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Thymic polypeptide preparation (calf-thymus extract); immunomodulatory bioregulator

Thymalin

Unclearaka Thymus polypeptide extract (calf thymus), Thymalinum

Thymalin is one of the original 'peptide bioregulators' associated with the Russian researcher Vladimir Khavinson. It has been used in Russia and some former-Soviet states to modulate immunity, and small, largely Russian-language studies have explored effects on immune function and ageing. High-quality, independently replicated trials are lacking, and it is an unapproved substance outside those markets.

Mechanism

Thymalin is a mixture of thymic polypeptides proposed to help restore balance to the immune system by supporting T-lymphocyte maturation and differentiation and normalising T-helper/T-suppressor ratios. As an extract rather than a single defined molecule, its precise active constituents and molecular targets are not fully characterised, and most mechanistic claims derive from older preclinical and Russian clinical work that has not been independently verified in large Western trials.

Regulatory Status by Region

  • United States (FDA)Not FDA-approved; no US marketing approval and not an approved medicine.
  • Russia and former-Soviet statesRegistered and used clinically in Russia (and some neighbouring states) as an immunomodulatory thymic preparation; not evaluated or approved by the FDA, EMA or TGA.
  • Australia (TGA)Not on the ARTG; an unapproved substance in Australia.
  • European Union (EMA)No EMA marketing authorisation; not an approved medicine in the EU.
  • WADANot listed by name on the Prohibited List; its status as a peptide immunomodulator is not clearly defined for anti-doping purposes, and athletes should verify current status with their anti-doping organisation.

Key Studies