documented protocols
Thymosin alpha-1: what is documented about dosing
The trials state what they gave and how often. Those figures are reported here as what a study did, which is all they are.
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What follows is what published and registered studies administered, reported as that and nothing else. This site publishes no dosing guidance for any compound.
Not medical advice
This page reports what has been documented about a compound. It is not medical advice, not a diagnosis, not a dosing protocol, and not a recommendation to obtain or use anything described here. Talk to a licensed clinician about anything concerning your health. Read the full disclaimer.
Reviewed against editorial standards Updated
What this page reports, and what it does not
We report what has been documented. We do not prescribe what should be done.
Nothing here is a dosing recommendation. Statements about dosing reflect community and research reports only.
No trial established an amount of Thymosin alpha-1 for a person. Most of the rows below record what a published study gave to its animals or its cells, in the model that study built, with the species and the route named on the line. One row records that other figures circulate in community write-ups, and that this site does not republish them. Nothing here is a protocol, nothing here is scaled for a person, and this site publishes no preparation steps, no administration technique and no equipment. The reasoning is in the editorial policy.
Commonly cited protocols (extrapolated, not validated)
| Study | What was given | Frequency | Duration | Notes |
|---|---|---|---|---|
| Sepsis, 2025 phase 3 | As stated in the trial report | Every 12 hours | 7 days | Subcutaneous injection. The largest trial of this molecule, primary outcome null |
| Chronic hepatitis C phase 3 | As stated in the trial report | Twice weekly | 48 weeks | Added to peginterferon and ribavirin. Intention-to-treat result null |
| Chronic hepatitis B monotherapy | The amount reported by a 2004 review of that literature | Twice weekly | 6 months | The schedule the older hepatitis B literature used |
| Melanoma | Three different amounts in separate arms | As stated in the registry record | As stated in the registry record | No relationship appeared between amount and tumour response |
| Any use for immune support in a healthy adult | Nothing documented | Nothing documented | Nothing documented | No trial found for this page tested that use |
The amounts and schedules across this record differ by more than an order of magnitude in exposure, from an injection every 12 hours for a week to twice weekly for a year. That is not a detail. A 2015 review names dose, schedule, combination treatment and choice of endpoint as questions the field has not properly addressed, and says that the more recent trials used higher amounts than the older ones.
The melanoma trial is the only one on this record that tested more than one amount head to head, and its posted results show no relationship between the amount given and the number of tumour responses. The highest of the three amounts produced the fewest.
Commonly cited protocols (extrapolated, not validated) circulate for this compound. They do not come from a trial in the population buying it, because no such trial was found for this page.
Nothing here is a dosing recommendation. Talk to a licensed clinician about anything concerning your health.
Our takeThe figures in the table are trial parameters. The exposures behind them differ enormously between conditions, the one trial that compared amounts found no relationship with response, and reviews of the field say the question is unsettled.,Talk to a licensed clinician about anything concerning your health.
Main routes people compare
Injection under the skin
The route used in every trial on this record and the route the pharmacokinetic figures describe. Absorption is rapid and the serum half-life is about two hours.
Any other route
Nothing found for this page describes this molecule given by any other route in a person. FDA's compounding assessment specifically cites immunogenicity risk for certain routes of administration, which is a statement about the agency lacking information rather than about a particular route being established as safe or unsafe.
What is said about cycle length and timing
Trial durations on this record run from seven days to 48 weeks depending on the condition studied. None of those is a cycle in the sense the term is used in the market, and no study found for this page established a duration for the use the compound is sold for.
Talk to a licensed clinician about anything concerning your health.
What has been measured about safety
A reader weighing what other people report giving usually wants the other half of the record next. What has been measured about Thymosin alpha-1, and what has never been studied reports what has actually been measured, in what system and over what period, and the questions no published study has put.
Frequently asked questions
What amounts have trials used?
They differ by more than an order of magnitude in total exposure, from an injection every 12 hours for seven days in the 2025 sepsis trial to twice weekly for 48 weeks in the hepatitis C phase 3. This site reports each as a trial parameter and gives no guidance.
Is there an established dose?
Not for the use this compound is sold for, because no trial found for this page tested that use. A 2015 review names dose and schedule among the questions the field has not properly addressed.
Does more do more?
The one trial on this record that compared amounts head to head, in melanoma, posted no relationship between amount and tumour response, and its highest amount produced the fewest responses.
How long does it stay in the body?
A 2001 review reports rapid absorption, a peak within about two hours and a serum half-life of roughly two hours, with levels back to baseline within 24 hours.
References
- Wu J, Pei F, Zhou L, Li W, Sun R, Li Y, Wang Z, He Z, Zhang X, Jin X, Long Y, Cui W, Wang C, Chen E, Zeng J, Yan J, Lin Q, Zhou F, Huang L, Shang Y, Duan M, Zheng W, Zhu D, Kou Q, Zhang S, Liu Y, Yao C, Shang M, Peng S, Zhou Q, Cheng KK, Guan X, TESTS study collaborator group. The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ. 2025. PMID 39814420 DOI 10.1136/bmj-2024-082583
- 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. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013. PMID 23327199 DOI 10.1186/cc11932
- Ciancio A, Andreone P, Kaiser S, Mangia A, Milella M, Solà R, Pol S, Tsianos E, De Rosa A, Camerini R, McBeath R, Rizzetto M. Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: an adjuvant role? J Viral Hepat. 2012. PMID 22233415 DOI 10.1111/j.1365-2893.2011.01524.x
- Yang YF, Zhao W, Zhong YD, Yang YJ, Shen L, Zhang N, Huang P. Comparison of the efficacy of thymosin alpha-1 and interferon alpha in the treatment of chronic hepatitis B: a meta-analysis. Antiviral Res. 2008. PMID 18078676 DOI 10.1016/j.antiviral.2007.10.014
- Chien RN, Liaw YF. Thymalfasin for the treatment of chronic hepatitis B. Expert Rev Anti Infect Ther. 2004. PMID 15482167 DOI 10.1586/14787210.2.1.9
- Shehadeh F, Benitez G, Mylona EK, Tran QL, Tsikala-Vafea M, Atalla E, Kaczynski M, Mylonakis E. A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection. J Infect Dis. 2023. PMID 36056913 DOI 10.1093/infdis/jiac362
- Tuthill CW, Awad A, Parrigon M, Ershler WB. A pilot trial of Thymalfasin (Ta1) to prevent covid-19 infection and morbidities in renal dialysis patients: Preliminary report. Int Immunopharmacol. 2023. PMID 36881981 DOI 10.1016/j.intimp.2023.109950
- Soeroto AY, Suryadinata H, Yanto TA, Hariyanto TI. The efficacy of thymosin alpha-1 therapy in moderate to critical COVID-19 patients: a systematic review, meta-analysis, and meta-regression. Inflammopharmacology. 2023. PMID 37845598 DOI 10.1007/s10787-023-01354-2
- Cao A, Feng F, Zhou X. Thymosin Alpha 1 Plus Routine Treatment for the Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. J Coll Physicians Surg Pak. 2024. PMID 39648386 DOI 10.29271/jcpsp.2024.12.1497
- Tian Y, Yao J, Ma Y, Zhang P, Zhou X, Xie W, Tang W. Thymosin alpha 1 alleviates inflammation and prevents infection in patients with severe acute pancreatitis through immune regulation: a systematic review and meta-analysis. Front Immunol. 2025. PMID 40599771 DOI 10.3389/fimmu.2025.1571456
- Simonova MA, Ivanov I, Shoshina NS, Komyakova AM, Makarov DA, Baranovskii DS, Klabukov ID, Telepenina KP, Atiakshin DA, Shegay PV, Kaprin AD, Stepanenko VN. Aging and Thymosin Alpha-1. Int J Mol Sci. 2025. PMID 41373628 DOI 10.3390/ijms262311470
- Dinetz E, Lee E. Comprehensive Review of the Safety and Efficacy of Thymosin Alpha 1 in Human Clinical Trials. Altern Ther Health Med. 2024. PMID 38308608
- Ancell CD, Phipps J, Young L. Thymosin alpha-1. Am J Health Syst Pharm. 2001. PMID 11381492 DOI 10.1093/ajhp/58.10.886
- Camerini R, Garaci E. Historical review of thymosin α 1 in infectious diseases. Expert Opin Biol Ther. 2015. PMID 26098768 DOI 10.1517/14712598.2015.1033393
- Tuthill C, Rios I, McBeath R. Thymosin alpha 1: past clinical experience and future promise. Ann N Y Acad Sci. 2010. PMID 20536460 DOI 10.1111/j.1749-6632.2010.05482.x
- Cheng Y, Wu P, Kan Y, Li M, Li H. Identification and determination of structurally related peptide impurities in thymalfasin by liquid chromatography-high-resolution mass spectrometry. Anal Bioanal Chem. 2022. PMID 36207535 DOI 10.1007/s00216-022-04336-5
- ClinicalTrials.gov. NCT02867267, the TESTS trial: a phase 3 multicentre randomized quadruple-masked placebo-controlled trial of thymosin alpha 1 in 1,106 adults with sepsis, sponsored by Sun Yat-sen University with SciClone Pharmaceuticals as collaborator, running September 2016 to March 2021, primary outcome 28-day all-cause mortality. No results are posted to the registry; the trial is published. Read through the v2 API on 23 August 2026. ClinicalTrials.gov. 2026. NCT02867267
- ClinicalTrials.gov. NCT00711620, the ETASS trial: a multicentre randomized controlled trial of thymosin alpha 1 in 361 patients with severe sepsis, sponsored by Sun Yat-sen University, completed. The registry records masking as DOUBLE, naming participant and outcomes assessor, while the publication's title describes the trial as single-blind. Both are recorded here and neither is resolved. Read through the v2 API on 23 August 2026. ClinicalTrials.gov. 2026. NCT00711620
- ClinicalTrials.gov. NCT01178996, a phase 3 multicentre double-masked trial in 552 patients with chronic hepatitis C who did not respond to prior peginterferon and ribavirin, sponsored by sigma-tau i.f.r. S.p.A. with SciClone Pharmaceuticals as collaborator, completed July 2009, primary outcome sustained virological response at week 72. No results are posted to the registry; the trial is published. Read through the v2 API on 23 August 2026. ClinicalTrials.gov. 2026. NCT01178996
- ClinicalTrials.gov. NCT00039962 and NCT00040027, two phase 3 randomized double-masked trials of thymalfasin plus peginterferon alfa-2a in hepatitis C non-responders, 500 participants each, sponsored by SciClone Pharmaceuticals, both started in 2002 and both recorded as completed. Neither has results posted, and no publication was located for either. Read through the v2 API on 23 August 2026. ClinicalTrials.gov. 2026. NCT00039962
- ClinicalTrials.gov. NCT00911443, a phase 2 open randomized dose-ranging trial in 488 participants with malignant melanoma, sponsored by sigma-tau i.f.r. S.p.A., completed September 2007, five arms of 97 to 99. Posted results: overall tumour response (complete plus partial) 7, 10, 6 and 12 in the four thymosin-alpha-1 arms against 4 in the dacarbazine plus interferon control arm; median overall survival 9.3, 8.6, 10.3 and 9.3 months against 6.6; median progression-free survival 1.9, 1.8, 1.8 and 2.0 months against 1.8. No statistical analyses are posted for any outcome. Read through the v2 API on 23 August 2026. ClinicalTrials.gov. 2026. NCT00911443
- ClinicalTrials.gov. NCT04428008, a randomized open-label trial of thymalfasin to prevent COVID-19 in 189 renal dialysis patients, completed January 2023. Posted results: COVID-19 infection in 5 of 91 on treatment against 7 of 98 in the control arm; hospitalisation 27 against 26; non-COVID infections 8 against 6; deaths 3 against 7. No analyses are posted. The record's limitations field states that the introduction of vaccine during the study made detection of infection by seroconversion unreliable. Read through the v2 API on 23 August 2026. ClinicalTrials.gov. 2026. NCT04428008
- ClinicalTrials.gov. Registry sweep for thymalfasin, thymosin alpha 1, thymosin alpha-1, Zadaxin and the bare term thymosin, run through the v2 API on 23 August 2026. The five queries return 91 distinct records, of which 62 name thymosin alpha-1 in their interventions: 9 at phase 3 including one phase 2/3, 32 at phase 2 including phase 1/2 and 2/3, 7 at phase 4, and 2 observational. Two of the 62 have posted results. The remaining 29 records in the union are almost entirely thymosin beta-4, a different molecule covered separately on this site. ClinicalTrials.gov. 2026. ClinicalTrials.gov
- US Food and Drug Administration. Drugs@FDA approved drug products, queried through the openFDA drugsfda endpoint on 23 August 2026 for thymalfasin, thymosin and Zadaxin across the generic name and brand name fields. All three queries returned NOT_FOUND: there is no approved US application under any of these names. openFDA. 2026. openFDA drugsfda
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. The category 2 table carries the row Thymosin-alpha 1 (Ta1), with the stated reasoning that compounded drugs containing it may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization, and that the safety-related information is inadequate for the agency to sufficiently understand the extent of any safety issues raised. Page content current as of 22 April 2026, fetched with a browser user agent and read on 23 August 2026. FDA human drug compounding. 2026. FDA category 2 list
- World Anti-Doping Agency. The 2026 Prohibited List. Cited here only for the definition of class S0, which covers substances with no current approval by any governmental regulatory health authority for human therapeutic use. Thymosin alpha-1 holds approvals as a medicine outside the United States, so that definition appears not to reach it. This site did not establish whether any other class on the list names or reaches this compound, and states the placement as unsettled rather than resolved. The URL serves zero bytes to automation and is ledgered in tools/unverified-sources.json. World Anti-Doping Agency. 2026. WADA 2026 Prohibited List