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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

Registered trial

  • NCT03937882Phase 3

    Status
    Completed (7 Oct 2021), results posted 28 Aug 2026
    Sponsor
    ReGenTree, LLC
    Site countries
    US
    Primary endpoint
    eye surface staining and discomfort scores
    Primary endpoint met
    not reported
    Last synced
    13 October 2026

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./us/academy/news/arise-3-thymosin-beta-4-results-posted/