What information is there about the new oncology drug Carpisetin/Tsuankede that will be launched in 2025?

Capivasertib, trade nameTruqap, developed by AstraZeneca, is an oral AKT inhibitor mainly used to treat patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. The drug was approved by the US FDA in November 2023 and marketing authorization in the European Union in June 2024. In April 2025, the National Institute for Health and Clinical Excellence (NICE) also approved its use in the British NHS system.

Carpiseti inhibits the growth of tumors by inhibiting the activity ofAKT protein and interfering with the proliferation and survival of tumor cells. The drug, used in combination with Fulvestrant, is indicated for patients with PIK3CA, AKT1 or PTEN gene mutations who have progressed or relapsed after receiving at least one endocrine therapy. This combination therapy has been shown to significantly extend progression-free survival.

Carpisetin was originally developed by AstraZeneca in collaboration withAstex Pharmaceuticals, which has a deep accumulation in the field of cancer research. AstraZeneca is a leading global biopharmaceutical company headquartered in Cambridge, UK, dedicated to developing innovative treatments for cancer, cardiovascular, respiratory and immune system diseases. The development process of carpiseti reflects AstraZeneca’s continued investment and innovation in the field of precision medicine.

In theCAPItello-291 clinical trial, the combination of capizetin and Fulvestrant showed significant efficacy in patients with advanced breast cancer. This study showed that patients carrying PIK3CA, AKT1 or PTEN mutations had a significantly longer time to disease progression after receiving this combination therapy. In addition, AstraZeneca is also conducting other clinical trials, such as CAPItello-292, to evaluate the effect of capicistat in combination with CDK4/6 inhibitors.

Common side effects of carpisetin include diarrhea, skin reactions, increased blood sugar, anemia, and leukopenia. These side effects are usually controllable, but patients need to monitor relevant indicators regularly during use.

Reference materials:https://www.drugs.com/mtm/capivasertib.html