NDASUBCUTANEOUSPOWDER
Approved
Oct 2012
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
5
Data completeness
5/8 — Partial
SYNRIBO (omacetaxine mepesuccinate) by Teva. Approved for chronic myeloid leukemia, acute myeloid leukemia. First approved in 2012.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYNRIBO (omacetaxine mepesuccinate) is a subcutaneous powder formulation approved in 2012 for chronic myeloid leukemia and other hematologic malignancies. It functions as a protein synthesis inhibitor targeting leukemic cell lines resistant to tyrosine kinase inhibitors. The drug addresses a niche population with limited treatment options after standard therapies fail.
$1MPart D
LOE Approaching6mo to LOEMinimal commercial footprint with near-term LOE in October 2026 signals a wind-down phase requiring transition planning for brand teams.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (2)
Clinical Trials (5)
Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Started Jul 2014
2 enrolled
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeAdult Acute Megakaryoblastic Leukemia (M7)Adult Acute Minimally Differentiated Myeloid Leukemia (M0)+14 more
An Open-Label Study to Investigate the Pharmacokinetics of Omacetaxine Mepesuccinate
Started Jul 2013
6 enrolled
Hematologic MalignanciesSolid Tumors
Pharmacokinetic (PK) Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients With Advanced Solid and Hematologic Tumors
Started Apr 2008
12 enrolled
Hematologic Tumors
Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML
Started Mar 2007
100 enrolled
Chronic Myeloid Leukemia
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
Started Sep 2006
103 enrolled
Chronic Myeloid Leukemia
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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.