TB-500 Clinical Trials: Registered Studies and Status
As of November 2, 2026, ClinicalTrials.gov lists 18 registered studies matching TB-500 or its known aliases as an intervention.
Summary
- Registered studies
- 18
- Most advanced phase
- Phase 3
- Recruiting or not yet recruiting
- 3
- Most recent start
- 2026-05-18
- Most frequent lead sponsor
- ReGenTree, LLC (6)
- Most common status
- Completed
Source: ClinicalTrials.gov, retrieved . Registry searches by name may miss studies that use other identifiers.
Registered studies
| NCT ID | Title | Phase | Status | Enrollment | Start | Lead sponsor |
|---|---|---|---|---|---|---|
| NCT07586865 | Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction | Phase 2 | Not yet recruiting | 189 | 2026-05-18 | Beijing Northland Biotech. Co., Ltd. |
| NCT07487363 | TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD | Phase 1 / Phase 2 | Recruiting | 80 | 2026-02-05 | Hudson Biotech |
| NCT05555589 | Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2 | Phase 3 | Recruiting | 70 | 2023-04-11 | ReGenTree, LLC |
| NCT05984134 | Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction | Phase 2 | Completed | 90 | 2022-07-15 | Beijing Northland Biotech. Co., Ltd. |
| NCT05485818 | Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.Infarction | Phase 2 | Completed | 62 | 2020-11-23 | Beijing Northland Biotech. Co., Ltd. |
| NCT01311518 | A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction | Phase 2 | Withdrawn | 0 | 2019-07 | RegeneRx Biopharmaceuticals, Inc. |
| NCT03937882 | Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 | Phase 3 | Completed | 700 | 2019-05-24 | ReGenTree, LLC |
| NCT04555850 | A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers | Phase 1 | Completed | 30 | 2018-07-30 | Beijing Northland Biotech. Co., Ltd. |
| NCT04555824 | A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers | Phase 1 | Completed | 54 | 2017-07-17 | Beijing Northland Biotech. Co., Ltd. |
| NCT02974907 | Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 | Phase 3 | Completed | 601 | 2016-11 | ReGenTree, LLC |
| NCT02597803 | Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1 | Phase 2 / Phase 3 | Completed | 317 | 2015-09 | ReGenTree, LLC |
| NCT01387347 | Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye | Phase 2 | Completed | 72 | 2011-08 | ReGenTree, LLC |
| NCT01393132 | Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye | Phase 2 | Completed | 9 | 2011-03 | Michigan Cornea Consultants, PC |
| NCT00743769 | A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers | Phase 1 | Withdrawn | 0 | 2008-04 | RegeneRx Biopharmaceuticals, Inc. |
| NCT00598871 | A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds | Phase 2 | Terminated | 12 | 2007-12 | ReGenTree, LLC |
| NCT00832091 | Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers | Phase 2 | Completed | 72 | 2006-07 | RegeneRx Biopharmaceuticals, Inc. |
| NCT00382174 | Study of Thymosin Beta 4 in Patients With Pressure Ulcers | Phase 2 | Completed | 72 | 2006-05 | RegeneRx Biopharmaceuticals, Inc. |
| NCT00311766 | A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa | Phase 2 | Terminated | 30 | 2006-02 | RegeneRx Biopharmaceuticals, Inc. |
Method and limitations
- Data source: ClinicalTrials.gov API v2, intervention search.
- Query used:
"TB-500" OR "thymosin beta-4" OR "thymosin beta 4" - Retrieved: November 2, 2026. Refreshed weekly; changes are reviewed before publication.
- Studies registered only under other names, sponsor codes, or in other registries may be missing.
- A match on name does not mean the study tested this peptide alone; some studies include it as a comparator or combination.
- Status values are reported by sponsors and may be out of date.