Zimislecel (VX-880)
In Development
Vertex Pharmaceuticals
Overview
An allogeneic, stem-cell-derived, fully differentiated islet cell therapy for type 1 diabetes designed to restore the body's own insulin production — a potential functional cure delivered as a one-time infusion.
In a pivotal Phase 1/2/3 program with FDA RMAT and Fast Track, EMA PRIME, and a UK Innovation Passport. All 10 participants in the reported cohort became insulin-independent at one year with >90% time-in-range; global regulatory submissions are expected in 2026.