Omacetaxine mepesuccinate
Synribo (omacetaxine mepesuccinate) is a small molecule pharmaceutical. Omacetaxine mepesuccinate was first approved as Synribo on 2012-10-26.
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Therapeutic Areas
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Trade Name
FDA
EMA
Synribo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Omacetaxine mepesuccinate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYNRIBO | Teva | N-203585 RX | 2012-10-26 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| synribo | New Drug Application | 2021-10-18 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Omacetaxine Mepesuccinate, Synribo, Teva Pharms Intl | |||
| 6987103 | 2026-10-26 | U-1300 | |
HCPCS
Code | Description |
|---|---|
| J9262 | Injection, omacetaxine mepesuccinate, 0.01 mg |
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | 6 | — | — | — | 6 | |
| Myeloid leukemia chronic-phase | D015466 | — | 4 | — | — | — | 4 | ||
| Myelodysplastic syndromes | D009190 | D46 | 1 | 2 | — | — | — | 2 | |
| Megakaryoblastic leukemia acute | D007947 | C94.2 | — | 1 | — | — | — | 1 | |
| Monocytic leukemia acute | D007948 | — | 1 | — | — | — | 1 | ||
| Myelomonocytic leukemia acute | D015479 | C92.5 | — | 1 | — | — | — | 1 | |
| Myeloid leukemia | D007951 | C92 | — | 1 | — | — | — | 1 | |
| Erythroblastic leukemia acute | D004915 | EFO_1001257 | C94.0 | — | 1 | — | — | — | 1 |
| Myeloid leukemia accelerated phase | D015465 | — | 1 | — | — | — | 1 | ||
| Blast crisis | D001752 | — | 1 | — | — | — | 1 |
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OMACETAXINE MEPESUCCINATE |
| INN | omacetaxine mepesuccinate |
| Description | Omacetaxine mepesuccinate is a cephalotaxine-derived alkaloid ester obtained from Cephalotaxus harringtonia; used for the treatment of chronic or accelerated phase chronic myeloid leukaemia. It has a role as an antineoplastic agent, a protein synthesis inhibitor, an apoptosis inducer and an anticoronaviral agent. It is an alkaloid ester, a tertiary alcohol, an organic heteropentacyclic compound and an enol ether. It is functionally related to a cephalotaxine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)C[C@](O)(CCCC(C)(C)O)C(=O)O[C@@H]1C(OC)=C[C@]23CCCN2CCc2cc4c(cc2[C@H]13)OCO4 |
Identifiers
| PDB | — |
| CAS-ID | 26833-87-4 |
| RxCUI | 27100 |
| ChEMBL ID | CHEMBL46286 |
| ChEBI ID | 71019 |
| PubChem CID | 285033 |
| DrugBank | DB04865 |
| UNII ID | 6FG8041S5B (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 415 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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653 adverse events reported
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