Regulatory Approval

Etripamil awaits NMPA verdict in China after already winning FDA nod

Corxel's nasal-spray PSVT drug seeks approval in China by the third quarter of 2026, a market with 3 to 6 million patients, building on its December 2025 FDA clearance.

By AppliedXLJuly 13, 2026Trial NCT03464019

Executive Summary

China's drug regulator is weighing approval of a nasal-spray heart-rhythm treatment that already cleared the FDA, shifting the question from whether the drug works to whether the same result replicates for a new population.
The disclosed opportunity spans a patient population in China several times larger than the trial base that supported the original approval, making the review a reach question as much as a regulatory one.
The registrational trial backing the drug's approved use closed out abruptly after posting results, a pattern that ended in submission rather than in abandonment.
No other active program shares the drug's calcium-channel mechanism in this heart-rhythm condition, leaving the asset without a direct mechanistic rival in the indication it targets.

The filing

The NMPA accepted the New Drug Application for etripamil nasal spray in PSVT on January 17, 2025, and Corxel Pharmaceuticals has said it expects approval in the third quarter of 2026. The drug, branded CARDAMYST, is a rapid-acting calcium channel blocker delivered as an as-needed nasal spray rather than an infusion, letting patients self-administer during an episode outside a hospital setting. The FDA approved the same drug for the same indication in December 2025, which the sponsor described as the first self-administered treatment able to convert PSVT to sinus rhythm in adults in more than 30 years. Everest

The disclosed market

PSVT affects an estimated 2.3 to 4 per 1,000 individuals, representing 3 to 6 million patients in China, according to the March 2026 disclosure announcing Everest Medicines' acquisition of Greater China commercialization rights to the drug from Corxel. Everest agreed to pay Corxel $30 million upfront plus up to $20 million in milestones for those rights, and assumed obligations under a 2021 license agreement Corxel had entered with Milestone Pharmaceuticals, the drug's originator. That population figure sits well above the 1,097-patient enrollment of the pivotal U.S. trial that supported the FDA clearance. Everest+1

The pivotal trial

The registrational study behind the drug, NCT03464019 (NODE-301), enrolled 1,097 patients across the United States, Spain, Canada, the Netherlands and Poland before reaching a primary completion date of January 20, 2023. Its primary endpoint measured time to conversion of a PSVT episode to sinus rhythm within 5 hours in an earlier trial part, and within 30 minutes in later parts, after self-administered dosing. Enrollment grew from an original target of 500 to 748 over the trial's life, and the study posted results in July 2024 before its registry status moved to Terminated the same month, after having already reached Completed status in February 2023. That sequence, completion followed by a later termination flag alongside a results posting, reflects registry housekeeping around the disclosed results rather than a program halted before data existed. NCT03464019

Competitive position

No other active trial shares etripamil's Cav1.2 target in PSVT; the only other same-indication program identified in the competitive field, a pulsed-field ablation study out of China, uses a device mechanism rather than a calcium-channel blocker. Among calcium-channel blockers broadly, the closest analog is Corxel's own etripamil program (NCT05410860), also in PSVT, while all other Cav1.2-targeting trials found in the landscape address unrelated conditions such as hypertension, atrial fibrillation and Alzheimer's disease. With no validated non-Cav1.2 mechanism established for self-administered acute PSVT conversion in the disclosed field, the bar for the NMPA decision is whether the China-specific package reproduces the safety and efficacy profile the FDA already accepted, not whether a new mechanism proves itself.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.