What disease does Darolutamide treat? What are the indications?

Darolutamide tablets (Darolutamide ) is a new non-steroidal androgen receptor inhibitor, mainly used to treat prostate cancer. It is one of the important oral drug options for patients with advanced prostate cancer. Its mechanism of action is to inhibit the growth of prostate cancer cells by highly selectively blocking the androgen receptor, thereby delaying the progression of the disease. It is suitable for types of prostate cancer that are responsive to androgen dependence.

The main indication currently approved in China is the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of metastasis. In such patients, testosterone levels have been suppressed to castration levels, but the tumors continue to progress and distant metastasis has not been found. Darostamide can effectively prolong metastasis-free survival in these patients without significantly increasing the risk of serious side effects.

At the beginning of 2025Bayer has submitted an indication application for darotamide for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) to the China Food and Drug Administration. mHSPCThe patient is still sensitive to androgen deprivation therapy, but has developed distant metastasis. Studies have shown that darotamide combined with traditional hormone therapy can significantly prolong overall survival and reduce the rate of disease progression, providing new treatment possibilities for this group.

In European and American countries, the indications of darotamide have also gradually expanded, including being used in combination with other drugs to treat patients with mHSPC. The drug has shown good safety and efficacy in multiple global clinical trials. In the future, with more research, darotamide is expected to be used in the treatment of a wider range of prostate cancer subtypes, including high-risk locally advanced patients. The continued expansion of indications will benefit more prostate cancer patients.

Reference materials:https://www.fda.gov/drugs/