TRUQAP® is the official global commercial brand name, and Kuikedé is its Chinese brand name developed by AstraZeneca. It is an oral pan-AKT kinase inhibitor that blocks AKT-mediated downstream PI3K/AKT signaling, suppressing tumor proliferation driven by PIK3CA, AKT1 or PTEN aberrations.
Main Indications
Combined use with fulvestrant for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer harboring PIK3CA/AKT1/PTEN alterations, whose disease progressed after endocrine therapy.
Clinical Research
Global phase III CAPItello-291 pivotal trials fully validated its significant progression-free survival benefit for endocrine-resistant mutant HR+/HER2- breast cancer;
Head-to-head comparative registration trials confirmed superior tumor control rate versus fulvestrant monotherapy with manageable metabolic toxicity;
Long-term follow-up cohorts demonstrated durable disease suppression under the 4-days-on / 3-days-off intermittent oral schedule;
Dose-finding research verified balanced anti-tumor efficacy and glycemic safety profile of the 400 mg twice-daily dosing cycle;
Chinese domestic registration trials confirmed consistent therapeutic activity and controllable adverse events for local mutant breast cancer populations.
Common Side Effects
Common mild adverse reactions: Hyperglycemia, diarrhea, fatigue, nausea, stomatitis and rash;
Laboratory abnormalities: Elevated blood glucose, elevated triglycerides, transient mild liver transaminase elevation and hypokalemia;
Severe but uncommon risks: Severe uncontrolled hyperglycemia, diabetic ketoacidosis, severe cutaneous adverse reactions and severe diarrhea leading to electrolyte disturbance.
Approval Status in China
Original drug TRUQAP® (Chinese brand: Kuikedé) was officially approved for marketing in China in 2024, with the specification of 200mg per tablet, 64 tablets per box (16 tablets per plate, 4 plates). It is currently a prescription targeted anti-tumor drug included in China’s Category B medical insurance catalogue.
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