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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
oral2018

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
NCT00189761Completed
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 Antibody1 trial
Active Trials
NCT05263999Terminated158Est. May 2025
Equillium
EquilliumCA - La Jolla
1 program
1
ItolizumabPhase 3Monoclonal Antibody
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 2/3
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_33 trials
Active Trials
NCT02956122Terminated1Est. May 2018
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: 8,528 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 Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

Start: Feb 2019Est. completion: Jun 202021 patients
Phase 4Completed

Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients

Start: Oct 2018Est. completion: Jul 2022284 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

Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients

Start: Sep 2017Est. completion: Oct 202020 patients
Phase 4Completed

Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients

Start: May 2017Est. completion: Dec 201825 patients
Phase 4Completed

To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients

Start: Sep 2016Est. completion: Jun 2019599 patients
Phase 4Completed

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

Start: Mar 2016Est. completion: Dec 201731 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

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

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

A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

Start: Jul 2013Est. completion: Mar 201517 patients
Phase 4Terminated

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

Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients

Start: Nov 2011Est. completion: Mar 201846 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

A Single Center, Open-label, Randomized, Pilot Study to Evaluate the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF®, Versus Tacrolimus Twice Daily, PROGRAF® in Stable Renal Recipients

Start: Apr 2011Est. completion: Apr 2013100 patients
Phase 4Completed

A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.

Start: Mar 2011Est. completion: Sep 2013853 patients
Phase 4Completed

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

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

Advagraf/Prograf Conversion Trial

Start: Dec 2010Est. completion: Dec 201453 patients
Phase 4Completed

RituxiMab INDuction in Renal Transplantation

Start: Nov 2010Est. completion: Oct 2022100 patients
Phase 4Unknown

A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF

Start: Sep 2010Est. completion: Feb 2013138 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 to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule/Injection) and Methotrexate (MTX) Combination Therapy for Prevention of Graft Versus Host Disease (GVHD) in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling Donor

Start: Feb 2008Est. completion: Feb 201039 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/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

Start: May 2005Est. completion: Mar 2009501 patients
Phase 4Completed

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

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

Protopic Ointment in Children Atopic Eczema

Start: Feb 2004Est. completion: Aug 2005487 patients
Phase 4Completed

Protopic Ointment in Adult Atopic Eczema of the Face

Start: Feb 2004Est. completion: Jul 2005577 patients
Phase 4Completed

Optima: Optimizing Prograf Therapy in Maintenance Allografts II

Start: Aug 2003Est. completion: Jul 200863 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

Optimizing Prograf® Therapy in Renal Transplant Patients

Start: Jan 2003Est. completion: Mar 2006323 patients
Phase 4Completed

Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis

Start: Dec 2002Est. completion: May 2003226 patients
Phase 4Completed

Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis

Start: Dec 2002Est. completion: Nov 2003426 patients
Phase 4Completed

A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis

Start: Oct 2002Est. completion: Nov 2003413 patients
Phase 4Completed

Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

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

Minimizing Immunosuppression in Old for Old Kidney Transplantation

Start: Mar 2002Est. completion: Oct 200890 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

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.