Halobetasol

In response to the clinical treatment needs of chronic inflammatory skin diseases such as moderate to severe plaque psoriasis and atopic dermatitis, potent topical glucocorticoids are one of the core medications for controlling local symptoms. Halobetasol, a super-potent third-generation halogen-containing glucocorticoid, binds to intracellular glucocorticoid receptors to inhibit the transcription of inflammatory factors, reduce mast cell degranulation, and exert anti-proliferative and vasoconstrictive effects at the same time. Its anti-inflammatory activity is more than 1000 times that of hydrocortisone, and its transdermal absorption is less than 1%, resulting in a low risk of systemic adverse reactions. It is clinically mainly used for chronic hypertrophic skin lesions in adults who have poor response to other glucocorticoid therapies. Short-term use can rapidly relieve symptoms such as erythema, scales and pruritus, and long-term intermittent maintenance treatment can reduce the recurrence frequency.

As a super-potent topical glucocorticoid variety with high clinical recognition, the global market size of halobetasol has maintained steady growth in recent years. In 2023, the global market size was approximately USD 320 million, with a compound annual growth rate of about 4.1%. The growth momentum mainly comes from the rising prevalence of diseases such as atopic dermatitis and the increasing demand of patients for potent topical preparations. The domestic market is still in the cultivation stage. Currently, the approved preparation varieties are mainly generic drugs. Since 2022, halobetasol propionate ointments from 3 enterprises have passed the consistency evaluation, and they have not been included in the national centralized procurement scope. The terminal retail price remains in the range of RMB 50-80 per tube, and there is still considerable room for improvement in the overall penetration rate.

The original research enterprise of halobetasol is GlaxoSmithKline, and the original brand names are Dovonex/Ultravate (brand names vary in different markets). Its core compound patent expired globally in 2004, and the formulation patents in major markets also expired successively before 2010. The originally marketed dosage form is 0.05% concentration ointment, with single tube specifications of 15g, 30g and 60g. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs (Fourth Batch)* of China. In terms of domestic API registration, 6 enterprises have obtained CDE registration numbers for halobetasol (halobetasol propionate) APIs, among which 4 registration statuses are A, which can be used for associated review; there are 8 approved halobetasol preparation varieties on the market in China, all of which are halobetasol propionate ointments. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for halobetasol API, which can cover the full-chain testing needs of residual starting materials, intermediates, by-products and degradation impurities in the synthesis process. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can be directly used in drug development, quality research and release testing scenarios, fully meeting the various needs of pharmaceutical enterprises for registration and declaration as well as production quality control.