{"id":"omacetaxine-mepesuccinate","rwe":[{"pmid":"41140451","year":"2025","title":"Omacetaxine and azacitidine for untreated patients with myelodysplastic syndromes and excess blasts: a phase I/II clinical trial.","finding":"","journal":"EClinicalMedicine","studyType":"Clinical Study"},{"pmid":"40979071","year":"2025","title":"Omacetaxine and venetoclax in relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with mutant RUNX1.","finding":"","journal":"Blood neoplasia","studyType":"Clinical Study"},{"pmid":"40293443","year":"2025","title":"Molecular mechanisms of radiation resistance in colorectal cancer: in silico identification of AURKA, BIRC5 and PLK1 proteins as potential biomarkers.","finding":"","journal":"International journal of radiation biology","studyType":"Clinical Study"},{"pmid":"40184838","year":"2025","title":"Homoharringtonine (omacetaxine mepesuccinate) limits the angiogenic capacity of endothelial cells and reorganises filamentous actin.","finding":"","journal":"Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie","studyType":"Clinical Study"},{"pmid":"39770529","year":"2024","title":"A Repurposed Drug Selection Pipeline to Identify CNS-Penetrant Drug Candidates for Glioblastoma.","finding":"","journal":"Pharmaceuticals (Basel, Switzerland)","studyType":"Clinical Study"}],"tags":[{"label":"omacetaxine mepesuccinate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"L01XX40","category":"atc"},{"label":"Subcutaneous","category":"route"},{"label":"Injection","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Chronic myeloid leukemia","category":"indication"},{"label":"Teva Pharms Intl","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antineoplastic Agents, Phytogenic","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Protein Synthesis Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":153.09,"date":"","count":46,"signal":"Myelosuppression","source":"DrugCentral FAERS","actionTaken":"Reported 46 times (LLR=153)"},{"llr":104.629,"date":"","count":55,"signal":"Platelet count decreased","source":"DrugCentral FAERS","actionTaken":"Reported 55 times (LLR=105)"},{"llr":92.58,"date":"","count":34,"signal":"Bone marrow failure","source":"DrugCentral FAERS","actionTaken":"Reported 34 times (LLR=93)"},{"llr":90.959,"date":"","count":38,"signal":"Injection site erythema","source":"DrugCentral FAERS","actionTaken":"Reported 38 times (LLR=91)"},{"llr":78.376,"date":"","count":89,"signal":"Nausea","source":"DrugCentral FAERS","actionTaken":"Reported 89 times (LLR=78)"},{"llr":60.954,"date":"","count":24,"signal":"Full blood count abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=61)"},{"llr":52.555,"date":"","count":35,"signal":"White blood cell count decreased","source":"DrugCentral FAERS","actionTaken":"Reported 35 times (LLR=53)"}],"commonSideEffects":[],"specialPopulations":{"Pregnancy":"Based on its mechanism of action and findings from animal studies, SYNRIBO can cause fetal harm when administered to pregnant women. In animal reproduction studies, subcutaneous administration of omacetaxine mepesuccinate to pregnant mice during organogenesis at doses approximately 0.25 to 0.5 times the maximum recommended human doses (MRHD) resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth (see Data). There are no available data on SYNRIBO use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risk to fetus [see Warnings and Precautions (5.4)]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively.","Geriatric use":"In the chronic and accelerated phase CML efficacy populations 23 (30%) and 16 (46%) patients were >=65 years of age. For the age subgroups of <65 years of age and >=65 years of age, there were differences between the subgroups, with higher rates of major cytogenetic responses (MCyRs) in younger patients with CP CML compared with older patients (23% vs. 9%, respectively) and higher rates of major hematologic responses (MaHRs) in older patients with AP CML compared with younger patients (46% vs. 30%, respectively).","Paediatric use":"The safety and effectiveness of SYNRIBO in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Teva Pharms Intl","patents":[{"applNo":"N203585","source":"FDA Orange Book","status":"Active","expires":"Oct 26, 2026","useCode":"U-1300","territory":"US","drugProduct":false,"patentNumber":"6987103","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=OMACETAXINE 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(EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:07:55.909555+00:00"}},"allNames":"synribo","offLabel":[],"synonyms":["omacetaxine mepesuccinate","synribo","homoharringtonine","CGX-635","NSC 141633","NSC-141633"],"timeline":[{"date":"2012-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from IVAX INTL to Teva Pharms Intl"},{"date":"2012-10-26","type":"positive","source":"DrugCentral","milestone":"FDA approval (Ivax Intl)"}],"brandName":"Synribo","ecosystem":[{"indication":"Chronic myeloid leukemia","otherDrugs":[{"name":"cyclophosphamide","slug":"cyclophosphamide","company":"Baxter Hlthcare"},{"name":"hydroxycarbamide","slug":"hydroxycarbamide","company":"Bristol Myers Squibb"},{"name":"mechlorethamine","slug":"mechlorethamine","company":"Recordati Rare"},{"name":"ponatinib","slug":"ponatinib","company":"Ariad"}],"globalPrevalence":480000}],"mechanism":{"novelty":"Follow-on","modality":"Small 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