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Ta15.0
Thymosin Alpha-1 Research
Too few graded studies
30 peer-reviewed studies
What the evidence says
Too few graded studies
Thymosin Alpha-1 doesn't have enough studies with structured effect-size data yet to pool a verdict. Browse the studies below for individual findings.
Most evidence is from high-quality meta-analyses and randomised trials published 1999–2026 with a typical study size of 316 participants.
Based on 30 studies · 12 meta-analyses · 11 RCTs · 3,587 total participants
Confidence
High confidence
By outcome
Immune supportIncreases CD4+ T cells and the CD4+/CD8+ ratio and reduces short-term mortality and infection in sepsis and severe acute pancreatitis meta-analyses (does not validate general immune-boost use in healthy people) · Days to weeks in acute-illness settings
Too few graded studies13 studies
Hepatitis & liver
Too few graded studies10 studies
Respiratory & lung
Too few graded studies4 studies
Safety profile
Too few graded studies4 studies
Active research area
19 studies in the last 5 years · Latest meta-analysis: 2026
199920122026
1Meta-Analysis2026
Naing C, Ni H, Aung HH, Aye SN, Nikolova D, Poovorawan Y · Cochrane Database Syst Rev (2026)
No plain-language summary recorded for this citation — open the paper to read its abstract.
In plain English: Key Words: Thymosin alpha 1, Efficacy, Acute exacerbation of chronic obstructive pulmonary disease, Meta-analysis.
Cao A, Feng F, Zhou X. · Journal of the College of Physicians and Surgeons--Pakistan : JCPSP (2024)
Thymosin alpha 1 could significantly boost the immune function, and improve pulmonary function and arterial blood gas of AECOPD patients than routine treatment only.
More high-quality randomised controlled trials are needed to further confirm Thymosin alpha 1 efficacy.
In plain English: It represents a promising therapeutic approach to counteract age-related immune dysfunction and inflammation, potentially by slowing the aging process.
Simonova MA, Ivanov I, Shoshina NS, Komyakova AM, Makarov DA, Baranovskii DS, Klabukov ID, Telepenina KP, Atiakshin DA, Shegay PV, Kaprin AD, Stepanenko VN. · International journal of molecular sciences (2025)
Preclinical and clinical studies show that Tα1 can improve vaccine response in the elderly and mitigate immunosenescence.
The hybrid drug Refnot (a fusion of tumor necrosis factor alpha (TNFα) and Tα1) combines Tα1's immunomodulation with TNF's antitumor activity but has reduced toxicity.
It represents a promising therapeutic approach to counteract age-related immune dysfunction and inflammation, potentially by slowing the aging process.
In plain English: Among ANP patients with hyperglycemia, immune-enhancing Tα1 treatment was associated with a reduced risk of IPN (ClinicalTrials.gov, Registry number: NCT02473406).
Huang X, Mao W, Hu X, Qin F, Zhao H, Zhang A, Wang X, Stoppe C, Zhou D, Ke L, Ni H, Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). · Gut and liver (2024)
Among them, 271 (54.0%) had hyperglycemia, 371 (73.9%) had hypertriglyceridemia and 229 (45.6%) had both.
Tα1 therapy was associated with reduced incidence of IPN among patients with hyperglycemia (18.8% vs 29.7%: hazard ratio, 0.80; 95% confidence interval, 0.37 to 0.97; p=0.03), but not in the other subgroups.
Additional multivariate regression models using three propensity-score methods yielded similar results.
In plain English: This article explores the experiences of researchers testing the effect of a thymic peptide hormone, thymosin alpha-1, in preclinical and clinical settings and discuss how its therapeutic utility in the precision medicine era can be accommodated within the PDD framework.
Garaci E, Paci M, Matteucci C, Costantini C, Puccetti P, Romani L. · Frontiers in medicine (2024)
Ultimately, disease definitions are mostly symptom-based rather than mechanism-based, and the therapeutics should be likewise.
In recent years, there has been a renewed interest in PDD due to its potential to address the complexity of human diseases, including the holistic picture of multiple metabolites engaging with multiple targets constituting the central hub of the metabolic host-microbe interactions.
Although PDD presents challenges such as hit validation and target deconvolution, significant achievements have been reached in the era of big data.
In plain English: Therefore, it is recommended that the FDA permits 503A compounding pharmacies to compound Tα1, considering its potential to treat a variety of conditions effectively.
Dinetz E, Lee E. · Alternative therapies in health and medicine (2024)
Conclusions Based on substantial evidence from clinical trials, Tα1 emerges as a well-tolerated and effective immune modulator.
The FDA›s restriction appears unfounded, as Tα1 has shown safety and efficacy beyond the initially specified conditions.
Urgent attention and intervention are warranted to ensure the continued availability of this life-saving peptide through prescription.
14RCT2024
In plain English: The conventional-dose and high-dose thymalfasin for injection effectively improves the perioperative immune function of CRC patients and reduces the incidence of postoperative complications, as an effective treatment for such patients, which can benefit patients.
Niu W, Li Z, Li Z, Hu X, Wang X, Ding Y, Li C, Yu B. · Biotechnology & genetic engineering reviews (2024)
Compared with control group, the conventional-dose group and high-dose group had notably lower incidences of perioperative infection (P < 0.05), with no significant difference in both groups (P > 0.05).
The experimental group had significantly lower overall incidence of early and late postoperative complications, local recurrence rate and the incidence of distant metastasis, and higher perioperative immune function indexes and median disease free survival (DFS) (P < 0.05).
The conventional-dose and high-dose thymalfasin for injection effectively improves the perioperative immune function of CRC patients and reduces the incidence of postoperative complications, as an effective treatment for such patients, which can benefit patients.
In plain English: Peptide therapeutics, therefore, represent a developing research domain whose relevance to thyroid care remains to be established through rigorous investigation.
Mazza AD. · Integrative medicine (Encinitas, Calif.) (2026)
Safety profiles vary across peptide classes, and clinical use remains largely investigational in the context of thyroid disease.
This review presents potential biologic pathways linking peptide activity to immune and metabolic aspects of thyroid disorders, as well as regulatory and ethical considerations surrounding emerging peptide applications.
Substantial evidence gaps persist, and well-designed thyroid-focused clinical trials are needed to clarify safety, efficacy, and appropriate clinical roles.
16Review2026
In plain English: Prospective controlled studies with standardized dosing, defined treatment contexts, consistent outcomes, and systematic harms reporting are needed.
Kim SD et al. · Pharmaceuticals (Basel, Switzerland) (2026)
Safety reporting was inconsistent.
One case described severe multisystem immune-related toxicity during combination treatment without establishing Tα1-specific causality.
Conclusions: Tα1 has been investigated mainly as an adjunctive immunomodulatory strategy in cancer care.
In plain English: Furthermore, key challenges and future research directions are highlighted to provide an updated perspective on the role of Tα1 as a potential adjunctive immunomodulatory agent in modern cancer immunotherapy.
Chuang SC et al. · European journal of pharmacology (2026)
This review summarizes the biological functions, immunoregulatory mechanisms, and therapeutic potential of Tα1 in oncology.
We discuss recent advances in Tα1-based combination strategies, clinical observations, translational opportunities, and current limitations of the evidence.
Furthermore, key challenges and future research directions are highlighted to provide an updated perspective on the role of Tα1 as a potential adjunctive immunomodulatory agent in modern cancer immunotherapy.
18Meta-AnalysisCited 26×n=2,736 · very large study2011
In plain English: For thymosin α(1), there was a trend for a reduced risk of dying and of improved DFS.
Wolf E, Milazzo S, Boehm K, Zwahlen M, Horneber M. · Cochrane Database Syst Rev (2011)
Cochrane systematic review/meta-analysis of thymic peptides as an adjunct to chemo-/radiotherapy in cancer: 26 trials, 2736 patients (6 trials used thymosin α1 or thymopentin)
For thymosin α1 specifically the pooled overall-survival RR was 1.21 (95% CI 0.94-1.56, P = 0.14) and disease-free-survival RR 3.37 (0.66-17.30, P = 0.15) — only non-significant trends, not proof of benefit
Purified thymus extracts reduced severe infectious complications during cancer therapy (RR 0.54, 0.38-0.78) but did not improve survival or tumour response
In plain English: Neoadjuvant serplulimab, SOX, and thymalfasin produced encouraging pathological response, substantial nodal clearance, and an acceptable safety profile in stage III G/EGJ adenocarcinoma.
Xu H, Li F, Li B, Yang D, Liu T, Xia Y, Hua H, Li Q, Wang J, Liu H, Xu Z. · BMC medicine (2026)
Results Thirty patients were enrolled and all underwent curative-intent minimally invasive gastrectomy. pCR was achieved in 30.0% (9/30), and MPR in 56.7% (17/30). ypN0 status was observed in 63.3% (19/30), with N-stage downstaging in 80.0% (24/30).
Any-grade adverse events (AEs) occurred in 93.3% of patients, grade ≥ 3 AEs in 26.7%, and immune-related AEs in 23.3%.
Conclusions Neoadjuvant serplulimab, SOX, and thymalfasin produced encouraging pathological response, substantial nodal clearance, and an acceptable safety profile in stage III G/EGJ adenocarcinoma.
In plain English: The use of Tα1 therapy in combination with conventional medical therapies may be effective in improving clinical outcomes in a targeted population of severe sepsis.
Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. · Crit Care (2013)
ETASS: the pivotal multicenter RCT — 361 severe-sepsis patients across six Chinese teaching hospitals randomized 1:1 to Tα1 or control
28-day all-cause mortality 26.0% (Tα1) vs 35.0% (control); relative risk 0.74 (95% CI 0.54-1.02) — a borderline result (nonstratified P = 0.062; log-rank P = 0.049)
Tα1 produced greater recovery of monocyte HLA-DR (an immune-restoration marker) on days 3 and 7, consistent with its immunomodulatory mechanism