Congenital Hyperinsulinism
3
Pipeline Programs
4
Companies
4
Clinical Trials
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
SandozAustria - Kundl
2 programs2
Pasireotide 0.6Mg Solution for InjectionPhase 2Peptide
Sandostatine LPPhase 2
RezoluteREDWOOD CITY, CA
2 programsRZ358 Sequential Group Cohort 1PHASE_21 trial
RZ358PHASE_31 trial
Active Trials
Trial Timeline
Clinical trial activity over time
2021
2022
2023
2024
2025
2026
2027
RezoluteRZ358
Hanmi PharmaceuticalHM15136
RezoluteRZ358 Sequential Group Cohort 1
NovartisSandostatine LP
Clinical Trials (4)
Total enrollment: 106 patients across 4 trials
RZ358 Treatment for Congenital Hyperinsulinism
Start: Jan 2024Est. completion: Nov 202756 patients
Phase 3Active Not Recruiting
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
Start: May 2022Est. completion: May 202717 patients
Phase 2Active Not Recruiting
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
Start: Feb 2020Est. completion: Aug 202223 patients
Phase 2Completed
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
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.