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 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JAKAFI (ruxolitinib) is an oral Janus Kinase (JAK) inhibitor approved in 2011 for hematologic malignancies and inflammatory conditions. It works by selectively inhibiting JAK1 and JAK2 signaling pathways to reduce abnormal cell proliferation and inflammatory responses. The drug represents a foundational kinase inhibitor class with broad mechanistic applicability across multiple disease areas.
$1.9BPart D
LOE Approaching2.5 years to LOEMature revenue base nearing patent expiration (2028) signals transition from growth to defense mode, with smaller specialized teams focused on lifecycle extension and label retention.
Mechanism 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)
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Started Aug 2026
324 enrolled
MyelofibrosisAnemia
Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
Started Aug 2026
268 enrolled
MyelofibrosisMyelofibrosis (MF)
Ruxolitinib-Enhanced Haplo HCT for Children and Young Adults With Sickle Cell Disease
Started Jun 2026
24 enrolled
Sickle Cell DiseaseHematopoetic Stem Cell TransplantHaploidentical Hematopoietic Stem Cell Transplant+2 more
Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)
Started Jun 2026
16 enrolled
Immune Effector Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS)
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
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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.