Peptilex
Study tracker · Healing · Eye

TB-500 / Thymosin beta-4

Updated 19 Oct 2026 · Peptilex evidence grade D / B (A = approved, large trials · D = mainly animal studies)

Thymosin beta-4 eye drops reached phase 3: in SEER-1 the cornea healed completely in 6 of 10 patients vs 1 of 8 on placebo; the global SEER-2 results are expected in late 2026. For TB-500 and injury recovery, the evidence comes from animal studies.
629PubMed papers
349Human studies
5Randomized trials
16Registered studies
2Ongoing / starting
5Phase 3+

Registered trials

From ClinicalTrials.gov, matched by name in the study title.

StudyPhaseStatusParticipantsStart
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
NCT05555589 · ReGenTree, LLC
Phase 3Recruiting702023-04
Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
NCT07586865 · Beijing Northland Biotech. Co., Ltd.
Phase 2Starting soon1892026-05
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
NCT03937882 · ReGenTree, LLC
Phase 3Completed7002019-05
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
NCT02974907 · ReGenTree, LLC
Phase 3Completed6012016-11
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
NCT02597803 · ReGenTree, LLC
Phase 2/3Completed3172015-09
Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction
NCT05984134 · Beijing Northland Biotech. Co., Ltd.
Phase 2Completed902022-07
Study of Thymosin Beta 4 in Patients With Pressure Ulcers
NCT00382174 · RegeneRx Biopharmaceuticals, Inc.
Phase 2Completed722006-05
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
NCT00832091 · RegeneRx Biopharmaceuticals, Inc.
Phase 2Completed722006-07
Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye
NCT01387347 · ReGenTree, LLC
Phase 2Completed722011-08
Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.Infarction
NCT05485818 · Beijing Northland Biotech. Co., Ltd.
Phase 2Completed622020-11
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
NCT01393132 · Michigan Cornea Consultants, PC
Phase 2Completed92011-03
A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers
NCT04555824 · Beijing Northland Biotech. Co., Ltd.
Phase 1Completed542017-07
A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers
NCT04555850 · Beijing Northland Biotech. Co., Ltd.
Phase 1Completed302018-07
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
NCT02600429 · ReGenTree, LLC
Phase 3Stopped early182015-09
A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
NCT00311766 · RegeneRx Biopharmaceuticals, Inc.
Phase 2Stopped early302006-02
A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds
NCT00598871 · ReGenTree, LLC
Phase 2Stopped early122007-12

1 further registry entry from a sponsor we could not verify is not listed.

Latest randomized trials & key papers

From PubMed. The full story – mechanism, all results, risks – is in the TB-500 profile of the book.

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