Guanfacine

Attention-deficit/hyperactivity disorder (ADHD), a neurodevelopmental disorder with high incidence in childhood and adolescence, has long had a clinical demand for non-stimulant treatment options. Guanfacine is a central α2A adrenergic receptor agonist. By selectively activating α2A receptors in the prefrontal cortex, it regulates the release of prefrontal neurotransmitters and improves attention regulation, impulse control and working memory functions. In addition to being used for the treatment of adult hypertension, it is currently one of the few non-stimulant drugs approved for adjuvant treatment of ADHD in children and adolescents aged 6 to 17 years, especially suitable for patient groups who are intolerant to stimulant drugs or have comorbidities.

At present, the global market size of ADHD therapeutic drugs has exceeded US$24 billion. The growth rate of non-stimulant categories continues to be higher than that of the overall market, with a compound annual growth rate of 8.2%. With clear clinical positioning, guanfacine has become a second-line and combined medication option recommended by ADHD treatment guidelines in many countries, and its market size is growing steadily. The domestic market is still dominated by original research products, and the number of generic drug declaration enterprises is small. With the improvement of clinical awareness of ADHD and the promotion of child medication security policies, the unmet clinical demand is continuing to be released. There is no publicly verifiable specific data on the domestic market size of guanfacine API.

The original research enterprise of guanfacine is Shionogi Pharma Co., Ltd. of Japan, and the original research brand name is Intuniv (guanfacine hydrochloride extended-release tablets). The expiration date of its core compound patent in the United States is 2022, and the compound patent in China has expired. The main dosage form promoted by the original research is extended-release tablets, with specifications including 1mg, 2mg, 3mg and 4mg, which has been included in the FDA Reference Listed Drug Catalog, and the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has also listed it as a reference listed drug. Up to now, there is no valid registration information of domestic or imported guanfacine API on the CDE API registration platform. Only the original research imported guanfacine hydrochloride extended-release tablets have been approved for marketing in China, and no domestic preparation has been approved. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of guanfacine impurity reference standards. Most of the products support spot supply. For spot products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as API R&D, quality research and consistency evaluation.