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Ersodetug

Phase 3

Tumor Hyperinsulinism (Tumor HI) | Small molecule | Oncology |Rezolute, Inc.|Last Updated: May 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06881992A Phase 3 Study of Ersodetug in Patients With Tumor HyperinsulinismPHASE3 RECRUITING 16Apr 16, 2025Sep 1, 2027May 18, 202613 United States, France +3
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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 — 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)
LOWMay 26, 2026NCT06881992primaryCompletionDate: changed
LOWMay 24, 2026NCT06881992studyFirstPostDate: changed