Home / Clinical trials / Thymosin beta-4
Are there clinical trials for Thymosin beta-4?
Thymosin beta-4 has 18 registered clinical trials, including 11 completed interventional studies and trials reaching Phase 3. Its use in humans is supported by established registered clinical evidence.
Trial breakdown
By phase
| Phase 2 | 12 |
| Phase 3 | 4 |
| Phase 1 | 4 |
By status
| Completed | 11 |
| Withdrawn | 2 |
| Recruiting | 2 |
| Terminated | 2 |
| Not yet recruiting | 1 |
Active trials
- Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial InfarctionPhase 2 · Not yet recruiting · 189 participants · Beijing Northland Biotech. Co., Ltd. · started 2026-05-18NCT07586865
- TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVDPhase 1 / Phase 2 · Recruiting · 80 participants · Hudson Biotech · started 2026-02-05NCT07487363
- Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2Phase 3 · Recruiting · 70 participants · ReGenTree, LLC · started 2023-04-11NCT05555589
Most recent registered trials
- Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial InfarctionPhase 2 · Not yet recruiting · 189 participants · Beijing Northland Biotech. Co., Ltd. · started 2026-05-18NCT07586865
- TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVDPhase 1 / Phase 2 · Recruiting · 80 participants · Hudson Biotech · started 2026-02-05NCT07487363
- Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2Phase 3 · Recruiting · 70 participants · ReGenTree, LLC · started 2023-04-11NCT05555589
- Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial InfarctionPhase 2 · Completed · 90 participants · Beijing Northland Biotech. Co., Ltd. · started 2022-07-15NCT05984134
- Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.InfarctionPhase 2 · Completed · 62 participants · Beijing Northland Biotech. Co., Ltd. · started 2020-11-23NCT05485818
- A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial InfarctionPhase 2 · Withdrawn · RegeneRx Biopharmaceuticals, Inc. · started 2019-07NCT01311518
- Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3Phase 3 · Completed · 700 participants · ReGenTree, LLC · started 2019-05-24NCT03937882
- A Phase 1b Study of Thymosin Beta 4 in Healthy VolunteersPhase 1 · Completed · 30 participants · Beijing Northland Biotech. Co., Ltd. · started 2018-07-30NCT04555850
- A Phase 1a Study of Thymosin Beta 4 in Healthy VolunteersPhase 1 · Completed · 54 participants · Beijing Northland Biotech. Co., Ltd. · started 2017-07-17NCT04555824
- Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2Phase 3 · Completed · 601 participants · ReGenTree, LLC · started 2016-11NCT02974907
- Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1Phase 2 / Phase 3 · Completed · 317 participants · ReGenTree, LLC · started 2015-09NCT02597803
- Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry EyePhase 2 · Completed · 72 participants · ReGenTree, LLC · started 2011-08NCT01387347
Frequently asked questions
Are there clinical trials for Thymosin beta-4?
Thymosin beta-4 has 18 registered clinical trials, including 11 completed interventional studies and trials reaching Phase 3. Its use in humans is supported by established registered clinical evidence.
Does a registered trial mean the peptide works?
No. Registration means a study was formally listed before or during the research. It says nothing about the result. A completed trial can find no benefit, and many registered studies are never published.
What is the difference between a registered trial and published evidence?
Registration records that a study exists. Publication reports what it found. This page counts registrations, which is the more complete picture of research activity, but it is not a measure of proven effectiveness.
Why do phases matter?
Phase 1 tests safety in a small group. Phase 2 looks for early signs of effect. Phase 3 tests effectiveness against a comparator in a large group, and is what regulators normally require. Phase 4 studies happen after approval. A compound with only Phase 1 trials has not been shown to work.
Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine. Studies where Thymosin beta-4 is registered as an intervention. Last updated 2026-09-23.