# HMPL-453

Source: https://onco.cc/drugs/hmpl-453/  
OnCo record `hmpl-453` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- ClinicalTrials.gov: trials of HMPL-453: https://clinicaltrials.gov/search?intr=HMPL-453

## Connected records

- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/)
- targets: [FGFR2](https://onco.cc/targets/fgfr2/)
- companies: [Hutchmed](https://onco.cc/companies/hutchmed/)
- trials: [HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma](https://onco.cc/trials/nct04353375/)

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