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TB-500 clinical trials

ClinicalTrials.gov lists 15 registered trials of TB-500: 3 recruiting or about to, 0 running, 7 completed, 5 in phase 3, 9 with results posted. Recruiting sites are in China, Italy, Poland, Spain, United States. The largest is Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 (700 people).

15registered trials

3recruiting now

0running

7completed

5in phase 3

9with results posted

Recruiting: 3Completed: 7Stopped or withdrawn: 515trials
  • Recruiting 3
  • Completed 7
  • Stopped or withdrawn 5

Where TB-500 is in testing

Registered trials by phase. Phase 3 trials are the large ones that decide approval.

0Early phase 1First doses in people
1Phase 1Safety and dosing
9Phase 2Does it work?
5Phase 3Large confirmatory trials
0Phase 4After approval
0Not phasedObservational and other

Timeline

Each bar runs from a trial's start to its planned end; faded bars have no end date. Click a bar to open the trial.

200620082010201220142016201820202022202420262028Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction · Recruiting · Phase 2 · 189 people · 2026-05-18 to 2027-08-17TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD · Recruiting · Phase 1, Phase 2 · 80 people · 2026-02-05 to 2027-02-14Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2 · Recruiting · Phase 3 · 70 people · 2023-04-11 to 2026-04-30A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction · Stopped or withdrawn · Phase 2 · 2019-07 to 2020-07Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 · Completed · Phase 3 · 700 people · 2019-05-24 to 2020-11-08Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2 · Completed · Phase 3 · 601 people · 2016-11 to 2017-09Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 · Stopped or withdrawn · Phase 3 · 18 people · 2015-09-17 to 2019-11-20Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1 · Completed · Phase 2, Phase 3 · 317 people · 2015-09 to 2016-06Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye · Completed · Phase 2 · 72 people · 2011-08 to 2011-10Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye · Completed · Phase 2 · 9 people · 2011-03 to 2012-12A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers · Stopped or withdrawn · Phase 1 · 2008-04 to 2017-01-01A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds · Stopped or withdrawn · Phase 2 · 12 people · 2007-12 to 2009-02Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers · Completed · Phase 2 · 72 people · 2006-07 to 2009-01Study of Thymosin Beta 4 in Patients With Pressure Ulcers · Completed · Phase 2 · 72 people · 2006-05 to 2008-12A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa · Stopped or withdrawn · Phase 2 · 30 people · 2006-02 to 2010-07
RecruitingRunningCompletedStopped or withdrawnStatus unknownToday

Where trials are recruiting

Countries with sites in trials that are recruiting now.

Recruiting now 3

Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction

Not yet recruitingPhase 2189 peopleRandomizedBeijing Northland Biotech. Co., Ltd.2026-05-18 → 2027-08-17🇨🇳 China

Studying: Acute Myocardial Infarction (AMI), Acute Myocardial Infarction of Anterior Wall, Acute Myocardial Infarction With ST Elevation, Acute Myocardial Infarction of Left Ventricle · NCT07586865

About this trial

The goal of this phase IIc clinical trial is to learn if recombinant human thymosin beta 4 injection (NL005) works to treat heart damage in people who have had a serious type of heart attack called ST-segment elevation myocardial infarction (STEMI) and have been treated with emergency percutaneous coronary intervention (PCI, a procedure to open the blocked artery). It will also learn about the safety of NL005. The main questions it aims to answer are: * Does NL005 lower the size of permanent heart muscle damage measured by cardiac magnetic resonance (CMR) scan 90 days after treatment? * What …

TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD

RecruitingPhase 1, Phase 280 peopleRandomizedHudson Biotech2026-02-05 → 2027-02-14🇨🇳 China

Studying: Atherosclerotic Cardiovascular Diseases, Endothelial Dysfunction · NCT07487363

About this trial

This fictional study is an example of a ClinicalTrials.gov-style record. It describes a Phase 1/2 trial evaluating the safety and tolerability of TB-500 (a 17-23 fragment of thymosin beta 4) versus placebo in adults with stable atherosclerotic cardiovascular disease (ASCVD). Exploratory endpoints assess vascular function and inflammation biomarkers

Completed 7

Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye

CompletedPhase 272 peopleRandomizedReGenTree, LLC2011-08 → 2011-10Results posted

Studying: Dry Eye Syndrome, Dry Eye · NCT01387347

About this trial

Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal, ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259 (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product that meets a major unmet medical need in patients with dry eye.

Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

CompletedPhase 272 peopleRandomizedRegeneRx Biopharmaceuticals, Inc.2006-07 → 2009-01🇮🇹🇵🇱 Italy, PolandResults posted

Studying: Venous Stasis Ulcers · NCT00832091

About this trial

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

Study of Thymosin Beta 4 in Patients With Pressure Ulcers

CompletedPhase 272 peopleRandomizedRegeneRx Biopharmaceuticals, Inc.2006-05 → 2008-12🇺🇸 United StatesResults posted

Studying: Pressure Ulcers · NCT00382174

About this trial

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers

Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye

CompletedPhase 29 peopleRandomizedMichigan Cornea Consultants, PC2011-03 → 2012-12🇺🇸 United StatesResults posted

Studying: Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease · NCT01393132

About this trial

Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing. The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, …

Stopped early or withdrawn 5

A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction

WithdrawnPhase 2RandomizedRegeneRx Biopharmaceuticals, Inc.2019-07 → 2020-07

Studying: Acute Myocardial Infarction, ST Elevation Myocardial Infarction, STEMI · NCT01311518

About this trial

The objective of this study is to evaluate the safety and tolerability of two active doses of RGN-352 (thymosin beta 4, Tβ4, Injectable Solution) in patients with acute myocardial infarction receiving percutaneous coronary intervention angioplasty with or without stent placement. Approximately 75 subjects will be randomized to receive one of two RGN-352 doses of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3 consecutive days and weekly for 4 more weeks.

A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds

TerminatedPhase 212 peopleRandomizedReGenTree, LLC2007-12 → 2009-02🇺🇸 United StatesResults posted

Studying: Diabetes · NCT00598871

About this trial

As a consequence of damage to multiple organ systems throughout the course of their disease, diabetic patients suffer a number of chronic complications giving rise to increased morbidity, mortality, and health care costs specific to this population. Within the ophthalmic domain, diabetic retinopathy (DR) frequently induces serious visual impairment. Although DR can be addressed surgically, surgery remains a less than ideal intervention within this population with a well-characterized compromised ability to heal. The introduction of a therapeutic agent that could accelerate wound closure and de…

A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa

TerminatedPhase 230 peopleRandomizedRegeneRx Biopharmaceuticals, Inc.2006-02 → 2010-07Results posted

Studying: Epidermolysis Bullosa · NCT00311766

About this trial

The purpose of this study is to investigate a treatment to enhance the healing of acute and chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source - FDA Office of Orphan Product Development (OOPD).

Registered trials include ones that haven't published results yet. Trials are matched on the compound's name and code names (TB-500, thymosin beta 4, thymosin beta-4, RGN-259, RGN-352) in the listed interventions.