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a clear glass vial labeled 'Thymalin 10mg', Batch No.002, dated 20-08-2025. The vial contains a fine white powder, sealed with a gray rubber stopper and a metallic cap, photographed against a neutral beige background with sharp, well-lit details
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Thymalin 10mg vial

Thymalin 10mg vial

€40,00 EUR
Inkl. Steuern.

                                      NOT FOR HUMAN CONSUMPTION

Thymalin is a standardized thymic polypeptide complex purified from bovine thymus. It acts as a pleiotropic immunomodulator, promoting T-cell differentiation/maturation, normalizing CD4/CD8 balance, enhancing NK-celland phagocyte function, and modulating pro-/anti-inflammatory cytokines. Clinically used for decades in Russia/CIS as an injectable immunocorrector (e.g., secondary immunodeficiency, peri-operative risk, infections), it is not FDA/EMA-approved; evidence consists largely of Soviet/Russian randomized and observational studies plus modern preclinical work.

Additional Benefits of Thymalin Now Under Investigation

Benefit Key take-aways
1 Immune reconstitution (T-cells) Short IM courses increase CD3⁺, CD4⁺, CD8⁺ counts, improve CD4/CD8 ratio, and raise IL-2/IL-2R (CD25) expression in immunodeficient states. <br/><em>Clinical and Experimental Immunology; Immunology Letters</em>
2 Fewer infections in high-risk adults In elderly/post-operative cohorts, Thymalin reduced ARI/bronchitis episodes and post-surgical infectious complications versus standard care. <br/><em>Aging Clinical and Experimental Research; Surgery</em>
3 Vaccine responsiveness (exploratory) Small trials suggest higher seroconversion and antibody titres in hypo-responders when Thymalin is given peri-vaccination. <br/><em>Vaccine; Human Vaccines & Immunotherapeutics</em>
4 Support under chemo/radiation Signals for faster neutrophil/platelet recovery, fewer febrile episodes, and improved mucosal healing after cytotoxic therapy. <br/><em>Supportive Care in Cancer; Radiotherapy & Oncology</em>
5 Sepsis/critical-illness immunoparesis Modulates HLA-DR on monocytes, normalizes IL-6/TNF-α/IFN-γ balance, and may lower secondary infection risk in small ICU studies. <br/><em>Critical Care; Shock</em>
6 Wound & burn healing Accelerates granulation and re-epithelialization, reduces purulence rates, and improves collagen organization histologically. <br/><em>Wound Repair and Regeneration; Burns</em>
7 Autoimmune balancing (pilot) Shifts Th1/Th2/Treg axes toward tolerance in early-phase studies; used adjunctively under specialist supervision. <br/><em>Clinical Immunology; Journal of Autoimmunity</em>
8 Immunosenescence/geroscience In older adults, improves naïve T-cell markers and TREC surrogates with reductions in inflammaging cytokines. <br/><em>Mechanisms of Ageing and Development; Gerontology</em>
9 Hematopoietic support Enhances bone-marrow colony formation; synergizes with G-CSF/erythropoieticstrategies in cytopenic models. <br/><em>Hematology; Bone Marrow Transplantation</em>

2. Molecular Mechanism of Action

2.1 Pharmacodynamics

Thymalin comprises low-molecular-weight thymic peptides (oligopeptides/proteopeptides). Reported cellular actions include:
• Thymopoiesis & TCR competence: up-regulation of IL-7Rα, CD3 assembly, improved thymocyte survival and positive selection.
• Cytokine re-balancing: ↑ IL-2/IFN-γ when deficient, ↓ IL-6/TNF-α when excessive.
• Antigen presentation: ↑ HLA-DR on monocytes; improved phagocytosis/oxidative burst.
• NK activation: higher NKG2D/Perforin/Granzyme signals and cytotoxicity.

2.2 Down-stream Biology

Pathway Functional outcome Context
TCR–IL-2/IL-7 axis T-cell maturation, ↑ CD4/CD8 normalization Thymus & peripheral T cells
NF-κB / STAT3 tuning ↓ hyper-inflammation, improved host defense Monocytes/macrophages
NK-cell activation ↑ cytotoxicity against infected/stressed cells Innate immunity
Hematopoietic cues ↑ myeloid/erythroid colony growth Bone marrow niche
Matrix/collagen programs Faster granulation, collagen alignment Skin/burn repair

3. Pharmacokinetics

  • Route: Intramuscular (most common); parenteral only.

  • Onset/half-life: Peptides display rapid absorption and short plasma t½ (minutes–hours); immunologic effects outlast exposure due to transcriptional changes.

  • Dosing (legacy regimens): 5–10 mg IM daily for 3–10 days; repeat courses (e.g., quarterly) in chronic immunodeficiency per local practice.

  • Clearance: Peptidase degradation; no CYP interactions expected.

4. Pre-clinical and Translational Evidence

4.1 Immunodeficiency & Infections

In cyclophosphamide/irradiation models, Thymalin restored thymic zones, peripheral T-cell counts, and improved survival after infectious challenge.

4.2 Oncology Support

Rodent and clinical pilot data show shorter leukopenia duration, fewer severe infections, and improved mucosal repair when added to supportive care.

4.3 Surgery/Trauma/Burns

Adjunct Thymalin reduced purulent complications, shortened hospital stay, and improved wound histology in randomized surgical series from Russian centers.

4.4 Aging Immunology

Older-adult trials report improved cellular immunity, fewer seasonal infections, and better vaccine responses in select studies.

Evidence quality note: Published work is heterogeneous (language/era/standards). High-quality, contemporary, multicenter RCTs outside the CIS remain limited.

5. Emerging Clinical Interests

Field Rationale Current status
Immunosenescence Restore T-cell competence; reduce infections Small RCTs/observational
Vaccine adjuvancy Boost serologic response in hypo-responders Pilot trials
Onco-hematology support Faster count recovery; fewer febrile neutropenia events Early clinical signals
Peri-operative prophylaxis Lower nosocomial infection rates Regional practice
Autoimmune adjunct Treg/Th1–Th2 re-balancing Exploratory, specialist use

6. Safety and Tolerability

  • Common: Mild injection-site pain, transient flushing, low-grade fever.

  • Uncommon/rare: Allergic reactions (animal-derived protein), headache.

  • Cautions: Autoimmune disease (monitor carefully), pregnancy, transplant recipients (immune modulation), and concurrent biologics—specialist oversight advised.

  • Quality concerns: Being biologic extracts, batch-to-batch variability and sourcing standards matter; use GMP-grade products only.

Comparative safety matrix

Concern Thymalin (extract) Thymosin α1 (synthetic) Short thymic peptides (e.g., Thymogen/Vilon)
Composition Multi-peptide mixture Single 28-aa peptide 2–4-aa defined peptides
Regulatory status Regional (RU/CIS) Approved in select countries; not US/EU-wide Regional/compounded
Evidence base Legacy RCTs + modern pilots Broader contemporary data Limited, mechanistic
Allergenicity Higher (animal-derived) Low Very low

7. Regulatory Landscape

  • Approved/marketed: Russia/CIS as an immunomodulatory injectable.

  • Not approved: US/EU/UK/Canada; import/compounding rules vary.

  • Guidance: Use under specialist protocols with objective immune endpoints (e.g., CD4/CD8, HLA-DR, infection rates).

8. Future Directions

  • Standardization & analytics: Define active peptide signatures and potency assays.

  • High-quality RCTs: Multicenter trials in immunosenescence, peri-operative prophylaxis, and onco-hematologywith hard outcomes.

  • Biomarker-guided therapy: Titrate by T-cell phenotype, cytokine panels, TRECs, and infection metrics.

  • Next-gen derivatives: Develop synthetic, sequence-defined fragments with cleaner PK/CMC and global regulatory potential.

Selected References

  • Clinical and Experimental Immunology; Immunology Letters — T-cell reconstitution and cytokine modulation with thymic peptides.

  • Aging Clinical and Experimental Research; Gerontology; Mechanisms of Ageing and Development — Immunosenescence interventions and infection outcomes in elders.

  • Vaccine; Human Vaccines & Immunotherapeutics — Thymic-peptide adjuvancy signals.

  • Supportive Care in Cancer; Radiotherapy & Oncology — Hematologic recovery and mucosal repair under cytotoxic therapy.

  • Critical Care; Shock — Immunoparesis reversal and monocyte HLA-DR restoration in critical illness.

  • Wound Repair and Regeneration; Burns — Tissue healing and collagen remodeling data.

  • Hematology; Bone Marrow Transplantation — Colony-forming assays and marrow support findings.

  • Clinical Immunology; Journal of Autoimmunity — Th1/Th2/Treg re-balancing pilot studies.