Rezolute, Inc. RZLT
Rezolute, Inc. (Nasdaq: RZLT) is an endocrine/women's health drug developer. Its lead program, Ersodetug (RZ358), is in Phase 3 for Hypoglycemia due to tumor hyperinsulinism (upLIFT); congenital hyperinsulinism (sunRIZE).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Ersodetug, upLIFT | Tumor hyperinsulinism (insulinoma / non-islet cell tumor hypoglycemia), single-arm registrational Phase 3 | antibody | Phase 3 |
| Ersodetug, sunRIZE | Congenital hyperinsulinism (Phase 3 missed primary endpoint Dec 2025; open-label extension ongoing; FDA reviewing data) | antibody | Phase 3 |
Recent results and decisions
- Oct 14, 2026completed enrollment Phase 3 upLIFT (single-arm, 16 participants) is fully enrolled; 7 of the first 8 participants were responders.
Rezolute Announces Completion of Enrollment in Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism
Filing - Jun 2, 2026positive Interim upLIFT data (open-label, single-arm): 6 of 8 enrolled participants met the primary responder criterion (>=50% reduction in IV glucose infusion rate), each with complete discontinuation of IV glucose; one non-responder withdrew to hospice.
Of the 8 participants enrolled, 6 have already met the responder criterion for the study’s primary endpoint, which is the number of participants achieving at least a 50 percent reduction from baseline in intravenous glucose requirements (glucose infusion rate; GIR) within the 8-week pivotal treatmen
Filing - May 1, 2026missed Expanded sunRIZE analyses at PES: primary endpoint (SMBG hypoglycemia events) still not met; company reports nominally significant CGM improvements (>50% reduction in time in hypoglycemia, FAS) across timepoints but not at Week 24 for the key secondary endpoint.
Although sunRIZE demonstrated reductions from baseline in hypoglycemia events, the study did not meet its primary endpoint, which assessed change in average weekly hypoglycemia events by self-monitored blood glucose (SMBG) compared to placebo.
Filing
3 more on record.
For subscribers
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Other phase 3 endocrine/women's health companies
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