Montreal, Quebec, and Charlotte, North Carolina — September 3, 2026
Milestone Pharmaceuticals announced that China’s National Medical Products Administration (NMPA) has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults, marking the first regulatory approval for etripamil outside the United States. The approval represents a significant regulatory and commercial milestone for Milestone as the company expands its cardiovascular medicine into the Chinese market. Etripamil, marketed in the United States as CARDAMYST® nasal spray, is a self-administered treatment designed to rapidly convert acute PSVT episodes to normal sinus rhythm. Under its agreement with Everest Medicines, which holds exclusive rights to develop and commercialize etripamil across Greater China, the approval also activates a $2 million milestone payment to Milestone..
Etripamil Targets an Important PSVT Treatment Need
PSVT is a type of abnormal heart rhythm characterized by sudden episodes of rapid heartbeat that can exceed 150 to 200 beats per minute and may cause palpitations, shortness of breath, chest discomfort, dizziness and significant disruption to daily activities. Milestone’s etripamil nasal spray is designed around a self-administered, rapid-response approach, potentially allowing adults experiencing an acute PSVT episode to receive treatment without immediately requiring medical administration. The China approval is particularly significant because an estimated 3 million to 6 million people in China are diagnosed with PSVT. By bringing an approved nasal formulation of a calcium channel blocker into this population, Milestone and Everest Medicines aim to expand treatment options for patients who may otherwise require emergency department care or other interventions during acute episodes. The regulatory decision therefore represents more than a geographic expansion, establishing an additional commercial market for Milestone’s lead cardiovascular product.
China Phase 3 Data Supported Regulatory Approval
The NMPA approval was supported by evidence from the global pivotal Phase 3 RAPID study together with the China-based Phase 3 JX02002 study. In JX02002, etripamil demonstrated statistically significant superiority over placebo in converting PSVT to sinus rhythm within 30 minutes of treatment, with a hazard ratio of 3.002 and a p-value of 0.0005. Safety findings across the Phase 3 studies were also supportive, with treatment-emergent adverse events reported as comparable between the etripamil and placebo groups and no serious adverse events reported within 24 hours after dosing. While these results supported the regulatory decision, the most important development for Milestone is that the data have now translated into a regulatory approval in China, moving etripamil beyond its U.S. market and creating a new opportunity for broader international commercialization
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Everest Medicines to Lead Greater China Commercialization
Under the licensing agreement, Everest Medicines will lead commercialization of etripamil across Greater China, including Mainland China, Hong Kong, Macau and Taiwan. Milestone is eligible to receive up to $98 million in development and commercial milestones, in addition to tiered royalties of up to 18% on future Greater China sales. The China approval provides the first regulatory foundation for this partnership and represents an important step in Milestone’s international expansion strategy for etripamil. In the United States, etripamil is already approved as CARDAMYST® for converting acute symptomatic PSVT episodes to sinus rhythm in adults, while the broader development program is evaluating etripamil in additional cardiovascular settings. With the NMPA decision now secured, attention will shift toward commercialization activities in China and the potential expansion of access to etripamil for adults living with PSVT across the Greater China region.
Source:Milestone Pharmaceuticals,press relese
