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 19h 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 myeloproliferative neoplasms and other JAK-driven diseases. It works by selectively inhibiting JAK1 and JAK2 kinases, blocking inflammatory and proliferative signaling pathways. The drug represents a foundational kinase inhibitor class with broad applicability across hematologic and inflammatory conditions.
$1.9BPart D
LOE ApproachingStable
2.2 years to LOEProduct approaching loss of exclusivity by late 2028 with substantial Part D volume (116K claims); brand teams should prepare transition strategies and defensive initiatives against competitive kinase inhibitors.
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)
Belumosudil Versus Ruxolitinib for Steroid-Refractory or Breakthrough Hepatic cGVHD
Started Oct 2026
170 enrolled
Hematopoietic Stem Cell Transplantation (HSCT)cGVHDHepatic cGVHD+2 more
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Started Sep 2026
324 enrolled
MyelofibrosisAnemia
Topical Ruxolitinib in the Treatment of Adults With Pyoderma Gangrenosum
Started Sep 2026
12 enrolled
Pyoderma Gangrenosum
Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
Started Aug 2026
268 enrolled
MyelofibrosisMyelofibrosis (MF)
Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)
Started Aug 2026
15 enrolled
Myelofibrosis
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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.