Rezolute, Inc. (RZLT)
Rezolute, Inc., a late-stage rare disease company, focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism in the United States. Its lead clinical asset is ersodetug, an intravenously administered human monoclonal antibody that is in Phase 3 clinical trial for the treatment of congenital hyperinsulinism, an ultra-rare pediatric genetic disorder, as well as for the treatment of hypoglycemia; and clinical trials of ersodetug for tumor hyperinsulinism. The company was formerly known as AntriaBio, Inc. and changed its name to Rezolute, Inc. in December 2017. Rezolute, Inc. was founded in 2010 and is headquartered in Redwood City, California.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Rezolute, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Active, not recruiting
RZ358 Treatment for Congenital Hyperinsulinism
RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC, RZ358 (10 mg/kg) or Placebo + SOC
Congenital Hyperinsulinism
NCT06208215Enrollment56StartJan 2024Primary CompletionNov 2025CompletionNov 2027est. - Phase 3Recruiting
A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Ersodetug
Tumor Hyperinsulinism (Tumor HI)
NCT06881992Enrollment16StartApr 2025Primary CompletionSep 2027est.CompletionSep 2027est. - Phase 2Completed
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2
Congenital Hyperinsulinism
NCT04538989Enrollment23StartFeb 2020Primary CompletionApr 2022CompletionAug 2022 - Phase 2Completed
Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)
Experimental: Group 1 - 50mg RZ402, Experimental: Group 2 - 200mg RZ402
Diabetic Macular Edema
NCT05712720Enrollment94StartFeb 2023Primary CompletionApr 2024CompletionApr 2024 - Expanded accessAvailable
Intermediate-Size Cohort EAP for Ersodetug in Patients With Inadequately Controlled Hypoglycemia Related to a Tumor
Ersodetug (9 mg/kg) + SOC
Tumor-associated Hyperinsulinism (Tumor HI)
NCT07262970Enrollment-Start-Primary Completion-Completion-
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Active, not recruiting | RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC, RZ358 (10 mg/kg) or Placebo + SOC | NCT06208215 |
| Phase 3 | Recruiting | Ersodetug | NCT06881992 |
| Phase 2 | Completed | RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2 | NCT04538989 |
| Phase 2 | Completed | Experimental: Group 1 - 50mg RZ402, Experimental: Group 2 - 200mg RZ402 | NCT05712720 |
| Expanded access | Available | Ersodetug (9 mg/kg) + SOC | NCT07262970 |