Trial Registered

HUTCHMED completes HMPL-453 drug-interaction study as pivotal ICC data already read out

The Phase 1 itraconazole and rifampin interaction study finished on schedule, arriving after fanregratinib's pivotal trial already reported a 42.5% response rate in FGFR2-fusion bile duct cancer.

By AppliedXLJuly 13, 2026Trial NCT07697157

Executive Summary

HUTCHMED closed a Phase 1 study testing how a CYP3A/P-glycoprotein inhibitor and a CYP enzyme inducer change blood levels of HMPL-453, finishing enrollment on its original planned date.
The study carries no efficacy endpoint. Its results will shape dosing and drug-interaction precautions rather than determine whether the drug works, because that question was already settled in a separate pivotal trial.
HMPL-453, also known as fanregratinib, already produced a positive pivotal readout in FGFR2-fusion bile duct cancer, which is the result that matters most for the program's trajectory.
The interaction data will feed into how broadly the drug can be prescribed alongside common antifungals, antibiotics, and other CYP3A-active medicines once regulatory filings move forward.

The study

The trial tested HMPL-453 tartrate tablets against two reference drugs commonly used to probe drug interactions: itraconazole, which inhibits the CYP3A enzyme and the P-glycoprotein transporter, and rifampin, which induces CYP enzymes. The primary endpoints measured total drug exposure (AUC from time zero to infinity and to the last measurable concentration) and peak concentration (Cmax) over a 25-day observation window, with adverse events tracked as a secondary measure through study completion. This is a pharmacokinetic interaction study, not an efficacy trial: it establishes how co-administered drugs change HMPL-453 blood levels, information that informs dosing instructions and interaction warnings on any eventual label. NCT07697157

Operational facts

The study started March 1, 2025, ran in China, and completed enrollment of 40 subjects against a target of 40, reaching its actual enrollment count with no reported growth or shortfall. It closed on its original guided primary completion date of December 31, 2025, a straightforward on-schedule finish with no protocol amendments recorded in its history. Results have not yet posted to the registry. NCT07697157

Why the drug already has an answer

HMPL-453, HUTCHMED's fanregratinib, has a separate and more consequential result already on record. In a pivotal Phase 2/3 registration study, HUTCHMED reported an independent-review-committee-assessed objective response rate of 42.5% (95% CI: 30.0%-53.6%) in pretreated patients with advanced intrahepatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements, with a median duration of response of 6.9 months and median overall survival of 16.6 months. That trial, NCT04353375, remains open with a primary completion date of June 30, 2028, but the topline efficacy result behind it has already been disclosed. Against that backdrop, the drug-interaction study now completing is a supporting piece of the regulatory package, not a test of whether fanregratinib works.

Portfolio context

HMPL-453 carries eight trials across HUTCHMED's pipeline: the pivotal cholangiocarcinoma study remains recruiting, five earlier Phase 1 pharmacology studies (food effect, radiolabeled ADME, and this interaction study) have completed, one Phase 2 mesothelioma study and one Phase 1/2 -malignancy study sit in unknown status, and one early dose-escalation study was terminated. HUTCHMED's completion rate across 86 tracked trials globally stands at 86%, with 74 completed and 12 terminated. The interaction study's on-time close is consistent with that broader execution record. NCT07697157

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.