Almotriptan

Migraine is the second most disabling neurological disease in the world. The accompanying symptoms such as throbbing headache, nausea and photophobia during attacks seriously affect patients' daily work and life. Triptans are currently the first-line drugs of choice for the treatment of acute migraine. Almotriptan is a second-generation 5-hydroxytryptamine 1B/1D receptor agonist, which exerts its effect by selectively constricting intracranial dilated blood vessels and inhibiting the release of inflammatory neuropeptides from the trigeminal nerve. It can not only quickly relieve the headache symptoms during migraine attacks, but also simultaneously improve the accompanying symptoms such as nausea, photophobia and phonophobia, and has a low incidence of cardiovascular adverse reactions. It is suitable for the acute treatment of migraine patients aged over 12 years old and adults, especially for people with poor tolerance to other triptans.

At present, the global market size of acute migraine treatment drugs has exceeded 4 billion US dollars, among which triptans account for about 35%. With higher tolerance, almotriptan maintains a steady growth among the second-generation triptan products, with a compound annual growth rate of about 2.1%. Globally, generic drugs have occupied nearly 85% of the market share, while the domestic market is still in the stage to be developed. At present, there are no domestic almotriptan preparations on the market, and the market coverage of the original research product is relatively low. With the improvement of migraine diagnosis and treatment rate, there will be a broad space for domestic substitution in the future.

The original research enterprise of almotriptan is Almirall S.A., and the original trade name is Almogran. The core compound patent expired in Europe in 2012 and in the United States in 2013. The main dosage form approved for the original research product is tablet, with specifications of 6.25mg and 12.5mg, which has been included in the FDA Orange Book Reference Listed Drug Catalog. At present, there are no almotriptan preparations approved for marketing in China, and no valid almotriptan API Drug Master File (DMF) has been found on the CDE API registration platform. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of almotriptan impurity reference standards, covering the impurity requirements of the whole path of synthesis process and degradation research. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully support the whole process of API R&D, quality research and declaration of this variety.