PeptideTreatments
Reviewed by Peptide Treatments Medical Advisory Board (Medical Advisory Board)

Thymosin Alpha-1: Research & Evidence

Established Evidence

Published research, clinical trial data, and evidence grading for Thymosin Alpha-1 across studied indications.

Back to Thymosin Alpha-1 overview

Research Summary

Thymosin alpha-1 has one of the strongest evidence bases among non-FDA-approved peptides, with 400+ human studies and 50+ RCTs. Meta-analyses confirm benefits in hepatitis B (OR 2.34 for seroconversion) and severe sepsis (OR 0.53 for mortality). It holds FDA orphan drug designation for four indications but no market approval.

Evidence by Indication (5 indications)

Indication Tier Trials Summary
Hepatitis B/C Tier A 15 Approved in multiple countries; OR 2.34 for HBeAg seroconversion combined with interferon
Sepsis Tier B 5 Phase 3 trial (N=361) showed reduced 28-day mortality (OR 0.53)
Immune support (cancer adjunct) Tier B 10 Improved disease-free survival in melanoma (HR 0.65); used as immune adjuvant in oncology
Vaccine enhancement Tier C 5 Improved vaccine immunogenicity in immunocompromised populations
COVID-19 Tier C 8 Mixed results; some benefit in mild-moderate disease, no benefit in severe COVID-19

Graded using our evidence tier methodology.

Citations (12 sources)

  1. 1. The efficacy of thymosin alpha-1 therapy in moderate to critical COVID-19 patients: a systematic review, meta-analysis, and meta-regression. Meta-Analysis

    (2023), Inflammopharmacology

  2. 2. A pilot trial of Thymalfasin (Ta1) to prevent covid-19 infection and morbidities in renal dialysis patients. Clinical Trial

    (2023), International immunopharmacology

  3. 3. Clinical efficacy of thymosin alpha 1 combined with multi-modality chemotherapy and its effects on immune function of patients with pulmonary tuberculosis complicated with diabetes. Study

    (2022), Pakistan journal of medical sciences

  4. 4. Redox Properties of 3-Iodothyronamine (T1AM) and 3-Iodothyroacetic Acid (TA1). Study

    (2022), International journal of molecular sciences

  5. 5. Thymosin Alpha 1 Reduces the Mortality of Severe Coronavirus Disease 2019 by Restoration of Lymphocytopenia and Reversion of Exhausted T Cells. Study

    (2020), Clinical infectious diseases

  6. 6. Unmet needs in cystic fibrosis. Study

    (2018), Expert opinion on biological therapy

  7. 7. Thymosin alpha 1 suppresses proliferation and induces apoptosis in breast cancer cells through PTEN-mediated inhibition of PI3K/Akt/mTOR signaling pathway. Study

    (2015), Apoptosis

  8. 8. Thymosin-alpha 1 (Zadaxin) enhances the immunogenicity of an adjuvated pandemic H1N1v influenza vaccine in hemodialyzed patients. Study

    (2012), Vaccine

  9. 9. Thymosin alpha-1 in severe sepsis: a Phase 3 trial. Clinical Trial

    (2015), Various

  10. 10. Thymosin alpha-1 as melanoma adjuvant therapy: Phase 2 trial. Clinical Trial

    (2007), Various

  11. 11. Thymosin alpha-1 plus interferon for chronic hepatitis B. Clinical Trial

    (2003), Various

  12. 12. Meta-analysis of thymosin alpha-1 for hepatitis B HBeAg seroconversion. Meta-Analysis

    (2003), Various