OJJAARA (momelotinib dihydrochloride)
OJJAARA is indicated for the treatment of Myelofibrosis; Anemia.
How OJJAARA Works
Momelotinib and its primary metabolite inhibit Janus Kinase 1 and 2 (JAK1/JAK2), including the mutant JAK2 V617F, which are involved in hematopoiesis and immune function signaling. The drug also inhibits activin A receptor type 1 (ACVR1), which is often hyperactivated in myelofibrosis. By inhibiting ACVR1, the medication reduces liver hepcidin expression and increases iron availability to promote red blood cell production. These actions collectively block the recruitment and activation of STAT proteins, thereby regulating gene transcription and reducing the inflammation associated with the disease.
Details
- Status
- Prescription
- First Approved
- 2023-09-15
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- TABLET
OJJAARA Approval History
What OJJAARA Treats
2 indicationsOJJAARA is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myelofibrosis
- Anemia
OJJAARA Target & Pathway
ProTarget
A member of the JAK family involved in signaling for interferons and several interleukins. JAK1 inhibition is effective in rheumatoid arthritis, atopic dermatitis, and other inflammatory conditions by blocking multiple cytokine pathways.
OJJAARA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to OJJAARA
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OJJAARA FDA Label Details
Indications & Usage
FDA Label (PDF)OJJAARA is indicated for the treatment of Myelofibrosis; Anemia.
OJJAARA Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for OJJAARA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 45 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 13 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.