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Graft Vs Host Disease

14
Pipeline Programs
15
Companies
35
Clinical Trials
2 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
0
5
0
3
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
450%
Small Molecule
450%
+ 12 programs with unclassified modality

On Market (2)

Approved therapies currently available

Novartis
GLEEVECApproved
imatinib mesylate
Novartis
oral2003
73M Part D
Novartis
SIMULECTApproved
basiliximab
Novartis
Interleukin-2 Receptor Blocking Antibody [EPC]single-use1998

Competitive Landscape

15 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
3 programs
1
SIMULECT(Basiliximab)N/AMonoclonal Antibody3 trials
GLEEVEC(Imatinib)PHASE_1Small Molecule5 trials
INC424PHASE_23 trials
Active Trials
NCT00928811Terminated5Est. Apr 2010
NCT00284947Completed7Est. Dec 2008
NCT00563108Unknown60Est. Dec 2008
+8 more trials
Sandoz
SandozAustria - Kundl
4 programs
1
1
1
MyforticPhase 3
INC424Phase 2
ImatinibPhase 1Small Molecule
BasiliximabN/AMonoclonal Antibody
Neovii Biotech
Neovii BiotechGermany - Grafelfing
1 program
1
ATG-Fresenius SPhase 31 trial
Active Trials
NCT00655343Completed202Est. Mar 2009
Dr. Falk Pharma
Dr. Falk PharmaGermany - Freiburg
1 program
1
BudesonidePhase 31 trial
Active Trials
NCT00128739Completed24Est. Aug 2005
CSL Seqirus
CSL SeqirusUK - Maidenhead
1 program
1
Alpha-1-AntitrypsinPhase 2
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
1
Extracorporeal PhotopheresisPhase 21 trial
Active Trials
NCT00048789Completed25Est. Jan 2009
REGiMMUNE
REGiMMUNETaiwan - Taipei
1 program
1
RGI-2001Phase 21 trial
Active Trials
NCT04014790Completed49Est. Apr 2023
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
RituximabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT04235036Terminated15Est. Dec 2022
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
BelimumabPhase 1Monoclonal Antibody
Cynata Therapeutics
Cynata TherapeuticsAustralia - Cremorne
1 program
1
Mesenchymoangioblast-derived mesenchymal stem cellsPhase 11 trial
Active Trials
NCT02923375Completed16Est. Jun 2020
Incyte
IncyteDE - Wilmington
1 program
1
RuxolitinibPhase 1Small Molecule1 trial
Active Trials
NCT06008808Recruiting41Est. Nov 2027
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
CliniMACS® deviceN/A1 trial
Active Trials
NCT05968170Withdrawn0Est. Jul 2035
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
RuxolitinibN/ASmall Molecule1 trial
Active Trials
NCT07184853Recruiting122Est. Sep 2028
CSL Behring
CSL BehringIL - Bradley
1 program
Alpha-1-AntitrypsinPHASE_21 trial
Active Trials
NCT01700036Completed40Est. Oct 2018
CytoDyn
CytoDynVANCOUVER, WA
1 program
PRO 140PHASE_21 trial
Active Trials
NCT02737306Terminated11Est. Sep 2021

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
NovartisINC424
NovartisImatinib
NovartisBasiliximab
NovartisImatinib
NovartisINC424
NovartisImatinib
NovartisImatinib
Neovii BiotechATG-Fresenius S
NovartisImatinib
Dr. Falk PharmaBudesonide
NovartisBasiliximab
NovartisINC424
AbbVieRituximab
REGiMMUNERGI-2001
CytoDynPRO 140

Showing 15 of 35 trials with date data

Clinical Trials (35)

Total enrollment: 3,551 patients across 35 trials

Exploratory Phase II Study of INC424 Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)

Start: May 2012Est. completion: Jan 201448 patients
Phase 4Completed

Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer

Start: Jun 2006Est. completion: Jul 201233 patients
Phase 4Completed

Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids

Start: Jan 2006Est. completion: Dec 20087 patients
Phase 4Completed

Chromosome Abnormalities in Chronic Myeloid Leukemia (CML) on Imatinib. GIST Patients on Imatinib

Start: Feb 2005Est. completion: Dec 200868 patients
Phase 4Terminated

INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.

Start: Aug 2011Est. completion: Jan 20172,233 patients
Phase 3Completed

Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

Start: Jun 2011Est. completion: Mar 201417 patients
Phase 3Terminated

Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)

Start: Jun 2004
Phase 3Completed

Acute Graft-Versus-Host Disease (aGvHD) Prophylaxis With ATG-Fresenius in Matched Unrelated Donor-Stem Cell Transplantation (MUD-SCT)

Start: Feb 2003Est. completion: Mar 2009202 patients
Phase 3Completed

Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)

Start: Nov 2002Est. completion: Jun 2007100 patients
Phase 3Completed

Treatment of Gastro-Intestinal and/or Hepatic Graft Versus Host Disease With Budesonide in Patients Following Peripheral Blood Stem Cell Transplantation

Start: Jan 2001Est. completion: Aug 200524 patients
Phase 3Completed

Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant

Start: May 2009Est. completion: Apr 20105 patients
Phase 2/3Terminated

Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant

Start: May 2020Est. completion: Aug 202446 patients
Phase 2Completed

Ibrutinib and Rituxan for Chronic GVHD

Start: Dec 2019Est. completion: Dec 202215 patients
Phase 2Terminated

RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation

Start: Nov 2019Est. completion: Apr 202349 patients
Phase 2Completed

A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation

Start: May 2017Est. completion: Sep 202111 patients
Phase 2Terminated
NCT01700036CSL BehringAlpha-1-Antitrypsin

A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease

Start: Jul 2013Est. completion: Oct 201840 patients
Phase 2Completed

An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints

Start: Aug 2010Est. completion: Jul 201110 patients
Phase 2Completed

Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma

Start: Dec 2008Est. completion: Jan 20111 patients
Phase 2Completed

Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

Start: Sep 2008Est. completion: Jul 201335 patients
Phase 2Completed

Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

Start: Jul 2006Est. completion: Jul 201124 patients
Phase 2Completed

A Study of Imatinib and Docetaxel in Prostate Cancer

Start: Aug 2005Est. completion: Mar 201449 patients
Phase 2Completed

Efficacy and Safety of Imatinib in Chordoma

Start: Oct 2004Est. completion: Apr 200855 patients
Phase 2Completed
NCT00048789Allergy TherapeuticsExtracorporeal Photopheresis

Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease

Start: Nov 2002Est. completion: Jan 200925 patients
Phase 2Completed

Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer

Start: Sep 2002Est. completion: Dec 200760 patients
Phase 2Completed

Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

Start: May 2024Est. completion: Nov 202741 patients
Phase 1Recruiting
NCT02923375Cynata TherapeuticsMesenchymoangioblast-derived mesenchymal stem cells

A Study of CYP-001 for the Treatment of Steroid-Resistant Acute Graft Versus Host Disease

Start: Mar 2017Est. completion: Jun 202016 patients
Phase 1Completed

A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease

Start: Sep 2008Est. completion: Apr 201215 patients
Phase 1Completed

Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

Start: Sep 2006Est. completion: Nov 200632 patients
Phase 1Completed

Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib

Start: Jun 2006Est. completion: Sep 200616 patients
Phase 1Completed

Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

Start: Aug 2005Est. completion: Nov 200659 patients
Phase 1Completed

Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD

Start: Sep 2025Est. completion: Sep 2028122 patients
N/ARecruiting

TCRαβ/CD19 Depletion of Stem Cell Grafts for Transplant

Start: May 2025Est. completion: Jul 20350
N/AWithdrawn

Effect of Imatinib on Bone Metabolism in Patients With Chronic Myelogenous Leukemia or Gastrointestinal Stromal Tumors

Start: Nov 2006Est. completion: Oct 201333 patients
N/ACompleted

Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia

Start: Jan 2006
N/ANo Longer Available

Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Start: Jun 2004Est. completion: Dec 200860 patients
N/AUnknown

Related Jobs

Phase Legend

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

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 3,551 patients
15 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.