The European Commission has granted orphan designation to asedebart (Lu AG13909), Lundbeck's investigational anti-ACTH monoclonal antibody, for endogenous Cushing's syndrome, covering ACTH-dependent and ACTH-independent forms. Asedebart is designed to bind ACTH and block its interaction with the melanocortin 2 receptor in the adrenal glands, reducing secretion of glucocorticoids, mineralocorticoids and androgens. Proof-of-concept trials are ongoing in Cushing's disease and classic congenital adrenal hyperplasia to assess efficacy and safety. The European Union designation may provide protocol assistance, fee reductions and, if approved, 10 years of market exclusivity for the designated indication. Asedebart is not approved by any regulatory authority, and its efficacy and safety have not been established.