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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.

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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/04
Phase 2
Not yet recruiting
2024/12/20
Phase 2
Recruiting
2024/12/19
Phase 2
Recruiting
First Affiliated Hospital of Zhejiang University
2024/07/03
Phase 2
Recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
2024/04/11
Phase 3
Recruiting
First Affiliated Hospital of Zhejiang University
2024/01/24
Phase 2
Recruiting
Children's Hospital of Soochow University
2023/04/07
Phase 2
Recruiting
The First Affiliated Hospital of Soochow University
2023/04/07
Not Applicable
Not yet recruiting
The First Affiliated Hospital of Soochow University
2023/02/13
Phase 3
Recruiting
2022/07/14
Phase 3
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Cephalon, LLC
63459-177
SUBCUTANEOUS
3.5 mg in 1 mL
11/28/2023

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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No TGA approvals found for this drug.

Health Canada Drug Approvals

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No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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