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Disease
Hyperinsulinism
Late-stage therapeutic developmentEmerging researchSteady momentum
4
Publications
17
Clinical trials
3
Related conditions
2
Related treatments
1
Related proteins
2023
Latest publication
Current focus
Precursors biologyTherapeutic developmentMetabolic & lifestyle factors
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this disease.
Research2023-01-11Journal of ovarian research
Research2016-07-26Endocrine reviews
Research2004-08-16Circulation
Research2002-03-01The Journal of clinical endocrinology and metabolism
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: Low
Key developments
- 3 clinical trials expected to report results, the earliest in Q3 2027.
Upcoming Milestones
- Q3 2027A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)
- Q4 202718F-DOPA II - PET Imaging Optimization
- Q1 2030Use of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of Hyperinsulinism
Major developments
Upcoming trial readoutHigh impact
Results expected Q3 20272026-05-18
Upcoming trial readoutImportant
Results expected Q4 20272026-02-09
Clinical MilestonesViewHide
Results expected
- 2026-05-18A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)Results expected Q3 2027
- 2026-02-0918F-DOPA II - PET Imaging OptimizationResults expected Q4 2027
- 2025-12-19Use of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of HyperinsulinismResults expected Q1 2030
Recently completed
- 2026-07-01A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)Primary completion
- 2025-11-14A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients With Congenital HyperinsulinismPrimary completion
Other updates
Activity timeline6
- 2030-12-30ClinicalInhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin ResistanceWithdrawn
- 2026-07-01ClinicalA Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)Primary completion
- 2026-05-18ClinicalA Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)Results expected Q3 2027
- 2026-02-09Clinical18F-DOPA II - PET Imaging OptimizationResults expected Q4 2027
- 2025-12-19ClinicalUse of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of HyperinsulinismResults expected Q1 2030
- 2025-11-14ClinicalA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients With Congenital HyperinsulinismPrimary completion
Research-associated treatments
Drugs and agents co-studied with this disease across the research literature — associative, not necessarily established treatments. Number shows shared papers.
Clinical trials
The current development programme across all trial phases.
Clinical programme
17
6
7
6
Late-stage studies
Recruiting
Recently completed
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Publications over time
20022023
Most influential
Recent publications
Major themes4
- Hyperandrogenism1
- Hyperinsulinism1
- Insulin Resistance1
- Polycystic Ovary Syndrome1
Leading journals4
- Circulation1
- Endocrine reviews1
- Journal of ovarian research1
- The Journal of clinical endocrinology and metabolism1
Leading researchers8
- Behle K1
- Cheng X1
- Doverspike A1
- Ehrmann DA1
- Elahi D1
- He B1
- Heimesaat MM1
- Hentosz T1
Affiliations (unnormalised)4
- Allegheny General Hospital1
- Medizinische Universitäts-Klinik1
- Shengjing Hospital1
- The University of Chicago Pritzker School of Medicine1
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Reference
Authoritative identity, definition & identifiers.
Defined in MeSH
A syndrome with excessively high INSULIN levels in the BLOOD. It may cause HYPOGLYCEMIA. Etiology of hyperinsulinism varies, including hypersecretion of a beta cell tumor (INSULINOMA); autoantibodies against insulin (INSULIN ANTIBODIES); defective insulin receptor (INSULIN RESISTANCE); or overuse of exogenous insulin or HYPOGLYCEMIC AGENTS.
Identifiers
References & data sources
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.