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ruxolitinib

Generic: RUXOLITINIB PHOSPHATE·Brand: JAKAFI, Jakafi, OPZELURA

ruxolitinib: developed by 1 company · 126 clinical trials tracked · 2 FDA decisions.

ruxolitinib evidence translation

What we can confirm

2 FDA records · 126 tracked trials

What it means

Source-backed records connect ruxolitinib to INCY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could ruxolitinib → INCY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 9 study sponsors
Development Pipeline (1)
CompanyPhase
Incyte Corp. (INCY)Approved
Clinical Trials (126)showing 10 most recent

Ruxolitinib for Chuvash Polycythemia

Expanded Access1 site · United StatesWashington University School of Medicine

Phase Ib/II Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis

NCT07734077·Phase 1/Phase 2
Not yet recruiting

Primary endpoint: Dose limiting toxicity (DLT)

Interventionalopen32 targetStarted 2026-12Completion 2028-121 site · United StatesJohn Mascarenhas

A Phase 2/3, Randomized, Open-label, Active-comparator-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543) Versus Best Available Therapy in Participants With Polycythemia Vera Who Have an Inadequate Response to or Are Intolerant to Hydroxyurea

NCT07722611·Phase 2/Phase 3
Not yet recruiting

Primary endpoint: Clinicohematologic Response (CHR) Rate

InterventionalRandomizedopen380 targetStarted 2026-09Completion 2032-11Merck Sharp & Dohme LLC

Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)

NCT07424222·Phase 1
Recruiting

Primary endpoint: Number of Participants with Clinical Response

Interventionalopen16 targetStarted 2026-07Completion 2029-021 site · United StatesSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Phase 2 Study of Belumosudil Combined With Ruxolitinib as Second Line Therapy to Treat Chronic Graft Versus Host Disease (cGvHD) After Steroid Failure (BELRUX)

NCT07643025·Phase 2
Not yet recruiting

Primary endpoint: Efficacy will be assessed using overall response rate (ORR) as per the NIH cGvHD Consensus Response Criteria at 24 weeks of combination treatment. Tolerability and safety will be assessed by the incidence and severity of adverse events (AEs)

Interventionalopen63 targetStarted 2026-07Completion 2030-071 site · CanadaDennis Kim

A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive

NCT07357727·Phase 3·NVS
Recruiting

Primary endpoint: Number of Participants with Splenic Response (SVR35) by Central Radiology Reads at Week 24 in participants with baseline total symptom score (TSS) ≥ 25

InterventionalRandomizedquadruple460 targetStarted 2026-06Completion 2030-1250 sites · Argentina, Australia, China, India…Novartis Pharmaceuticals

Ruxolitinib-Enhanced Conditioning for Pediatric and Young Adult Patients With Symptomatic Sickle Cell Disease Undergoing Haploidentical Hematopoietic Cell Transplantation

NCT07252050·Phase 1/Phase 2
Recruiting

Primary endpoint: Event Free Survival

Interventionalopen24 targetStarted 2026-06Completion 2029-114 sites · United StatesArkansas Children's Hospital Research Institute

An Open Label, Non-Randomized, Multi-Center Pilot Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for GVHD Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation

NCT07249346·Phase 2
Recruiting

Primary endpoint: Severe acute GVHD-free Survival (SGFS)

Interventionalopen124 targetStarted 2026-06Completion 2027-061 site · United StatesHannah Choe, MD

Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer

NCT06616155·Phase 1/Phase 2
Recruiting

Primary endpoint: Dose-limiting toxicity (DLT)

Interventionalopen20 targetStarted 2026-06Completion 2030-063 sites · United StatesUniversity of Michigan Rogel Cancer Center

An Open-Label, Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants

NCT07588139·Phase 1·INCY
Recruiting

Primary endpoint: Pharmacokinetics Parameter (PK): Cmax of dermal interstitial fluid (dISF) ruxolitinib

Interventionalopen24 targetStarted 2026-05Completion 2026-091 site · United StatesIncyte Corporation
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ( 1.1 ) the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. ( 1.2(INCY)FDA ↗
NDA215309Type 10 - New Indication Submitted as Distinct NDA - Not ConsolidatedPriorityTopicalCream
Approval1 INDICATIONS AND USAGE JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. ( 1.3 ) chronic g(INCY)FDA ↗
NDA202192Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet

Frequently asked questions

Who is developing ruxolitinib?

ruxolitinib is being developed by Incyte Corp..

How many clinical trials involve ruxolitinib?

BioSniper tracks 126 clinical trials involving ruxolitinib.

What is ruxolitinib's latest FDA decision?

The most recent tracked FDA decision for ruxolitinib is Approval for 1 INDICATIONS AND USAGE OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ( 1.1 ) the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. ( 1.2, dated September 21, 2021.