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Ersodetug

Phase 3

Tumor Hyperinsulinism (Tumor HI) | Small molecule | Endocrine |Rezolute, Inc.|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

BREAKTHROUGH_THERAPYORPHAN_DRUG

Clinical trial landscape

Ersodetug · 1 trial · 1 indication

Phase 3 1
NCT06881992A Phase 3 Study of Ersodetug in Patients With Tumor HyperinsulinismTumor Hyperinsulinism (Tumor HI)
RECRUITING16 Analytics
PHASE3RECRUITING
A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Tumor Hyperinsulinism (Tumor HI)Unlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.
8 weeks

Secondary Endpoints

Change from baseline in average daily IV glucose/dextrose infusion rate (GIR).
8 weeks
Change from baseline in average daily total IV glucose delivery (g)
8 weeks
Time to complete weaning off IV glucose administration after initiating ersodetug.
8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors)OTHER -

Interventions

NameTypeDescription
ErsodetugDRUGErsodetug (9 mg/kg) + SOC
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

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)...

Countries:United StatesFranceNetherlandsSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 17, 2026NCT06881992lastUpdatePostDate: changed
LOWAug 17, 2026NCT06881992lastUpdatePostDate: changed

Frequently asked questions about Ersodetug

What is Ersodetug used for?

Ersodetug is an investigational small molecule being developed for Tumor Hyperinsulinism (Tumor HI), a condition of excess insulin secretion caused by tumors. It is currently in Phase 3 clinical development and has not been approved by the FDA.

What does Ersodetug target?

Ersodetug is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its ability to address Tumor Hyperinsulinism (Tumor HI), a condition characterized by excessive insulin production.

Who makes Ersodetug?

Ersodetug is being developed by Rezolute, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RZLT. The company is conducting a Phase 3 clinical trial for the drug in Tumor Hyperinsulinism.

What phase is Ersodetug in?

Ersodetug is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Breakthrough Therapy and Orphan Drug designations by the FDA.

What clinical trials is Ersodetug in?

Ersodetug is being studied in a Phase 3 trial (NCT06881992) for Tumor Hyperinsulinism. The trial is recruiting 16 adult patients across the United States, France, Netherlands, Switzerland, and the United Kingdom. It is an open-label, uncontrolled study.

Is Ersodetug the same as any other drug?

Ersodetug is the sole name provided for this investigational drug. No alternative names have been reported. It is a small molecule being developed by Rezolute, Inc. for Tumor Hyperinsulinism.