Congenital Heart Disease

3
Pipeline Programs
9
Companies
8
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
0
2
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
2 programs
1
1
Empagliflozin 10 mgPhase 31 trial
Sacubitril 49 MG / Valsartan 51 MG [Entresto] BIDPhase 2/31 trial
Active Trials
NCT05580510Unknown160Est. Mar 2024
NCT06955260Not Yet Recruiting410Est. Mar 2028
Biotronik
BiotronikGermany - Berlin
1 program
1
Closed loop stimulationPhase 2/31 trial
Active Trials
NCT03361189Terminated4Est. Nov 2021
Xeltis
XeltisNetherlands - Eindhoven
1 program
Bioabsorbable Pulmonary Valved ConduitN/A1 trial
Active Trials
NCT02700100UnknownEst. Apr 2022
Alder Therapeutics
Alder TherapeuticsSweden - Solna
1 program
Calprotectin and Gut Disease StudyN/A1 trial
Active Trials
NCT07112794Not Yet Recruiting300Est. Dec 2027
Artivion
ArtivionKENNESAW, GA
1 program
PhotoFixN/A1 trial
Active Trials
NCT05314868TerminatedEst. Nov 2022
United Therapeutics
United TherapeuticsMD - Silver Spring
1 program
RemodulinN/A1 trial
Active Trials
NCT01980979Withdrawn0Est. Dec 2015
Pfizer
PfizerNEW YORK, NY
1 program
Six minute walk testN/A1 trial
Active Trials
NCT00308230Completed34Est. Sep 2004

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Boehringer IngelheimEmpagliflozin 10 mg
Boehringer IngelheimSacubitril 49 MG / Valsartan 51 MG [Entresto] BID
BiotronikClosed loop stimulation
Alder TherapeuticsCalprotectin and Gut Disease Study
ArtivionPhotoFix
XeltisBioabsorbable Pulmonary Valved Conduit
United TherapeuticsRemodulin
PfizerSix minute walk test

Clinical Trials (8)

Total enrollment: 908 patients across 8 trials

NCT06955260Boehringer IngelheimEmpagliflozin 10 mg

SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

Start: May 2025Est. completion: Mar 2028410 patients
Phase 3Not Yet Recruiting
NCT05580510Boehringer IngelheimSacubitril 49 MG / Valsartan 51 MG [Entresto] BID

" Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "

Start: Feb 2023Est. completion: Mar 2024160 patients
Phase 2/3Unknown
NCT03361189BiotronikClosed loop stimulation

Specialized Pacing for Patients With Congenital Heart Disease

Start: May 2021Est. completion: Nov 20214 patients
Phase 2/3Terminated
NCT07112794Alder TherapeuticsCalprotectin and Gut Disease Study

Calprotectin and Gut Disease Study

Start: Nov 2025Est. completion: Dec 2027300 patients
N/ANot Yet Recruiting
NCT05314868ArtivionPhotoFix

Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery

Start: Mar 2022Est. completion: Nov 2022
N/ATerminated
NCT02700100XeltisBioabsorbable Pulmonary Valved Conduit

Study to Assess Safety of the Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract Reconstruction

Start: Jun 2016Est. completion: Apr 2022
N/AUnknown
NCT01980979United TherapeuticsRemodulin

Efficacy of Remodulin in Adults With Congenital Heart Disease (ACHD) and Pulmonary Hypertension

Start: Nov 2013Est. completion: Dec 20150
N/AWithdrawn
NCT00308230PfizerSix minute walk test

Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP)

Start: Dec 2001Est. completion: Sep 200434 patients
N/ACompleted

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
9 companies competing in this space