{"entity":{"id":"hmpl-453","kind":"drug","name":"HMPL-453","aka":[],"tldr":"HMPL-453 is an experimental small-molecule drug from Hutchmed in phase 3 trials for biliary tract cancer, aimed at FGFR2.","summary":"HMPL-453 is a small-molecule drug developed by Hutchmed. Its target is FGFR2 (the sponsor names FGFR2). ClinicalTrials.gov describes the intervention as: Cohort\\_1:HMPL-453 150mg QD continuously in 21-day cycles; Cohort\\_2, Cohort\\_3 and Cohort\\_4:HMPL-453 tartrate 300 mg QD orally (for 14 consecutive days \\[Day 1 to 14\\], followed by 7 days off \\[Day 15 to 21\\], 21 days as a treatment cycle. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT04353375 (HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma), in biliary tract cancer. The largest, NCT04353375, plans to enrol 235 participants with primary completion expected 2028-06-30. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of HMPL-453","url":"https://clinicaltrials.gov/search?intr=HMPL-453"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma"],"sections":[],"technologies":[],"targets":["fgfr2"],"drugs":[],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04353375"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"small molecule (structure undisclosed or not yet in PubChem)","mechanism":"Small-molecule drug directed at FGFR2, as stated in the ClinicalTrials.gov intervention record; the detailed mechanism is not stated.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/hmpl-453/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"}],"target":[{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"}],"company":[{"id":"hutchmed","kind":"company","name":"Hutchmed","route":"/companies/hutchmed/"}],"trial":[{"id":"nct04353375","kind":"trial","name":"HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma","route":"/trials/nct04353375/"}]}}