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Thymosin Alpha-1

Thymosin Alpha-1 (Thymalfasin / Zadaxin)

Immune modulationAnti-viralVaccine adjuvantAnti-inflammatory28 amino acids

What it is

A synthetic 28-amino-acid acetylated peptide identical to the naturally occurring thymic peptide first isolated by Allan Goldstein in 1977. Thymosin alpha-1 is the most clinically studied thymic peptide, with over 30 randomized controlled trials involving more than 11,000 human subjects across hepatitis B/C, sepsis, cancer immunotherapy, and vaccine adjuvant applications. It is approved in 35+ countries (primarily in Asia, South America, and Eastern Europe) under the brand name Zadaxin, but has never received FDA or Health Canada marketing approval. Its mechanism of action involves dendritic cell maturation, T-cell differentiation, and toll-like receptor signaling modulation.

Community-reported ranges

Dosing reflects the approved Zadaxin regimen used in clinical trials across 35+ countries. This is not dosing guidance.

Reported dose range

16001600 mcg

Estimated half-life

~2 hours

Source: human pharmacokinetic data (clinical trials)

Reported cycle length

2452 weeks on

4-8 weeks off

Route

subcutaneous

Common vial sizes

1.6mg, 3.2mg

Reported timing

AM or PM, consistent schedule

Reported frequency

2x weekly

Frequently discussed alongside

Based on community forum discussions. Not a recommendation to combine compounds.

Published research

Thymosin alpha-1 has been studied in over 30 randomized controlled trials. In hepatitis B, four trials (195 patients) demonstrated HBV DNA clearance of approximately 41% vs. 9% for controls at 6 months. In hepatitis C, combination therapy with IFN-α2b produced 65% HCV RNA clearance vs. 29% with IFN alone. A 2015 meta-analysis of 12 sepsis trials (n=1,480) found a pooled relative risk of mortality of 0.68 (95% CI 0.59–0.78), though a large 2025 placebo-controlled trial found no clear mortality benefit. Additional trials exist in melanoma, COVID-19, cystic fibrosis, drug-resistant tuberculosis, and vaccine adjuvant applications in immunocompromised populations. The standard clinical dose across trials is 1.6 mg SC twice weekly.

Reported side effects

From community self-reports. Not from controlled studies.

Clinical trial data across >11,000 subjects shows an excellent safety profile. The most commonly reported adverse event is mild, transient injection site irritation. Doses up to 16 mg twice weekly for 4 weeks showed no adverse reactions in clinical studies. Preclinical toxicology demonstrated no adverse events at 800× the clinical dose. No mutagenicity, teratogenicity, or carcinogenicity signals have been identified.

Regulatory status

FDA (United States)

Not approved. Holds orphan drug designations for chronic hepatitis B, hepatocellular carcinoma, and DiGeorge syndrome. History: placed on Category 2 (Safety Concerns — prohibited for 503A/503B compounding) in September 2023; nominators withdrew in September 2024 and it was removed from Category 2. Reviewed at the December 2024 PCAC meeting. As of March 2026, thymosin alpha-1 is not on the Category 2 list and can be legally compounded by 503A pharmacies.

Health Canada

Not authorized as a therapeutic product. No Drug Identification Number (DIN) assigned.

WADA (Competitive Athletes)

Not specifically named on the WADA Prohibited List. Thymosin beta-4 is explicitly prohibited under S2.3, but thymosin alpha-1 is structurally and functionally unrelated. Athletes should consult anti-doping authorities regarding catch-all provisions.

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