Ruxolitinib XR

Phase 2Small molecule

Incyte

Ruxolitinib XR is one of 173 small molecule programs targeting Lymphoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

172

Competitors

Pipeline

Status by Indication[3][1]

Indication

LymphomaNot yet recruiting

Acute Lymphoblastic LeukemiaTerminated

Myelodysplastic SyndromeActive, not recruiting

Chronic Lymphocytic LeukemiaActive, not recruiting

Metastatic Endometrial CarcinomaActive, not recruiting

LymphomaPhase 1

Not yet recruiting

Acute Lymphoblastic LeukemiaPhase 2

Terminated

Myelodysplastic SyndromePhase 2

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 2

Active, not recruiting

Metastatic Endometrial CarcinomaPhase 1

Active, not recruiting

Competition

Competitive Landscape

375 competitors in Lymphoma

#DrugCompanyPhaseTrials

Ruxolitinib XR

Incyte

Phase 2

1 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Nuvigil

NNuvo Research GmbH

Preclinical

1 6

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—7

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—8

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

1 10

JY231

SShenzhen Genocury Biotech Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Not yet recruiting

Lymphoma

NCT07278856

Q2 2027

Phase 2Active, not recruiting

Myelodysplastic Syndrome

NCT01787487

Q1 2028

Phase 1Active, not recruiting

Metastatic Endometrial Carcinoma

NCT03120624

Phase 3Recruiting

Study completion

NCT07317700

Q3 2028

Phase 2Active, not recruiting

Chronic Lymphocytic Leukemia

NCT02131584

Clinical

Trials by Indication[1]

Acute Lymphoblastic Leukemia3 trials

Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02420717·11 enrolled

Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT02779283·7 enrolled

Phase 2a Study of Adding Ruxolitinib With Tacrolimus/Methotrexate Regimen for Graft-versus-Host Disease Prophylaxis in Myeloablative Conditioning Hematopoietic Cell Transplantation in Pediatric and Young Adult Patients

Recruiting·CCity of Hope Medical Center·Phase 2·NCT06128070·40 enrolled

Myelofibrosis3 trials

Ruxolitinib Phosphate, Tacrolimus and Sirolimus in Preventing Acute Graft-versus-Host Disease During Reduced Intensity Donor Hematopoietic Cell Transplant in Patients With Myelofibrosis

Withdrawn·—·Phase 1·NCT02528877

Ruxolitinib Phosphate and Chemotherapy Given Before and After Reduced Intensity Donor Stem Cell Transplant in Treating Patients With Myelofibrosis

Completed·—·Phase 1·NCT02917096·18 enrolled

Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis

Completed·MMayo Clinic·Phase 2·NCT01732445·14 enrolled

Oral2 trials

A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants

Completed· Incyte logo

Incyte·Phase 1·NCT06555081·168 enrolled

A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants.

Completed· Incyte logo

Incyte·Phase 1·NCT06310304·24 enrolled

Psoriasis2 trials

A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis

Completed· Incyte logo

Incyte·Phase 2·NCT00778700·199 enrolled

A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis

Completed· Incyte logo

Incyte·Phase 2·NCT00820950·29 enrolled

Atopic Dermatitis2 trials

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

Completed· Incyte logo

Incyte·Phase 2·NCT03011892·307 enrolled

A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis

Completed· Incyte logo

Incyte·Phase 1·NCT03257644·70 enrolled

13 more indications

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03041636·1 enrolled

Myelodysplastic Syndrome1 trial

Ruxolitinib Phosphate and Azacytidine in Treating Patients With Myelofibrosis or Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01787487·121 enrolled

Breast Cancer1 trial

Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer

Completed·MMayo Clinic·Phase 1·NCT03012230·12 enrolled

Acute Myeloid Leukemia1 trial

Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT02257138·30 enrolled

T-cell non-Hodgkin lymphoma1 trial

Ruxolitinib Phosphate to Treat Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma After Stem Cell Transplant

Completed·UUniversity of Nebraska·Phase 2·NCT01431209·71 enrolled

Myeloid Leukemia1 trial

Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia

Completed·OOHSU Knight Cancer Institute·Phase 2·NCT02092324·51 enrolled

Lymphoma1 trial

Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas

Not yet recruiting·—·Phase 1·NCT07278856·20 enrolled

Leukemia1 trial

INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease

Completed·CChildren's Oncology Group·Phase 1·NCT01164163·49 enrolled

Primary Peritoneal Cancer1 trial

Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Completed·NNRG Oncology·Phase 1/2·NCT02713386·147 enrolled

Alopecia Areata1 trial

A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)

Terminated· Incyte logo

Incyte·Phase 2·NCT02553330·90 enrolled

Chronic Lymphocytic Leukemia1 trial

Administration of Jakafi (Ruxolitinib) for Symptom Control of Patients With Chronic Lymphocytic Leukemia (CLL): A Phase II Study

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02131584·10 enrolled

Metastatic Endometrial Carcinoma1 trial

Phase I Trial of Intravenous Administration of Vesicular Stomatitis Virus Genetically Engineered to Express Thyroidal Sodium Iodide Symporter (NIS) and Human Interferon Beta (hIFNb), in Patients With Metastatic or Recurrent Endometrial Cancer

Active, not recruiting·MMayo Clinic·Phase 1·NCT03120624·34 enrolled

Unspecified1 trial

A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis

Recruiting·CChengdu Zenitar Biomedical Technology Co., Ltd·Phase 3·NCT07317700·105 enrolled

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Ruxolitinib XR. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ruxolitinib XR compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ruxolitinib XR. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Incyte company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Incyte

Ruxolitinib XR

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q1 2028

Q3 2028

Trials by Indication[1]

Acute Lymphoblastic Leukemia3 trials

Myelofibrosis3 trials

Oral2 trials

Psoriasis2 trials

Atopic Dermatitis2 trials

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Myelodysplastic Syndrome1 trial

Breast Cancer1 trial

Acute Myeloid Leukemia1 trial

T-cell non-Hodgkin lymphoma1 trial

Myeloid Leukemia1 trial

Lymphoma1 trial

Leukemia1 trial

Primary Peritoneal Cancer1 trial

Alopecia Areata1 trial

Chronic Lymphocytic Leukemia1 trial

Metastatic Endometrial Carcinoma1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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