Aceclidine

As the world's leading irreversible blinding eye disease, glaucoma has intraocular pressure (IOP) control as the core intervention target to delay the progression of the disease in clinical practice. Aceclidine is a cholinergic M receptor agonist. It acts directly on the M cholinergic receptors on the pupillary sphincter, causing pupil constriction and widening of the anterior chamber angle space, promoting aqueous humor outflow and thus reducing intraocular pressure. It is especially suitable for patients with open-angle glaucoma and angle-closure glaucoma who are intolerant to pilocarpine, and can also be used for miosis operations in ophthalmic surgery, making it an important alternative drug for local treatment of glaucoma.

At present, the global market size of anti-glaucoma drugs exceeds 16 billion US dollars, of which cholinergic drugs account for about 7%. Driven by the increasing prevalence of glaucoma year by year and the rising demand for long-term medication by patients, the compound annual growth rate in the past 3 years has remained at 4.2%. Since aceclidine is positioned as a niche alternative product in clinical practice, the number of manufacturers is small, and the market competition pattern is relatively concentrated. Europe and China are the main API supply regions in the world. The domestic centralized procurement of anti-glaucoma drugs has not yet covered this variety. The existing supply is dominated by generic drugs, and the market share of the original research product is less than 15%.

The original research enterprise of aceclidine is Laboratoires Théa, a French company, with the original trade name Miostat. The core compound patent in the EU region expired in 2014. The original marketed dosage form is ophthalmic injection, with common specifications of 1ml:0.5mg and 2ml:1mg, which has been included in the FDA Orange Book Reference Preparation Catalog. As of the time of retrieval, there are no approved aceclidine preparation products on the market in China, and no valid aceclidine registration number with A status or I status has been found on the CDE API registration platform. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for aceclidine API. All products of the full series comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and can be directly used for drug quality research and stability investigation. Most impurities are in sufficient stock. Orders submitted and paid before 16:00 can be shipped on the same day, which can fully shorten the R&D cycle and reduce supply chain risks.