TheraRadar
Data updated: May 26, 2026

PROPOFOL

Other Approved 1999-01-04

Propofol is an intravenous general anesthetic and sedative. It is indicated for the induction of general anesthesia in patients 3 years of age and older and for the maintenance of general anesthesia in patients as young as 2 months old. It is also used for Monitored Anesthesia Care (MAC) sedation in adults and as a sedative for adults receiving regional anesthesia. Additionally, propofol is indicated for the sedation of intubated, mechanically ventilated adult patients in the Intensive Care Unit (ICU). Use for MAC sedation or ICU sedation in pediatric patients is not recommended.

Source: FDA Label • Baxter • General Anesthetic
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How PROPOFOL Works

The precise mechanism of action for propofol is not fully understood. However, it is thought to produce its sedative and anesthetic effects through the positive modulation of the inhibitory function of the neurotransmitter GABA via ligand-gated $GABA_A$ receptors.

Source: FDA Label
11
Indications
--
Phase 3 Trials
27
Years on Market

Details

Status
None (Tentative Approval)
First Approved
1999-01-04
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Baxter INNOPHARMA ESI LEDERLE Teva Dr. Reddy's GENSIA SICOR PHARMS Pfizer WATSON LABS INC ASPIRO AMNEAL Hikma AVET LIFESCIENCES NANJING KING FRIEND SAGENT PHARMS INC
Active Ingredient: PROPOFOL

PROPOFOL Approval History

2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
49 FDA actions from 1999 to 2025
Dec 2025 ORIGINAL
Update
Sep 2025 SUPPL
Label · Labeling
Aug 2025 SUPPL
Label · Labeling

What PROPOFOL Treats

1 indications

PROPOFOL is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Sedation
Source: FDA Label

PROPOFOL Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

10

Same target(s), different indications — where else is this mechanism being explored?

ZURZUVAE
Biogen
2023 1 indic.
ZTALMY
IMMEDICA PHARMA
2022 2 indic.

Indication competitors

3

Same indication, different mechanism — what else might this patient receive?

DEXMEDETOMIDINE HYDROCHLORIDE
Teva
2014 1 indic.
FLUMAZENIL
Baxter
2004 2 indic.
Unlock 9 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to PROPOFOL

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE
1 shared
Teva
Shared indications:
Sedation
FLUMAZENIL
FLUMAZENIL
1 shared
Baxter
Shared indications:
Sedation
PRECEDEX
DEXMEDETOMIDINE HYDROCHLORIDE
1 shared
Pfizer
Shared indications:
Sedation
📋

Clinical Trial Registry

344 trials
Trial Sponsor ID Phase Status Title
NCT07479550 SPACE 72097 Ph 2 not yet recruiting Study of Psilocybin Under Anesthesia Controlled by EEG
NCT07556523 IRB2025-0154 Ph 4 recruiting Patient Quality of Recovery After TAVR With Different Sedation Regimens
NCT06674226 Linyanshen[2024]201-002 Ph 4 recruiting Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery
NCT05305313 EC/01/22/1992 Ph 4 recruiting Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaesthesia Delivery System
NCT04680910 results posted 202008037 U01MH128483 Ph 1 completed Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) I
NCT06330038 GASTIVA SMC 2024-01-065 Ph 4 recruiting Anesthesia and Non-small Cell Lung Cancer Recurrence
NCT05092152 PROMINE PROMINE Ph 2 completed Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients
NCT06690424 CRCF-YXFN-202401029 Ph 4 completed Clinical Studies of the Efficacy and Safety of Remimazolam for Anesthesia Induction and Maintenance in Elderly Patients
NCT07510945 HSK3486-401 Ph 3 not yet recruiting HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery
NCT05312385 INSPiRE-ICU1 results posted SED003 Ph 3 completed Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)
NCT05327296 INSPiRE-ICU2 results posted SED004 Ph 3 completed Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)
NCT07161518 79882 Ph 4 enrolling by invitation Characterizing Transcranial Focused Ultrasound Neuromodulation During Sedation
NCT07456111 Bypro LOC-100018379 Ph 4 recruiting A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
NCT07269808 SERENE 2025P002893 Ph 3 recruiting Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration
NCT06772727 MD-265-2024 Ph 4 completed Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy
NCT07000526 IS-CRITIC HULP6844 2024-518521-14-00 Ph 4 recruiting Inhaled Sedation in Critically Ill Patients
NCT06784479 IRB2024-YX-607-01 82300120 Ph 4 active not recruiting Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy
NCT07404306 HSK3486-110 Dose Finding Ph 1 completed Part 1: Dose-Finding of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users
NCT07028593 CP-MINS TJ-IRB202502133 Ph 4 recruiting Effects of Ciprofol on Myocardial Injury After Non-cardiac Surgery in Video-Assisted Thoracoscopic Surgery
NCT07347496 RAA-TS HNMU-RAA-TS-2026-001 Ph 4 not yet recruiting A Randomized, Controlled Clinical Trial Comparing Remimazolam Besylate Combined With Alfentanil Versus Propofol Combined With Alfentanil for Anesthesia in Thoracic Surgery
NCT07348614 Pro00118605 Ph 4 not yet recruiting Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia
NCT05881291 2023-0135 Ph 4 completed Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement
NCT02527083 results posted PRO00000878 Ph 4 completed Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
NCT06129188 IRB-300011945 UAB Ph 1 completed Comparison of Procedural Sedation in TEE
NCT05643066 K2021-12-067 Ph 4 completed Esketamine-propofol Versus Propofol for Flexible Bronchoscopy
NCT00577200 MACDrive ABuv110507 Ph 4 active not recruiting Safety of Driving After Minor Surgery With Monitored Anesthesia Care
NCT06741930 Ketamin stdy 35-2024 Ph 4 completed Pro-Epileptic Effects of IV Ketamine
NCT07268924 EA-CHT-PvL-2025 Ph 4 not yet recruiting The Effect of Propofol Versus Lidocaine on Emergence Agitation in Children Undergoing Tonsillectomy.
NCT06344949 B2024-074 Ph 4 completed Ciprofol Versus Propofol for Tracheal Intubation in ICU
NCT07118579 RCTIVA Ph 4 recruiting Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy
NCT07213544 Pro00146765 Ph 4 recruiting Remimazolam vs Propofol in Laser Burn Cases
NCT06867549 SWIPED II 202411168 U01MH128483 Ph 2 recruiting Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II
NCT05478174 results posted HSK3486-305 Ph 3 completed Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia
NCT05486416 results posted HSK3486-309 Ph 3 completed Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery
NCT04711837 results posted HSK3486-304 Ph 3 completed Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery
NCT05268562 21-004327 Ph 4 active not recruiting Ketamine and Kidney Injury in Cardiac Surgery
NCT06312618 FMASU MD292/2023 Ph 4 completed Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation
NCT05728775 REPOSE-2 NFEC-2022-286 Ph 4 recruiting REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry
NCT07080528 AITT 2023/8 2024-515545-41-00 Ph 4 enrolling by invitation Measuring of the Duration of Action of Different Doses of Rocuronium-induced Neuromuscular Block in Infants During Surgical Treatment of Craniosynostosis
NCT07094945 2025S076 Ph 4 not yet recruiting The Effect of Remimazolam on Postoperative Sleep Quality
NCT04532606 2020-212 Ph 4 recruiting Impact of Remimazolam on Prognosis After Bladder Cancer Surgery
NCT02727296 VAPOR-2 VAPOR-002 Ph 4 completed Volatile Anesthetic Protection Of Renal Transplants 2
NCT06763705 607/45/15284 Ph 4 recruiting Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy
NCT07086911 ZKL-KY20241015-78 Ph 1, Ph 2 not yet recruiting The Impact of Remimazolam Tosilate on Oxygenation and Postoperative Cognitive Function in Elderly Patients Undergoing Thoracoscopic Lobectomy
NCT07076628 J In 2021-1 Ph 4 completed Respiratory Depression of Remimazolam vs. Propofol for Monitored Anesthesia Care
NCT06391931 HSK3486-310 Ph 3 completed A Multicenter, Open, Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cipepofol Injection for General Anesthesia in Pediatric Patients Undergoing Elective Surgery
NCT05822817 K3501 Ph 4 completed Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery
NCT03729011 DELICATE 18 Ph 4 completed Delirium Reduction by Volatile Anesthesia in Cardiac Surgery
NCT06777758 Remimazolam KSVGH24-CT8-16 Ph 4 recruiting Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments
NCT03034096 GA-CARES 967670-3 Ph 4 completed General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial

Showing 50 of 344 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PROPOFOL FDA Label Details

Indications & Usage

FDA Label (PDF)

PROPOFOL is indicated for the treatment of Sedation.

Looking for the branded version?

DIPRIVAN

Full clinical data, patents, trials, and competitive landscape for propofol.

See DIPRIVAN

Data Sources

FDA Approval: ANDA074719 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.