Naftopidil

Benign prostatic hyperplasia (BPH) is a common degenerative urinary system disease in middle-aged and elderly men, with a prevalence rate of over 50% among people over 60 years old. Symptoms such as urinary obstruction, frequent urination and urgent urination severely reduce the quality of life of patients. Naftopidil is a highly selective α1 adrenergic receptor antagonist, which can simultaneously block α1A and α1D receptor subtypes. It can not only relax the smooth muscle of the prostate and urethra to reduce urethral pressure, but also inhibit overactive bladder to relieve symptoms during the urine storage period. It is mainly used clinically to relieve urination disorders caused by BPH. Compared with traditional non-selective α receptor antagonists, it has a lower incidence of adverse reactions such as orthostatic hypotension, and is especially suitable for BPH patients with hypertension.

At present, the global market size of naftopidil is about 120 million US dollars, with an annual compound growth rate of about 3.8%. The growth momentum mainly comes from the acceleration of the global population aging process and the continuous release of clinical treatment demand for BPH. In terms of the domestic market, with the advancement of the volume-based procurement policy, the price of naftopidil preparations has dropped significantly, and drug accessibility has been significantly improved. The domestic market size has achieved an annual compound growth rate of 7.2% in the past three years. The current competitive landscape is dominated by generic drugs, and preparations produced by local enterprises have occupied more than 90% of the domestic market share, and the supply of upstream API has basically achieved localization.

The original research enterprise of naftopidil is Nippon Chemical Pharmaceutical Co., Ltd., and the original research trade name is Flivas. The expiration time of its core compound patent in Japan is 2002, and the compound patent for entering the Chinese market expired in 2004. The main dosage forms approved for the original research are tablets, with specifications including 25mg and 50mg. Its 25mg specification tablet has been included in the Chinese Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. Up to now, more than 10 domestic enterprises have obtained A status for their naftopidil APIs through CDE registration, and more than 20 generic naftopidil tablets and capsules have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity standards for naftopidil API, covering a full spectrum of reference materials such as synthetic process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in all links such as impurity research, quality control, and registration declaration.