Thymosin beta-4

Also known as: thymosin beta 4 · RGN-259

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 5 of 608 publications on PubMed
Registered clinical trials 19 3 active
Adverse event reports 3 2 classified as serious
  • Thymosin beta-4 is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 608 publications mentioning it, including 5 randomized controlled trials and 212 animal-only studies.
  • ClinicalTrials.gov lists 19 registered studies testing it (3 active).
  • FDA's adverse event system (FAERS) holds 3 reports mentioning it; 2 classified as serious. Reports do not prove causation.

Research topics

  • Thymosin beta(4) 118
  • Cell Proliferation 21
  • Proteomics 16
  • Cell Movement 15
  • Apoptosis 11
  • Cell Differentiation 11
  • Actins 10
  • Cell Survival 10
  • Myocardium 10
  • Myocytes, Cardiac 10

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 608
  • Human (MeSH) 334
  • Animal only 212
  • Clinical trials 5
  • Randomized controlled trials 5
  • Systematic reviews & meta-analyses 1
  • Case reports 2
  • Retracted 4

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
19
Active
3
With posted results
9

Conditions studied

  • Acute Myocardial Infarction 3
  • Dry Eye 3
  • Dry Eye Syndrome 3
  • Neurotrophic Keratopathy 2
  • Healthy 2
  • Acute Myocardial Infarction (AMI) 1
  • Acute Myocardial Infarction of Anterior Wall 1
  • Acute Myocardial Infarction With ST Elevation 1
  • Acute Myocardial Infarction of Left Ventricle 1
  • Acute Myocardial Infarction With ST Segment Elevation 1
  • Atherosclerotic Cardiovascular Diseases 1
  • Endothelial Dysfunction 1
Study Status Phase Start
Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
NCT07586865 Beijing Northland Biotech. Co., Ltd.
Not yet recruiting Phase 2 May 18, 2026
TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
NCT07487363 Hudson Biotech
Recruiting Phase 1, Phase 2 February 5, 2026
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
NCT05555589 ReGenTree, LLC
Recruiting Phase 3 April 11, 2023
Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction
NCT05984134 Beijing Northland Biotech. Co., Ltd.
Completed Phase 2 July 15, 2022
Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.Infarction
NCT05485818 Beijing Northland Biotech. Co., Ltd.
Completed Phase 2 November 23, 2020
A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction
NCT01311518 RegeneRx Biopharmaceuticals, Inc.
Withdrawn Phase 2 Jul 2019
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
NCT03937882 ReGenTree, LLC Results posted
Completed Phase 3 May 24, 2019
A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers
NCT04555850 Beijing Northland Biotech. Co., Ltd.
Completed Phase 1 July 30, 2018
A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers
NCT04555824 Beijing Northland Biotech. Co., Ltd.
Completed Phase 1 July 17, 2017
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
NCT02974907 ReGenTree, LLC Results posted
Completed Phase 3 Nov 2016
Show 9 more studies
Study Status Phase Start
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
NCT02600429 ReGenTree, LLC Results posted
Terminated Phase 3 September 17, 2015
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
NCT02597803 ReGenTree, LLC
Completed Phase 2, Phase 3 Sep 2015
Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye
NCT01387347 ReGenTree, LLC Results posted
Completed Phase 2 Aug 2011
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
NCT01393132 Michigan Cornea Consultants, PC Results posted
Completed Phase 2 Mar 2011
A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers
NCT00743769 RegeneRx Biopharmaceuticals, Inc.
Withdrawn Phase 1 Apr 2008
A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds
NCT00598871 ReGenTree, LLC Results posted
Terminated Phase 2 Dec 2007
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
NCT00832091 RegeneRx Biopharmaceuticals, Inc. Results posted
Completed Phase 2 Jul 2006
Study of Thymosin Beta 4 in Patients With Pressure Ulcers
NCT00382174 RegeneRx Biopharmaceuticals, Inc. Results posted
Completed Phase 2 May 2006
A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa
NCT00311766 RegeneRx Biopharmaceuticals, Inc. Results posted
Terminated Phase 2 Feb 2006

All 19 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
3
Serious
2
With death outcome
0

Most reported reactions

  • Blood insulin decreased 1
  • Blood potassium increased 1
  • Drug ineffective 1
  • Hepatic enzyme increased 1
  • Hypertension 1
  • Impaired gastric emptying 1
  • Malaise 1
  • Manufacturing production issue 1
  • Mast cell activation syndrome 1
  • Obesity 1
  • Product dispensing error 1
  • Product label issue 1

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.