SYNRIBO (omacetaxine mepesuccinate)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2012-10-26
- Patent Cliff
- 2026
- Routes
- SUBCUTANEOUS
- Dosage Forms
- POWDER
SYNRIBO Approval History
What SYNRIBO Treats
2 FDA approvalsOriginally approved for its first indication in 2012 . Covers 2 distinct patient populations.
- Other (2)
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04874194 results posted | 2020-0890 NCI-2021-03341, 2020-0890 | Ph 1, Ph 2 | terminated | Omacetaxine and Venetoclax for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1 |
| NCT02078960 results posted | C41443/2057 2013-005320-42 | Ph 1, Ph 2 | terminated | A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study) |
| NCT02440568 results posted | 2015-0181 2015-0181 | Ph 1, Ph 2 | terminated | AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients |
| NCT02029417 results posted | I 245213 NCI-2013-02425, I 245213 | Ph 2 | terminated | Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT01844869 | C41443/1103 Study 2012-004003-12 | Ph 1 | completed | An Open-Label Study to Investigate the Pharmacokinetics of Omacetaxine Mepesuccinate |
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.
SYNRIBO FDA Label Details
SYNRIBO Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for SYNRIBO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 1 active patents
Trial Analysis
- • 8 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment