Jakafi

(Ruxolitinib)

ApprovedSmall molecule

Ruxolitinib is used to treat certain blood disorders like myelofibrosis and polycythemia vera, as well as severe eczema. It works by reducing inflammation and helping the body's immune system function more normally.[2] Jakafi is currently approved and in use across 97 indications[4].[1]

Jakafi is one of 1102 small molecule programs targeting Lymphoma. It is currently in Approved.

Indications

324

Total Trials

Active Trials

1,101

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

LymphomaCompleted

TreatmentCompleted

Hematological MalignanciesWithdrawn

Atopic EczemaApproved

Classic Hodgkin LymphomaApproved

Chuvash PolycythemiaActive, not recruiting

Eczematoid DermatitisActive, not recruiting

Pancreatic NeoplasmApproved

T-Cell Large Granular Lymphocyte LeukemiaApproved

Chronic Myelogenous LeukemiaApproved

LymphomaPhase 2

Completed

TreatmentPhase 2

Completed

Hematological MalignanciesPhase 2

Withdrawn

Atopic EczemaApproved

Approved

Classic Hodgkin LymphomaApproved

Approved

Chuvash PolycythemiaPreclinical

Active, not recruiting

Eczematoid DermatitisApproved

Active, not recruiting

Pancreatic NeoplasmApproved

Approved

T-Cell Large Granular Lymphocyte LeukemiaApproved

Approved

Chronic Myelogenous LeukemiaApproved

Approved

Showing 10 of 97 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Jakafi

Abraxane

34 3

Decadron

AAspen Global Incorporated

Phase 3

10 4

Adstiladrin

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

4 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

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

Timeline

Expected Milestones

Q3 2026

Phase 2Not yet recruiting

Agvhd

NCT06075225

Q4 2026

Phase 1/2Not yet recruiting

Bone Marrow Failure

NCT06607367

Phase 2Recruiting

Lymphoma

NCT02974647

Phase 1Recruiting

TNBC

NCT06008275

Phase 3Active, not recruiting

Myelofibrosis

NCT04468984

Phase 2Recruiting

Myeloid Malignancies

NCT07238712

Clinical

Trials by Indication[1]

Myelofibrosis37 trials

Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial

Completed· Novartis logo

Novartis·Phase 3·NCT00934544·219 enrolled

To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Terminated· Incyte logo

Incyte·Phase 3·NCT04551066·252 enrolled

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

Show 34 more trials

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Active, not recruiting·KKaryopharm Therapeutics Inc·Phase 3·NCT04562389·353 enrolled

Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis

Completed· Incyte logo

Incyte·Phase 2·NCT01445769·45 enrolled

A Study of APG-1252 in Patients With Myelofibrosis Who Progressed After Initial Therapy

Withdrawn· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1/2·NCT04354727

To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Terminated· Incyte logo

Incyte·Phase 3·NCT04551053·177 enrolled

Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.

Terminated· Novartis logo

Novartis·Phase 3·NCT02598297·49 enrolled

A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis

Recruiting· Takeda logo

Takeda·Phase 2·NCT05037760·135 enrolled

A Phase 2 Study of INCB57643 (BET Inhibitor) in Combination With Ruxolitinib in JAK Inhibitor-naïve Patients With Myelofibrosis

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT06619522

Evaluation of Ruxolitinib in Combination With PU-H71 for Treatment of Myelofibrosis

Terminated·SSamus Therapeutics, Inc.·Phase 1·NCT03373877·4 enrolled

Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01712308·56 enrolled

Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

Completed·JJohn Mascarenhas·Phase 2·NCT04281498·6 enrolled

Panobinostat and Ruxolitinib In MyElofibrosis (PRIME Trial)

Completed·JJohn Mascarenhas·Phase 1/2·NCT01693601·15 enrolled

PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis

Completed·SSt. Petersburg State Pavlov Medical University·Phase 1/2·NCT02806375·20 enrolled

A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis

Completed· Incyte logo

Incyte·Phase 2·NCT03144687·23 enrolled

Actuate 1901: 9-ING-41 in Myelofibrosis

Completed·AActuate Therapeutics Inc.·Phase 2·NCT04218071·17 enrolled

A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis

Completed· AbbVie logo

AbbVie·Phase 2·NCT03222609·191 enrolled

A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)

Terminated· Novartis logo

Novartis·Phase 2·NCT02091752·3 enrolled

Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis

Completed·QQilu Hospital of Shandong University··NCT05410470·130 enrolled

Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients

Completed· Incyte logo

Incyte·Phase 2·NCT01340651·41 enrolled

JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis

Active, not recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT02251821·61 enrolled

A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis

Unknown status·QQilu Hospital of Shandong University·Phase 4·NCT05447260·87 enrolled

Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis

Terminated·WWashington University School of Medicine·Phase 1·NCT03386214·8 enrolled

Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT04468984·330 enrolled

A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT04817007·216 enrolled

A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination With Ruxolitinib for the Treatment of Intermediate- or High-Risk Myelofibrosis (MF)

Completed· Roche logo

Roche·Phase 1·NCT02593760·10 enrolled

Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis

Active, not recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT04384692·53 enrolled

Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Recruiting·KKartos Therapeutics, Inc.·Phase 3·NCT06479135·600 enrolled

Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis

Completed· AbbVie logo

AbbVie·Phase 3·NCT04472598·252 enrolled

Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

Terminated· Novartis logo

Novartis·Phase 1/2·NCT04097821·45 enrolled

Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis

Terminated· AbbVie logo

AbbVie·Phase 1·NCT04480086·1 enrolled

Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02784496·8 enrolled

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Completed·—·Phase 3·NCT01969838·432 enrolled

A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03069326·30 enrolled

Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02267278·25 enrolled

Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

Completed· Novartis logo

Novartis·Phase 2·NCT02966353·51 enrolled

Atopic Dermatitis12 trials

TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Completed· Incyte logo

Incyte·Phase 3·NCT03745651·618 enrolled

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

Completed· Incyte logo

Incyte·Phase 3·NCT06238817·241 enrolled

Show 9 more trials

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

Recruiting· Incyte logo

Incyte··NCT06627335·5,621 enrolled

Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Completed· Incyte logo

Incyte·Phase 3·NCT03745638·631 enrolled

Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population

Recruiting· Incyte logo

Incyte··NCT06259669·958 enrolled

Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis

Completed· Incyte logo

Incyte·Phase 3·NCT05456529·103 enrolled

A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis

Completed· Incyte logo

Incyte·Phase 1·NCT03920852·41 enrolled

The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.

Terminated· Incyte logo

Incyte·Phase 4·NCT05696392·47 enrolled

Study of Ruxolitinib Cream in Children With Atopic Dermatitis

Completed· Incyte logo

Incyte·Phase 1·NCT05034822·29 enrolled

The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis

Completed· Incyte logo

Incyte·Phase 2·NCT04839380·49 enrolled

Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement

Completed· Incyte logo

Incyte·Phase 2·NCT05127421·77 enrolled

Vitiligo8 trials

Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)

Completed· Incyte logo

Incyte·Phase 3·NCT04057573·344 enrolled

A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)

Completed· Incyte logo

Incyte·Phase 2·NCT04896385·60 enrolled

Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas

Completed·—·Phase 2·NCT05872477·20 enrolled

Show 5 more trials

A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Completed· Incyte logo

Incyte·Phase 2·NCT03099304·157 enrolled

A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo

Completed· Incyte logo

Incyte·Phase 2·NCT05750823·49 enrolled

Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

Completed· Incyte logo

Incyte·Phase 3·NCT04052425·330 enrolled

Comparative Effectiveness of Ruxolitinib Monotherapy Versus Its Combination With Tacrolimus and Corticosteroids in the Management of Vitiligo: A Randomized Controlled Trial

Completed·—·Phase 4·NCT07368673·120 enrolled

Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

Completed· Incyte logo

Incyte·Phase 3·NCT04530344·458 enrolled

Polycythemia Vera8 trials

Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy.

Completed· Novartis logo

Novartis·Phase 3·NCT02038036·149 enrolled

Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)

Completed· Incyte logo

Incyte·Phase 3·NCT01243944·222 enrolled

KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera

Unknown status·KKartos Therapeutics, Inc.·Phase 2·NCT03669965·20 enrolled

Show 5 more trials

MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera

Recruiting·UUniversity of Birmingham·Phase 3·NCT04116502·586 enrolled

Ruxolitinib in Thrombocythemia and Polycythemia Vera

Recruiting·MMassachusetts General Hospital·Phase 2·NCT04644211·60 enrolled

MAP to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera

No longer available· Novartis logo

Novartis··NCT05269771

Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.

Completed· Novartis logo

Novartis·Phase 3·NCT02292446·161 enrolled

Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study

Completed· Incyte logo

Incyte·Phase 3·NCT01632904·110 enrolled

COVID-198 trials

COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19

Completed·LLomonosov Moscow State University Medical Research and Educational Center·Phase 2·NCT04403243·70 enrolled

Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection

No longer available· Incyte logo

Incyte··NCT04355793

Treatment of SARS Caused by COVID-19 With Ruxolitinib

Completed·GGrupo Cooperativo de Hemopatías Malignas·Phase 1/2·NCT04334044·77 enrolled

Show 5 more trials

Inflammatory Signal Inhibitors for COVID-19 (MATIS)

Completed·IImperial College London·Phase 1/2·NCT04581954·185 enrolled

Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness

No longer available· Novartis logo

Novartis··NCT04337359

Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation

Completed·UUniversity of Jena·Phase 2·NCT04338958·193 enrolled

Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm

Completed· Novartis logo

Novartis·Phase 3·NCT04362137·432 enrolled

Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

Terminated· Incyte logo

Incyte·Phase 3·NCT04377620·211 enrolled

89 more indications

Essential Thrombocythemia7 trials

Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis

Completed· Novartis logo

Novartis·Phase 1·NCT01433445·61 enrolled

Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)

Completed· Incyte logo

Incyte·Phase 2·NCT01348490·66 enrolled

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib

Unknown status·KKartos Therapeutics, Inc.·Phase 1/2·NCT04485260·36 enrolled

Show 4 more trials

Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis

Completed· Incyte logo

Incyte·Phase 1/2·NCT00509899·154 enrolled

Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia

Terminated· Incyte logo

Incyte·Phase 2·NCT00726232·73 enrolled

Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

Completed· Gilead logo

Gilead·Phase 2·NCT01369498·54 enrolled

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease

Terminated· Gilead logo

Gilead·Phase 1·NCT02436135·10 enrolled

Lymphoma5 trials

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

Recruiting·JJonathan Brammer·Phase 2·NCT07356245·44 enrolled

Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02974647·83 enrolled

A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

Completed·TThe Lymphoma Academic Research Organisation·Phase 2·NCT01877005·33 enrolled

Show 2 more trials

Dose Escalation Study to Determine the Maximum Tolerated Dose of the Combination of Ruxolitinib and Bortezomib in Patients With Relapsed or Refractory Lymphoma

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 1·NCT02613598·15 enrolled

Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

Recruiting·VVeronika Bachanova·Phase 1/2·NCT03681561·54 enrolled

Chronic Hand Eczema3 trials

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

Withdrawn· Incyte logo

Incyte·Phase 3·NCT05219864

Topical Ruxolitinib Evaluation in Chronic Hand Eczema

Completed· Incyte logo

Incyte·Phase 2·NCT05906628·186 enrolled

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2

Withdrawn· Incyte logo

Incyte·Phase 3·NCT05233410

Myeloid Leukemia3 trials

Ruxolitinib in Treating Participants With Chronic Myeloid Leukemia With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01751425·8 enrolled

Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia

Active, not recruiting·SSWOG Cancer Research Network·Phase 2·NCT03654768·81 enrolled

Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT01702064·11 enrolled

Leukemia3 trials

Ruxolitinib for Adult T-Cell Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT01712659·19 enrolled

The Role of Ruxolitinib in Secondary Acute Myelogenous Leukemia Evolving From Myeloproliferative Neoplasm

Unknown status·SSeoul National University Hospital·Phase 1/2·NCT03558607·17 enrolled

Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia

Completed·UUniversity Health Network, Toronto·Phase 1/2·NCT01914484·4 enrolled

Acute Lymphoblastic Leukemia3 trials

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2/3·NCT03117751·790 enrolled

A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

Completed· Incyte logo

Incyte·Phase 2·NCT02723994·171 enrolled

Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia

Terminated·SSt. Jude Children's Research Hospital·Phase 1·NCT03515200·12 enrolled

Treatment3 trials

Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

Recruiting·TTelios Pharma, Inc.·Phase 1/2·NCT05280509·70 enrolled

Safety and Tolerability of Combined Treatment With Nilotinib and Ruxolitinib in CML and Ph+ ALL Patients

Completed· Novartis logo

Novartis·Phase 1·NCT02253277·5 enrolled

Study of Combination Ruxolitinib and Decitabine Treatment for Accelerated Phase MPN or Post-MPN AML

Completed·JJohn Mascarenhas·Phase 1/2·NCT02076191·49 enrolled

Multiple Myeloma3 trials

Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma

Recruiting·OOncotherapeutics·Phase 1·NCT06209606·30 enrolled

A Study to Determine the Effect and Safety of an Oral Janus Kinase 2 (JAK2)-Inhibitor (Ruxolitinib; INBC018424) in Patients With Multiple Myeloma

Completed· Incyte logo

Incyte·Phase 2·NCT00639002·13 enrolled

A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Recruiting·OOncotherapeutics·Phase 1·NCT03110822·134 enrolled

Graft Versus Host Disease3 trials

De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis

Active, not recruiting·MMedical College of Wisconsin·Phase 2·NCT05622318·56 enrolled

Novel First-line Therapies for Grade II Acute GVHD(Graft-versus-host Disease )

Recruiting·DDaihong Liu·Phase 2·NCT07340723·168 enrolled

A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06973668·80 enrolled

Breast Cancer3 trials

Ruxolitinib in Estrogen Receptor Positive Breast Cancer

Completed·—·Phase 2·NCT01594216·25 enrolled

Ruxolitinib in Patients With Breast Cancer

Terminated·—·Phase 2·NCT01562873·21 enrolled

Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer

Completed·—·Phase 1/2·NCT02066532·32 enrolled

Acute Graft Vs. Host Disease2 trials

Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation

Completed· Novartis logo

Novartis·Phase 3·NCT02913261·310 enrolled

Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease

Completed· Novartis logo

Novartis·Phase 1/2·NCT03491215·45 enrolled

Chronic Graft Versus Host Disease2 trials

Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids

Completed·UUniversity of Nebraska·Phase 2·NCT03616184·49 enrolled

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Recruiting· Incyte logo

Incyte·Phase 2·NCT06388564·120 enrolled

Histiocytosis2 trials

Ruxolitinib as First Line Treatment in Primary Haemophagocytic Lymphohistiocytosis (R-HLH)

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05762640·20 enrolled

Use Of A Response-Adapted Ruxolitinib-Containing Regimen For The Treatment Of Hemophagocytic Lymphohistiocytosis

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 1/2·NCT04551131·10 enrolled

First Line Therapy2 trials

Ruxolitinib and Steroid As First Line Therapy for Acute GVHD

Terminated·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 2·NCT03701698·1 enrolled

First Line Therapy for High Risk Acute GVHD

Completed·—·Phase 2·NCT04061876·198 enrolled

Refractory2 trials

Ruxolitinib for Steroid-refractory GVHD

Completed·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT02997280·75 enrolled

Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD

Recruiting·—·Phase 1·NCT06233110·30 enrolled

Efficacy and Safety2 trials

Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease

Recruiting· Novartis logo

Novartis·Phase 4·NCT06824103·50 enrolled

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

Completed· Incyte logo

Incyte·Phase 2·NCT05593445·61 enrolled

Hematological Malignancies2 trials

Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT05579769·3 enrolled

HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

Recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 1/2·NCT05745714·26 enrolled

Advanced Malignancies2 trials

Study of INCB053914 in Subjects With Advanced Malignancies

Terminated· Incyte logo

Incyte·Phase 1/2·NCT02587598·97 enrolled

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Terminated· Incyte logo

Incyte·Phase 1/2·NCT02711137·137 enrolled

Primary Myelofibrosis2 trials

Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF

Completed· Novartis logo

Novartis·Phase 2·NCT01392443·120 enrolled

Open Label Phase 1/2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT06327100·33 enrolled

Myeloproliferative Neoplasms2 trials

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Recruiting· Incyte logo

Incyte·Phase 1·NCT06034002·230 enrolled

Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms

Completed·OOhio State University Comprehensive Cancer Center·Phase 1/2·NCT03878199·12 enrolled

Graft Vs Host Disease2 trials

Ruxolitinib as add-on Therapy in Steroid-refractory Graft-vs-host Disease

Completed·YYi-Lun Wang·Phase 3·NCT05663827·6 enrolled

Upfront Ruxolitinib for Chronic Graft-vs-host Disease

Terminated·—·Phase 1·NCT06695507·1 enrolled

Acute Graft Versus Host Disease2 trials

Prevention of Severe Acute Graft-versus-host Disease in Adult Patients Using a daGOAT Model

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05600855·115 enrolled

Prevention of Severe Acute Graft-versus-host Disease in Pediatric Patients Using a daGOAT Model

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05599256·40 enrolled

Acute Respiratory Distress Syndrome1 trial

Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection

Unknown status·AAzienda USL Toscana Nord Ovest··NCT04361903·13 enrolled

Hidradenitis Suppurativa1 trial

Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Completed· Incyte logo

Incyte·Phase 2·NCT05635838·69 enrolled

Dermatitis1 trial

Topical Ruxolitinib in Chronic Hand Dermatitis

Completed·UUniversity of Rochester·Phase 1/2·NCT05293717·16 enrolled

ETP-ALL1 trial

Ruxolitinib Plus LVP in Patients With R/R ETP-ALL

Unknown status·SSichuan University·Phase 1/2·NCT03613428·12 enrolled

Thrombocytopenia1 trial

A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Recruiting·KKaryopharm Therapeutics Inc·Phase 2·NCT05980806·58 enrolled

Hematopoietic Stem Cell Transplant1 trial

An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

Approved for marketing· Incyte logo

Incyte··NCT03147742

Myelodysplastic Syndrome1 trial

Ruxolitinib for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01895842·31 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma

Completed·PPeter Hosein, MD·Phase 1·NCT05440942·28 enrolled

Hypereosinophilic syndrome1 trial

Tyrosine Kinase Inhibition to Treat Myeloid Hypereosinophilic Syndrome

Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00044304·70 enrolled

Myeloproliferative Disorder1 trial

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

Active, not recruiting· Incyte logo

Incyte·Phase 1/2·NCT04455841·84 enrolled

Neuromyelitis Optica1 trial

Efficacy and Safety of Ruxolitinib in Neuromyelitis Optica Spectrum Disorders

Withdrawn·TTianjin Medical University General Hospital·Phase 1/2·NCT05909943

Hemophagocytic Syndrome1 trial

A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT02400463·6 enrolled

Pancreatic Cancer1 trial

Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

Terminated· Incyte logo

Incyte·Phase 3·NCT02117479·321 enrolled

Sickle Cell Disease1 trial

Ruxolitinib-Enhanced Haplo HCT for Children and Young Adults With Sickle Cell Disease

Not yet recruiting·UUniversity of Colorado, Denver·Phase 1/2·NCT07252050·24 enrolled

Solid Malignancies1 trial

Retifanlimab and Ruxolitinib In Solid Malignancies

Recruiting·UUniversity of California, San Diego·Phase 1/2·NCT07219576·40 enrolled

Acute Myeloid Leukemia1 trial

Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)

Terminated·MMacroGenics·Phase 1/2·NCT02152956·244 enrolled

Chronic1 trial

A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML

Withdrawn·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT02973711

Peripheral Blood Stem Cell Transplantation1 trial

A 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)

Recruiting· Incyte logo

Incyte·Phase 3·NCT06615050·572 enrolled

Prurigo Nodularis1 trial

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

Completed· Incyte logo

Incyte·Phase 3·NCT05764161·190 enrolled

Dermatomyositis1 trial

Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis

Recruiting·TThe Cleveland Clinic·Phase 2·NCT06857240·15 enrolled

TNBC1 trial

Neratinib in Combination With Ruxolitinib in Patients With mTNBC

Recruiting·—·Phase 1·NCT06008275·20 enrolled

Myeloid1 trial

Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

Withdrawn·OOncology Institute of Southern Switzerland·N/A·NCT03274778

Toxicities1 trial

Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities

Recruiting·UUniversity of Zurich·Phase 2·NCT06399029·20 enrolled

High Risk1 trial

The Ruxolitinib Versus Best Available Therapy Trial in Patients With High Risk ET in Second Line

Terminated·FFrench Innovative Leukemia Organisation·Phase 2/3·NCT02962388·13 enrolled

Relapsed/Refractory AML1 trial

CART123 + Ruxolitinib in Relapsed/Refractory AML

Active, not recruiting·UUniversity of Pennsylvania·Phase 1·NCT06768476·12 enrolled

Bone Marrow Failure1 trial

REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation 2

Not yet recruiting·MMelbourne Health·Phase 1/2·NCT06607367·20 enrolled

Corticosteroids1 trial

Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 1/2·NCT05123040·10 enrolled

Lichen Planus1 trial

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus

Completed· Incyte logo

Incyte·Phase 2·NCT05593432·64 enrolled

Completed·—·Phase 2·NCT04492618·12 enrolled

Pancreatic Adenocarcinoma1 trial

Study of Trametinib and Ruxolitinib in Colorectal Cancer and Pancreatic Adenocarcinoma

Unknown status·NNational Cancer Centre, Singapore·Phase 1·NCT04303403·48 enrolled

Prostate Cancer1 trial

Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT06616155·39 enrolled

Acute Leukemia1 trial

Phase l/II Study of Ruxolitinib for Acute Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT01251965·27 enrolled

Safety and Efficacy1 trial

A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT01776723·50 enrolled

Lung Adenocarcinoma1 trial

Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT02155465·22 enrolled

Chronic Lymphocytic Leukemia1 trial

Ruxolitinib Combined With Ibrutinib in Chronic Lymphocytic Leukemia Patients

Unknown status·SSunnybrook Health Sciences Centre·Phase 1/2·NCT02912754·36 enrolled

Methylprednisolone1 trial

A Trial of Selinexor, Ruxolitinib and Methylprednisolone

Recruiting·OOncotherapeutics·Phase 1·NCT06225310·30 enrolled

Fecal Microbiota Transplantation1 trial

Fecal Microbiota Transplantation With Ruxolitinib and Steroids as an Upfront Treatment of Severe Acute Intestinal GVHD

Terminated·SSt. Petersburg State Pavlov Medical University·Phase 1/2·NCT04269850·2 enrolled

TED1 trial

Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistant/Intolerant PV

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05870475·94 enrolled

Head and Neck Cancer1 trial

Ruxolitinib in Operable Head and Neck Cancer

Terminated·UUniversity of California, San Francisco·Phase 2·NCT03153982·16 enrolled

Inclusion Body Myositis1 trial

Ruxolitinib Treatment in Inclusion Body Myositis

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06536166·80 enrolled

Trial1 trial

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Steroid-Refractory Acute Graft-Versus-Host Disease1 trial

A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)

Completed· Incyte logo

Incyte·Phase 2·NCT02953678·71 enrolled

Bronchiolitis Obliterans1 trial

Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT03674047·50 enrolled

Overlap Syndrome1 trial

Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)

Recruiting·MMichael Savona·Phase 1/2·NCT04061421·94 enrolled

Pneumonia1 trial

Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia

Terminated·UUniversity Health Network, Toronto·N/A·NCT04331665·3 enrolled

Macrophage Activation Syndrome1 trial

Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome

Unknown status·—·Phase 3·NCT05137496·40 enrolled

Conditioning1 trial

PTCy and and Ruxolitinib for GVHD Prophylaxis After HSCT With Thymoglobulin in Conditioning Regimen in Patients With Inborn Errors of Immunity

Recruiting·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·Phase 2·NCT06199427·100 enrolled

Glioblastoma1 trial

Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma

Active, not recruiting·—·Phase 1·NCT03514069·60 enrolled

Hematopoietic Cell Transplantation1 trial

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

Recruiting·WWashington University School of Medicine·Phase 1·NCT06008808·41 enrolled

Metastatic Prostate Cancer1 trial

Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

Terminated· Incyte logo

Incyte·Phase 2·NCT00638378·22 enrolled

aGVHD1 trial

MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib

Not yet recruiting·SSichuan University·Phase 2·NCT06075225·62 enrolled

Aged1 trial

Managed Access Programs for INC424, Ruxolitinib

Available· Novartis logo

Novartis··NCT04745637

Myeloid Neoplasm1 trial

Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

Active, not recruiting· Incyte logo

Incyte·Phase 1·NCT04279847·140 enrolled

AML/MDS1 trial

Multi-Ctr PII Cmb.Modality Tx Ruxolitinib, Decitabine, and DLI for Post HSCT in AML/MDS

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT04055844·14 enrolled

Discoid Lupus Erythematosus1 trial

Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

Completed·UUniversity of Rochester·Phase 2·NCT04908280·10 enrolled

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

Patients With Advanced Solid Tumors1 trial

An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors

Terminated· Incyte logo

Incyte·Phase 1·NCT01822756·42 enrolled

Breast Disease1 trial

Ruxolitinib for Premalignant Breast Disease

Active, not recruiting·JJulie Nangia·Phase 2·NCT02928978·100 enrolled

Second-line Treatment1 trial

Basiliximab Combined With Ruxolitinib as Second-line Treatment of Grade 3-4 Steroid-resistant aGVHD

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 4·NCT05021276·50 enrolled

Idiopathic Multicentric Castleman Disease1 trial

Ruxolitinib in Previously Treated Idiopathic Multicentric Castleman Disease

Recruiting·UUniversity of Pennsylvania·Phase 2·NCT07085039·14 enrolled

Myeloid Malignancies1 trial

Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor

Recruiting·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT07238712·60 enrolled

Thalassemia1 trial

Study of Efficacy and Safety of INC424 in Regularly Transfused Patients With Thalassemia.

Completed· Novartis logo

Novartis·Phase 2·NCT02049450·30 enrolled

Acute Promyelocytic Leukemia1 trial

Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 4·NCT04446806·100 enrolled

Bone Marrow Transplantation1 trial

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

Completed· Incyte logo

Incyte·Phase 3·NCT03112603·330 enrolled

Tacrolimus1 trial

PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT

Completed·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT04669210·128 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 16, 2011

JAKAFI

NDA NDA202192

Nov 16, 2011

JAKAFI

NDA NDA202192

Jun 12, 2013

JAKAFI

NDA NDA202192

Nov 7, 2013

JAKAFI

NDA NDA202192

Nov 25, 2013

JAKAFI

NDA NDA202192

May 30, 2014

JAKAFI

NDA NDA202192

Jul 25, 2014

JAKAFI

NDA NDA202192

Dec 4, 2014

JAKAFI

NDA NDA202192

Dec 15, 2014

JAKAFI

NDA NDA202192

Oct 6, 2015

JAKAFI

NDA NDA202192

Dec 2, 2015

JAKAFI

NDA NDA202192

Mar 10, 2016

JAKAFI

NDA NDA202192

Oct 10, 2017

JAKAFI

NDA NDA202192

Dec 6, 2017

JAKAFI

NDA NDA202192

Oct 26, 2018

JAKAFI

NDA NDA202192

May 24, 2019

JAKAFI

NDA NDA202192

Jan 14, 2020

JAKAFI

NDA NDA202192

Sep 21, 2021

OPZELURA

NDA NDA215309

Sep 22, 2021

JAKAFI

NDA NDA202192

Sep 27, 2021

JAKAFI

NDA NDA202192

Dec 19, 2022

JAKAFI

NDA NDA202192

Jan 31, 2023

JAKAFI

NDA NDA202192

May 1, 2026

JAKAFI XR

NDA NDA217180

May 1, 2026

JAKAFI XR

NDA NDA217180

Jul 20, 2026

JAKAFI

NDA NDA202192

Sources

References

[1]
ClinicalTrials.gov — 324 trial records for Ruxolitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Jakafi drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ruxolitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ruxolitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA202192). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Jakafi. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Incyte company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tyrosine-Protein Kinase JAK1 Inhibitor; Tyrosine-Protein Kinase TYK2 Inhibitor; Tyrosine-Protein Kinase JAK2 Inhibitor; Tyrosine-Protein Kinase JAK3 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Incyte

Patent Landscape[6]

Patent Cliff

Dec 12, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10639310Dec 12, 2026

9206187Dec 12, 2026

8530485Dec 12, 2026

11744832Dec 12, 2026

9079912Dec 12, 2026

49 more patents

9814722Dec 12, 2026

9974790Dec 12, 2026

9814722*PEDJun 12, 2027

9079912*PEDJun 12, 2027

10639310*PEDJun 12, 2027

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8415362Dec 24, 2027

7598257Dec 24, 2027

10016429Jun 12, 2028

8722693Jun 12, 2028

10610530Jun 12, 2028

8822481Jun 12, 2028

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11213528Jun 12, 2028

7598257*PEDJun 24, 2028

8415362*PEDJun 24, 2028

11213528*PEDDec 11, 2028

8822481*PEDDec 12, 2028

10016429*PEDDec 12, 2028

10610530*PEDDec 12, 2028

8722693*PEDDec 12, 2028

8829013*PEDDec 12, 2028

12564593May 20, 2031

10869870May 20, 2031

11219624May 20, 2031

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12544381May 20, 2031

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10758543*PEDNov 20, 2031

10869870*PEDNov 20, 2031

11219624*PEDNov 20, 2031

11576865Nov 14, 2033

11576864Nov 14, 2033

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10874616Nov 14, 2033

11337927Jan 17, 2034

11576865*PEDMay 13, 2034

10874616*PEDMay 13, 2034

11576864*PEDMay 13, 2034

11896717*PEDMay 13, 2034

11337927*PEDJul 16, 2034

11590138Jun 10, 2040

12233067Jul 28, 2040

11590137Sep 4, 2040

11510923Sep 4, 2040

12589096Sep 4, 2040

11602536May 5, 2041

Jakafi

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Myelofibrosis37 trials

Atopic Dermatitis12 trials

Vitiligo8 trials

Polycythemia Vera8 trials

COVID-198 trials

Essential Thrombocythemia7 trials

Lymphoma5 trials

Chronic Hand Eczema3 trials

Myeloid Leukemia3 trials

Leukemia3 trials

Acute Lymphoblastic Leukemia3 trials

Treatment3 trials

Multiple Myeloma3 trials

Graft Versus Host Disease3 trials

Breast Cancer3 trials

Acute Graft Vs. Host Disease2 trials

Chronic Graft Versus Host Disease2 trials

Histiocytosis2 trials

First Line Therapy2 trials

Refractory2 trials

Efficacy and Safety2 trials

Hematological Malignancies2 trials

Advanced Malignancies2 trials

Primary Myelofibrosis2 trials

Myeloproliferative Neoplasms2 trials

Graft Vs Host Disease2 trials

Acute Graft Versus Host Disease2 trials

Acute Respiratory Distress Syndrome1 trial

Hidradenitis Suppurativa1 trial

Dermatitis1 trial

ETP-ALL1 trial

Thrombocytopenia1 trial

Hematopoietic Stem Cell Transplant1 trial

Myelodysplastic Syndrome1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Hypereosinophilic syndrome1 trial

Myeloproliferative Disorder1 trial

Neuromyelitis Optica1 trial

Hemophagocytic Syndrome1 trial

Pancreatic Cancer1 trial

Sickle Cell Disease1 trial

Solid Malignancies1 trial

Acute Myeloid Leukemia1 trial

Chronic1 trial

Peripheral Blood Stem Cell Transplantation1 trial

Prurigo Nodularis1 trial

Dermatomyositis1 trial

TNBC1 trial

Myeloid1 trial

Toxicities1 trial

High Risk1 trial

Relapsed/Refractory AML1 trial

Bone Marrow Failure1 trial

Corticosteroids1 trial

Lichen Planus1 trial

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Adult1 trial

Necrobiosis Lipoidica1 trial

Pancreatic Adenocarcinoma1 trial

Prostate Cancer1 trial

Acute Leukemia1 trial

Safety and Efficacy1 trial

Lung Adenocarcinoma1 trial

Chronic Lymphocytic Leukemia1 trial

Methylprednisolone1 trial

Fecal Microbiota Transplantation1 trial

TED1 trial

Head and Neck Cancer1 trial

Inclusion Body Myositis1 trial

Trial1 trial

Steroid-Refractory Acute Graft-Versus-Host Disease1 trial

Bronchiolitis Obliterans1 trial

Overlap Syndrome1 trial