Dossier overview
5
research areas
3
references
3
handling notes
01
Mechanism of action
Thymosin Alpha-1 has been characterised as an immunomodulatory peptide affecting T-cell maturation and TLR signalling. Mechanism literature describes effects on macrophage polarisation, T-cell function, and Toll-like 7 / SHIP1 pathways in research models.
02
Research applications
- Immunomodulation clinical research
- Chronic hepatitis B and C clinical research
- Sepsis and critical-care clinical research
- Cancer immunology research (macrophage polarisation, TAM phenotype)
- Influenza vaccine adjuvant research
Evidence at a glance
What's behind this profile
3 citations · 2015–2025
- Human
- 2
- Review
- 1
Studies in human volunteers or patients (incl. early-phase trials).
Narrative or systematic reviews; no primary data.
Publication years
- 15
- 16
- 17
- 18
- 19
- 20
- 21
- 22
- 23
- 24
- 25
Counts are derived from the cited studies below. A study covering both in vivo and in vitro work is counted by its primary model. Sample size is reported in 2 of 3 citations. Findings remain model-specific and are not extrapolated to therapeutic use.
03
Study references
Each profile cites a minimum of two peer-reviewed sources, with model type and reported sample size where the source provides it. Findings are model-specific and must not be extrapolated to therapeutic use.
The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial
2025
Wu J et al. · BMJ
- Model
- Phase 3 multicentre double-blind randomised placebo-controlled trial in adults with sepsis
- Sample
- n=1106
Thymosin α1 was not associated with a significant reduction in 28-day all-cause mortality overall, though subgroup analyses suggested potential differential effects by age and diabetes status.
A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection
2023
Shehadeh F et al. · Journal of Infectious Diseases
- Model
- Prospective open-label randomised pilot trial in hospitalised COVID-19 patients with hypoxaemia and lymphocytopenia
- Sample
- n=49
Thymosin α1 was associated with accelerated CD4+ T-cell recovery versus standard care in the pilot cohort of hospitalised COVID-19 patients with baseline low-flow oxygen support.
Thymosin alpha-1 treatment in chronic hepatitis B
2015
Wu X et al. · Expert Opinion on Biological Therapy
- Model
- Narrative review of thymosin α1 monotherapy and combination therapy in chronic hepatitis B
- Sample
- N/A (review)
Reviewed the chronic-hepatitis-B clinical literature in which thymosin α1 alone or with antivirals was associated with HBV DNA suppression and HBeAg seroconversion in subsets of treated patients.
Evidence caveats
- Approval status varies widely by jurisdiction. The compound is not FDA-approved in the United States.
- The most recent Phase III sepsis trial (Wu 2025) did not show a significant primary outcome benefit overall; subgroup effects require confirmation in further trials.
04
Storage and handling
Approved product follows manufacturer instructions where marketed. Research-grade material must be stored under controlled laboratory conditions per protocol.
- Approved product (where marketed) follows the manufacturer label and pharmacy cold-chain.
- Research-grade material requires controlled laboratory storage and full batch documentation.
- Regulatory status varies by jurisdiction — verify before any clinical reference.