Thymosin Alpha-1 Clinical Trials 2026: 2026 Endpoints Comparison
NSCLC Combination (Phase III) Progression-free survival (PFS) by RECIST 1.1 1.6mg subcutaneous twice weekly + pembrolizumab Advanced NSCLC, PD-L1 ≥50%, treatment-naive Q3 2027 Combination shows 14-point PFS improvement in Phase II. Phase III confirms if durabl
This comparison does not assign a generated winner or score.
- NSCLC Combination (Phase III)
- Progression-free survival (PFS) by RECIST 1.1
- 1.6mg subcutaneous twice weekly + pembrolizumab
- Advanced NSCLC, PD-L1 ≥50%, treatment-naive
- Q3 2027
- Combination shows 14-point PFS improvement in Phase II. Phase III confirms if durable
- Sepsis Mortality (Phase II/III)
- 28-day all-cause mortality
- 1.6mg subcutaneous twice weekly × 14 days, initiated within 24h of sepsis diagnosis
- ICU patients, confirmed bacterial sepsis, lymphocyte count <800/μL
- Q4 2026
- Targets immune paralysis reversal. Hard mortality endpoint eliminates surrogate bias
- Chronic HBV Clearance (Phase III)
- HBsAg loss at week 72 (24 weeks post-treatment)
- 1.6mg subcutaneous twice weekly + Peg-IFN × 48 weeks
- Chronic HBV, HBsAg-positive >6 months, HBV DNA >2000 IU/mL
- Q2 2027
- 22% vs 8% HBsAg loss in Phase II. Functional cure rate nearly triples if replicated
- Post-Infection Immune Recovery (Phase II)
- CD4+ T-cell count and CD4/CD8 ratio at week 12
- 1.6mg subcutaneous twice weekly × 12 weeks
- Post-sepsis or post-COVID with CD4+ <400/μL at discharge
- Q1 2027
- Measures immune reconstitution functionally. Cytokine production and proliferation assays included
- These thymosin alpha-1 clinical trials 2026 share a common thread: they measure hard clinical outcomes (survival, viral clearance, immune function) rather than surrogate markers. That design choice reflects accumulated evidence that immune modulation trials often show impressive lab changes (cytokine levels, cell counts) without translating to meaningful clinical benefit. The 28-day mortality endpoint in the sepsis trial is particularly notable. It eliminates the ambiguity that plagues ICU intervention studies where discharge timing and post-discharge care confound results.