Cyproheptadine

Allergic diseases fall into the category of chronic diseases with a high incidence globally. Traditional antihistamines are often accompanied by obvious central sedative side effects, and there has been a long-standing clinical demand for medications that balance efficacy and tolerability. Cyproheptadine is a first-generation piperidine H1 receptor antagonist that can simultaneously block 5-hydroxytryptamine receptors and inhibit mast cell degranulation. In addition to relieving symptoms such as itching and rashes caused by allergic diseases including urticaria, eczema, and contact dermatitis, it can also be used as an adjuvant treatment for neurodermatitis and migraine. Some diagnosis and treatment guidelines also list it as an optional therapeutic drug for children with cold urticaria, and its applicable population covers adults and children over 2 years old.

At present, the global market size of antihistamine API exceeds 3.5 billion US dollars. As a commonly used low-cost antihistamine variety in clinical practice, the overall market size of cyproheptadine maintains a compound annual growth rate of 3.2%. In the domestic market, cyproheptadine is a Category A drug under the medical insurance system, with stable clinical demand. At present, nearly 10 enterprises have obtained preparation approvals. The supply of API is dominated by local enterprises, the market competition pattern is relatively scattered, and there is no leading monopoly. No verifiable market size data of this sub-category has been retrieved.

The original research enterprise of cyproheptadine is Merck & Co., Inc., with the original brand name Periactin. The core compound patent expired globally in 1982. The original dosage form is mainly 2mg oral tablet, which has been included in the FDA Reference Listed Drug Catalog. No original preparation has been approved for import in China yet. As of now, 6 enterprises have submitted cyproheptadine API registration numbers on the API registration platform of China CDE, among which 3 are in the activated status and can be used for the association of domestic preparation declarations. A number of generic varieties of domestic cyproheptadine hydrochloride tablets have been approved for marketing. (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 cyproheptadine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for relevant pharmaceutical enterprises in API R&D, quality research and preparation declaration.