Liver Transplantation

Gastroenterology
17
Pipeline Programs
11
Companies
48
Clinical Trials
1 recruiting
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
2
0
5
9
Early DiscoveryClinical DevelopmentMarket

On Market (4)

Approved therapies currently available

U
CYCLOSPORINEApproved
cyclosporine
Unknown Company
Calcineurin Inhibitor Immunosuppressant [EPC]oral2019
Novartis
NEORALApproved
cyclosporine
Novartis
Calcineurin Inhibitor Immunosuppressant [EPC]oral1995
Novartis
SANDIMMUNEApproved
cyclosporine
Novartis
Calcineurin Inhibitor Immunosuppressant [EPC]oral1990
U
VERKAZIAApproved
cyclosporine
Unknown Company
Calcineurin Inhibitor Immunosuppressant [EPC]ophthalmic2021

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Astellas
AstellasChina - Shenyang
9 programs
1
4
3
ADVAGRAF®Phase 41 trial
PrografPhase 41 trial
Tacrolimus granulesPhase 41 trial
PrografPhase 31 trial
Prograf-XLPhase 31 trial
+4 more programs
Active Trials
NCT02143479Completed398Est. May 2017
NCT00693524Completed94Est. Mar 2004
NCT00719745Completed74Est. Jun 2008
+10 more trials
Novartis
NovartisBASEL, Switzerland
3 programs
1
1
CyclosporinePhase 41 trial
Everolimus + reduced tacrolimusPhase 31 trial
Tacrolimus Withdrawal and Everolimus MonotherapyN/A1 trial
Active Trials
NCT02736227Completed28Est. Mar 2021
NCT01888432Completed285Est. Apr 2018
NCT00332462Completed34Est. Jan 2009
Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
Mycophenolate mofetil, adjusted dosePhase 41 trial
Active Trials
NCT00545402Completed180Est. Jul 2011
Expression Therapeutics
1 program
1
Gradual immunosuppression drug withdrawalPhase 21 trial
Active Trials
NCT00647283Unknown80Est. Dec 2012
GC Biopharma
GC BiopharmaKorea - Yongin
1 program
1
Immuncell-LCPhase 1/21 trial
Active Trials
NCT03983967CompletedEst. Aug 2022
OrganOx
OrganOxUK - Oxford
3 programs
Normothermic Machine PerfusionN/A1 trial
Normothermic Machine PerfusionN/A1 trial
Transplant with normothermic machine perfusedN/A1 trial
Active Trials
NCT04862156Terminated19Est. Jul 2023
NCT02775162Completed267Est. Feb 2021
NCT05526326Completed315Est. Feb 2025
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
2 programs
Prospective Evaluation of Predictors for Organ Failure Following Liver TransplantationN/A1 trial
TacrolimusN/A1 trial
Active Trials
NCT00408889Completed150
NCT04444817Unknown100Est. Dec 2021
Verona Pharma
Verona PharmaUK - London
1 program
Application of a prognostic scoreN/A1 trial
Active Trials
NCT05594901Active Not RecruitingEst. Jun 2025
CONMED
CONMEDCO - Greenwood Village
1 program
ECOM ETTN/A1 trial
Active Trials
NCT01299441TerminatedEst. Oct 2016
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis CN/A1 trial
Active Trials
NCT01428700CompletedEst. Jan 2013
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
Intrathecal MorphineN/A1 trial
Active Trials
NCT07123740RecruitingEst. Jul 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AstellasTacrolimus granules
Astellasmicafungin
AstellasADVAGRAF®
Astellasmicafungin
Astellasmicafungin
Astellasmicafungin
Astellasmicafungin
Astellasmicafungin
AstellasPrograf
Astellasmicafungin
RocheMycophenolate mofetil, adjusted dose
Astellasmicafungin
NovartisCyclosporine
NovartisEverolimus + reduced tacrolimus
Astellasmicafungin

Showing 15 of 48 trials with date data

Clinical Trials (48)

Total enrollment: 44,705 patients across 48 trials

NCT05153915AstellasTacrolimus granules

A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

Start: Dec 2021Est. completion: Mar 202456 patients
Phase 4Completed

Micafungin Pharmacokinetics in Obese Patients

Start: Jan 2017Est. completion: Jul 201724 patients
Phase 4Completed

To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients

Start: Jul 2015Est. completion: Dec 201731 patients
Phase 4Completed

Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

Start: Mar 2014Est. completion: Dec 2014105 patients
Phase 4Terminated

Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis

Start: Mar 2014Est. completion: Jun 201543 patients
Phase 4Terminated

A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia

Start: Sep 2013Est. completion: Aug 201559 patients
Phase 4Terminated

Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome

Start: Sep 2010Est. completion: Apr 2018113 patients
Phase 4Completed

Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation

Start: Apr 2010Est. completion: May 2012145 patients
Phase 4Unknown

A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

Start: Apr 2009Est. completion: Dec 201044 patients
Phase 4Completed

Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins

Start: Dec 2008Est. completion: May 201021 patients
Phase 4Completed
NCT00545402RocheMycophenolate mofetil, adjusted dose

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

Start: Nov 2007Est. completion: Jul 2011180 patients
Phase 4Completed

A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis

Start: Feb 20070
Phase 4Withdrawn

A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients

Start: May 2006Est. completion: Jan 200934 patients
Phase 4Completed
NCT01888432NovartisEverolimus + reduced tacrolimus

Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

Start: Sep 2013Est. completion: Apr 2018285 patients
Phase 3Completed

Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis

Start: Feb 2013Est. completion: Dec 201430 patients
Phase 3Terminated

Liver Transplant European Study Into the Prevention of Fungal Infection

Start: Dec 2009Est. completion: May 2012350 patients
Phase 3Completed

A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.

Start: Dec 2007Est. completion: Sep 200948 patients
Phase 3Completed
NCT00459719AstellasTacrolimus modified-release

A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation

Start: Mar 2007Est. completion: Mar 200942 patients
Phase 3Completed

A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients

Start: Feb 2006Est. completion: Jun 200874 patients
Phase 3Completed

Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

Start: Aug 2004Est. completion: Jul 200624 patients
Phase 3Completed

Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

Start: Jan 2003Est. completion: Dec 2005637 patients
Phase 3Completed

Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia

Start: Sep 2015Est. completion: Jun 201766 patients
Phase 2Completed

Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis

Start: May 2015Est. completion: Apr 201835 patients
Phase 2Completed

A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects

Start: Jul 2010Est. completion: Dec 2011252 patients
Phase 2Completed

Micafungin Salvage Mono-therapy in Invasive Aspergillosis

Start: Jun 2006Est. completion: Sep 200817 patients
Phase 2Terminated
NCT00647283Expression TherapeuticsGradual immunosuppression drug withdrawal

Assessment Of the Safety and Benefit of Prospective Immunosuppressive Drug Withdrawal in Liver Transplantation and Prediction of Operational Tolerance

Start: Nov 2005Est. completion: Dec 201280 patients
Phase 2Unknown

Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis

Start: Dec 2002Est. completion: Feb 20032 patients
Phase 2Terminated

Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX

Start: Nov 2002Est. completion: Mar 200494 patients
Phase 2Completed

Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation

Start: Jan 2019Est. completion: Aug 2022
Phase 1/2Completed

A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis

Start: Jan 2014Est. completion: Nov 20149 patients
Phase 1Terminated

A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant

Start: Nov 2007Est. completion: Mar 200942 patients
Phase 1Completed

Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

Start: Oct 2007Est. completion: Sep 201184 patients
Phase 1Completed

Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

Start: Oct 2007Est. completion: Oct 20099 patients
Phase 1Completed

An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Start: Aug 2007Est. completion: Oct 200713 patients
Phase 1Completed
NCT07123740City TherapeuticsIntrathecal Morphine

Comparison of the Postoperative Analgesic Effects of ITM and Bi-level ESPB in Liver Transplantation Donors

Start: Aug 2025Est. completion: Jul 2026
N/ARecruiting
NCT05526326OrganOxTransplant with normothermic machine perfused

OrganOx Metra® New Enrollment PAS

Start: Nov 2022Est. completion: Feb 2025315 patients
N/ACompleted
NCT05594901Verona PharmaApplication of a prognostic score

Impact of a Risk Stratification Tool on the Outcome of Liver Transplant Recipients Colonized With Carbapenem Resistant Enterobacteriaceae: an Observational Study

Start: Nov 2022Est. completion: Jun 2025
N/AActive Not Recruiting
NCT04862156OrganOxNormothermic Machine Perfusion

WP02 Continued Access Study

Start: Oct 2021Est. completion: Jul 202319 patients
N/ATerminated

Evaluation of the Impact of Tacrolimus-based Immunosuppression on Heidelberg Liver Transplant Cohort (HDTACRO): Study Protocol for an Investigator Initiated, Non-interventional Prospective Study

Start: Nov 2018Est. completion: Dec 2021100 patients
N/AUnknown

Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study

Start: Jun 2017Est. completion: May 2018120 patients
N/ACompleted
NCT02775162OrganOxNormothermic Machine Perfusion

WP01 - Normothermic Liver Preservation

Start: Oct 2016Est. completion: Feb 2021267 patients
N/ACompleted
NCT02736227NovartisTacrolimus Withdrawal and Everolimus Monotherapy

Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation

Start: Mar 2016Est. completion: Mar 202128 patients
N/ACompleted

Use of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology

Start: Jul 2014Est. completion: Jan 2016150 patients
N/ACompleted

A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year

Start: Jun 2014Est. completion: May 2017398 patients
N/ACompleted

Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents

Start: Oct 2012Est. completion: Apr 201840,110 patients
N/ACompleted
NCT01428700Allergy TherapeuticsGene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

Start: Aug 2011Est. completion: Jan 2013
N/ACompleted

Endotracheal Cardiac Output Monitor (ECOM) for Patients Undergoing Liver Transplantation

Start: Feb 2011Est. completion: Oct 2016
N/ATerminated
NCT00408889Heidelberg PharmaProspective Evaluation of Predictors for Organ Failure Following Liver Transplantation

Prospective Evaluation of Predictors for Organ Failure Following Liver Transplantation

Start: Dec 2006150 patients
N/ACompleted

Related Jobs in Gastroenterology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 44,705 patients
11 companies competing in this space