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Jakafi (RUXOLITINIB)
Jakafi (Ruxolitinib) is a Janus Kinase Inhibitor developed by Incyte Corp, targeting the Tyrosine-protein kinase JAK2. It is a small molecule modality approved by the FDA in 2011 for various myeloproliferative disorders, graft-versus-host disease, and other conditions. Jakafi is a patented medication with no generic manufacturers available. Key safety considerations include the risk of anemia, thrombocytopenia, and neutropenia. Jakafi's commercial status remains unchanged as it is still under patent.
At a glance
| Generic name | RUXOLITINIB |
|---|---|
| Sponsor | Incyte Corp |
| Target | Ankyrin repeat and protein kinase domain-containing protein 1, Bone morphogenetic protein receptor type-1B, Calcium/calmodulin-dependent protein kinase type IV |
| Modality | Small molecule |
| Therapeutic area | Bone |
| Phase | FDA-approved |
| First approval | 2011 |
| Annual revenue | 2600 |
Approved indications
- Acute graft-versus-host disease
- Chronic graft-versus-host disease
- Myelofibrosis
- Myeloproliferative disorder
- Polycythemia vera
- Splenomegaly
- Vitiligo
Common side effects
- Subjects with any TEAE
- Nasopharyngitis
- Bronchitis
- Ear infection
- Eosinophil count increased
- Urticaria
- Diarrhea
- Folliculitis
- Tonsillitis
- Rhinorrhea
- Neutropenia
- Allergic conjunctivitis
Key clinical trials
- Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts (PHASE4)
- Ruxolitinib + Allogeneic Stem Cell Transplantation in AML (PHASE2)
- A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma (PHASE1)
- A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms (PHASE1)
- Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids (PHASE1, PHASE2)
- Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (PHASE1)
- MAGIC Ruxolitinib for aGVHD (PHASE2)
- 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 (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Jakafi CI brief — competitive landscape report
- Jakafi updates RSS · CI watch RSS