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Omacetaxine Mepesuccinate · Synribo, CGX-635

Small molecule · Inhibitor of 80S ribosome · developed by Teva Pharms Intl

Approved FDA, Oct 2012
TEVA Developer
4 Registered trials

What is Omacetaxine Mepesuccinate?

Omacetaxine mepesuccinate is a semisynthetic plant alkaloid that binds the ribosome and inhibits protein synthesis, reducing levels of oncoproteins including Bcr-Abl and anti-apoptotic proteins.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Synribo, CGX-635, NSC-141633, homoharringtonine
Drug type
Small molecule
Targets
80S ribosome, Bcr-Abl (BCR) (secondary target)
Mechanism
Inhibitor of 80S ribosome
Pathways
protein synthesis inhibition, apoptosis
Therapy area
Hematology, Oncology
Developer
Teva Pharms Intl (TEVA)
Also in trials of
AAPG
FDA status
Approved as Synribo (October 26, 2012), NDA203585 · FDA label
UNII
6FG8041S5B

✅ FDA-approved uses

From the indications section of the FDA label (version of Sep 30, 2022). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT04501120 Phase 1/2 Relapsed/Refractory Acute Myeloid Leukaemia Recruiting AAPG
NCT04126681 Phase 2 Chronic Myeloid Leukemia, Chronic Phase Completed AAPG
NCT02835794 Phase 1/2 Myelodysplastic Syndromes Withdrawn TEVA
NCT02029417 Phase 2 Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic… Terminated TEVA

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Myeloid MalignancyRelapsed/Refractory Acute Myeloid LeukaemiaAdult Acute Megakaryoblastic Leukemia (M7)Adult Acute Minimally Differentiated Myeloid Leukemia (M0)Adult Acute Monoblastic Leukemia (M5a)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Acute Myelomonocytic Leukemia (M4)

More from Teva Pharms Intl

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the TEVA page.

Follow TEVA, the company behind Omacetaxine Mepesuccinate

See TEVA's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.