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Congenital Hyperinsulinism

3
Pipeline Programs
4
Companies
5
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
0
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
1100%
+ 5 programs with unclassified modality

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
2 programs
2
Pasireotide 0.6Mg Solution for InjectionPhase 2Peptide1 trial
Sandostatine LPPhase 21 trial
Active Trials
NCT03053284Withdrawn0Est. Apr 2018
NCT00987168Completed10Est. Jun 2011
Hanmi Pharmaceutical
1 program
1
HM15136Phase 21 trial
Active Trials
NCT04732416Recruiting16Est. Dec 2025
Rezolute
RezoluteREDWOOD CITY, CA
2 programs
RZ358 Sequential Group Cohort 1PHASE_21 trial
RZ358PHASE_31 trial
Active Trials
NCT04538989Completed23Est. Aug 2022
NCT06208215Active Not Recruiting56Est. Nov 2027
Novartis
NovartisBASEL, Switzerland
1 program
Sandostatine LPPHASE_2

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
RezoluteRZ358
Hanmi PharmaceuticalHM15136
RezoluteRZ358 Sequential Group Cohort 1
SandozPasireotide 0.6Mg Solution for Injection
SandozSandostatine LP

Clinical Trials (5)

Total enrollment: 105 patients across 5 trials

NCT06208215RezoluteRZ358

RZ358 Treatment for Congenital Hyperinsulinism

Start: Jan 2024Est. completion: Nov 202756 patients
Phase 3Active Not Recruiting
NCT04732416Hanmi PharmaceuticalHM15136

HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

Start: May 2022Est. completion: Dec 202516 patients
Phase 2Recruiting
NCT04538989RezoluteRZ358 Sequential Group Cohort 1

An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism

Start: Feb 2020Est. completion: Aug 202223 patients
Phase 2Completed
NCT03053284SandozPasireotide 0.6Mg Solution for Injection

Pasireotide in Hyperinsulinemic Hypoglycemia

Start: Apr 2017Est. completion: Apr 20180
Phase 2Withdrawn
NCT00987168SandozSandostatine LP

Sandostatine® LP and Hyperinsulinism

Start: May 2009Est. completion: Jun 201110 patients
Phase 2Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 actively recruiting trials targeting 105 patients
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.