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Serabelisib · FTH-001, MLN1117

Small molecule · Inhibitor of PI3K alpha (PIK3CA) · developed by Faeth Therapeutics

Phase 2 Most advanced trial
FTH Developer
1 Registered trials

What is Serabelisib?

Serabelisib is an orally bioavailable inhibitor of class I phosphoinositide 3-kinase (PI3K) alpha isoform. It selectively inhibits PI3K alpha kinase, including PIK3CA mutations, in the PI3K/Akt/mTOR pathway to induce tumor cell apoptosis and growth inhibition. It is studied in endometrial cancer.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
FTH-001, MLN1117, INK-1117
Drug type
Small molecule
Targets
PI3K alpha (PIK3CA)
Mechanism
Inhibitor of PI3K alpha (PIK3CA)
Pathways
PI3K/Akt/mTOR
Therapy area
Oncology
Developer
Faeth Therapeutics (FTH)
FDA status
Investigational, not approved in the US. Most advanced trial: Phase 2
UNII
43J9Q56T3W

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT06463028 Phase 2 Endometrial Cancer Recruiting FTH

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Endometrial Cancer

Other drugs acting on PIK3CA

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the FTH page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

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