Zimislecel
10 of 12 patients were insulin-free at one year, with immunosuppression. Dosing paused for a manufacturing review.
The immune system destroys insulin-making cells. Cell therapies have freed patients from insulin in trials, but still need immunosuppression or are in very small studies.
The latest developments, newest first.
Sana's single-patient result, published in NEJM. Just one case, but it is what the field is chasing.
Islet transplant using tegoprubart instead of tacrolimus, at the University of Chicago.
Paused for a manufacturing analysis. No filing date.
Each column is a step on the road to the pharmacy. Colors show the type of treatment.
10 of 12 patients were insulin-free at one year, with immunosuppression. Dosing paused for a manufacturing review.
One patient: cells still making insulin at 14 months with no anti-rejection drugs.
Pilot: all 12 participants off external insulin, with short follow-up.
Algorithm delivers all insulin, meals included. 34 participants.
Candidates that looked promising and were stopped. Most treatments tested never reach the market.
2025 · Vertex's encapsulated cells; did not make enough insulin.
None yet. Current treatment: Lifelong insulin.
Fasevia tracks 4 candidates: Zimislecel (Phase 3); UP421 (Phase 1); Ilhotas + tegoprubart (Lab / pilot); AIDANET (Lab / pilot).
The furthest along today is Zimislecel (Vertex), in phase 3. 10 of 12 patients were insulin-free at one year, with immunosuppression. Dosing paused for a manufacturing review.
A drug has to complete phase 3 and be reviewed by health agencies such as the FDA or EMA, which usually takes several years. The leading candidate today is in phase 3.