Thymosin Alpha-1 Reconstitution Calculator

No. Thymosin alpha-1 (thymalfasin, Zadaxin) lacks US FDA approval but is registered in multiple countries for chronic hepatitis B and as a vaccine-response enhancer in immunocompromised patients. In China it is used broadly in cancer, severe infection, and critical care, with a 2025 expert consensus issuing 10 recommendations for infectious disease and critical care applications. The overall evidence base is RCT/meta-analysis level in sepsis, chronic hepatitis B, and COPD exacerbation,,.

1.6 mg subcutaneously twice weekly dominates clinical practice across oncology, infection, and immunocompromised indications,. PRaG radioimmunotherapy protocols use 1.6 mg thrice weekly, with a 7-day daily loading phase first when baseline T-lymphocyte counts are low. Sepsis trials use 3.2 mg (2 × 1.6 mg vials) subcutaneously twice daily for 7 days. Fertility/recurrent implantation failure protocols: 1.6–3.2 mg daily or alternate-day for ≥118 days, cumulative ~20–22 mg,. No validated body-weight adjustment exists.

Subcutaneous injection is the established clinical route; essentially all published administration is SC,. Oral dosing is not viable: the 28-amino-acid peptide has a ~3 h plasma half-life and negligible gastrointestinal absorption (mechanistic, practitioner consensus). Half-life extensions exist in research: an IgG1-CH3 fusion achieves 47 h, and injectable liquid-crystal depots sustain in vitro release up to 2 weeks. No commercial oral form exists.

Duration is indication-dependent; no maximum is established. Seven days in acute sepsis trials; 6–12 months in chronic hepatitis B; ≥118 days in fertility protocols; continued until progression or intolerable toxicity in cancer maintenance. Decades of twice-weekly clinical use show no cumulative toxicity signal,.

Favorable safety record: serious adverse events were lower with Tα1 vs control in a Cochrane HBV analysis (RR 0.72); a sepsis meta-analysis showed 28-day mortality RR 0.77, and a Phase III sepsis trial found fewer treatment-emergent AEs than placebo,. One case of multisystem immune-related toxicity occurred with PD-1 inhibitor (sintilimab) plus Tα1; Tα1-specific causality was not established. Pregnancy: no controlled human data. Empiric use in recurrent implantation failure/IVF (1.6–3.2 mg) improved implantation rates (63.4%) without adverse signal,. Avoid initiating in pregnancy/lactation except under medical supervision (practitioner consensus).

Tα1 carries the strongest human dataset among thymic peptides: RCT/meta-analysis evidence in sepsis, HBV, and COPD, while TB4 and BPC-157 remain largely preclinical,,. In a 76-RCT sepsis network meta-analysis (22,194 patients), ulinastatin ranked first for mortality; ulinastatin plus Tα1 also lowered mortality and cut ICU stay by ~2.9 days. Versus interferon-α in HBV: comparable efficacy, better tolerability, more gradual sustained response. COVID-19 evidence conflicts: one multicenter cohort found higher non-recovery with Tα1 (OR 1.5); another found reduced mortality in severe COVID with lymphocytopenia (11.1% vs 30.0%) (benefit is most plausible in patients with depleted T-cell counts).

Refrigerate lyophilized and reconstituted vials at 2–8 °C, protected from light; lyophilized vials may be frozen (practitioner consensus). Use reconstituted peptide within ~14 days (practitioner consensus). For travel, carry an insulated cold-chain case with ice packs and written prescription documentation; medication exemptions from liquid limits generally apply to injectables (practitioner consensus).