Fenfluramine

Facing refractory epilepsy, a nervous system disease that seriously affects children's growth and family life, there has been a long-term lack of targeted treatment options in clinical practice, so the clinical value of fenfluramine has received widespread attention. As a serotonin receptor agonist, it can reduce neuronal hyperexcitability by regulating the activity of serotonin and sigma-1 receptors. At present, it is mainly used for the adjuvant treatment of epileptic seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in children aged 2 years and older, filling the clinical gap in the treatment of epilepsy in children with rare diseases, and providing new medication options for this patient group that lacks effective intervention methods.

Globally, the total prevalence of Dravet syndrome and Lennox-Gastaut syndrome is about 2 to 8 cases per 100,000 people. Corresponding to this, the global market size of fenfluramine had exceeded USD 350 million in 2023, and the compound annual growth rate from 2024 to 2030 is expected to be about 8.2%. Currently, the original research product still dominates the market, and only a small number of domestic pharmaceutical companies are engaged in the R&D of generic drugs. With the implementation of the security policy for rare disease medications, the clinical usage of this variety is showing a steady upward trend.

The original research enterprise of fenfluramine is UCB Pharma (Belgium), and the brand name of the original research product is Fintepla®. Its core compound patent expired in Europe in 2021, and the compound patent in the United States will expire in 2027. The dosage form of the original research approved product is oral solution, with a specification of 2.2 mg/mL. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalogue of Reference Preparations for Chemical Drugs (Third Batch)* of China. Up to now, there is no publicly announced domestic fenfluramine API registration number with A status in China, and the original research oral solution was approved by the NMPA for marketing in China in 2020. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for fenfluramine API. Most products are available from stock. For in-stock orders, payment made before 16:00 can be shipped on the same day. All products meet the regulatory requirements of multiple regions such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical enterprises in the whole process of R&D, quality research and production.