Clobazam

There is a long-standing unmet need in the clinical treatment of drug-resistant epilepsy. Approximately 30% of patients have poor response to conventional antiepileptic drugs. Childhood refractory epilepsy such as Lennox-Gastaut syndrome (LGS) severely affects the growth and development of affected children due to its complex seizure types and high difficulty in control. Clobazam is a new type of benzodiazepine antiepileptic drug. By binding to γ-aminobutyric acid type A receptors, it enhances the conduction of inhibitory neurotransmitters and reduces neuronal excitability. It is currently the first-line treatment for LGS-related drop seizures, and can also be used as adjuvant therapy for other refractory epilepsy, with high safety and tolerability in pediatric patients.

The global clobazam market size was approximately USD 480 million in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 5.2%. The growth drivers mainly come from the improvement of the global diagnosis rate of refractory epilepsy and the further expansion of pediatric indications. In terms of the domestic market, after clobazam was included in the temporary import policy list in 2022, its clinical accessibility has improved rapidly. In 2023, the sales of clobazam in domestic sample hospitals exceeded RMB 120 million. At present, the localization process is accelerating, and 3 domestic enterprises have obtained approval for generic drug preparations, and the market share of the original research drug is gradually being replaced by domestic products.

The original research enterprise of clobazam is Sanofi, with the original brand name Frisium®. Its core compound patents have all expired in major global markets. The main dosage form approved for the original research drug is tablet, with specifications of 10mg and 20mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the *List of Chemical Drugs* of China. In terms of domestic API registration, as of now, 7 enterprises have obtained CDE registration numbers for clobazam APIs, among which 4 are in Status A and can be directly used for associated preparation declaration; the original research drug and 3 domestic generic preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the needs of generic drug consistency evaluation and quality control of clobazam, CATO provides a full set of impurity reference standards for this API, covering all categories such as synthetic process impurities and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the quality requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can be directly used for impurity qualitative and quantitative research and stability investigation, helping enterprises efficiently complete R&D and declaration work.