Is Besudil/Yilaike considered a hormonal drug?

Belumosudil mesylate tablets (Belumosudil) is not a hormone drug, but a small molecule targeted immunomodulator. Its mechanism of action is essentially different from that of glucocorticoids. Traditional treatments for chronic graft-versus-host disease (cGVHD) mostly rely on hormonal drugs, such as prednisone or methylprednisolone, which reduce the inflammatory response by broadly suppressing the immune system. Although hormone therapy can quickly control symptoms in the short term, long-term use can cause side effects such as osteoporosis, high blood sugar, and increased risk of infection. In contrast, the emergence of besudil marks a new stage in cGVHD treatment from "non-specific immunosuppression" to "precision immune regulation".

Besudil selectively inhibitsRho-related protein kinase 2 (ROCK2), thereby reducing the production of inflammatory factors, regulating T cell balance, especially promoting the functional recovery of regulatory T cells (Treg) and reducing autoimmune attacks. This mechanism can more accurately repair immune imbalances without affecting the body's normal immune defense. Therefore, it does not have the systemic side effects of hormonal drugs, nor will it cause typical hormonal dependence or withdrawal reactions.

Clinically, besudil is often used in patients with cGVHD who are ineffective or intolerant to hormone therapy, and has become an important second-line or third-line treatment option. It can be used as a single drug or in combination with low-dose hormones to help gradually reduce hormone dependence and improve long-term medication safety. From a pharmacological perspective, Besudil is a targeted immunomodulator rather than a hormonal drug. Its advantages include strong specificity, few side effects, and long-term maintenance of immune balance.

To sum up, besudil is not a hormonal drug, but an innovative targeted immunotherapy, providing a safer and longer-lasting treatment option for patients with chronic graft-versus-host disease. As the drug is promoted in China, its non-hormonal properties also make more doctors inclined to use it as an alternative or combined solution to help patients achieve long-term immune stability and improve their quality of life.

Reference: https://www.drugs.com/pro/rezurock.html