AI illustration · not actual product photoDetails from the source.
This catalogue entry records Thymosin Alpha-1, 5 mg × 10 vials (SKU TA5), using the supplied source listing. The cited dossier describes: Human and preclinical research has investigated thymosin alpha-1 in hepatitis B and C, HIV, sepsis, COVID-19, influenza-vaccine response, some cancers, infections after hematopoietic stem-cell transplantation, COPD, and ME/CFS. These are investigated topics, not established uses. It also distinguishes available human evidence, limitations, safety concerns, and regulatory context. It does not verify this supplier-specific item’s identity, formulation, lot quality, or approval. This is not medical advice, a treatment recommendation, or authorization for human use.
- Catalogue code
- TA5
- Source specification
- 5mg*10vials
- Source document
- PriceList(1).pdf, page 3
- Photograph
- AI-generated illustration only — not an actual product photo or verified molecular depiction; owner-approved product photo still pending.
Product information is presented from supplied source materials. Inclusion on this website does not state that a product is an approved medicine or authorize human use. This is educational content, not medical advice.
Compound-level research and safety context.
Evidence below concerns the research family associated with this listing. For blends, findings about individual components do not establish evidence for the combination. This does not verify the supplier-specific vial or lot. Reviewed 2026-10-30.
What it is
The exact catalogue name is “Thymosin Alpha-1.” Compound-level description: a 28-amino-acid peptide, also known in synthetic form as thymalfasin. This does not verify the contents, chemical form, formulation, or source of the listed vial. Supplied PriceList(1).pdf entries: TA5 — *10vials — 86 per 10 vials; TA10 — *10vials — 157 per 10 vials. Currency is not stated.
Biological mechanism
Studied as an immune-modulating peptide. FDA materials describe activity involving Toll-like receptor 9 (TLR9) on dendritic and lymphoid progenitor cells; reviews describe effects involving antigen-presenting cells, T-cell development, and immune signalling. Mechanistic findings are not proof of clinical benefit or of the composition of this catalogue vial. [1] [2]
Research focus
Human and preclinical research has investigated thymosin alpha-1 in hepatitis B and C, HIV, sepsis, COVID-19, influenza-vaccine response, some cancers, infections after hematopoietic stem-cell transplantation, COPD, and ME/CFS. These are investigated topics, not established uses. [1]
Potential applications in the evidence
Potential applications only as investigated include immune modulation in viral infections and sepsis, vaccine-response research, and adjunct research in selected cancers or transplant-associated infection settings. Evidence does not establish prevention or treatment benefit for these conditions, and does not establish an application for the TA5 or TA10 vial. FDA found evidence insufficient for several uses reviewed. [1]
Human evidence
Human trials exist, but results vary. The 2025 multicentre, double-blind, placebo-controlled phase 3 TESTS sepsis trial reported 28-day mortality of 23.4% with thymosin alpha-1 and 24.1% with placebo, without a conclusive mortality reduction. A 2025 meta-analysis found a pooled signal across 11 trials, but not a statistically significant mortality difference in high-quality or multicentre subgroups and concluded the total evidence remains inadequate for certainty. Older hepatitis studies were mixed and limited; FDA judged evidence insufficient to determine effectiveness for hepatitis B or C. A U.S. registered COVID-19 pilot was terminated without results posted. [1] [4] [5] [6]
Known and potential effects
Reported effects in human studies include injection-site irritation, redness, or discomfort; liver-enzyme flares in chronic hepatitis B, thyroid-stimulating-hormone abnormalities in a hepatitis C study, and nipple pain were also reported. A report in stem-cell-transplant recipients described fatal immune hemolytic anemia and engraftment failure; the context does not establish a general risk rate. In the phase 3 sepsis trial, overall adverse-event rates were similar between groups and no unexpected serious adverse event attributed to thymosin alpha-1 was reported. Animal and in-vitro findings on immune signalling or tumor/viral models are preclinical and should not be represented as demonstrated human effects. [1] [2] [4]
Safety and contraindications
FDA identifies potential concerns for people undergoing deliberate immunosuppression, including hematopoietic stem-cell-transplant recipients, because immune stimulation could contribute to graft-versus-host disease or engraftment failure. FDA also says evidence is insufficient to assess use as an adjuvant with U.S.-licensed influenza vaccines. FDA warns that compounded Ta1 products may pose immunogenicity risks for certain routes related to aggregation, peptide-related impurities, and inadequate characterization. These are concerns about proposed compounded preparations, not a determination about this vial. No product label was supplied, so product-specific contraindications cannot be verified; foreign label warnings for pregnancy, lactation, children, autoimmune disease, or immunosuppression cannot automatically be applied to this unidentified product. [1] [3]
U.S. FDA / regulatory status
As of 2026-10-30, FDA’s 2024 review stated that it had approved no drug products containing thymosin alpha-1; the related bulk-substance nomination discussed in that review had been withdrawn. FDA currently lists Ta1 among bulk substances associated with significant compounding safety risks. This is not evidence that this catalogue vial is compounded, research-only, or approved. The source PDF provides no manufacturer, lot, formulation/source, jurisdictional authorization, or approval number. Approval and regulatory status of the exact vial cannot be verified and cannot be inferred from the active-compound name or a branded/overseas formulation. [1] [3]
Evidence limitations
Evidence varies by indication. Older studies were often small, open-label, outside the United States, based on older assays or non-current comparators, or reliant on surrogate and inconsistent outcomes. The large 2025 sepsis trial did not confirm a clear overall mortality benefit, while meta-analysis signals do not remove the uncertainty. Animal and in-vitro findings are not human evidence. No literature about a compound can confirm identity, purity, sterility, strength, salt form, stability, or clinical equivalence of the supplier’s TA5 or TA10 vials. [1] [2] [4] [5]
Supporting sources
- Thymosin Alpha-1 Related Bulk Drug Substances U.S. Food and Drug Administration · Regulatory review/presentation. Supports: FDA statements that no drug products containing Ta1 are FDA-approved; withdrawn nomination; compound characterization; mechanism; reviewed indications, evidence limitations, and safety concerns.
- Thymosin alpha 1: A comprehensive review of the literature World Journal of Virology / PubMed Central · Peer-reviewed review. Supports: Peptide classification, proposed immunologic mechanisms, investigated applications, and reported effects in human studies.
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration · Regulatory safety information. Supports: FDA-listed risks for compounded Ta1 products, including potential immunogenicity, peptide-related impurities, and API characterization concerns.
- The efficacy and safety of thymosin α1 for sepsis The BMJ · Peer-reviewed phase 3 randomized controlled trial. Supports: TESTS trial mortality results and adverse-event comparison in adults with sepsis.
- Efficacy of thymosin α1 for sepsis: a systematic review and meta-analysis Frontiers in Cellular and Infection Microbiology / PubMed Central · Peer-reviewed systematic review and meta-analysis. Supports: Pooled sepsis findings, non-significant high-quality/multicentre subgroups, geographic and methodological limitations, and uncertainty.
- Thymalfasin to Treat COVID-19 Infection ClinicalTrials.gov, U.S. National Library of Medicine · Clinical trial registry. Supports: U.S. COVID-19 pilot study registry record, termination reason, and absence of posted results.