Heart Transplantation

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody

1100%

+ 22 programs with unclassified modality

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

SandozAustria - Kundl

7 programs

Enteric-coated Mycophenolate SodiumPhase 41 trial

EverolimusPhase 41 trial

EverolimusPhase 31 trial

+2 more programs

Active Trials

NCT00297830Completed111Est. Jan 2014

NCT00098007Completed199Est. Jan 2007

NCT00150046Completed176

+4 more trials

GenentechCA - Oceanside

5 programs

DaclizumabPhase 4Monoclonal Antibody1 trial

mycophenolate mofetil [CellCept]Phase 42 trials

mycophenolate mofetilPhase 31 trial

MycophenolatmofetileN/A1 trial

prednisolonN/A1 trial

Active Trials

NCT00359814Completed23Est. Jun 2008

NCT00359658Completed40Est. Jun 2008

NCT02091414Completed36Est. Feb 2009

+3 more trials

PfizerNEW YORK, NY

1 program

Cyclosporine discontinuationPhase 4

Heidelberg PharmaGermany - Ladenburg

2 programs

Building Research Initiative Group: Chronic Illness Management and Adherence in TransplantationN/A1 trial

Cyclosporine discontinuationPHASE_41 trial

Active Trials

NCT01608477Unknown1,365Est. Dec 2020

NCT00123331Completed40Est. Apr 2005

AstellasChina - Shenyang

1 program

Building Research Initiative Group: Chronic Illness Management and Adherence in TransplantationN/A

UNION therapeuticsDenmark - Hellerup

1 program

Donor Circadian Rhythm and Its Correlation With Prognosis After Heart TransplantationN/A1 trial

Active Trials

NCT07301788Completed200Est. Dec 2025

Oregon TherapeuticsFrance - Paris

1 program

Evidence Based Evaluation and Acceptance of Donor Hearts for TransplantationN/A1 trial

Active Trials

NCT02376387Completed4,333Est. May 2020

Colorado TherapeuticsCO - Louisville

1 program

Genetic Predictors of Renal Dysfunction Following Heart TransplantationN/A1 trial

Active Trials

NCT01686191Unknown300Est. Dec 2025

XVIVOSweden - Mölndal

1 program

XVIVO heart preservation devicesN/A1 trial

Active Trials

NCT03991923Active Not Recruiting230Est. Dec 2028

RocheSTAVANGER NORWAY, Norway

1 program

prednisolonN/A

T-TherapeuticsUK - Cambridge

1 program

enriched hematopoetic stem cell infusionPHASE_1_21 trial

Active Trials

NCT00497757CompletedEst. Dec 2016

Providence TherapeuticsAB - Calgary

1 program

Bortezomib, Thymoglobulin, Rituximab, Gamimune N,PHASE_21 trial

Active Trials

NCT01556347Terminated2Est. May 2016

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

SandozEverolimus

Genentechmycophenolate mofetil [CellCept]

SandozEverolimus

GenentechDaclizumab

Heidelberg PharmaCyclosporine discontinuation

SandozEnteric-coated Mycophenolate Sodium

Genentechmycophenolate mofetil

SandozEverolimus

Genentechmycophenolate mofetil [CellCept]

SandozZoledronic acid

Providence TherapeuticsBortezomib, Thymoglobulin, Rituximab, Gamimune N,

T-Therapeuticsenriched hematopoetic stem cell infusion

UNION therapeuticsDonor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation

Showing 15 of 21 trials with date data

Clinical Trials (21)

Total enrollment: 7,658 patients across 21 trials

NCT02864706 SandozEverolimus

SCHEDULE Follow Up Visit 5-7 yr

Start: Jan 2016Est. completion: Sep 201795 patients

Phase 4Completed

NCT00862979 SandozEverolimus

A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients

Start: Feb 2009Est. completion: Mar 2017162 patients

Phase 4Completed

NCT00121784 Genentechmycophenolate mofetil [CellCept]

Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients

Start: Oct 2005Est. completion: Aug 200612 patients

Phase 4Terminated

NCT00170859 SandozEverolimus

Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

Start: Aug 2004Est. completion: Dec 2006

Phase 4Completed

NCT02554955 GenentechDaclizumab

A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants

Start: Feb 2004Est. completion: Dec 200736 patients

Phase 4Completed

NCT00123331 Heidelberg PharmaCyclosporine discontinuation

Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation

Start: Oct 2003Est. completion: Apr 200540 patients

Phase 4Completed

NCT00574743 SandozEnteric-coated Mycophenolate Sodium

Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients

Start: Jan 2002162 patients

Phase 4Completed

NCT02091414 Genentechmycophenolate mofetil

A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.

Start: Aug 2006Est. completion: Feb 200936 patients

Phase 3Completed

NCT00150046 SandozEverolimus

Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients

Start: Dec 2004176 patients

Phase 3Completed

NCT00098007 SandozEverolimus

A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients

Start: Aug 2004Est. completion: Jan 2007199 patients

Phase 3Completed

NCT00408213 Genentechmycophenolate mofetil [CellCept]

A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.

Start: Jun 2004Est. completion: Sep 2007136 patients

Phase 3Completed

NCT00297830 SandozZoledronic acid

Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation

Start: Nov 2005Est. completion: Jan 2014111 patients

Phase 2/3Completed

NCT01556347 Providence TherapeuticsBortezomib, Thymoglobulin, Rituximab, Gamimune N,

Multi-Drug Desensitization Protocol for Heart Transplant Candidates

Start: Jul 2012Est. completion: May 20162 patients

Phase 2Terminated

NCT00497757 T-Therapeuticsenriched hematopoetic stem cell infusion

Induction of Donor Specific Tolerance in Recipients of Cardiac Allografts by Donor Stem Cell Infusion

Start: Jul 2003Est. completion: Dec 2016

Phase 1/2Completed

NCT07301788 UNION therapeuticsDonor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation

Donor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation

Start: Oct 2023Est. completion: Dec 2025200 patients

N/ACompleted

NCT03991923 XVIVOXVIVO heart preservation devices

Non-ischemic Preservation of the Donor Heart in Heart Transplantation

Start: Nov 2020Est. completion: Dec 2028230 patients

N/AActive Not Recruiting

NCT02376387 Oregon TherapeuticsEvidence Based Evaluation and Acceptance of Donor Hearts for Transplantation

Evidence Based Evaluation and Acceptance of Donor Hearts for Transplantation

Start: Mar 2015Est. completion: May 20204,333 patients

N/ACompleted

NCT01686191 Colorado TherapeuticsGenetic Predictors of Renal Dysfunction Following Heart Transplantation

Genetic Predictors of Renal Dysfunction Following Heart Transplantation

Start: Aug 2012Est. completion: Dec 2025300 patients

N/AUnknown

NCT01608477 Heidelberg PharmaBuilding Research Initiative Group: Chronic Illness Management and Adherence in Transplantation

Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation

Start: Mar 2012Est. completion: Dec 20201,365 patients

N/AUnknown

NCT00359658 Genentechprednisolon

Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation

Start: Nov 2004Est. completion: Jun 200840 patients

N/ACompleted

NCT00359814 GenentechMycophenolatmofetile

Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation

Start: Nov 2004Est. completion: Jun 200823 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

3 late-stage (Phase 3) programs, potential near-term approvals

14 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.