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Tersolisib · LY4064809, STX-478

Small molecule · Inhibitor of PI3K p110alpha (PIK3CA) H1047X mutant (PIK3CA) · developed by ELI LILLY &

Phase 3 Most advanced trial

LLY Developer

1 Registered trials

What is Tersolisib?

Tersolisib is an orally bioavailable, brain-penetrant inhibitor that selectively and allosterically binds the PIK3CA H1047X mutant form of the class I PI3K catalytic subunit alpha. By blocking this mutant, it prevents activation of the PI3K/Akt/mTOR pathway and induces apoptosis and growth inhibition in PIK3CA H1047X-expressing tumor cells. It is studied in breast neoplasms and neoplasm metastasis.

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

At a glance

Also known as: LY4064809, STX-478
Drug type: Small molecule
Targets: PI3K p110alpha (PIK3CA) H1047X mutant (PIK3CA)
Mechanism: Inhibitor of PI3K p110alpha (PIK3CA) H1047X mutant (PIK3CA)
Pathways: PI3K/Akt/mTOR pathway, apoptosis, growth inhibition
Therapy area: Oncology
Developer: ELI LILLY & (LLY)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 3
UNII: AGX9NKC8M9

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07174336	Phase 3	Breast Neoplasms	Recruiting	LLY

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

Conditions studied

Breast NeoplasmsNeoplasm Metastasis

Other drugs acting on PIK3CA

Gedatolisib FDA approved CGT6297 Phase 1 Samotolisib Phase 2 Serabelisib Phase 2

More from ELI LILLY &

Abemaciclib FDA approved Baricitinib FDA approved Donanemab FDA approved Dulaglutide FDA approved Imlunestrant FDA approved Lebrikizumab FDA approved Mirikizumab FDA approved Orforglipron FDA approved Pirtobrutinib FDA approved Selpercatinib FDA approved Tirzepatide FDA approved Brenipatide Phase 3

Sources

NCI Thesaurus

Updated Oct 11, 2026. Something wrong or missing? Report it on the LLY 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