CYPSEDO (Cipepofol)

CYPSEDO (cipepofol), from Haisco Pharmaceutical Group, is an intravenous general anaesthetic approved by the US FDA on 29 May 2026 for the induction of general anaesthesia in adults undergoing surgery. According to Haisco, it is the first innovative intravenous anaesthetic originating in China to be approved in the US.

Like propofol, cipepofol acts on GABA-A receptors in the brain to produce a rapid loss of consciousness. In a US Phase III non-inferiority trial against propofol, it induced anaesthesia at a comparable rate, with fewer patients reporting pain on injection. The dose is calculated from the patient’s weight and adjusted for age group, BMI and ASA physical status.

• Contraindicated in patients allergic to cipepofol or any of its ingredients, or with a history of anaphylaxis to eggs, egg products, soybeans or soy products.
• Life-threatening allergic reactions, slow heart rate, low blood pressure, cardiac arrest and breathing depression can occur; patients must be monitored continuously by anaesthesia staff.
• It is an emulsion that can support microbial growth: use strict aseptic technique, use each vial for one patient only and discard opened vials within 12 hours.
• Not approved for children. Repeated or prolonged use of general anaesthetics in children under 3 years may affect brain development.
• In the US, cipepofol is a Schedule IV controlled substance.

Who can order CYPSEDO?

CYPSEDO is used only in operating theatres by anaesthesia teams, so it is ordered by a hospital (usually the anaesthesia department or hospital pharmacy) on a named-patient or hospital basis, not by individual patients.

Which pack sizes are available?

The US label lists a single strength: 50 mg in 20 mL (2.5 mg/mL), a white to off-white ready-to-use emulsion in single-dose vials, supplied in packs of 5, 10 or 25 vials.

What documents do we need?

• A requisition from the hospital’s anaesthesia department or a prescription from the treating anaesthesiologist
• Details of the hospital where it will be used
• For a hospital order, the hospital’s registration details; for a named patient, the patient’s photo ID

Nothing is booked until our team has gone through the requisition or prescription.

How is CYPSEDO stored?

The US label asks for vials to be stored between 2 °C and 25 °C and not frozen. Shake the vial well before use. FDA’s approval letter gives a shelf life of 36 months from manufacture under these conditions.

Because CYPSEDO is a newly approved anaesthetic and a controlled substance in the US, supply depends on the manufacturer’s commercial launch and export permissions. We confirm availability, pack size and expected timelines with every hospital enquiry.

Hospitals can ask about CYPSEDO price in India on +91 96548 60915 or +91 93100 90915 (WhatsApp +91 98104 69557), or at info@indianpharmanetwork.in.

Global Approval Status:

• United States: FDA-approved on 29 May 2026 for induction of general anaesthesia in adults undergoing surgery. DEA placed cipepofol in Schedule IV (interim final rule effective 27 August 2026).
• China: Approved earlier for several uses, including sedation and anaesthesia for procedures, induction and maintenance of general anaesthesia, and ICU sedation.

Sources:

• CYPSEDO US Prescribing Information (FDA, 2026)
• FDA approval letter, NDA 220482 (Haisco-USA Pharmaceuticals)
• DEA: Placement of cipepofol in Schedule IV (Federal Register, 27 August 2026)

Information last checked: November 2026.

What is CYPSEDO indicated for?

It is an intravenous GABA-A receptor modulator anaesthetic, prescribed for induction of general anaesthesia in adults.

Which company makes CYPSEDO?

Haisco Pharmaceutical Group.

What is the mechanism of CYPSEDO?

Like propofol, cipepofol acts on GABA-A receptors in the brain to produce a rapid loss of consciousness.

How is CYPSEDO different from propofol?

It acts on the same GABA-A target; in its US trial it was comparable to propofol for inducing anaesthesia and caused less injection-site pain.

Is CYPSEDO a controlled substance?

Yes, in the United States. The DEA placed cipepofol in Schedule IV through an interim final rule effective 27 August 2026.

Does CYPSEDO have FDA approval?

Yes. The FDA approved CYPSEDO on 29 May 2026 for the induction of general anaesthesia in adults undergoing surgery.