Dantrolene

For malignant hyperthermia, a clinically rare anesthetic emergency with an extremely high fatality rate, the emergence of specific targeted therapeutic drugs has greatly reduced the risk of death in patients. Dantrolene is a skeletal muscle relaxant that inhibits calcium release from the ryanodine receptor (RyR1) of the sarcoplasmic reticulum and blocks the pathological pathway of abnormal sustained contraction of skeletal muscle. It is currently the only specific drug approved globally for the prevention and emergency treatment of malignant hyperthermia. Meanwhile, it can also be used for the symptomatic treatment of chronic spasticity caused by stroke, spinal cord injury, multiple sclerosis and other diseases. Its applicable population covers two major groups: patients receiving anesthesia during the perioperative period and patients with muscle spasm caused by central nervous system injury.

The global dantrolene market size was approximately USD 320 million in 2023, and the compound annual growth rate is expected to remain at 4.7% from 2024 to 2030. The core growth driver comes from the increased demand for clinical drug stock brought by the improvement of the rare disease diagnosis and treatment system. The competitive landscape is characterized by original research dominance and few generic manufacturers. Due to the relatively niche indications and high production process barriers, there are fewer than 10 API manufacturers with stable mass production capacity worldwide. The domestic market has long relied on imported preparations in the past. Since 2021, with the approval of local generic drugs, clinical accessibility has been significantly improved.

The original research enterprise of dantrolene is Procter & Gamble Pharmaceuticals of the United States, with the original brand name Dantrium, and the core compound patent expired globally in 1985. The main dosage forms approved for the original product include oral capsules (25mg, 50mg, 100mg) and freeze-dried powder for injection (20mg). Among them, the injection has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. In terms of domestic API registration, 2 enterprises' dantrolene APIs have been publicized through CDE registration numbers with the status of A, and another 5 domestic dantrolene sodium for injection preparations have been approved for marketing, which can meet the domestic demand for routine clinical drug stock. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for dantrolene API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in drug research and development, quality control and consistency evaluation work.