---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-085614"
form_type: "8-K"
ticker: "RZLT"
cik: "0001509261"
company_name: "Rezolute, Inc."
filed_at: "2024-08-05T23:59:59+00:00"
generated_at: "2026-05-31T13:05:44.178607+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Rezolute receives FDA IND clearance for Phase 3 study of RZ358 in tumor hyperinsulinism

## Summary
- FDA cleared IND for RZ358 (ersodetug) Phase 3 registrational trial treating hypoglycemia due to tumor HI.
- Double-blind, placebo-controlled study of 24 participants; enrollment expected to start H1 2025.
- Ongoing Phase 3 for congenital HI; topline data anticipated mid-2025.
- Drug is a fully human monoclonal antibody binding to insulin receptor allosteric site.
- Prior Expanded Access Program showed real-world benefit in tumor HI patients.

## SEC filing metadata
- accession: 0001104659-24-085614
- form_type: 8-K
- ticker: RZLT
- cik: 0001509261
- company_name: Rezolute, Inc.
- filed_at: 2024-08-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/0001104659-24-085614-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1509261/000110465924085614/tm2420844d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-085614
- JSON: https://secwatch.observer/filing/0001104659-24-085614.json
- Plain text: https://secwatch.observer/filing/0001104659-24-085614.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.