With 11 RCTs in the PubMed record, Thymosin Alpha-1 has deep human evidence in the PeptideX index. Research information is not evidence of FDA approval; check the source-linked regulatory profile. Historical articles may no longer reflect current regulatory status. Check the cited primary source.
Thymosin Alpha-1 (Tα1) has 11 human RCTs. It has been studied in hepatitis B, hepatitis C, HIV, sepsis, COVID-19, DiGeorge syndrome, and cancer immunotherapy. It has 856 indexed PubMed citations and a confidence score of 4/5 on PeptideX. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
And most people in Western longevity circles have never heard of it.
Tα1 is a 28-amino-acid peptide that occurs naturally in the thymus gland. First isolated by Allan Goldstein in 1977 at the Albert Einstein College of Medicine, it was found to be a critical mediator of T-cell maturation and immune function. Product-specific approval claims are not verified in this dataset. Nomination withdrawn. FDA substance context: Thymosin alpha-1. Previously in Category 2; FDA still identifies potential significant safety risks. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
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Tα1 promotes T-cell maturation, enhances dendritic cell function, and modulates innate and adaptive immunity through TLR signaling pathways and upregulation of MHC class I antigen presentation. It acts as both an activator in immunodeficiency states (increasing T-cell counts in lymphopenic patients) and a modulator in inflammatory states (reducing cytokine storm signals in severe infection).
1. A 2025 meta-analysis of 11 human RCTs (n=1,927) found statistically significant reduction in 28-day mortality in sepsis patients (OR 0.73, p=0.003). This is a meaningful clinical signal across nearly 2,000 patients.
2. In COVID-19 patients with severe lymphocytopenia, Tα1 supplementation restored T-cell counts and reduced mortality in multiple documented hospital cohorts during the 2020-2022 period.
3. In hepatitis B and C clinical trials, Tα1 demonstrated antiviral immunostimulatory effects — which led to its FDA orphan drug designation for several indications, even without full US market approval.
Nomination withdrawn. FDA substance context: Thymosin alpha-1. Previously in Category 2; FDA still identifies potential significant safety risks. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Regulatory source checked October 10, 2026. Sources: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Full compound profile: peptidex.ai/compounds/thymosin-alpha-1
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