Wednesday, July 8, 2026

Drug profile · INN

omacetaxine mepesuccinate

omacetaxine mepesuccinate (TEKINEX) is a protein synthesis inhibitor. Associated with Teva Pharma GmbH. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: application withdrawn Antineoplastic and immunomodulating agents (L01) L01XX40
US status approved
Patents linked 0
Pipeline programs 10
News articles 0
Drug details — omacetaxine mepesuccinate
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
SUBCUTANEOUS
Patents
0
Programs
10
Data quality
0.89

Quick answer

omacetaxine mepesuccinate (TEKINEX) is a protein synthesis inhibitor. Associated with Teva Pharma GmbH. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN omacetaxine mepesuccinate
Brand TEKINEX
Mechanism Protein synthesis inhibitor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route SUBCUTANEOUS
Formulation POWDER
ATC code L01XX40

Mechanism of action

Protein synthesis inhibitor

Approval history

Authority Status Date
FDA approved
EMA application withdrawn

Pipeline programs

  1. MEP Phase 3 · Chinese Academy of · Nasopharyngeal Carcinoma
  2. C4921003 Phase 2 · First Biotech (Australia) · Heart failure
  3. Omacetaxine Phase 2 · Teva Pharma · Myelodysplastic Syndromes
  4. Omacetaxine Phase 2 · Teva Pharma · Acute Myelogenous Leukemia (AML)
  5. Omacetaxine Phase 2 · Teva Pharma · Leukemia
  6. Omacetaxine mepesuccinate Phase 2 · Teva Pharma · Chronic Myeloid Leukemia
  7. C5671001 Phase 1 · First Biotech (Australia) · CCI
  8. Omacetaxine Phase 1 · Teva Pharma · Hematologic Tumors

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is omacetaxine mepesuccinate?

omacetaxine mepesuccinate (TEKINEX) is a protein synthesis inhibitor. Associated with Teva Pharma GmbH. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for omacetaxine mepesuccinate?

TEKINEX is a marketed brand name for omacetaxine mepesuccinate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of omacetaxine mepesuccinate?

omacetaxine mepesuccinate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.