Thymosin α-1

Immune modulation

Status

On watchlist — not yet prescribable

Mechanism

Thymosin alpha-1 is a 28-amino-acid peptide originally isolated from thymosin fraction 5 of thymic tissue. It enhances T-cell maturation and function, stimulates dendritic cell differentiation, and upregulates MHC class I expression. It has been used clinically in Asia and Europe for hepatitis B/C and as an immune adjuvant.

Indications

→Immune reconstitution and T-cell support

→Chronic viral infection adjunct therapy

→Post-illness immune recovery

→Vaccine response augmentation

Regulatory status

Thymosin alpha-1 (Zadaxin) is approved in over 35 countries but not by the FDA for US marketing. It is on the 503A Category 2 list, prohibiting routine compounding. Northline monitors US regulatory developments.

References

01Romani L, et al. Thymosin α1 activates dendritic cell tryptophan catabolism and establishes a regulatory environment for balance of inflammation and tolerance. Blood. 2006.

02FDA 503A Category 2 — ineligible for compounding.

This fact sheet is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Compounded medications are not FDA-approved. Prescribing decisions are made by a licensed clinician based on individual medical necessity. Not all patients qualify.