Synribo

(omacetaxine mepesuccinate)

Phase 2Small molecule

Teva

Synribo is one of 137 small molecule programs targeting Chronic Myelogenous Leukemia. It is currently in Phase 2.

Indications

Total Trials

Active Trials

136

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Chronic Myelogenous LeukemiaActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Myeloid LeukemiaActive, not recruiting

Chronic Myelogenous LeukemiaPhase 2

Active, not recruiting

Myelodysplastic SyndromePhase 1/Phase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Active, not recruiting

Myeloid LeukemiaPhase 1/Phase 2

Active, not recruiting

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Rydapt

Novartis

Phase 3

17 2

Fludara

Sanofi

Phase 3

15 3

Busulfex

Akero Therapeutics

Phase 3

22 4

Empaveli

Gilead

Phase 3

4 5

Intron a

Sanofi

Phase 3

1 6

Tibsovo

SServier

Phase 3

8 7

Retin-a

VValeant Pharmaceuticals

Phase 3

2 8

Lenograstim

Sanofi

Phase 3

1 9

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Phase 3

1 10

Homoharringtonine

Ascentage Pharma Group Inc.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Chronic Myelogenous Leukemia4 trials

Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

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

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

Show 1 more trial

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

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

MACE2 trials

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

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

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

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

Advanced1 trial

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

Completed· Teva logo

Teva·Phase 2·NCT00462943·100 enrolled

3 more indications

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

Tics1 trial

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

Completed· Teva logo

Teva·Phase 1·NCT01844869·6 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

Regulatory

FDA Approval Timeline[4]

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]
Open Targets Platform — Drug–disease associations for omacetaxine mepesuccinate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203585). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Synribo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Teva

Patent Landscape[5]

Patent Cliff

Oct 26, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

6987103Oct 26, 2026

Synribo

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Chronic Myelogenous Leukemia4 trials

MACE2 trials

Myeloid Leukemia2 trials

Acute Myeloid Leukemia1 trial

Advanced1 trial

Myelodysplastic Syndrome1 trial

Tics1 trial

Relapsed/Refractory AML1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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