Immune & antimicrobial
Thymalin
Also called Thymaline, Timalin, Тималин, Calf thymus polypeptide extract
Thymalin is a mix of small protein pieces (peptides) taken from the thymus gland of young calves. It has been a prescription immune drug in Russia since the Soviet era, given as an injection into muscle 15. Most published studies on it are small and come from the group that developed it 25. It is not an FDA-approved drug in the United States 910.
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Overview
Thymalin is a mix of small protein pieces (peptides) taken from the thymus gland of young calves. It has been a prescription immune drug in Russia since the Soviet era, given as an injection into muscle 15. Most published studies on it are small and come from the group that developed it 25. It is not an FDA-approved drug in the United States 910.
How it works
Described in the Russian product information (based mainly on developer studies): thymalin is presented as an immune modulator that helps restore disturbed immune responses, affects the numbers and balance of T and B white blood cells, supports cell-based immunity and boosts phagocytosis (the process where immune cells swallow germs) 1. Proposed (lab and computer studies only): researchers suggest its short peptides, such as KE and EW, may bind DNA and change which genes are switched on; this comes from computer modeling 7. In human immune cells grown in a dish, thymalin lowered the inflammatory signals TNF-alpha and IL-1 beta after a bacterial-toxin challenge, and the KE and EW dipeptides lowered TNF-alpha 7. In blood stem cell cultures, thymalin was linked to signs that stem cells were maturing toward T cells 8. These ideas have not been confirmed by independent researchers.
What research shows
- Randomized, single-blind trial (human, n=80, one hospital in Chita, Russia): adults with severe COVID-19 got thymalin plus standard care (n=36) or saline plus standard care (n=44). Hospital deaths were 19.4% with thymalin vs 40.9% without, and lymphocyte counts recovered more often. The study was small, and some co-authors are thymalin's developers 4.
- Long-term studies in older adults (human, two small trials in St. Petersburg and Kiev, run by the developers): the authors reported fewer deaths and fewer respiratory infections over 6 to 8 years in people given courses of thymalin. Groups were small (for example, 24 thymalin vs 22 placebo in the St. Petersburg trial; 58 thymalin vs 48 control in Kiev). The authors describe the trials as placebo-controlled, but the methods are only briefly reported 3.
- Developer review of clinical studies (human, mostly older Soviet-era studies): reports use in skin and bone infections, pneumonia and asthma in children, and immune support during cancer chemotherapy and radiation. Reported group sizes range from about 20 to several hundred patients, and many study summaries do not describe how controls were chosen or whether patients were randomized 5.
- Cell study (human immune cells in a dish, cells from 4 donors): thymalin and its KE and EW dipeptides lowered some inflammatory signals after a bacterial-toxin challenge. Computer modeling suggested these dipeptides could bind DNA 7.
- Cell study (human blood stem cells in a dish): thymalin lowered levels of two stem-cell markers by about 2 to 3 times and raised CD28, a marker of mature T cells, about 6.8 times 8.
- Animal studies (guinea pigs, rats, mice): the developers report effects on immune cells and the thymus, blood clotting, and recovery after radiation 6.
- The reviews summarizing thymalin research were written by Khavinson and colleagues and mostly cite their own group's work; many papers are in Russian-language journals, and independent replication was not found 25.
Doses studied in people
| Study or label | Dose used | Source |
|---|---|---|
| Russian official product information, adults, treatment of immune deficiency | 5–20 mg intramuscularly once daily, 30–100 mg total per course | 1 |
| Russian official product information, adults, prevention | 5–10 mg intramuscularly once daily for 3–5 days | 1 |
| Randomized trial in adults with severe COVID-19 (n=80) | 10 mg intramuscularly once daily for 10 days, added to standard care | 4 |
| Long-term study in older women, St. Petersburg | 10 mg intramuscularly once daily for 10 days per course (100 mg per course) | 3 |
| Long-term study in older adults, Kiev | 10 mg intramuscularly per injection, 50 mg per course | 3 |
These doses come only from the Russian product information and published human studies; they are listed for reference and are not a recommendation 134.
Read this first: these are the amounts given to participants in published studies or written on official prescribing labels, reported for reference. They are not recommendations. Trial doses were chosen for specific patients under medical supervision, and a dose that is safe in one person can be harmful in another.
Vial math
Many research vials hold 5 or 10 mg of powder. This table shows how much ends up in each mark on a U-100 insulin syringe for common amounts of added liquid. It is arithmetic only, not a dose.
| Vial | Liquid added | Concentration | Per unit (0.01 mL) | |
|---|---|---|---|---|
| 5 mg | 1 mL | 5 mg/mL | 50 mcg | Open in calculator |
| 5 mg | 2 mL | 2.5 mg/mL | 25 mcg | Open in calculator |
| 5 mg | 3 mL | 1.67 mg/mL | 16.7 mcg | Open in calculator |
| 10 mg | 1 mL | 10 mg/mL | 100 mcg | Open in calculator |
| 10 mg | 2 mL | 5 mg/mL | 50 mcg | Open in calculator |
| 10 mg | 3 mL | 3.33 mg/mL | 33.3 mcg | Open in calculator |
More sizes: all vial sizes · How this works: Syringes and units · Reconstitution guide.
Safety
- The Russian product information lists allergic reactions as the possible side effect. It says the drug should not be used by people allergic to its ingredients or during pregnancy and breastfeeding, and should be used with caution in people with a history of allergies 1.
- The developers report no side effects, but their papers do not include detailed, systematic safety data 35.
- No large independent long-term safety studies were found.
- No independent data were found on the content, purity or sterility of thymalin products sold outside regulated pharmacies.
- Thymalin is not an FDA-approved drug and was not found on the FDA compounding lists checked 910.
Report side effects of any drug or product to the FDA through MedWatch. For a possible poisoning in the US, call Poison Control at 1-800-222-1222.
Legal status
- FDA
- Not FDA-approved. Not named on the FDA page of bulk substances that may pose significant safety risks in compounding (Category 2), as retrieved (page dated April 22, 2026) 10.
- Compounding
- Not found on the FDA list of bulk drug substances nominated for 503A compounding, as retrieved (updated May 14, 2026). The list does include thymulin acetate, a different thymus-related substance 9.
- Sports (WADA)
- Not named on the 2026 WADA Prohibited List 11. The list's S0 class covers substances with no current approval by any government health authority; thymalin is registered in Russia 1, but athletes should confirm its status with their anti-doping organization.
- Other
- According to the Vidal drug reference, thymalin is registered in Russia as a prescription drug (lyophilisate for intramuscular injection, 10 mg per vial) under registration certificate ЛП-№(005867)-(РГ-RU) dated 21 June 2024, held by SAMSON-MED 1. Developer papers state it was first approved by the USSR Ministry of Health in November 1982 35.
Rules change often. See Legal status of peptides for how these categories work.
History
According to a review by its developers, V. G. Morozov and V. Kh. Khavinson developed a method in 1974 to isolate low-molecular-weight peptides from calf thymus, which led to thymalin, the first drug in what they call the peptide bioregulator class 6. The same review says this work built on experimental studies carried out at the Kirov Military Medical Academy since 1973 6. Developer papers state that the USSR Ministry of Health approved thymalin for medical use on 10 November 1982 35. These two papers give different order numbers for the approval. According to the Vidal drug reference, thymalin remains registered in Russia as a prescription injectable product, with a registration certificate dated 21 June 2024 1.
Common questions
Is thymalin a single peptide?
Is thymalin an approved medicine?
How strong is the evidence?
Is thymalin the same as thymosin alpha-1 or thymulin?
What side effects are known?
Is thymalin banned in sports?
It is not named on the 2026 WADA Prohibited List 11. Athletes should check its status with their anti-doping organization.
Related compounds
Thymosin alpha-1
thymalfasin · Zadaxin
Thymosin alpha-1 is a small protein fragment first found in the thymus, the organ that trains immune T cells.
Vilon
KE dipeptide · Lys-Glu
Vilon is the smallest of Vladimir Khavinson's Russian 'peptide bioregulators': just two amino acids (lysine and glutamic acid).
Epitalon
epithalon · epithalone
Epitalon is a tiny four-amino-acid peptide made in the lab, modeled on an extract from the pineal gland.
Bronchogen
AEDL peptide · Ala-Glu-Asp-Leu
Bronchogen is a tiny lab-made peptide, four amino acids long, from the Russian 'peptide bioregulator' program led by Vladimir Khavinson.
Cortagen
Kortagen · AEDP peptide
Cortagen is a small lab-made peptide (four amino acids) from Vladimir Khavinson's Russian 'peptide bioregulator' program, aimed at the brain cortex.
LL-37
cathelicidin LL-37 · human cathelicidin
LL-37 is the only cathelicidin-type germ-fighting peptide made by the human body.
Sources
- Тималин (Thymalin): official instructions for use and registration details — Vidal Russia drug reference Regulatory
- Khavinson VKh, Linkova NS, Chalisova NI, Ivko OM. The use of thymalin for immunocorrection and molecular aspects of biological activity. Biology Bulletin Reviews. 2021;11(4):377–382. doi:10.1134/S2079086421040046 Journal
- Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. 2003;24(3/4):233–240 Journal
- Kuznik B, Khavinson V, Shapovalov K, et al. Peptide drug thymalin regulates immune status in severe COVID-19 older patients. Advances in Gerontology. 2021;11(4):368–376. doi:10.1134/S2079057021040068 Journal
- Khavinson VKh, Kuznik BI, Ryzhak GA. Peptide bioregulators: a new class of geroprotectors. Report 2: The results of clinical trials. Advances in Gerontology. 2014;4(4):346–361. doi:10.1134/S2079057014040122 Journal
- Khavinson VKh, Kuznik BI, Ryzhak GA. Peptide bioregulators: a new class of geroprotectors. Message 1: Results of experimental studies. Advances in Gerontology. 2013;3(3):225–235. doi:10.1134/S2079057013030065 Journal
- Linkova N, Khavinson V, Diatlova A, et al. The influence of KE and EW dipeptides in the composition of the thymalin drug on gene expression and protein synthesis involved in the pathogenesis of COVID-19. Int J Mol Sci. 2023;24(17):13377. doi:10.3390/ijms241713377 Journal
- Khavinson VK, Linkova NS, Kvetnoy IM, Polyakova VO, Drobintseva AO, Kvetnaia TV, Ivko OM. Thymalin: activation of differentiation of human hematopoietic stem cells. Bull Exp Biol Med. 2020;170(1):118–122. doi:10.1007/s10517-020-05016-z Journal
- FDA: Bulk drug substances nominated for use in compounding under section 503A of the FD&C Act (updated May 14, 2026) Regulatory
- FDA: Certain bulk drug substances for use in compounding that may present significant safety risks Regulatory
- The 2026 Prohibited List, World Anti-Doping Code (official English text, Tractatenblad) Regulatory
Last reviewed 2026-10-28 · How we research · Found an error? See our corrections policy.