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Congenital Diaphragmatic Hernia

5
Pipeline Programs
8
Companies
10
Clinical Trials
3 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
1
0
1
3
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
3 programs
1
Inhaled Nitric OxidePhase 4
Congenital diaphragmatic hernia resuscitation with an intact umbilical cordN/A1 trial
Fetoscopic Endoluminal Tracheal OcclusionN/A1 trial
Active Trials
NCT03242044Completed10Est. Oct 2020
NCT03674372Recruiting10Est. Mar 2030
Utah Medical
Utah MedicalIreland - Dublin
1 program
1
Inhaled Nitric OxidePhase 4
Mott
MottCT - Farmington
1 program
1
Inhaled Nitric OxidePhase 4
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
1 program
1
Fetoscopic Endoluminal Tracheal OcclusionPhase 31 trial
Active Trials
NCT06946576Not Yet Recruiting80Est. Apr 2030
Human BioSciences
Human BioSciencesWV - Martinsburg
3 programs
1
MilrinonePhase 21 trial
DINGN/A1 trial
Diaphragmatic Hernia Research & Exploration, Advancing Molecular ScienceN/A1 trial
Active Trials
NCT03314233Completed21Est. Oct 2018
NCT00950118Recruiting3,000Est. Sep 2026
NCT02951130Completed66Est. May 2025
KARL STORZ Endoscopy
KARL STORZ EndoscopyCA - El Segundo
2 programs
11540KE and Balt Goldbal 2 balloonN/A1 trial
Fetal Treatment ArmN/A1 trial
Active Trials
NCT02710968Active Not Recruiting21Est. Mar 2028
NCT07166172Recruiting80Est. Dec 2031
Rare Disease Therapeutics
1 program
Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic HerniaN/A1 trial
Active Trials
NCT05666986Unknown20Est. Mar 2024
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
Repair of CDH w/SIS GoldPHASE_31 trial
Active Trials
NCT00257946TerminatedEst. Aug 2007

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Oregon TherapeuticsFetoscopic Endoluminal Tracheal Occlusion
City TherapeuticsRepair of CDH w/SIS Gold
Human BioSciencesMilrinone
KARL STORZ EndoscopyFetal Treatment Arm
Rare Disease TherapeuticsEngagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia
Colorado TherapeuticsFetoscopic Endoluminal Tracheal Occlusion
Colorado TherapeuticsCongenital diaphragmatic hernia resuscitation with an intact umbilical cord
Human BioSciencesDING
KARL STORZ Endoscopy11540KE and Balt Goldbal 2 balloon
Human BioSciencesDiaphragmatic Hernia Research & Exploration, Advancing Molecular Science

Clinical Trials (10)

Total enrollment: 3,308 patients across 10 trials

NCT06946576Oregon TherapeuticsFetoscopic Endoluminal Tracheal Occlusion

Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia

Start: Sep 2025Est. completion: Apr 203080 patients
Phase 3Not Yet Recruiting
NCT00257946City TherapeuticsRepair of CDH w/SIS Gold

Type of Material in Repair of Congenital Diaphragmatic Hernia

Start: Dec 2005Est. completion: Aug 2007
Phase 3Terminated
NCT02951130Human BioSciencesMilrinone

Milrinone in Congenital Diaphragmatic Hernia

Start: Oct 2017Est. completion: May 202566 patients
Phase 2Completed
NCT07166172KARL STORZ EndoscopyFetal Treatment Arm

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

Start: Jun 2025Est. completion: Dec 203180 patients
N/ARecruiting
NCT05666986Rare Disease TherapeuticsEngagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia

Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia

Start: Mar 2023Est. completion: Mar 202420 patients
N/AUnknown
NCT03674372Colorado TherapeuticsFetoscopic Endoluminal Tracheal Occlusion

Fetoscopic Endoluminal Tracheal Occlusion

Start: Nov 2018Est. completion: Mar 203010 patients
N/ARecruiting
NCT03242044Colorado TherapeuticsCongenital diaphragmatic hernia resuscitation with an intact umbilical cord

Resuscitation of Infants With Congenital Diaphragmatic Hernia With an Intact Umbilical Cord

Start: Jan 2018Est. completion: Oct 202010 patients
N/ACompleted
NCT03314233Human BioSciencesDING

Delayed Cord Clamping for Congenital Diaphragmatic Hernia

Start: Oct 2017Est. completion: Oct 201821 patients
N/ACompleted
NCT02710968KARL STORZ Endoscopy11540KE and Balt Goldbal 2 balloon

Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)

Start: Aug 2015Est. completion: Mar 202821 patients
N/AActive Not Recruiting
NCT00950118Human BioSciencesDiaphragmatic Hernia Research & Exploration, Advancing Molecular Science

Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science

Start: Jun 2005Est. completion: Sep 20263,000 patients
N/ARecruiting

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
3 actively recruiting trials targeting 3,308 patients
8 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.