PeptideTrace
Research CompoundBovine Thymus Extract (Russian Approval)Immune & Anti-inflammatory

Thymalin (Thymalin polypeptide complex)

C

Evidence Grade C — Moderate human evidence. 234 published studies, 156 human. 0 registered clinical trials.

234 studiesUSEUCA

Medically reviewed by a licensed medical professional

Overview

Thymalin is an undefined mixture of peptides extracted from bovine (cow) thymus glands, developed in the Soviet Union in the 1970s. Unlike most compounds in this database, it is not a single defined molecule but a crude biological extract. It has been used clinically in Russia for immune restoration but has never been evaluated by Western regulatory agencies.

Also Known As

Thymalin is also known by these brand and alternate names:

Research Activity

234studies
Human 156
Animal 76
In-vitro 19
Reviews 5

234 published studies: 156 human, 76 animal, 19 in-vitro, 5 reviews

Regulatory Status

US
Not approved by FDA(FDA)
EU
Not authorised by EMA(EMA)
CA
Not approved by Health Canada(Health Canada)

Legal Status

USNot applicable (not approved)
EUNot applicable (not authorised)
CANot applicable (not approved)

Summary

Thymalin is approved in Russia for immune restoration indications. It has not been approved by the FDA, EMA, or other major Western regulatory agencies. A study of elderly subjects observed over 6–8 years reported mortality differences between treated and control groups, but this study's methodology has not been evaluated through Western regulatory review.

As an undefined biological mixture derived from animal tissue, Thymalin faces inherent challenges in molecular characterisation, batch-to-batch consistency, and quality standardisation. The clinical evidence base has not met the standards required for FDA or EMA approval.

Mechanism of Action

Research suggests Thymalin may influence T-cell differentiation and immune cell function. As an undefined mixture of bovine thymus-derived peptides, the active component(s) and their specific molecular targets cannot be precisely characterised. The proposed mechanisms are based on immunological assessments from Russian clinical studies.

Research Summary

Research from the Khavinson group reports reduced mortality with combined Thymalin and Epithalamin treatment in elderly subjects followed for 6-8 years. However, nearly all clinical data originates from a single research group, sample sizes are very small (20-24 per group), and no confidence intervals were reported. As an undefined bovine tissue extract, Thymalin faces inherent challenges in batch-to-batch consistency and quality standardisation. A theoretical prion contamination risk exists for animal-derived brain and gland tissue products. Much of the supporting literature is in Russian only. Over 40 years of use in Russia is reportedly safe, but formal pharmacovigilance by Western standards is absent.

Clinical Trials

PeptideTrace tracks 0 registered clinical trials for Thymalin sourced from ClinicalTrials.gov.

No trials registered on ClinicalTrials.gov for this compound.

Scientific Detail

Overview (Scientific)

Thymalin is a polypeptide complex extracted from bovine (calf) thymus glands via mild acid extraction, developed by Vladimir Khavinson and Vyacheslav Morozov at the Military Medical Academy in St. Petersburg beginning in the 1970s. It is classified as a cytomedine, a class of short peptide bioregulators. The pharmaceutical product is a heterogeneous mixture of peptides with MW <10,000 Da, not a single molecular entity. Key active short peptides identified within the complex include EW (Glu-Trp, basis for Thymogen), KE (Lys-Glu, basis for Vilon), and EDP (Glu-Asp-Pro, basis for Crystagen). CAS: 79621-14-0. Standard dosing in Russian clinical practice is 10 mg IM daily for 10 days per course. Available as Thymalin injectable (Russia) and Vladonix oral capsule form. Not approved by any Western regulatory agency.

Mechanism of Action (Scientific)

Research suggests Thymalin stimulates differentiation and maturation of T-lymphocytes (CD4+ and CD8+), restores T/B lymphocyte ratios, enhances NK cell activity, increases phagocytic function, and normalizes circulating immune complexes. At the gene level, its constituent short peptides (EW, KE, EDP) research suggests bind double-stranded DNA and histone proteins, regulating expression of genes related to immune function, inflammation, DNA repair, and apoptosis. Thymalin also modulates the cAMP/cGMP intracellular signaling axis and interacts bidirectionally with the hypothalamus-pituitary axis, following a circadian rhythm.

Summary (Scientific)

The landmark study is Khavinson and Morozov 2003 (Neuroendocrinology Letters 2003;24(3/4):233-240; PMID 14523363), a double-blind trial enrolling N=266 elderly persons aged 60+ observed for 6-8 years. The 15-year follow-up subset showed: control group (N=22) had 81.8% mortality; Thymalin alone (N=24) had 41.7% mortality (P<0.05); Epithalamin alone (N=24) had 45.8% (P<0.05); Thymalin + Epithalamin (N=24) had 33.3% (P<0.01); and annual combined treatment for 6 years (N=20) had 20.0% mortality (P<0.01). Research suggests a 2.0-fold mortality reduction with Thymalin alone and 4.1-fold with annual combined treatment. A COVID-19 study (N=36, PMC8654498) research suggests Thymalin halved hospital mortality in elderly patients with severe disease. Brand names include Thymalin (injectable, Russia) and Vladonix (oral capsule).

The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.

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This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.