Graft vs Host Disease

12
Pipeline Programs
5
Companies
50
Clinical Trials
1 recruiting
6
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
4
0
1
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
267%
Monoclonal Antibody
133%
+ 4 programs with unclassified modality

On Market (6)

Approved therapies currently available

U
FYARROApproved
sirolimus
Unknown Company
mTOR Inhibitor Immunosuppressant [EPC]intravenous2021
Novartis
GLEEVECApproved
imatinib mesylate
Novartis
oral2003
U
HYFTORApproved
sirolimus
Unknown Company
mTOR Inhibitor Immunosuppressant [EPC]topical2022
Pfizer
RAPAMUNEApproved
sirolimus
Pfizer
mTOR Inhibitor Immunosuppressant [EPC]oral1999
Novartis
SIMULECTApproved
basiliximab
Novartis
Interleukin-2 Receptor Blocking Antibody [EPC]single-use1998
U
SIROLIMUSApproved
sirolimus
Unknown Company
mTOR Inhibitor Immunosuppressant [EPC]oral2025

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
3 programs
1
1
1
INC424Phase 23 trials
GLEEVEC(Imatinib)Phase 1Small Molecule5 trials
SIMULECT(Basiliximab)N/AMonoclonal Antibody5 trials
Active Trials
NCT00928811Terminated5Est. Apr 2010
NCT00284947Completed7Est. Dec 2008
NCT00563108Unknown60Est. Dec 2008
+10 more trials
Pfizer
PfizerNEW YORK, NY
1 program
1
1
sirolimusPhase 35 trials
Active Trials
NCT00037531Completed769Est. Aug 2004
NCT00044720Completed484Est. Jul 2005
NCT00261820Completed160Est. Jan 2005
+2 more trials
CSL Behring
CSL BehringIL - Bradley
1 program
1
Alpha-1-AntitrypsinPhase 21 trial
Active Trials
NCT01700036Completed40Est. Oct 2018
CytoDyn
CytoDynVANCOUVER, WA
1 program
1
PRO 140Phase 21 trial
Active Trials
NCT02737306Terminated11Est. Sep 2021
Astex Pharmaceuticals
Astex PharmaceuticalsUK - Cambridge
1 program
1
PentostatinPhase 2Small Molecule1 trial
Active Trials
NCT00144430CompletedEst. Aug 2008

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Pfizersirolimus
Pfizersirolimus
NovartisImatinib
NovartisImatinib
NovartisINC424
Pfizersirolimus
NovartisImatinib
NovartisImatinib
Pfizersirolimus
Pfizersirolimus
Pfizersirolimus
NovartisImatinib
NovartisImatinib
Pfizersirolimus
Pfizersirolimus

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 10,467 patients across 50 trials

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Est. completion: Jan 2005160 patients
Phase 4Completed

Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients

Est. completion: Jul 2005484 patients
Phase 4Completed

Asciminib Roll-over Study

Start: Aug 2022Est. completion: Aug 2030347 patients
Phase 4Recruiting

Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator

Start: Mar 2013Est. completion: Apr 2033155 patients
Phase 4Active Not Recruiting

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

Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

Start: Mar 2011Est. completion: Jun 2018101 patients
Phase 4Completed

Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

Start: Oct 2010Est. completion: May 20113 patients
Phase 4Terminated

An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

Start: Dec 2009Est. completion: Dec 201252 patients
Phase 4Completed

Impact of Conversion From Tacrolimus to Sirolimus in African American Renal Transplant Recipients

Start: Sep 2009Est. completion: Jun 201150 patients
Phase 4Unknown

Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients

Start: Jun 2009Est. completion: Aug 2013254 patients
Phase 4Completed

Tacrolimus to Sirolimus Conversion for Delayed Graft Function

Start: Apr 2009Est. completion: Jul 201432 patients
Phase 4Terminated

Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to CAMN107A2109 Trial

Start: Dec 200819 patients
Phase 4Completed

Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Start: Aug 2008Est. completion: Jan 201289 patients
Phase 4Completed

Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients

Start: Feb 2008Est. completion: Oct 2012320 patients
Phase 4Completed

Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients

Start: Jun 2007Est. completion: Mar 2019275 patients
Phase 4Completed

Treatment of Patients With Everolimus and Imatinib Mesylate Who Have Progressive Gastro Intestinal Stromal Tumors (GIST) and Are Resistant to Imatinib Mesylate

Start: Oct 2006Est. completion: Nov 201228 patients
Phase 4Completed

Study Evaluating Sirolimus in the Treatment of Kidney Transplant

Start: Aug 2006100 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

A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

Start: Aug 2005Est. completion: Oct 200747 patients
Phase 4Completed

Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)

Start: Apr 2005Est. completion: Jun 200780 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

Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

Start: Jul 200464 patients
Phase 4Completed

Study Evaluating Sirolimus in Kidney Transplant Recipients in India

Start: Apr 2004Est. completion: Dec 2005100 patients
Phase 4Completed

Pilot Study on the Use of Sirolimus to Treat Chronic Allograft Nephropathy in Children After Kidney Transplant

Start: Mar 2004Est. completion: Oct 200840 patients
Phase 4Completed

Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

Start: Mar 2004Est. completion: Jul 2007420 patients
Phase 4Completed

An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.

Start: May 200248 patients
Phase 4Completed

The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

Start: Apr 2001Est. completion: Dec 2008165 patients
Phase 4Completed

Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

Start: Oct 2000Est. completion: Aug 2001150 patients
Phase 4Completed

Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

Est. completion: Aug 2004769 patients
Phase 3Completed

Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML

Start: Nov 2023Est. completion: Dec 2025164 patients
Phase 3Active Not Recruiting

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Start: Oct 2021Est. completion: Jan 2031406 patients
Phase 3Active Not Recruiting

A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

Start: Jul 2014Est. completion: Jan 2017225 patients
Phase 3Completed

An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years

Start: Mar 2014Est. completion: Oct 201914 patients
Phase 3Terminated

Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance

Start: Oct 2012Est. completion: Aug 201310 patients
Phase 3Completed

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

Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients

Start: Apr 2011Est. completion: Oct 2014267 patients
Phase 3Completed

Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus (SRL)-Based Immunosuppression-

Start: Jul 2010Est. completion: Dec 201412 patients
Phase 3Terminated

Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

Start: Apr 2010Est. completion: Apr 2014144 patients
Phase 3Terminated

Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg

Start: Jun 2009Est. completion: Aug 201294 patients
Phase 3Terminated

Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)

Start: Jun 2009Est. completion: Jul 2015207 patients
Phase 3Completed

Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib

Start: May 2009Est. completion: Jul 2014191 patients
Phase 3Completed

A Study of Nilotinib Versus Imatinib in GIST Patients

Start: Mar 2009Est. completion: Oct 2014644 patients
Phase 3Completed

Efficacy of Nilotinib Versus Imatinib in Ph+ CML in Early CP Who Have a Suboptimal Molecular Response to Imatinib

Start: Jan 2009Est. completion: Jun 2014100 patients
Phase 3Unknown

A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Start: Jan 2009Est. completion: Apr 20116 patients
Phase 3Completed

Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.

Start: Nov 2008Est. completion: Jul 2014125 patients
Phase 3Completed

Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Start: Oct 2007Est. completion: Oct 20086 patients
Phase 3Terminated

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Start: Jul 2007Est. completion: Aug 2019846 patients
Phase 3Completed

Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib

Start: Mar 2007Est. completion: Jun 2011248 patients
Phase 3Completed

Phase Legend

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

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 10,467 patients
5 companies competing in this space