Beraprost Sodium Market

The Beraprost Sodium market is witnessing a CAGR of 6.5% during the forecast period of 2025-2035. Beraprost sodium is an oral prostacyclin analog used for treating conditions like pulmonary arterial hypertension (PAH) and chronic arterial occlusive disease. The evolution of beraprost sodium constituted a tremendous break in the treatment of cardiovascular ailments, presenting the option of stable administration that contrasted sharply with naturally unstable prostacyclin. Vasodilation and inhibition of platelets by the substance help make it effective in terms of enhancing exercise tolerance and curative symptomatolysis for such vascular pathologies.​

Preparation of beraprost sodium requires a sophisticated multi-step chemical reaction for the purpose of obtaining high-purity active pharmaceutical ingredient (API). It involves preparation of certain intermediates and control of reaction conditions in a way to provide the requisite stereochemistry and potency of the product. For example, sodium hydroxide is favored for use in the preparation of beraprost sodium salt to attain maximum yield and purity.

Regulatory control is an important aspect in the approval and surveillance of beraprost sodium. In the US, the Food and Drug Administration (FDA) granted beraprost sodium orphan drug status for PAH treatment on December 22, 2011. But the status was withdrawn on January 17, 2020. Worldwide, beraprost sodium has been approved in Japan and South Korea for PAH treatment, and in China, the National Medical Products Administration (NMPA) approved a sustained-release version called Careload® for the same indication. Clinical trials have played a key role in proving the safety and efficacy of beraprost sodium. For instance, a multinational phase IIb/III trial in several Asian countries followed strict ethical guidelines and obtained approval from relevant regulatory authorities. These trials have shown that beraprost sodium has a marked effect on exercise tolerance and hemodynamic indices in PAH patients.