{"id":"mobocertinib","rwe":[{"pmid":"41903301","year":"2026","title":"Phase Ia/Ib trial of the safety and efficacy of mobocertinib in combination with T-DM1 for patients with HER2-mutant solid tumors (WJOG16022M).","finding":"","journal":"European journal of cancer (Oxford, England : 1990)","studyType":"Clinical Study"},{"pmid":"41732005","year":"2026","title":"Sunvozertinib A Next-Generation EGFR Exon 20 Insertion Inhibitor Transforming NSCLC Therapy.","finding":"","journal":"Zhongguo ying yong sheng li xue za zhi = Zhongguo yingyong shenglixue zazhi = Chinese journal of applied physiology","studyType":"Clinical Study"},{"pmid":"41694159","year":"2025","title":"Evolving treatment strategies for EGFRex20ins-mutated NSCLC: a comprehensive review of Amivantamab's role and future directions.","finding":"","journal":"Ecancermedicalscience","studyType":"Clinical Study"},{"pmid":"41487495","year":"2025","title":"Efficacy and safety of later-line targeted therapies in advanced non-small cell lung cancer with EGFR exon 20 insertion mutations: a systematic review.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"},{"pmid":"41401466","year":"2025","title":"Comparing the effect of traditional and novel tyrosine kinase inhibitors for epidermal growth factor receptor exon 20 insertions by molecular dynamics simulation.","finding":"","journal":"The Journal of international medical research","studyType":"Clinical Study"}],"tags":[{"label":"Kinase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Receptor tyrosine-protein kinase erbB-4","category":"target"},{"label":"ERBB4","category":"gene"},{"label":"BLK","category":"gene"},{"label":"ERBB2","category":"gene"},{"label":"L01EB10","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Active","category":"status"},{"label":"Advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations","category":"indication"},{"label":"Takeda Pharms Usa","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":180.981,"date":"","count":126,"signal":"Diarrhoea","source":"DrugCentral FAERS","actionTaken":"Reported 126 times (LLR=181)"},{"llr":59.878,"date":"","count":32,"signal":"Malignant neoplasm progression","source":"DrugCentral FAERS","actionTaken":"Reported 32 times (LLR=60)"},{"llr":50.683,"date":"","count":16,"signal":"Metastases to central nervous system","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=51)"},{"llr":47.743,"date":"","count":39,"signal":"Decreased appetite","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=48)"}],"commonSideEffects":[],"specialPopulations":{"Lactation":"There are no data on the presence of mobocertinib or its metabolites in human milk or their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with EXKIVITY and for week after the last dose.","Pregnancy":"EXKIVITY can cause fetal harm when administered to pregnant woman. There are no available data on EXKIVITY use in pregnant women. Oral administration of mobocertinib to pregnant rats during the period of organogenesis resulted in embryolethality (embryo-fetal death) and maternal toxicity at plasma exposures approximately 1.7 times the human exposure based on AUC at the 160 mg once daily clinical dose. Advise pregnant women of the potential risk to fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.","Geriatric use":"Of the 114 patients who received EXKIVITY in clinical studies, 37% were 65 years and over, and 7% were 75 years and over. No overall difference in effectiveness was observed between patients aged 65 and older and younger patients. Exploratory analysis suggests higher incidence of Grade and adverse reactions (69% vs 47%) and serious adverse reactions (64% vs 35%) in patients 65 years and older as compared to those younger than 65 years.","Paediatric use":"The safety and effectiveness of EXKIVITY in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Takeda","patents":[{"applNo":"N215310","source":"FDA Orange Book","status":"Active","expires":"May 13, 2035","useCode":"U-3220","territory":"US","drugProduct":true,"patentNumber":"10227342","drugSubstance":true},{"applNo":"N215310","source":"FDA Orange Book","status":"Active","expires":"May 13, 2035","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9796712","drugSubstance":true}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MOBOCERTINIB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:41:57.601529+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:41:56.092498+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Mobocertinib","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:42:04.047178+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:42:02.689241+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Epidermal growth factor receptor erbB1 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:42:04.047114+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4650319/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:42:03.695066+00:00"}},"allNames":"exkivity","offLabel":[],"synonyms":["mobocertinib","mobocertinib succinate","exkivity","TAK-788","AP32788"],"timeline":[{"date":"2021-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from TAKEDA PHARMS USA to Takeda Pharms Usa"},{"date":"2021-09-15","type":"positive","source":"DrugCentral","milestone":"FDA approval (Takeda Pharms Usa)"},{"date":"2026-09-15","type":"negative","source":"FDA Orange Book","milestone":"New Chemical Entity exclusivity expires"},{"date":"2028-09-15","type":"negative","source":"FDA Orange Book","milestone":"ODE-374 exclusivity expires"},{"date":"2035-05-13","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 10227342 expires"}],"approvals":[{"date":"2021-09-15","orphan":true,"company":"TAKEDA PHARMS USA","regulator":"FDA"}],"brandName":"Exkivity","ecosystem":[{"indication":"Advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations","otherDrugs":[{"name":"amivantamab","slug":"amivantamab","company":"Janssen Biotech"}],"globalPrevalence":2200000}],"mechanism":{"target":"Receptor tyrosine-protein kinase erbB-4","novelty":"Follow-on","targets":[{"gene":"ERBB4","source":"DrugCentral","target":"Receptor tyrosine-protein kinase erbB-4","protein":"Receptor tyrosine-protein kinase erbB-4"},{"gene":"BLK","source":"DrugCentral","target":"Tyrosine-protein kinase Blk","protein":"Tyrosine-protein kinase Blk"},{"gene":"ERBB2","source":"DrugCentral","target":"Receptor tyrosine-protein kinase erbB-2","protein":"Receptor tyrosine-protein kinase erbB-2"},{"gene":"JAK3","source":"DrugCentral","target":"Tyrosine-protein kinase JAK3","protein":"Tyrosine-protein kinase JAK3"},{"gene":"TXK","source":"DrugCentral","target":"Tyrosine-protein kinase TXK","protein":"Tyrosine-protein kinase TXK"},{"gene":"BTK","source":"DrugCentral","target":"Tyrosine-protein kinase BTK","protein":"Tyrosine-protein kinase BTK"},{"gene":"EGFR","source":"DrugCentral","target":"Epidermal growth factor receptor","protein":"Epidermal growth factor receptor"}],"moaClass":"Cytochrome P450 3A Inducers","modality":"Small Molecule","drugClass":"Kinase Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Exkivity (mobocertinib) is a selective inhibitor of the epidermal growth factor receptor (EGFR) with a focus on EGFR exon 20 insertion mutations, which are a common cause of resistance to other EGFR inhibitors. By binding to the ATP-binding site of the EGFR kinase domain, Exkivity prevents the phosphorylation of downstream signaling proteins, ultimately inhibiting tumor growth and proliferation."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Mobocertinib","title":"Mobocertinib","extract":"Mobocertinib, sold under the brand name Exkivity, is used for the treatment of non-small cell lung cancer.","wiki_history":"== History ==\nMobocertinib was studied in participants with previously treated metastatic non-small cell lung cancer with EGFR exon 20 insertions.\n\nThe FDA granted the application for mobocertinib orphan drug designation."},"commercial":{"launchDate":"2021","_launchSource":"DrugCentral (FDA 2021-09-15, TAKEDA PHARMS 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