opens in a new tab)