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Graft-Versus-Host Disease trial readouts

registry pull 2026-08-19

Primary-completion dates that listed drug and biotech companies filed with ClinicalTrials.gov for studies in Graft-Versus-Host Disease. They are the sponsor's own estimated windows, revised as a study runs — not announcement dates. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Upcoming readout windows

next 180 days · by month

2 studies across 2 companies, in the next 180 days.

September 2026 1

TickerNameStudyPhaseStatusPrimary completionReadout inUpdated
SNYSanofiStudy to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male ParticipantsNCT07726914AUClastPhase 1Not yet recruiting2026-09-28in 39 d2026-07-24

January 2027 1

TickerNameStudyPhaseStatusPrimary completionReadout inUpdated
INCYIncyte CorporationA Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHDNCT06843408Number of participants with Treatment-emergent Adverse Events (TEAEs)Phase 1/2Active, not recruiting2027-01-06in 139 d2026-08-10

Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.

Every registered study in Graft-Versus-Host Disease

most recently updated first

38 studies match.

TickerNameMarket capStudyPhaseStatusInterventionsConditionsEnrollmentStartPrimary completionReadout inUpdated
SNYSanofiA Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host DiseaseNCT07771439Overall response ratePhase 3Not yet recruitingDrug: Belumosudil · Other: Best available therapy (BAT)Chronic Graft Versus Host Disease3562026-09-072029-09-14in 1,121 d2026-08-18
INCYIncyte Corporation$24.7BA Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHDNCT06843408Number of participants with Treatment-emergent Adverse Events (TEAEs)Phase 1/2Active, not recruitingDrug: INCA034176Chronic Graft-versus-host-disease322025-06-252027-01-06in 139 d2026-08-10
INCYIncyte Corporation$24.7BA Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host DiseaseNCT06585774Event Free Survival (EFS)Phase 3RecruitingDrug: INCA034176, Placebo, CorticosteroidsChronic Graft-versus-host-disease2402025-01-212027-09-28in 404 d2026-08-06
SNYSanofiStudy to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male ParticipantsNCT07726914AUClastPhase 1Not yet recruitingDrug: Belumosudil, BelumosudilChronic Graft Versus Host Disease582026-08-062026-09-28in 39 d2026-07-24
INCYIncyte Corporation$24.7BA Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of ItacitinibNCT04640025Treatment Emergent Adverse Events (TEAE's)Phase 2Terminatedsponsor's stated reason: The decision to close the study was made due to the expiration of remaining drug supply.Drug: itacitinibMyelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease182021-03-102026-05-11actual2026-06-26
SNDXSyndax Pharmaceuticals$1.8BA Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)NCT04710576results2024-10-10Overall Response Rate (ORR) in the First 6 Cycles as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease (cGVHD)Phase 2RecruitingDrug: AxatilimabChronic Graft-versus-host-disease2962021-03-042023-04-07actual2026-06-16
SNYSanofiA Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)NCT07116031Phase 1: AUCPhase 2RecruitingDrug: Belumosudil, BelumosudilChronic Graft Versus Host Disease372025-12-022028-09-25in 767 d2026-06-05
INCYIncyte Corporation$24.7BA Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)NCT07124078Objective Response (OR) at 6 monthsPhase 2RecruitingDrug: INCA034176, Best available Treatment (BAT)Chronic Graft-versus-host-disease602026-05-202029-01-31in 895 d2026-06-02
SNYSanofiA Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic TherapiesNCT06616415Plasma concentrations of belumosudil at specified time pointsPhase 4CompletedDrug: BelumosudilChronic Graft Versus Host Disease62024-12-042026-05-12actual2026-05-27
INCYIncyte Corporation$24.7BA Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host DiseaseNCT06388564Objective Response RatePhase 2Active, not recruitingDrug: Axatilimab, Ruxolitinib, CorticosteroidsChronic Graft-versus-host-disease1302024-10-112027-06-01in 285 d2026-05-22
INCYIncyte Corporation$24.7BA Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)NCT06615050GVHD-free survival (GFS)Phase 3RecruitingDrug: Tacrolimus (Tac), Methotrexate (MTX), Ruxolitinib (Rux), Cyclophosphamide, Mycophenolate mofetil (MMF)Graft-versus-host Disease (GVHD)5722025-04-022031-01-17in 1,611 d2026-05-20
SNYSanofiA Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)NCT07135973Drug related Grade ≥ 3 treatment emergent adverse events (TEAE)Phase 4Not yet recruitingDrug: BelumosudilChronic Graft Versus Host Disease262026-08-102027-08-30in 375 d2026-05-12
INCYIncyte Corporation$24.7BA Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic TherapyNCT06821542Objective Response (OR) at 6 monthsPhase 3Active, not recruitingDrug: INCA034176, Best Available Therapy (BAT)Chronic Graft-versus-host-disease92025-06-042028-05-31in 650 d2026-03-23
INCYIncyte Corporation$24.7BSafety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric SubjectsNCT03721965results2023-02-21Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)Phase 1/2Terminatedsponsor's stated reason: The study was terminated due to insufficient efficacy in a separate phase III studyDrug: Itacitinib, CorticosteroidsAcute Graft-versus-host Disease22019-12-312020-02-17actual2025-11-04
MESOMesoblast, Inc.Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD ParticipantsNCT00284986Response by Day 28Phase 2CompletedDrug: ProchymalGraft Versus Host Disease112005-11-182006-04-25actual2025-10-30
INCYIncyte Corporation$24.7BGRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host DiseaseNCT03584516results2025-01-27Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)Phase 2/3Terminatedsponsor's stated reason: The study was terminated due to insufficient efficacy to support moving into Part 2 of the study; there were no safety concerns that contributed to this decision.Drug: Itacitinib, Placebo, Methylprednisolone, PrednisoneChronic Graft-versus-host Disease1552019-01-172023-11-03actual2025-10-20
SNYSanofiA Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.NCT06143891Event-Free Survival (EFS)Phase 3Active, not recruitingDrug: Belumosudil, Placebo, Prednisone, PrednisoloneChronic Graft Versus Host Disease2602024-01-232028-09-29in 771 d2025-10-14
SNDXSyndax Pharmaceuticals$1.8BA Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHDNCT03604692results2024-11-27Phase 1: Number of Participants With DLTsPhase 1/2CompletedDrug: axatilimabChronic Graft-versus-host-disease412018-11-012022-08-12actual2025-09-15
INCYIncyte Corporation$24.7BGRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host DiseaseNCT03139604results2020-05-15Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response IndexPhase 3CompletedDrug: Itacitinib, Placebo, Prednisone, MethylprednisoloneGraft-versus-host Disease (GVHD)4392017-07-192019-05-02actual2025-09-02
INCYIncyte Corporation$24.7BA Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)NCT03112603results2022-04-15Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 VisitPhase 3CompletedDrug: Ruxolitinib, Extracorporeal photopheresis (ECP), Low-dose methotrexate (MTX), Mycophenolate mofetil (MMF), mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus), Infliximab, Rituximab, Pentostatin, Imatinib, IbrutinibGraft-versus-host Disease (GVHD)3302017-06-292020-05-08actual2025-08-12
EQEquillium$149MA Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)NCT05263999The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.Phase 3Terminatedsponsor's stated reason: The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data.Biological: Itolizumab · Drug: EQ001 PlaceboGraft Versus Host Disease, GVHD, Acute-graft-versus-host Disease, Acute GVHD, aGVHD1582022-04-292025-04-22actual2025-06-17
INCYIncyte Corporation$24.7BExpanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHDNCT05722912expanded accessApproved for marketingDrug: RuxolitinibGraft-versus-host Disease (GVHD)2023-02-10
FATEFate Therapeutics$307MStudy of ProTmune for Allogeneic HCT in Adult Patients With Hematologic MalignanciesNCT02743351results2023-02-08Percentage of Participants With Cumulative Incidence of Grade II to IV aGvHD Through Day +100 Based on Investigator AssessmentPhase 1/2CompletedBiological: ProTmune, Control ArmHematologic Malignancies, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia, Acute Graft-versus-host Disease962016-12-202020-12-04actual2023-02-08
OCGNOcugen$454MStudy of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host DiseaseNCT03591874results2022-07-06Change From Baseline to Day 84 in Validated Bulbar Redness (VBR) ScorePhase 3Terminatedsponsor's stated reason: Primary endpoint was not met.Drug: Brimonidine Tartrate, PlacebosGraft Versus Host Disease, Ocular Surface Disease, oGVHD, Ocular Graft vs Host Disease, Brimonidine Tartrate, Lubricant Eye Drops, Ophthalmic Solutions, Graft vs Host Disease592018-12-232020-04-30actual2022-07-06
INCYIncyte Corporation$24.7BAn Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell TransplantNCT03147742expanded accessApproved for marketingDrug: RuxolitinibGraft-versus-host Disease (GVHD)2022-06-07
MESOMesoblast, Inc.Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)NCT00366145Percentage of Participants achieving Complete Response of Greater Than or Equal to 28 Days DurationPhase 3CompletedBiological: Prochymal® · Drug: Placebo, Standard of Care for GVHDGraft Versus Host Disease2602006-08-172008-12-26actual2022-02-10
MESOMesoblast, Inc.Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD)NCT00562497Percentage of Participants with Treatment SuccessPhase 3CompletedDrug: Prochymal® · Other: Placebo, CorticosteroidGraft Versus Host Disease1922008-01-312009-07-14actual2022-01-19
INCYIncyte Corporation$24.7BA Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)NCT02953678results2019-08-20Overall Response Rate (ORR) at Day 28Phase 2CompletedDrug: Ruxolitinib, Prednisone or methylprednisoloneGraft-versus-host Disease (GVHD)712016-12-302018-01-31actual2021-11-24
JAZZJazz Pharmaceuticals$16.4BAn Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)NCT03339297results2021-08-18Cumulative Incidence Percentage of Grade B to D Acute Graft Versus Host Disease (aGvHD) by Day +100 Post-Hematopoietic Stem Cell Transplant (HSCT)Phase 2CompletedDrug: Defibrotide, Standard of CareGraft-versus-host Disease, Acute-graft-versus-host Disease1522018-02-212020-05-12actual2021-08-18
MESOMesoblast, Inc.Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHDNCT00759018expanded accessNo longer availableBiological: remestemcel-LGraft vs Host Disease, Graft-Versus-Host Disease2020-03-09
MESOMesoblast, Inc.Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)NCT00826046expanded accessNo longer availableDrug: Prochymal®Graft-Versus-Host Disease2020-03-09
INCYIncyte Corporation$24.7BSafety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese SubjectsNCT03497273Number of treatment-emergent adverse eventsPhase 1CompletedDrug: Itacitinib, CorticosteroidAcute Graft-versus-host Disease142018-03-202019-11-30actual2020-03-03
INCYIncyte Corporation$24.7BStudy of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHDNCT02614612Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse eventsPhase 1CompletedDrug: Itacitinib (200 mg), Itacitinib (300 mg), prednisone or methylprednisolone (corticosteroids)Graft-versus-host Disease (GVHD)31Dec 2015Jun 2016actual2019-03-08
GILDGilead Sciences$177.9BEfficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)NCT02701634results2018-12-26Best Overall Response RatePhase 2TerminatedDrug: ENTO, PlaceboChronic Graft Versus Host Disease662016-05-272017-12-19actual2018-12-26
RIGLRigel Pharmaceuticals$815MSafety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)NCT02040623results2016-10-10Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.Phase 2CompletedDrug: R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5% · Other: Placebo Ophthalmic SolutionChronic Graft-versus-host Disease35Mar 2014Jul 2016actual2016-10-10
SOBI.STSwedish Orphan BiovitrumTrial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) TransplantationNCT00189488results2014-09-15Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)Phase 2CompletedDrug: Palifermin, Placebo, Methotrexate · Other: Conditioning Regimen · Procedure: Allogeneic stem cell transplantGraft Versus Host Disease, Hematologic Malignancies155Dec 2005Nov 2008actual2014-09-15
4503.TAstellas Pharma Inc$26.0BA Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-NCT00189748Phase 2CompletedDrug: TacrolimusBone Marrow Transplantation, Graft Versus Host Disease, Graft-Versus-Host Disease, Graft-Vs-Host DiseaseAug 20042006-09-20
4503.TAstellas Pharma Inc$26.0BA Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT RecipientsNCT00189761Phase 2CompletedDrug: TacrolimusBone Marrow Transplantation, Graft Versus Host Disease, Graft-Vs-Host Disease, Graft-Versus-Host Disease2006-09-20

Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.

How Graft-Versus-Host Disease is matched — 8 exact registry spellings

A study is on this page when its ClinicalTrials.gov record names one of these conditions exactly (letter case aside). Nothing is matched by substring or stem, so a longer condition that merely contains one of these words is a different page. The list was curated by hand and last measured 2026-08-19; a spelling filed by only one study was not curated, so the counts here are a floor rather than the registry's own total for the disease.

  • Chronic Graft Versus Host Disease
  • Graft Versus Host Disease
  • Chronic Graft-versus-host-disease
  • Graft-versus-host Disease (GVHD)
  • Graft-Versus-Host Disease
  • Acute Graft-versus-host Disease
  • Acute-graft-versus-host Disease
  • Chronic Graft-versus-host Disease

Permalink · All conditions · Catalyst calendar · Every registered study · Search the whole pipeline for “Graft-Versus-Host Disease” (a text search, wider than this page)