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Peptency Academy · Research progress

ARISE-3: registry data posted for a thymosin beta 4 trial

ARISE-3 (NCT03937882) is a phase 3 randomised, placebo controlled trial of thymosin beta 4; ClinicalTrials.gov posted its outcome data on 28 Aug 2026, with no statistical analysis for either primary endpoint. Source sentencephases PHASE3; allocation RANDOMIZED; armGroups RGN-259 and PLACEBO_COMPARATOR; resultsFirstPostDateStruct 2026-08-28 (ACTUAL); outcomeMeasuresModule: analyses none listed1 ClinicalTrials.gov NCT03937882 Thymosin beta 4 is the protein also called timbetasin (PubChem CID 16132341, about 4963 Da); the TB-500 page covers how the name TB-500 maps to it and to its 7 residue fragment. Source sentencePubChem CID 16132341: title Timbetasin; MolecularFormula C212H350N56O78S; MolecularWeight 4963; PMID 38382158: "TB-500 (Ac-LKKTETQ), derived from the active site of thymosin β4"; PMID 22962027 title: "N-terminal acetylated 17-23 fragment of thymosin beta 4 identified in TB-500"2 PubChem CID 161323413 J Chromatogr B 2024

Trial result, Version 1Edited 9 sources

What happened

  • The sponsor submitted the results on 6 May 2026 and they passed registry quality control on 24 Aug 2026. Source sentencestatusModule: resultsFirstSubmitDate 2026-05-06; resultsFirstSubmitQcDate 2026-08-241 ClinicalTrials.gov NCT03937882
  • Participants, care providers, investigators and outcome assessors were masked, and the sponsor is ReGenTree, LLC. Source sentencedesignModule: allocation RANDOMIZED; masking QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR); armGroups RGN-259 and PLACEBO_COMPARATOR; leadSponsor ReGenTree, LLC1 ClinicalTrials.gov NCT03937882
  • The registry lists 700 participants enrolled at 20 sites, all in the United States. The trial started on 24 May 2019 and was completed on 7 Oct 2021. Source sentenceenrollmentInfo count 700 (ACTUAL); 20 locations, country United States; startDate 2019-05-24; completionDate 2021-10-07 (ACTUAL)1 ClinicalTrials.gov NCT03937882
  • The study material is RGN-259, which contains thymosin beta 4; the comparator contains the same excipients without thymosin beta 4. Source sentenceinterventions: RGN-259, otherNames "Thymosin Beta 4"; arm Placebo: "It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4"1 ClinicalTrials.gov NCT03937882
  • The two primary endpoints are scored eye surface measures: inferior corneal staining on the Ora Calibra scale and an ocular discomfort score. Source sentenceprimaryOutcomes: change in inferior corneal staining (Ora Calibra scale); change in ocular discomfort (Ora Calibra Ocular Discomfort and 4-Symptom Questionnaire)1 ClinicalTrials.gov NCT03937882

Why it matters for researchers

  • It adds a registered phase 3 randomised trial with posted outcome data for thymosin beta 4 itself, not for the 7 residue fragment. Source sentenceinterventions: RGN-259, otherNames "Thymosin Beta 4"; PubChem CID 16132341: title Timbetasin; MolecularFormula C212H350N56O78S; MolecularWeight 49631 ClinicalTrials.gov NCT039378822 PubChem CID 161323414 Drug Test Anal 2012
  • Earlier randomised human studies of thymosin beta 4 in eye surface settings were published, including a phase 2 trial (PMID 25826322) and the phase 3 SEER-1 trial (NCT02600429, PMID 36613994). Source sentencePubMed publication types: Randomized Controlled Trial, Clinical Trial, Phase II (25826322); Randomized Controlled Trial, Clinical Trial, Phase III (36613994); NCT02600429 title ends ": SEER-1"5 Cornea 20156 Int J Mol Sci 20227 ClinicalTrials.gov NCT02600429
  • The registered trial that names the fragment is a different record: NCT07487363, "TB-500 (thymosin beta 4 17-23 fragment)", recruiting in China and posted on 23 Mar 2026. Source sentenceNCT07487363 briefTitle "TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD"; overallStatus RECRUITING; studyFirstPostDate 2026-03-23; location country China8 ClinicalTrials.gov NCT07487363
  • Because the posted record carries outcome values for each arm but no analysis, met or not met cannot be read from the registry; the trial row stays "not reported". Source sentenceresultsSection.outcomeMeasuresModule: 16 outcome measures, reportingStatus POSTED, analyses: none listed1 ClinicalTrials.gov NCT03937882

What is not known

Sources

  1. 1ClinicalTrials.gov NCT03937882 accessed 13 Oct 2026
  2. 2PubChem CID 16132341 accessed 13 Oct 2026
  3. 3J Chromatogr B 2024 accessed 13 Oct 2026
  4. 4Drug Test Anal 2012 accessed 13 Oct 2026
  5. 5Cornea 2015 accessed 13 Oct 2026
  6. 6Int J Mol Sci 2022 accessed 13 Oct 2026
  7. 7ClinicalTrials.gov NCT02600429 accessed 13 Oct 2026
  8. 8ClinicalTrials.gov NCT07487363 accessed 13 Oct 2026
  9. 9PubMed search for RGN-259 and ARISE-3, 13 October 2026 accessed 13 Oct 2026

About this page

Research-use information. This library summarises published literature and regulator records. It is not guidance for use, not medical advice, and not a statement that any material is suitable for use in people or animals.

Reviewed by the Peptency editorial process. Version 1, last edited 13 October 2026, 9 sources.

Cite this page: Peptency Academy. ARISE-3 thymosin beta 4 trial: registry data posted. Version 1./eu/academy/news/arise-3-thymosin-beta-4-results-posted/