Indication
A specific disease or condition for which a drug has been approved by regulatory authorities. Approved indications are listed in the prescribing information and determine which patients can receive the drug within its approved use. Semaglutide has separate approved indications for type 2 diabetes and weight management.
Technical Context
Approved indications are defined with specificity: patient population (adults, children ≥12 years, patients with BMI ≥30), disease/condition (type 2 diabetes mellitus, chronic weight management, moderate-to-severe pruritus in CKD on haemodialysis), treatment context (adjunct to diet and exercise, in combination with metformin, as monotherapy), and limitations (not recommended for type 1 diabetes, not studied in patients with a history of pancreatitis). Semaglutide illustrates how the same molecule can have different approved indications with different formulations, doses, and brand names: Ozempic (SC, 0.5/1/2mg, type 2 diabetes), Wegovy (SC, 2.4mg, weight management), and Rybelsus (oral, 3/7/14mg, type 2 diabetes). Each indication requires its own clinical development programme and regulatory submission. New indication development can take 3-5 years from concept to approval.