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Graft Versus Host Disease

21
Pipeline Programs
22
Companies
50
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
3
7
2
5
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
550%
Small Molecule
550%
+ 15 programs with unclassified modality

On Market (1)

Approved therapies currently available

Astellas
PROGRAFApproved
tacrolimus
Astellas
injection1994

Competitive Landscape

20 companies ranked by most advanced pipeline stage

Astellas
AstellasChina - Shenyang
1 program
1
1
TACROLIMUS(tacrolimus)Phase 35 trials
Active Trials
NCT00293930Completed645Est. Nov 2006
NCT00189722Completed160Est. Jul 2005
NCT00293891Completed658Est. Jan 2007
+2 more trials
Ocugen
OcugenPA - Malvern
1 program
1
Brimonidine TartratePhase 31 trial
Active Trials
NCT03591874Terminated59Est. Apr 2020
Biocon
BioconIndia - Bangalore
1 program
1
ItolizumabPhase 3Monoclonal Antibody
Equillium
EquilliumCA - La Jolla
1 program
1
ItolizumabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT05263999Terminated158Est. May 2025
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
Tacrolimus and MMF.Phase 31 trial
Active Trials
NCT02178683Unknown50Est. Dec 2018
Kamada
KamadaIsrael - Negev
1 program
1
GLASSIAPhase 2/31 trial
Active Trials
NCT02956122Terminated1Est. May 2018
Chimeric Therapeutics
Chimeric TherapeuticsAustralia - Carlton
1 program
1
anti-thymocyte globulinPhase 2/31 trial
Active Trials
NCT00004255CompletedEst. May 2003
Sandoz
SandozAustria - Kundl
4 programs
2
2
Imatinib Mesylate and NilotinibPhase 2Small Molecule1 trial
PanobinostatPhase 2Small Molecule1 trial
Interleukin-2Phase 11 trial
LDE225Phase 11 trial
Active Trials
NCT00529035Completed29Est. May 2020
NCT02086513Terminated17Est. Dec 2016
NCT02891395Completed65Est. Jul 2017
+1 more trials
Alliance Pharmaceuticals
3 programs
3
AbataceptPhase 2
carmustinePhase 21 trial
pentostatinPhase 2Small Molecule1 trial
Active Trials
NCT00006747Completed4Est. Feb 2003
NCT00074035Completed39Est. Nov 2014
Bayer
BayerLEVERKUSEN, Germany
1 program
1
AlemtuzumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT00775632Completed78Est. Sep 2010
Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
PaliferminPhase 2
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
IbrutinibPhase 1/2Small Molecule1 trial
Active Trials
NCT02195869Completed45Est. Sep 2017
REGiMMUNE
REGiMMUNETaiwan - Taipei
1 program
1
RGI-2001Phase 1/21 trial
Active Trials
NCT01379209Completed68Est. Apr 2017
ViGenCell
ViGenCellKorea - Geumcheon-gu
1 program
1
VM-001 1X10^6 cells/kgPhase 1/21 trial
Active Trials
NCT05276076Unknown12Est. Nov 2025
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
voriconazolePhase 1Small Molecule1 trial
Active Trials
NCT00792246Completed5Est. Jul 2012
Novartis
NovartisBASEL, Switzerland
1 program
Interleukin-2PHASE_1
Biogen
BiogenCAMBRIDGE, MA
1 program
NatalizumabPHASE_2Monoclonal Antibody1 trial
Active Trials
NCT02176031Completed21Est. Feb 2019
Swedish Orphan Biovitrum
1 program
PaliferminPHASE_21 trial
Active Trials
NCT00189488Completed155Est. Aug 2013
Roche
RocheSTAVANGER NORWAY, Norway
1 program
RituximabPHASE_2Monoclonal Antibody
Takeda
TakedaTOKYO, Japan
1 program
GLASSIAPHASE_2_32 trials
Active Trials
NCT02722304Terminated7Est. Sep 2018
NCT02525861Completed34Est. Jul 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus
Astellastacrolimus

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 9,264 patients across 50 trials

A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

Start: Jan 2022Est. completion: Mar 202455 patients
Phase 4Completed

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

A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

Start: Mar 2018Est. completion: Sep 201880 patients
Phase 4Completed

A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients

Start: May 2015Est. completion: Jun 201720 patients
Phase 4Completed

Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE)

Start: Jul 2013Est. completion: Mar 2015104 patients
Phase 4Unknown

Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk

Start: Oct 2012Est. completion: Dec 201736 patients
Phase 4Completed

Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

Start: Sep 2012Est. completion: Nov 2013125 patients
Phase 4Completed

A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome

Start: Jul 2012Est. completion: Aug 2017144 patients
Phase 4Completed

Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)

Start: May 2012Est. completion: Mar 2015286 patients
Phase 4Unknown

A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)

Start: Dec 2011Est. completion: May 2015128 patients
Phase 4Completed

A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

Start: Jun 2011Est. completion: Apr 201747 patients
Phase 4Terminated

A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation

Start: Jun 2011Est. completion: Feb 201552 patients
Phase 4Completed

A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients

Start: Apr 2011Est. completion: Apr 201637 patients
Phase 4Terminated

Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients

Start: Dec 2010Est. completion: Aug 2012105 patients
Phase 4Completed

A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen

Start: May 2010Est. completion: Oct 201213 patients
Phase 4Terminated

Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Start: Aug 2009Est. completion: Jun 201178 patients
Phase 4Completed

A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Start: May 2008Est. completion: Aug 200950 patients
Phase 4Completed

Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Start: May 2007Est. completion: Oct 200850 patients
Phase 4Completed

TACrolimus in Renal Transplantation: Individualization by Pharmacogenetic

Start: Apr 2006Est. completion: Dec 2008280 patients
Phase 4Completed

Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

Start: Jul 2005Est. completion: Mar 200785 patients
Phase 4Terminated

Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients

Start: Apr 2004Est. completion: Dec 2009150 patients
Phase 4Completed

Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation

Start: May 2003Est. completion: Dec 2007300 patients
Phase 4Unknown

Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

Start: Oct 2002Est. completion: Jan 200840 patients
Phase 4Completed

Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Start: Sep 2001Est. completion: Jan 2006240 patients
Phase 4Completed

A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients

Start: Nov 1999Est. completion: Dec 2007397 patients
Phase 4Completed

Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)

Start: Apr 1999Est. completion: Feb 2006107 patients
Phase 4Completed

A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis

Est. completion: Jan 2007658 patients
Phase 3Completed

A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis

Est. completion: Nov 2006645 patients
Phase 3Completed

A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

Start: Apr 2022Est. completion: May 2025158 patients
Phase 3Terminated
NCT03591874OcugenBrimonidine Tartrate

Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

Start: Dec 2018Est. completion: Apr 202059 patients
Phase 3Terminated

Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency

Start: Nov 2016Est. completion: Sep 20187 patients
Phase 3Terminated

GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study

Start: Mar 2016Est. completion: Jul 202034 patients
Phase 3Completed

A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis

Start: Mar 2015Est. completion: Sep 2018314 patients
Phase 3Completed

Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression

Start: Nov 2010Est. completion: Dec 201850 patients
Phase 3Unknown

An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients

Start: Sep 2007Est. completion: Dec 200727 patients
Phase 3Completed

A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients

Start: Oct 2006Est. completion: Nov 2007112 patients
Phase 3Completed

A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients

Start: Oct 2006Est. completion: Jul 2007128 patients
Phase 3Completed

Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

Start: Sep 2006Est. completion: May 200832 patients
Phase 3Completed

An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

Start: Feb 2006Est. completion: Feb 200911 patients
Phase 3Completed

A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis

Start: Jan 2006Est. completion: Aug 2007658 patients
Phase 3Completed

Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation

Start: Nov 2005Est. completion: Feb 2008198 patients
Phase 3Completed

Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts

Start: May 2005Est. completion: Oct 2007101 patients
Phase 3Completed

Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.

Start: Mar 2005Est. completion: Jun 2007627 patients
Phase 3Completed

Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.

Start: Oct 2004Est. completion: Aug 2006267 patients
Phase 3Completed

To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.

Start: Oct 2004Est. completion: Jul 2006634 patients
Phase 3Completed

Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys

Start: Sep 2004Est. completion: Mar 2008142 patients
Phase 3Completed

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.

Start: Aug 2004Est. completion: Dec 2006475 patients
Phase 3Completed

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

Start: Aug 2004Est. completion: Dec 2006699 patients
Phase 3Completed

Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens

Start: May 2004Est. completion: Jul 2008111 patients
Phase 3Completed

Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

Start: May 2004Est. completion: Jan 200852 patients
Phase 3Completed

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
22 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.