Synribo

(omacetaxine mepesuccinate)

Small molecule

Teva

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Chronic Myelogenous Leukemia4 trials

Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00003694·60 enrolled

Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00002574·87 enrolled

Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00003239·90 enrolled

Show 1 more trial

Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00006364·50 enrolled

Myeloid Leukemia2 trials

Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation

Completed· Teva logo

Teva·Phase 2·NCT00375219·103 enrolled

A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study)

Terminated· Teva logo

Teva·Phase 1/2·NCT02078960·10 enrolled

MACE2 trials

Combination of Quizartinib and Omacetaxine Mepesuccinate for AML Carrying FLT3-ITD

Unknown status·TThe University of Hong Kong·Phase 2·NCT03135054·40 enrolled

AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients

Terminated·UUniversity of Illinois at Chicago·Phase 1/2·NCT02440568·22 enrolled

Advanced1 trial

Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML

Completed· Teva logo

Teva·Phase 2·NCT00462943·100 enrolled

Tics1 trial

An Open-Label Study to Investigate the Pharmacokinetics of Omacetaxine Mepesuccinate

Completed· Teva logo

Teva·Phase 1·NCT01844869·6 enrolled

3 more indications

Acute Myeloid Leukemia1 trial

Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Terminated·RRoswell Park Cancer Institute·Phase 2·NCT02029417·2 enrolled

Relapsed/Refractory AML1 trial

Combination of Sorafenib and Omacetaxine Mepesuccinate in Newly Diagnosed or Relapsed/Refractory AML Carrying FLT3-ITD

Completed·TThe University of Hong Kong·Phase 2·NCT03170895·5 enrolled

Myelodysplastic Syndrome1 trial

Omacetaxine and Venetoclax for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT04874194·24 enrolled

Regulatory

FDA Approval Timeline[3]

Oct 26, 2012

SYNRIBO

NDA NDA203585

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for omacetaxine mepesuccinate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — omacetaxine mepesuccinate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA203585). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Synribo. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: Teva

Patent Landscape[4]

Patent Cliff

Oct 26, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

6987103Oct 26, 2026

Synribo

Trials by Indication[1]

Chronic Myelogenous Leukemia4 trials

Myeloid Leukemia2 trials

MACE2 trials

Advanced1 trial

Tics1 trial

Acute Myeloid Leukemia1 trial

Relapsed/Refractory AML1 trial

Myelodysplastic Syndrome1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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