Phentermine/topiramate extended-release capsule (Qsymia^®) is a fixed-dose combination of phentermine and topiramate, which is being developed by VIVUS (a subsidiary of Icahn Enterprises) for the treatment of obesity, sleep apnoea syndrome, type 2 diabetes mellitus and non-alcoholic steatohepatitis (NASH). The once-daily formulation of phentermine (a sympathomimetic amine) and topiramate is designed to combat obesity by decreasing appetite and increasing satiety. In July 2022, phentermine/topiramate received its first approval in the USA, as an adjunct to a reduced-calorie diet and increased physical activity, for chronic weight management in pediatric patients aged ≥ 12 years with BMI in the 95th percentile or greater standardized for age and sex. Phentermine/topiramate is approved in the US and South Korea for obesity in adults. Clinical development of phentermine/topiramate for sleep apnoea syndrome and type-2 diabetes in obese patients and preclinical development for NASH is ongoing in the US. This article summarizes the milestones in the development of phentermine/topiramate leading to this pediatric first approval for chronic weight management in adolescents.

芬特明/托吡酯缓释胶囊（Qsymia ^®) 是芬特明和托吡酯的固定剂量组合，由 VIVUS（伊坎企业的子公司）开发，用于治疗肥胖症、睡眠呼吸暂停综合征、2 型糖尿病和非酒精性脂肪性肝炎 (NASH)。芬特明（一种拟交感神经胺）和托吡酯的每日一次配方旨在通过降低食欲和增加饱腹感来对抗肥胖。2022 年 7 月，芬特明/托吡酯在美国首次获得批准，作为减少热量饮食和增加身体活动的辅助手段，用于年龄≥ 12 岁、BMI 在 95% 或更高标准的儿童患者的慢性体重管理年龄和性别。芬特明/托吡酯在美国和韩国被批准用于成人肥胖症。美国正在进行芬特明/托吡酯治疗肥胖患者睡眠呼吸暂停综合征和 2 型糖尿病的临床开发以及 NASH 的临床前开发。本文总结了芬特明/托吡酯开发的里程碑，导致该儿科首次批准用于青少年慢性体重管理。