{"entity":{"id":"olmutinib","kind":"drug","name":"Olmutinib","aka":["HM61713","BI 1482694"],"tldr":"Olmutinib was a Korean-developed EGFR pill approved in South Korea in 2016 for lung cancers that had developed the T790M resistance mutation, the same niche as osimertinib; severe skin reactions and osimertinib's success ended its development.","summary":"Hanmi Pharmaceutical's olmutinib became the first third-generation EGFR inhibitor to reach any market when South Korea's Ministry of Food and Drug Safety approved it in May 2016 for T790M-positive non-small cell lung cancer after first-line EGFR therapy. Boehringer Ingelheim licensed it worldwide but returned the rights within months after reports of fatal toxic epidermal necrolysis and Stevens-Johnson syndrome and after osimertinib's phase 3 results. Hanmi ended development in 2018 and the drug is no longer marketed. It is remembered as a case study in how a first-to-market approval on early data can be overtaken.","status":"withdrawn","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Olmutinib","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Olmutinib"},{"label":"ChEMBL CHEMBL3545110","url":"https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545110"}],"tags":["gap-fill","chembl-universe"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":["osimertinib"],"companies":["hanmi-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":["nct02485652","nct02444819","nct03228277"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Olita","modality":"Oral third-generation EGFR kinase inhibitor","mechanism":"A covalent inhibitor that binds cysteine 797 of EGFR and blocks the T790M resistance mutation while sparing the normal receptor.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/olmutinib/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"drug":[{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"}],"company":[{"id":"hanmi-pharmaceutical","kind":"company","name":"Hanmi Pharmaceutical","route":"/companies/hanmi-pharmaceutical/"}],"trial":[{"id":"nct03228277","kind":"trial","name":"Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA","route":"/trials/nct03228277/"},{"id":"nct02485652","kind":"trial","name":"Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung","route":"/trials/nct02485652/"},{"id":"nct02444819","kind":"trial","name":"Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy","route":"/trials/nct02444819/"}]}}