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Ersodetug · 2 trials · 2 indications
Change in average weekly hypoglycemia events from baseline by point-of-care Self-Monitoring Blood Glucose (SMBG)
| Arm | Type | Description |
|---|---|---|
| Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors) | OTHER | - |
| SoC (Standard-of-Care) + RZ358 (5 mg/kg) or Placebo | PLACEBO_COMPARATOR | Participants ≥1 year old who receive SOC therapy and 5 mg/kg of RZ358 or placebo |
| SoC + RZ358 (10 mg/kg) or Placebo | PLACEBO_COMPARATOR | Participants ≥1 year old who receive SOC therapy and 10 mg/kg of RZ358 or placebo |
| Open Label Arm, SoC + RZ358 (start 5mg/kg and increase to 10 mg/kg per protocol schedule | EXPERIMENTAL | Infant participants from ≥3 months to \<1 year old who receive SOC therapy + RZ358 starting at 5 mg/kg and increasing to 10 mg/kg of RZ358, as needed, per the protocol schedule |
| Name | Type | Description |
|---|---|---|
| Ersodetug | DRUG | Ersodetug (9 mg/kg) + SOC |
| RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC | DRUG | Participants ≥1 year old who receive SOC therapy and 5 mg/kg of RZ358 or placebo |
| RZ358 (10 mg/kg) or Placebo + SOC | DRUG | Participants ≥1 year old who receive SOC therapy and 10 mg/kg of RZ358 or placebo |
| RZ358 (5-10 mg/kg) + SOC | DRUG | Infant participants from ≥3 months to \<1 year old who receive SOC therapy + RZ358 starting at 5 mg/kg and increasing to 10 mg/kg of RZ358, as needed, per the protocol schedule |
Inclusion Criteria: * The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI, which must include an oncologist * Male or female participants of ≥18 years of age who provide written informed consent. * Clinical diagnosis of neuroendocrine tumor (NET)...
Ersodetug is an investigational small molecule being developed for congenital hyperinsulinism and tumor hyperinsulinism (Tumor HI), two conditions marked by excessive insulin release. It is in Phase 3 clinical development and has received FDA Breakthrough Therapy and Orphan Drug designations for these indications.
Ersodetug targets the insulin receptor. By acting on this receptor, the small molecule is designed to reduce the excessive insulin signaling that drives the low blood sugar episodes characteristic of congenital hyperinsulinism and tumor hyperinsulinism. It is administered alongside standard-of-care treatment in the ongoing Phase 3 studies.
Ersodetug is being developed by Rezolute, Inc., which trades under the ticker RZLT. The company is running Phase 3 clinical trials of the drug in congenital hyperinsulinism and tumor hyperinsulinism, and holds FDA Breakthrough Therapy and Orphan Drug designations for the asset.
Ersodetug is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Two Phase 3 trials are underway: one in congenital hyperinsulinism that is active but not recruiting, and one in tumor hyperinsulinism that is currently recruiting participants.
Ersodetug is being studied in two Phase 3 trials. NCT06208215 is a Phase 3 study of RZ358 in congenital hyperinsulinism with 56 participants, now active and not recruiting. NCT06881992 is a Phase 3 study in tumor hyperinsulinism with 16 participants, currently recruiting across the United States, France, Netherlands, Switzerland, and the United Kingdom.
Yes, Ersodetug is also known as RZ358. The names appear interchangeably in trial listings, including arms such as RZ358 plus standard-of-care or placebo plus standard-of-care in the Phase 3 congenital hyperinsulinism and tumor hyperinsulinism studies. Ersodetug is the international nonproprietary name for the same investigational compound.