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LY4064809 Test Formulation

Phase 1

Healthy Participants | Small molecule | Other |Eli Lilly and Company|Last Updated: Apr 20, 2026

Target and mechanism

Molecular targetPIK3CA
Target classGene
ModalitySmall molecule

Also known as LY4064809

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

LY4064809 Test Formulation · 1 trial · 1 indication

Phase 1 1
NCT07339735A Study of LY4064809 in Healthy Adult ParticipantsHealthy Participants
COMPLETED24 Analytics
PHASE1COMPLETED
A Study of LY4064809 in Healthy Adult Participants
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Study Endpoints

Primary Endpoints

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809
Predose on Day 1 Through Day 28

PK: Cmax of LY4064809

PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809
Predose on Day 1 Through Day 28

PK: AUC of LY4064809

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY4064809 TestEXPERIMENTALLY4064809 test (Phase 3 formulation) formulation administered orally in one of two periods.
LY4064809 ReferenceEXPERIMENTALLY4064809 reference (Phase 1 formulation) formulation administered orally in one of two periods.

Interventions

NameTypeDescription
LY4064809 Test FormulationDRUGAdministered orally
LY4064809 Reference FormulationDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission. * Have clinical laboratory test results within the normal range * Have normal blood pressure and pulse rate or...

Countries:United States
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Frequently asked questions about LY4064809 Test Formulation

What is LY4064809 used for?

LY4064809, also known as tersolisib, is an investigational small molecule being studied for the treatment of advanced breast cancer with a PIK3CA genetic change. It is being evaluated in combination with other anti-cancer treatments in a Phase 3 clinical trial enrolling participants with breast neoplasms and metastasis.

What does LY4064809 target?

LY4064809 targets the PIK3CA gene. It is being studied in patients whose tumors carry a PIK3CA genetic change, as part of a Phase 3 trial for advanced breast cancer. The drug is designed to act on this specific genetic alteration.

Who makes LY4064809?

LY4064809 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker LLY. The drug is also known as tersolisib and is currently in clinical development for oncology indications.

What phase is LY4064809 in?

LY4064809 is in Phase 3 clinical development for advanced breast cancer with a PIK3CA genetic change. It is an investigational drug and has not been approved by regulatory authorities. Earlier Phase 1 studies in healthy participants have been completed.

What clinical trials is LY4064809 in?

LY4064809 is being studied in a Phase 3 trial, NCT07174336, which is recruiting 800 participants with advanced breast cancer and PIK3CA mutations across multiple countries. Additional Phase 1 studies in healthy participants, including NCT07247357, NCT07339735, and NCT07519525, have been completed.

Is LY4064809 the same as tersolisib?

Yes, LY4064809 is also known as tersolisib. The Phase 3 clinical trial for advanced breast cancer refers to the drug as tersolisib (LY4064809/STX-478). Both names refer to the same investigational small molecule being developed by Eli Lilly and Company.