Fospropofol

Overview

Fospropofol is a water soluble prodrug and is converted to propofol in the liver. Fospropofol is a short acting hypnotic/sedative/anesthetic agent. Unlike propofol, does not cause injection-site pain as it is unable to activate TRPA1. FDA approved in December 2008. Fospropofol is a Schedule IV controlled substance in the United States under the Controlled Substances Act.

Background

Indication

For monitored anaesthesia care sedation in patients undergoing diagnostic procedures like bronchoscopy and colonscopy or minor surgical procedures like arthroscopy and bunionectomy.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment	2024/12/13	NCT06732427	Not Applicable	Not yet recruiting	Affiliated Hospital of Nantong University
Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial	2024/08/27	NCT06573489	Phase 4	Recruiting	Hui Xu
ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia	2024/04/03	NCT06344325	Phase 4	Recruiting	Tongji Hospital
Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation.	2024/02/15	NCT06261996	Not Applicable	Not yet recruiting	Henan Provincial People's Hospital
Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients	2024/02/09	NCT06251999	Phase 4	Not yet recruiting	Shanghai 6th People's Hospital
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients	2023/05/23	NCT05870514	Phase 2	Recruiting	Xiaobo Yang, MD
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients	2022/08/08	NCT05491278	Phase 2	Completed	Xiaobo Yang, MD
Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol	2011/07/25	NCT01401049	Phase 4	Completed	NYU Langone Health
Evaluate The Effectiveness Of Fospropofol (Lusedra®) For Induction Of Anesthesia	2011/06/22	NCT01378754	Not Applicable	Withdrawn	Grace Shih, MD
Fospropofol for Sedation During Elective Awake Intubation	2011/02/03	NCT01289483	Not Applicable	Withdrawn	The Cleveland Clinic

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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