TRUQAP® (capivasertib) is an oral, small-molecule kinase inhibitor targeting all three isoforms of serine/threonine kinase AKT (AKT1, AKT2, AKT3). By blocking AKT phosphorylation and downstream signaling, TRUQAP disrupts oncogenic pathways driven by *PIK3CA/AKT1/PTEN* alterations, which are implicated in resistance to endocrine therapies. Approved by the U.S. FDA in 2023, it is administered in combination with fulvestrant, an estrogen receptor antagonist, to enhance antitumor efficacy in HR-positive/HER2-negative advanced breast cancer.

The approval is based on the CAPItello-291 trial, a randomized Phase III study demonstrating significant improvement in progression-free survival (PFS) versus placebo-fulvestrant (median PFS: 7.3 vs. 3.1 months; HR=0.50, p<0.0001) in the biomarker-positive subgroup. Common adverse reactions include hyperglycemia (57%), diarrhea (72%), cutaneous reactions (58%), and cytopenias. Rigorous glucose monitoring, proactive management of diarrhea, and dermatologic assessments are critical due to risks of diabetic ketoacidosis, dehydration, and severe skin toxicities. Dose adjustments or discontinuation may be required based on severity.