NDAORALTABLETPriority Review
Approved
Nov 2011
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
JAKAFI (ruxolitinib) by Incyte is janus kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2011.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JAKAFI (ruxolitinib) is an oral small-molecule Janus Kinase (JAK) inhibitor approved by the FDA in November 2011. It is indicated for myeloproliferative neoplasms and other kinase-driven hematologic conditions. The drug works by inhibiting JAK signaling pathways that drive abnormal cell proliferation. JAKAFI established the JAK inhibitor class as a foundational therapy in hematology-oncology.
$1.9BPart D
2.6 years to LOEMechanism of Action
Janus Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
Started Aug 2026
268 enrolled
MyelofibrosisMyelofibrosis (MF)
Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Started Jun 2026
39 enrolled
Castration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
Started Jun 2026
124 enrolled
LeukemiaMyelodysplasiaChronic Myelomonocytic Leukemia
Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation
Started May 2026
40 enrolled
Acute Myeloid Leukemia
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Started May 2026
460 enrolled
Primary Myelofibrosis (PMF)Post-polycythemia Vera Myelofibrosis (PPV-MF)Post-essential Thrombocythemia Myelofibrosis (PET-MF)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.