Thymosin alpha-1 (thymalfasin) is a 28-amino-acid acetylated peptide originally isolated from thymus tissue that acts through Toll-like receptors on dendritic.
Human trialsPeptide research profile
Also known as: Tα1, Thymalfasin, Thymosin alpha 1, Zadaxin, alpha1-Thymosin, Thymalfasin (USAN:INN), UNII W0B22ISQ1C, CCRIS 7707
Amounts reported for Thymosin Alpha-1 are listed under Reported protocols, each with its source and study kind. No amount ladder is inferred from them. This is educational source context, not a protocol or recommendation.
No source-supported amount ladder is shown
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No independently verified schedule
Clinical context
Human study rows are described per source under Reported protocols; they belong to their trial populations and are not a general amount.
Storage, handling and interpretation
Product identity
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Storage & handling
Follow the product label, certificate and validated laboratory SOP; no universal storage assumption is applied here.
Prepared solutions
Label concentration and preparation date, use sterile technique where applicable, and follow a validated stability protocol.
Reported protocols for Thymosin Alpha-1
What published studies and recent community write-ups report about amounts, timing and course length. 5 clinical and 2 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.
Context
Dose
Frequency
Route
Course
Source
Clinical5 rows
TESTS: Phase 3 placebo-controlled sepsis trial1,106 adults aged 18-85 with sepsis at 22 Chinese centers, 2016-2020
1.6 mg in 1 mL of sterile water
Every 12 hours
Subcutaneous
7 days, unless discharged from intensive care or withdrawnNot applicable
28-day mortality was 23.4% with thymosin alpha-1 and 24.1% with placebo, a null result, and no secondary or safety outcome differed. The authors chose 1.6 mg twice daily because the twice-weekly hepatitis dose seemed too low for sepsis given the drug's half-life of about 1.5 hours; prespecified subgroups hinted at benefit in people aged 60 or over or with diabetes and harm in younger patients, which the authors flag as hypothesis-generating. SciClone, the manufacturer, supported the trial.
ETASS: earlier randomized severe-sepsis trial361 ICU patients with severe sepsis at six Chinese teaching hospitals, 2008-2010
1.6 mg (Zadaxin, reconstituted to 1.6 mg/mL)
Twice daily for 5 days, then once daily for 2 days
Mortality at 28 days was 26.0% versus 35.0% in controls, which reached significance only on the log-rank test, and monocyte HLA-DR recovered faster in the treated group. This single-blind trial is what motivated the larger TESTS trial, which did not confirm the mortality signal.
Randomized trial added to peginterferon in chronic hepatitis B51 HBeAg-positive chronic hepatitis B patients in Korea
1.6 mg
Twice a week
Subcutaneous, alongside 180 mcg peginterferon alfa-2a weekly
12 weeks of thymosin alpha-1 within 48 weeks of peginterferonNot applicable
Combined response rates (HBeAg seroconversion, viral suppression and normal ALT) were 23.1% with the combination and 20.0% with peginterferon alone at follow-up, so the short course added nothing measurable. The hepatitis indication predates direct-acting antivirals and nucleoside analogs, and reviews now describe it as historical.
Randomized pilot trial for COVID-19 prevention in dialysis patients (NCT04428008)189 adults on maintenance hemodialysis in Kansas City, 2021-2023 (91 treated, 98 standard care)
This is the one US trial registration with results posted for the standard twice-weekly dose; it was open-label with no placebo and counted COVID-19 infections, hospitalizations and deaths over 6 months. The registry page lists the design and arms but the outcome tables need to be read on the record itself.
Comprehensive review of dosing across indicationsPatients with chronic viral hepatitis, cancers, sepsis and immunodeficiency across the published literature
Single doses of 0.8-6.4 mg; multiple-dose courses of 1.6-16 mg for 5-7 days
Usually twice a week
Subcutaneous
Varies by indication; hepatitis B regimens ran 26-52 weeksNot described
The review records a 40.6% complete virological response with 1.6 mg twice weekly in hepatitis B, calls the drug well tolerated across doses, and argues for repurposing it in COVID-19. It is a narrative review from a single hospital system rather than a systematic analysis.
Community-reported2 rows
Community dosing chart built around the clinical dose
1.6 mg (about 3.2 mg per week)
Twice weekly, for example Monday and Thursday
Subcutaneous, from a 5 mg vial reconstituted with 2 mL of bacteriostatic water (2.5 mg/mL, so 1.6 mg is 64 units on a U-100 syringe)
8-26 weeks commonly describedNot specified
Community resource2025
This 2025 chart reproduces the clinical twice-weekly schedule exactly and adds the syringe math and a 7-day limit on a reconstituted vial. It states plainly that the drug is approved in 35 or more countries but not in the United States, where it is investigational, and frames every figure as research reference only.
Community guide with course length and weight adjustment
1.6 mg; 40 mcg/kg for adults under 40 kg
Twice weekly, 3-4 days apart
Subcutaneous in the abdomen, thigh or upper arm; a 10 mg vial in 2 mL gives 5 mg/mL and six doses
6 months in hepatitis B monotherapy and cancer-adjunct use; up to 12 months in hepatitis C combination useNot specified
Community resource2026
This guide traces almost every published dose back to the one core 1.6 mg twice-weekly protocol and takes the under-40 kg adjustment from the Zadaxin clinical materials. It makes no claim beyond the approved indications and describes the figures as research-context dosing.
Plus 2 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.
Overview
Thymosin alpha-1 (thymalfasin) is a 28-amino-acid acetylated peptide originally isolated from thymus tissue that acts through Toll-like receptors on dendritic and other immune cells to promote T-cell maturation and balance cytokine output. Its synthetic form, Zadaxin, is approved in dozens of countries, mainly in Asia, for chronic hepatitis B and as a vaccine or chemotherapy adjunct, and the regimen used in those labels and in most trials is 1.6 mg injected under the skin twice a week; it is not approved in the United States or the European Union. The largest recent trials have been in sepsis, where a 1,106-patient Phase 3 trial published in 2025 found no reduction in 28-day mortality with 1.6 mg every 12 hours for a week.
What researchers are exploring
These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.
1
Immune & inflammation
Innate defense, inflammatory signaling and barrier models.
2
TESTS: Phase 3 placebo-controlled sepsis trial
28-day mortality was 23.4% with thymosin alpha-1 and 24.1% with placebo, a null result, and no secondary or safety outcome differed. The authors chose 1.6 mg twice daily because the twice-weekly hepatitis dose seemed.
3
ETASS: earlier randomized severe-sepsis trial
Mortality at 28 days was 26.0% versus 35.0% in controls, which reached significance only on the log-rank test, and monocyte HLA-DR recovered faster in the treated group. This single-blind trial is what motivated the.
4
Randomized trial added to peginterferon in chronic hepatitis B
Combined response rates (HBeAg seroconversion, viral suppression and normal ALT) were 23.1% with the combination and 20.0% with peginterferon alone at follow-up, so the short course added nothing measurable. The.
5
Randomized pilot trial for COVID-19 prevention in dialysis patients (NCT04428008)
This is the one US trial registration with results posted for the standard twice-weekly dose; it was open-label with no placebo and counted COVID-19 infections, hospitalizations and deaths over 6 months. The registry.
6
Comprehensive review of dosing across indications
The review records a 40.6% complete virological response with 1.6 mg twice weekly in hepatitis B, calls the drug well tolerated across doses, and argues for repurposing it in COVID-19. It is a narrative review from a.
What the current evidence can support
Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.
Human
Human studies and registrations
5 protocol rows on this page come from human trials, trial registrations, regulator labels or reviews of human data. Approval status and populations are stated per row.
Not graded
Community-reported use
2 rows record what blogs, vendor write-ups or forums describe for Thymosin Alpha-1. None has been verified against primary literature.
Chemistry identifiers
Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.