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Omacetaxine mepesuccinate

Generic Name
Omacetaxine mepesuccinate
Brand Names
Synribo
Drug Type
Small Molecule
Chemical Formula
C29H39NO9
CAS Number
26833-87-4
Unique Ingredient Identifier
6FG8041S5B

Overview

Omacetaxine mepesuccinate (formerly known as HHT or Homoharringtonine), is a cephalotaxine ester and protein synthesis inhibitor with established clinical activity as a single agent in hematological malignancies. Omacetaxine mepesuccinate is synthesized from cephalotaxine, which is an extract from the leaves of the plant, Cephalotaxus species. In October 2005, omacetaxine mepesuccinate received Orphan Drug designation from the EMEA for the treatment of chronic myeloid leukemia (CML). Then in March 2006, it received Orphan Drug status from the FDA for the treatment of CML. In November 2006, omacetaxine mepesuccinate, for the treatment of CML, was granted Fast Track designation by the FDA. Most recently, in October 2012, omacetaxine mepesuccinate was marketed under the brand name Synribo and FDA approved for patients who are intolerant and/or resistant to two or more tyrosine kinase inhibitors used to treat accelerated or chronic phase CML.

Background

Omacetaxine mepesuccinate (formerly known as HHT or Homoharringtonine), is a cephalotaxine ester and protein synthesis inhibitor with established clinical activity as a single agent in hematological malignancies. Omacetaxine mepesuccinate is synthesized from cephalotaxine, which is an extract from the leaves of the plant, Cephalotaxus species. In October 2005, omacetaxine mepesuccinate received Orphan Drug designation from the EMEA for the treatment of chronic myeloid leukemia (CML). Then in March 2006, it received Orphan Drug status from the FDA for the treatment of CML. In November 2006, omacetaxine mepesuccinate, for the treatment of CML, was granted Fast Track designation by the FDA. Most recently, in October 2012, omacetaxine mepesuccinate was marketed under the brand name Synribo and FDA approved for patients who are intolerant and/or resistant to two or more tyrosine kinase inhibitors used to treat accelerated or chronic phase CML.

Indication

Used in patients who are intolerant and/or resistant to two or more tyrosine kinase inhibitors used to treat accelerated or chronic phase CML.

Associated Conditions

  • Refractory, accelerated phase Chronic myeloid leukemia
  • Refractory, chronic phase Chronic myeloid leukemia

Clinical Trials

Phase 2
Not yet recruiting
Posted: 2025/03/04
Phase 2
Recruiting
Posted: 2024/12/19
Sponsor:
First Affiliated Hos...

FDA Approved Products

SYNRIBO
Manufacturer:Cephalon, LLC
Route:SUBCUTANEOUS
Strength:3.5 mg in 1 mL
Approved: 2023/11/28
NDC:63459-177

Singapore Approved Products

No Singapore products found for this drug

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