Ruxolitinib

Generic Name: Ruxolitinib

Brand Names: Jakafi, Jakavi, Opzelura

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₈N_₆

CAS Number: 941678-49-5

Unique Ingredient Identifier: 82S8X8XX8H

Background: Ruxolitinib, formerly known as INCB018424 or INC424, is an anticancer drug and a Janus kinase (JAK) inhibitor. It is a potent and selective inhibitor of JAK1 and JAK2, which are tyrosine kinases involved in cytokine signalling and hematopoiesis. Myeloproliferative neoplasms, such as myelofibrosis and polycythemia vera, are often characterized by aberrant act...

Indication: Ruxolitinib is indicated for the treatment of the following conditions:

Topical ruxolitinib is indicated for:

Associated Conditions: Acute Graft-Versus-Host Disease (GVHD), Chronic Graft-Versus-Host Disease, Non-segmental Vitiligo, Post Polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis (Post-ET MF), Primary Myelofibrosis (PMF), High risk Myelofibrosis, Intermediate risk Myelofibrosis, Mild Atopic dermatitis, Moderate Atopic dermatitis, Refractory Polycythemia vera

Associated Therapies: -

Clinical Trials

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Phase 3

Recruiting

Conditions: Myelofibrosis

Interventions: Drug: Selinexor
Other: Placebo
Drug: Ruxolitinib

First Posted Date: 2020-09-24

Last Posted Date: 2024-07-24

Lead Sponsor: Karyopharm Therapeutics Inc

Target Recruit Count: 330

Registration Number: NCT04562389

Locations: 🇺🇸
UAB Division of Hematology/Oncology, Birmingham, Alabama, United States
🇺🇸
UCLA - Satellite Site, Encino, California, United States
🇺🇸
City of Hope, Duarte, California, United States

and more 130 locations

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

Phase 3

Terminated

Conditions: Myelofibrosis
Post Polycythemia Vera Myelofibrosis
Primary Myelofibrosis
Post Essential Thrombocythemia Myelofibrosis

Interventions: Drug: parsaclisib
Drug: placebo
Drug: ruxolitinib

First Posted Date: 2020-09-16

Last Posted Date: 2024-08-23

Lead Sponsor: Incyte Corporation

Target Recruit Count: 177

Registration Number: NCT04551053

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 167 locations

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

Phase 1

Active, not recruiting

Conditions: Hemophagocytic Lymphohistiocytosis

Interventions: Drug: Ruxolitinib
Drug: Dexamethasone
Drug: Etoposide

First Posted Date: 2020-09-16

Last Posted Date: 2024-08-28

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 62

Registration Number: NCT04551131

Locations: 🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
John Hopkins University, Baltimore, Maryland, United States
🇺🇸
Texas Children's Hospital, Houston, Texas, United States

and more 10 locations

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

Phase 3

Terminated

Conditions: Myelofibrosis
Post Polycythemia Vera Myelofibrosis
Primary Myelofibrosis
Post Essential Thrombocythemia Myelofibrosis

Interventions: Drug: parsaclisib
Drug: placebo
Drug: ruxolitinib

First Posted Date: 2020-09-16

Last Posted Date: 2024-12-19

Lead Sponsor: Incyte Corporation

Target Recruit Count: 252

Registration Number: NCT04551066

Locations: 🇺🇸
Kelsey Seybold Clinic, Houston, Texas, United States
🇧🇪
A.Z. St.-Jan A.V., Brugge, Belgium
🇺🇸
Oregon Health & Science University, Portland, Oregon, United States

and more 172 locations

Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia

Phase 2

Terminated

Conditions: Myelofibrosis
Thrombocytopenia

Interventions: Drug: Fostamatinib
Drug: Ruxolitinib

First Posted Date: 2020-09-10

Last Posted Date: 2023-12-15

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 3

Registration Number: NCT04543279

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

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

Phase 3

Completed

Conditions: Vitiligo

Interventions: Drug: ruxolitinib
Drug: Vehicle

First Posted Date: 2020-08-28

Last Posted Date: 2023-07-19

Lead Sponsor: Incyte Corporation

Target Recruit Count: 458

Registration Number: NCT04530344

Locations: 🇺🇸
First Oc Dermatology, Fountain Valley, California, United States
🇺🇸
Dermatology Research Associates, Los Angeles, California, United States
🇺🇸
Advanced Pharma, Miami, Florida, United States

and more 81 locations

Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica

Phase 2

Completed

Conditions: Necrobiosis Lipoidica

Interventions: Drug: Ruxolitinib

First Posted Date: 2020-07-30

Last Posted Date: 2023-02-08

Lead Sponsor: Aaron R. Mangold

Target Recruit Count: 12

Registration Number: NCT04492618

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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

Phase 1

Recruiting

Conditions: Myelofibrosis

Interventions: Drug: KRT-232
Drug: Ruxolitinib

First Posted Date: 2020-07-24

Last Posted Date: 2022-05-09

Lead Sponsor: Kartos Therapeutics, Inc.

Target Recruit Count: 36

Registration Number: NCT04485260

Locations: 🇫🇷
Institut Paoli-Calmettes, Marseille, France
🇵🇱
Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie, Kraków, Poland
🇵🇱
Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii, Opole, Poland

and more 35 locations

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

Phase 1

Terminated

Conditions: Myelofibrosis (MF)

Interventions: Drug: Mivebresib
Drug: Ruxolitinib
Drug: Navitoclax

First Posted Date: 2020-07-21

Last Posted Date: 2023-08-29

Lead Sponsor: AbbVie

Target Recruit Count: 1

Registration Number: NCT04480086

Locations: 🇺🇸
Stony Brook University Hospital /ID# 222653, Stony Brook, New York, United States
🇰🇷
Inje University Busan Paik Hospital /ID# 224043, Busan, Korea, Republic of
🇺🇸
UC Health - Cincinnati /ID# 224079, Cincinnati, Ohio, United States

and more 4 locations

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

Phase 3

Active, not recruiting

Conditions: Myelofibrosis (MF)

Interventions: Drug: Navitoclax
Drug: Placebo for Navitoclax
Drug: Ruxolitinib

First Posted Date: 2020-07-15

Last Posted Date: 2024-06-27

Lead Sponsor: AbbVie

Target Recruit Count: 252

Registration Number: NCT04472598

Locations: 🇨🇦
Lakeridge Health - Oshawa /ID# 222080, Oshawa, Ontario, Canada
🇺🇸
Indiana Blood & Marrow Transpl /ID# 221586, Indianapolis, Indiana, United States
🇺🇸
University of Texas MD Anderson Cancer Center /ID# 217994, Houston, Texas, United States

and more 191 locations

Drug Development Updates

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