Data edition of
Residue An evidence-graded reference for peptide science

TB-500 clinical trials

Every study registered on ClinicalTrials.gov that lists TB-500 as an intervention, as of the data edition — what is being tested, in whom, by whom, and how far it has got.

Registered studies
20
Active or recruiting
3
Completed
11
With posted results
9
Planned or actual enrollment
2,482participants, summed
Registered studies of TB-500 by phase and status
PhaseStudiesBreakdown
Phase 1 3
2 completed, 0 active or recruiting, 1 stopped, 0 other
Phase 2 12
6 completed, 2 active or recruiting, 4 stopped, 0 other
Phase 3 5
3 completed, 1 active or recruiting, 1 stopped, 0 other
Figure 1. 20 studies on ClinicalTrials.gov match the registry search "thymosin beta 4" OR "thymosin beta-4" OR TB-500 OR RGN-259 OR RGN-137. Multi-phase studies are counted at their highest phase. Open the full trial feed

Conditions studied

  1. Dry Eye3
  2. Dry Eye Syndrome3
  3. Acute Myocardial Infarction3
  4. Healthy2
  5. Neurotrophic Keratopathy2
  6. Dry Eye Syndromes1
  7. Sjogren's Syndrome1
  8. Graft vs. Host Disease1
  9. Junctional Epidermolysis Bullosa1
  10. Dystrophic Epidermolysis Bullosa1
  11. Atherosclerotic Cardiovascular Diseases1
  12. Endothelial Dysfunction1

Lead sponsors

  1. ReGenTree, LLC7
  2. Beijing Northland Biotech. Co., Ltd.5
  3. RegeneRx Biopharmaceuticals, Inc.5
  4. Michigan Cornea Consultants, PC1
  5. Lenus Therapeutics, LLC1
  6. Hudson Biotech1

The registry, study by study

Registration is not evidence of benefit; many registered studies never publish. Status and dates are as reported by sponsors to ClinicalTrials.gov.

Status
Phase

20 shown

Registered studies of TB-500
StudyPhaseStatusStartnSponsor
NCT07586865Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction Phase 2 Not yet recruiting May 2026 189 Beijing Northland Biotech. Co., Ltd.
NCT07487363TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD Phase 1/Phase 2 Recruiting Feb 2026 80 Hudson Biotech
NCT05555589Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2 Phase 3 Recruiting Apr 2023 70 ReGenTree, LLC
NCT05984134Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction Phase 2 Completed Jul 2022 90 Beijing Northland Biotech. Co., Ltd.
NCT05485818Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.Infarction Phase 2 Completed Nov 2020 62 Beijing Northland Biotech. Co., Ltd.
NCT01311518A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction Phase 2 Withdrawn Jul 2019 0 RegeneRx Biopharmaceuticals, Inc.
NCT03937882Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3Results posted Phase 3 Completed May 2019 700 ReGenTree, LLC
NCT03578029Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa Phase 2 Terminated May 2019 4 Lenus Therapeutics, LLC
NCT04555850A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers Phase 1 Completed Jul 2018 30 Beijing Northland Biotech. Co., Ltd.
NCT04555824A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers Phase 1 Completed Jul 2017 54 Beijing Northland Biotech. Co., Ltd.
NCT02974907Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2Results posted Phase 3 Completed Nov 2016 601 ReGenTree, LLC
NCT02600429Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1Results posted Phase 3 Terminated Sep 2015 18 ReGenTree, LLC
NCT02597803Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1 Phase 2/Phase 3 Completed Sep 2015 317 ReGenTree, LLC
NCT01387347Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry EyeResults posted Phase 2 Completed Aug 2011 72 ReGenTree, LLC
NCT01393132Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry EyeResults posted Phase 2 Completed Mar 2011 9 Michigan Cornea Consultants, PC
NCT00743769A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers Phase 1 Withdrawn Apr 2008 0 RegeneRx Biopharmaceuticals, Inc.
NCT00598871A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal WoundsResults posted Phase 2 Terminated Dec 2007 12 ReGenTree, LLC
NCT00832091Study of Thymosin Beta 4 in Patients With Venous Stasis UlcersResults posted Phase 2 Completed Jul 2006 72 RegeneRx Biopharmaceuticals, Inc.
NCT00382174Study of Thymosin Beta 4 in Patients With Pressure UlcersResults posted Phase 2 Completed May 2006 72 RegeneRx Biopharmaceuticals, Inc.
NCT00311766A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis BullosaResults posted Phase 2 Terminated Feb 2006 30 RegeneRx Biopharmaceuticals, Inc.

Run this search on ClinicalTrials.gov → Query term: "thymosin beta 4" OR "thymosin beta-4" OR TB-500 OR RGN-259 OR RGN-137