OJJAARA
OJJAARA (momelotinib) is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis in adult patients. The approval encompasses primary myelofibrosis and secondary forms, specifically post-polycythemia vera and post-essential thrombocythemia. This medication is specifically indicated for patients who also present with anemia. It serves as a therapeutic option for managing the constitutive activation and dysregulated signaling characteristic of these myeloproliferative neoplasms.
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
- 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 Competitors
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Competitors share the same molecular target (JAK1). Earlier expiry dates signal biosimilar/generic opportunities.
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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
ProIndications & Usage
FDA Label (PDF)OJJAARA is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia. OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.
OJJAARA Patents & Exclusivity
Patents (36 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.