Apraclonidine

Glaucoma is the world's leading irreversible blinding eye disease, and there has long been an urgent clinical need for therapeutic drugs with both intraocular pressure lowering effects and neuroprotective effects. Apraclonidine is an α₂ adrenergic receptor agonist. By selectively activating intraocular α₂ receptors, it reduces aqueous humor production and increases aqueous humor outflow through the uveoscleral pathway, which can rapidly lower intraocular pressure. It is mainly used clinically for intraocular pressure control in glaucoma patients during the perioperative period, and can also be used as an adjuvant therapy when other intraocular pressure lowering drugs have poor efficacy, especially suitable for open-angle glaucoma patients who are intolerant to β receptor blockers.

The global market size of anti-glaucoma drugs was approximately USD 7.2 billion in 2023, and is expected to reach USD 9.4 billion in 2028, with a compound annual growth rate of approximately 5.5%. As a commonly used drug for short-term intraocular pressure control, apraclonidine accounts for approximately 1.2% of the anti-glaucoma drug market share. At present, the competition of its generic drugs is relatively mild. Only 3 domestic enterprises have been approved to produce related preparations, and the supply of active pharmaceutical ingredients is mainly imported. With the increasing clinical attention to perioperative intraocular pressure management, its annual market demand growth rate remains at around 8%.

The original research enterprise of apraclonidine is Alcon, with the original brand name Iopidine. Its compound patent in the US market expired in 2002, and the core patent in China expired in 2004. The main dosage forms approved by the original research are eye drops, with two specifications of 0.5% and 1%. They have been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Listed Drugs of Chemical Drugs (Fifth Batch)*. There is no approved A-status apraclonidine registration number on the domestic active pharmaceutical ingredient registration platform at present. All domestically approved and marketed preparations are generic drugs, and no original research preparation has been approved for import. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of apraclonidine impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. Meanwhile, they meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet various needs of pharmaceutical enterprises in active pharmaceutical ingredient R&D, quality research and preparation consistency evaluation.