The US FDA has approved Cypsedo (cipepofol, formerly ciprofol/HSK 3486) injection, an intravenous anesthetic developed by China’s Haisco Pharmaceutical Group, marking the first time a China-originated innovative intravenous anesthetic has received US marketing authorization. The approval represents a notable milestone for Haisco and Chinese pharmaceutical innovation, representing the first China-originated innovative intravenous anesthetic to enter the global market.
Cipepofol acts as a positive allosteric modulator of GABA-A receptors — the same primary target as propofol, the decades-old standard of care for anesthesia induction and procedural sedation. Haisco’s chemists modified the core alkylphenol scaffold by introducing a chiral cyclopropyl group, a structural change the company says yields a more favorable safety profile, including reduced injection-site pain, more stable hemodynamics, and a lower incidence of respiratory depression compared with propofol.
The US pivotal program was notably accelerated: after receiving FDA clearance to conduct clinical trials in 2021, Haisco was granted a waiver for Phase II evaluation and advanced directly to Phase III. All US clinical studies were completed in 2024. The pivotal data were published in Anesthesiology (Gan TJ, Bertoch T, Habib AS, et al., 2024), describing a multicenter, randomized, double-blind, controlled Phase III non-inferiority trial comparing cipepofol with propofol for induction of general anesthesia in adults. The trial met its primary non-inferiority endpoint, with Haisco reporting superior results in the head-to-head comparison against the standard of care.
Propofol has been the dominant intravenous induction agent since its initial FDA approval in 1989, but its clinical profile carries well-recognized limitations: injection-site pain on administration, dose-dependent hypotension, and respiratory depression, particularly in elderly or hemodynamically vulnerable patients. Etomidate offers an alternative where cardiovascular stability is paramount, though its use is constrained by adrenocortical suppression with repeated dosing. Cipepofol’s structural modification was designed specifically to address the respiratory and hemodynamic liabilities of propofol while preserving the rapid onset and clean recovery that make alkylphenol anesthetics clinically attractive.
In China, where cipepofol received NMPA approval in December 2020 under the trade name Sishuning, the drug has accumulated a substantial real-world footprint — adopted across more than 3,300 medical institutions and used in over 40 million patient visits as of May 2026, the company said. Multiple indications have since been added to the Chinese label, including ICU sedation during mechanical ventilation and, in September 2025, induction and maintenance of general anesthesia in children and adolescents. Whether the FDA label will ultimately encompass a similarly broad range of indications was not specified in Haisco’s announcement.