Congenital Hyperinsulinism

3
Pipeline Programs
2
Companies
3
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
2
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Rezolute
RezoluteREDWOOD CITY, CA
2 programs
1
1
RZ358Phase 31 trial
RZ358 Sequential Group Cohort 1Phase 21 trial
Active Trials
NCT04538989CompletedEst. Aug 2022
NCT06208215Active Not RecruitingEst. Nov 2027
Novartis
NovartisBASEL, Switzerland
1 program
1
Sandostatine LPPhase 21 trial
Active Trials
NCT00987168Completed10Est. Jun 2011

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
RezoluteRZ358
RezoluteRZ358 Sequential Group Cohort 1
NovartisSandostatine LP

Clinical Trials (3)

Total enrollment: 10 patients across 3 trials

NCT06208215RezoluteRZ358

RZ358 Treatment for Congenital Hyperinsulinism

Start: Jan 2024Est. completion: Nov 2027
Phase 3Active Not Recruiting
NCT04538989RezoluteRZ358 Sequential Group Cohort 1

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

Start: Feb 2020Est. completion: Aug 2022
Phase 2Completed
NCT00987168NovartisSandostatine 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 late-stage (Phase 3) programs — potential near-term approvals
2 companies competing in this space