2 completed, 1 active not recruiting, 1 available, 1 recruiting. 2 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 2 | Completed 2 |
| Phase 3 | 2 | Active not recruiting 1, Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism Ersodetug - Tumor Hyperinsulinism (Tumor HI) | Phase 3 | Recruiting | Rezolute | 16 | 2025-04-16 | 2026-09-28 |
| RZ358 Treatment for Congenital Hyperinsulinism RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC, RZ358 (10 mg/kg) or Placebo + SOC, RZ358 (5-10 mg/kg) + SOC - Congenital Hyperinsulinism | Phase 3 | Active not recruiting | Rezolute | 56 | 2024-01-11 | 2026-01-08 |
| Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) Experimental: Group 1 - 50mg RZ402, Experimental: Group 2 - 200mg RZ402, Experimental: Group 3 - 400mg RZ402 - Diabetic Macular Edema | Phase 2 | Completed | Rezolute | 94 | 2023-02-06 | 2026-09-01 |
| An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2, RZ358 Sequential Group Cohort 3 - Congenital Hyperinsulinism | Phase 2 | Completed | Rezolute | 23 | 2020-02-24 | 2025-05-28 |
| 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) | Available | Rezolute | 2026-10-07 |
Hyperinsulinism (4) · Hypoglycemia (4) · Adenoma, Islet Cell (2) · Congenital Hyperinsulinism (2) · Digestive System Diseases (2) · Fibrosarcoma (2) · Glucose Metabolism Disorders (2) · Insulinoma (2) · Liposarcoma (2) · Metabolic Diseases (2) · Neoplasms (2) · Neuroectodermal Tumors, Primitive (2) · Neuroendocrine Tumors (2) · Pancreatic Diseases (2) · Diabetes Mellitus (1)
Standard of Care (1)
United States (5) · United Kingdom (3) · Bulgaria (2) · Denmark (2) · France (2) · Georgia (2) · Germany (2) · Spain (2) · Turkey (Türkiye) (2) · Canada (1) · Greece (1) · Israel (1) · Netherlands (1) · Oman (1) · Qatar (1)
Gopal Saha, MD (1)