Belite Bio (NASDAQ: BLTE) fully enrolls DRAGON II tinlarebant trial in adolescent Stargardt disease
Rhea-AI Filing Summary
Belite Bio reported that it has completed enrollment of 60 adolescent patients, including 15 in Japan, in its global Phase 2/3 DRAGON II clinical trial of oral drug candidate tinlarebant for Stargardt disease type 1 (STGD1). DRAGON II is a 24‑month, randomized, double‑masked, placebo‑controlled study in patients aged 12 to 20 across Japan, the United States, and the United Kingdom, with participants assigned 1:1 to tinlarebant or placebo to assess efficacy, safety, and tolerability.
The company says it remains on track to submit a New Drug Application (NDA) to the U.S. FDA for tinlarebant in the first half of 2026. Tinlarebant aims to reduce vitamin A‑based toxins in the retina by lowering serum retinol binding protein 4, and has received multiple expedited and orphan designations in the U.S., Europe, and Japan for STGD1. Belite Bio notes it has already completed a separate Phase 3 DRAGON trial in adolescent STGD1 and is also running a Phase 3 PHOENIX trial in geographic atrophy.
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Insights
Belite Bio has fully enrolled its DRAGON II STGD1 trial and reaffirmed its NDA timing for tinlarebant.
Completing enrollment of 60 adolescents in the Phase 2/3 DRAGON II trial marks a key operational step for Belite Bio as it advances tinlarebant in Stargardt disease type 1. The study’s 24‑month, randomized, double‑masked, placebo‑controlled design in patients aged 12 to 20 across Japan, the U.S., and the U.K. is intended to generate efficacy, safety, and tolerability data that can support regulatory review, including alignment with Japan’s PMDA requirements.
The company reiterates that it remains on track to submit a U.S. NDA for tinlarebant in the first half of
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15b-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of January 2026
Commission File Number: 001-41359
Belite Bio, Inc
(Exact name of registrant as specified in its charter)
Not Applicable
(Translation of Registrant’s name into English)
12750 High Bluff Drive Suite 475,
San Diego, CA 92130
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
On January 27, 2026, Belite Bio, Inc issued a press release entitled “Belite Bio Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1).” A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
This Report on Form 6-K and the related exhibit are incorporated by reference into all effective registration statements filed by the registrant under the Securities Act of 1933 and shall be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
| Exhibit No. | Description of Exhibit |
| 99.1 | Press Release |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Belite Bio, Inc | ||
| By: | /s/ Yu-Hsin Lin | |
| Name: | Yu-Hsin Lin | |
| Title: | Chief Executive Officer and Chairman | |
Date: January 27, 2026
Exhibit 99.1
Belite Bio Completes Enrollment in the DRAGON II
Clinical Trial of Tinlarebant for Stargardt Disease
(STGD1)
| ● | Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint in the pivotal, global Phase 3 DRAGON trial with 36% reduction in lesion growth (p-value=0.0033) |
| ● | 60 adolescent STGD1 subjects enrolled in DRAGON II clinical trial across Japan, the United States, and the United Kingdom |
| ● | Belite Bio plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 1H 2026 |
SAN DIEGO, January 27, 2026 (GLOBE NEWSWIRE)- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment of 60 subjects, including 15 Japanese subjects, in the Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1).
DRAGON II clinical trial is a global, 24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1. The trial had a targeted enrollment of 60 adolescent subjects aged 12 to 20 years old across Japan, the United States, and the United Kingdom, with participants randomized 1:1 to receive either tinlarebant or placebo.
“We are pleased to complete enrollment in the DRAGON II clinical trial and sincerely thank the investigators, the adolescent participants, and their families who made this study possible,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “Their commitment reflects the strong engagement of the Stargardt disease community and supports our broader clinical development and commercialization efforts. Importantly, we remain on track to submit an NDA to the FDA for tinlarebant in the first half of 2026.”
“Completing enrollment in DRAGON II clinical trial represents continued execution of our tinlarebant clinical development program,” said Dr. Hendrik Scholl, Chief Medical Officer of Belite Bio. “We are pleased to have implemented a registration-enabling study that aligns with the requirements of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), supporting Belite Bio’s ability to pursue potential approval in Japan while advancing research for adolescents living with Stargardt disease globally.”
About Tinlarebant (a/k/a LBS-008)
Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1.
About Belite Bio
Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical need, such as Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry AMD, in addition to specific metabolic diseases. Belite Bio’s lead candidate, tinlarebant, is an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye. The Company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects and is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook or visit us at www.belitebio.com.
Important Cautions Regarding Forward Looking Statements
This press release contains forward-looking statements regarding future expectations, plans and prospects, as well as other statements regarding matters that are not historical facts.
These statements include, but are not limited to, statements regarding the potential implications of clinical data for patients, and Belite Bio's advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates, the ability of Tinlarebant to treat STGD1 and GA, the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the timing to submit trial data to regulatory authorities for drug approval, as well as any other statements regarding matters that are not historical facts, and any other statements containing the words “expect”, “will”, “believe”, “target”, “plan,” and other similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors related to Belite Bio’s business, including but not limited to Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; expectations for the timing of initiation, enrollment and completion of, and data relating to, its clinical trials; the timing to complete any ancillary clinical trials and/or to receive the interim/final data of such clinical trials; the timing to communicate with and submit trial data to regulatory authorities in various jurisdictions for drug approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; timing for Belite Bio to share additional data at upcoming medical meetings; the potential efficacy of Tinlarebant to set a new benchmark for future research in inherited retinal disorders, as well as those risks more fully discussed in the “Risk Factors” section in Belite Bio’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Belite Bio, and Belite Bio undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Media and Investor Relations Contact:
Jennifer Wu / ir@belitebio.com
Sophie Hunt / belite@argotpartners.com
FAQ
What did Belite Bio (BLTE) announce in its latest 6-K filing?
Belite Bio announced that it has completed enrollment of 60 adolescent subjects, including 15 in Japan, in its global Phase 2/3 DRAGON II clinical trial of tinlarebant for Stargardt disease type 1 (STGD1).
What is the design of Belite Bios DRAGON II clinical trial for tinlarebant?
DRAGON II is described as a 24‑month, randomized, double-masked, placebo-controlled Phase 2/3 study in adolescent STGD1 patients aged 12 to 20 in Japan, the United States, and the United Kingdom, with participants randomized 1:1 to receive tinlarebant or placebo.
When does Belite Bio plan to submit an NDA for tinlarebant?
Belite Bio states that it remains on track to submit a New Drug Application (NDA) to the FDA for tinlarebant in the first half of 2026.
What regulatory designations has tinlarebant received for Stargardt disease?
Tinlarebant has received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations in the U.S., Orphan Drug designation in the U.S., Europe, and Japan, and Sakigake designation in Japan, all for the treatment of STGD1.
How does tinlarebant work in Stargardt disease and geographic atrophy?
Tinlarebant is an oral therapy intended to reduce accumulation of vitamin A-based toxins (bisretinoids) by lowering serum retinol binding protein 4 (RBP4), the carrier for retinol from the liver to the eye. By limiting retinol entering the eye, it aims to reduce bisretinoid formation in STGD1 and potentially slow progression in geographic atrophy.
What other clinical trials is Belite Bio running with tinlarebant?
Belite Bio notes that it has completed a Phase 3 DRAGON trial in adolescent STGD1 subjects and is conducting a Phase 3 PHOENIX trial in subjects with geographic atrophy, alongside the Phase 2/3 DRAGON II trial in adolescent STGD1.
