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Graft Vs Host Disease

14
Pipeline Programs
15
Companies
15
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 Antibody
GLEEVEC(Imatinib)PHASE_1Small Molecule
INC424PHASE_2
Sandoz
SandozAustria - Kundl
4 programs
1
1
1
MyforticPhase 31 trial
INC424Phase 21 trial
ImatinibPhase 1Small Molecule1 trial
BasiliximabN/AMonoclonal Antibody1 trial
Active Trials
NCT00563108Unknown60Est. Dec 2008
NCT00760981Completed15Est. Apr 2012
NCT03774082Completed46Est. Aug 2024
+1 more trials
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 21 trial
Active Trials
NCT01700036Completed40Est. Oct 2018
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_2
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
SandozMyfortic
Neovii BiotechATG-Fresenius S
Dr. Falk PharmaBudesonide
SandozINC424
AbbVieRituximab
REGiMMUNERGI-2001
CytoDynPRO 140
CSL SeqirusAlpha-1-Antitrypsin
Allergy TherapeuticsExtracorporeal Photopheresis
IncyteRuxolitinib
Cynata TherapeuticsMesenchymoangioblast-derived mesenchymal stem cells
SandozImatinib
UNION therapeuticsRuxolitinib
Angeles TherapeuticsCliniMACS® device
SandozBasiliximab

Clinical Trials (15)

Total enrollment: 700 patients across 15 trials

NCT00298324SandozMyfortic

Myfortic - Treatment for Extensive cGvHD

Start: Sep 2006Est. completion: Nov 201034 patients
Phase 3Terminated
NCT00655343Neovii BiotechATG-Fresenius S

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
NCT00128739Dr. Falk PharmaBudesonide

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
NCT03774082SandozINC424

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
NCT04235036AbbVieRituximab

Ibrutinib and Rituxan for Chronic GVHD

Start: Dec 2019Est. completion: Dec 202215 patients
Phase 2Terminated
NCT04014790REGiMMUNERGI-2001

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
NCT02737306CytoDynPRO 140

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 SeqirusAlpha-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
NCT00048789Allergy TherapeuticsExtracorporeal Photopheresis

Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease

Start: Nov 2002Est. completion: Jan 200925 patients
Phase 2Completed
NCT06008808IncyteRuxolitinib

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
NCT00760981SandozImatinib

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

Start: Sep 2008Est. completion: Apr 201215 patients
Phase 1Completed
NCT07184853UNION therapeuticsRuxolitinib

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

Start: Sep 2025Est. completion: Sep 2028122 patients
N/ARecruiting
NCT05968170Angeles TherapeuticsCliniMACS® device

TCRαβ/CD19 Depletion of Stem Cell Grafts for Transplant

Start: May 2025Est. completion: Jul 20350
N/AWithdrawn
NCT00563108SandozBasiliximab

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

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

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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
2 actively recruiting trials targeting 700 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.