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100 µCi HMPL-306

Phase 1

Undisclosed | Small molecule | Other |HUTCHMED (China) Limited|Trials Updated: Jul 30, 2025

100 µCi HMPL-306 target and mechanism

ModalitySmall molecule

Also known as 100 µCi [14C] HMPL-306

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

100 µCi HMPL-306 clinical trials

100 µCi HMPL-306 · 1 trial · 1 indication

Phase 1 1
NCT06671873Study on Mass Balance of [14C]HMPL-306(Isocitrate Dehydrogenase Inhibitor) in Healthy Chinese Adult Male SubjectsMass Balance Study
COMPLETED6 Analytics
PHASE1COMPLETED
Study on Mass Balance of [14C]HMPL-306(Isocitrate Dehydrogenase Inhibitor) in Healthy Chinese Adult Male Subjects
Mass Balance StudyUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
100 µCi [14C] HMPL-306DRUGD1: 250 mg/100 µCi \[14C\] HMPL-306 Single dose
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Frequently asked questions about 100 µCi HMPL-306

What is 100 µCi HMPL-306?

100 µCi HMPL-306 is a radiolabeled form of the small molecule HMPL-306, developed by HUTCHMED (China) Limited. It is used in a Phase 1 mass balance study to trace how the drug is absorbed, distributed, metabolized, and excreted in the body. The 100 µCi designation refers to the radioactivity dose used in the study.

Who is developing 100 µCi HMPL-306?

100 µCi HMPL-306 is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. HUTCHMED is a biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases.

What phase is 100 µCi HMPL-306 in?

100 µCi HMPL-306 is in Phase 1 clinical development. The only listed trial for this radiolabeled version is a completed Phase 1 mass balance study. The drug remains investigational and has not been approved by the FDA or any other regulatory agency for any indication.

What clinical trials is 100 µCi HMPL-306 in?

100 µCi HMPL-306 has been studied in one clinical trial: NCT06671873, titled "Study on Mass Balance of [14C]HMPL-306 (Isocitrate Dehydrogenase Inhibitor) in Healthy Chinese Adult Male Subjects." This Phase 1 trial was completed and enrolled 6 participants. It was an uncontrolled, non-randomized study.

Is 100 µCi HMPL-306 the same as 100 µCi [14C] HMPL-306?

Yes, 100 µCi HMPL-306 is also known as 100 µCi [14C] HMPL-306. The bracketed [14C] indicates that the molecule is radiolabeled with carbon-14, which is used as a tracer in mass balance studies to track the drug's metabolic pathway and excretion.