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propofol (drug)
propofol (drug) is a GABA receptor agonist Small molecule drug developed by B. Braun Melsungen AG. It is currently in Phase 3 development for General anesthesia, Sedation for mechanical ventilation, Sedation for diagnostic or surgical procedures.
Propofol is a short-acting sedative-hypnotic agent that acts on the central nervous system to induce and maintain anesthesia.
Propofol is a small molecule that acts as a positive allosteric modulator of the GABA-A receptor, an anion channel. It is used in medical settings for conditions such as sedation, anesthesia, and spinal anesthesia, among others.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | propofol (drug) |
|---|---|
| Sponsor | B. Braun Melsungen AG |
| Drug class | GABA receptor agonist |
| Target | GABA_A receptor |
| Modality | Small molecule |
| Therapeutic area | Anesthesiology |
| Phase | Phase 3 |
Mechanism of action
Propofol works by enhancing the inhibitory neurotransmission mediated by GABA (gamma-aminobutyric acid), a major inhibitory neurotransmitter in the brain. This results in a decrease in neuronal excitability, leading to sedation, hypnosis, and amnesia.
Approved indications
- General anesthesia
- Sedation for mechanical ventilation
- Sedation for diagnostic or surgical procedures
Common side effects
- Respiratory depression
- Hypotension
- Bradycardia
- Nausea and vomiting
- Headache
- Dizziness
Key clinical trials
- Total Intravenous and Balanced Anesthesia in Diabetic Patients Undergoing Video-Assisted Thoracoscopy (PHASE4)
- The Relationship Between Opioid-Free Anesthesia and Postoperative Agitation-Delirium and Quality of Recovery in Pediatric Ear, Nose, and Throat Cases Monitored With Perioperative Bispectral Index
- EEG and Pain Monitor Data Under Anesthesia to Study Pharmacodynamic Effects of Opioids and Sedatives (NA)
- Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery (PHASE1)
- Effect of Remimazolam and Propofol on Postoperative Delirium (NA)
- Hemodynamic Effects of Remimazolam vs Propofol During Robot-assisted Gynecologic Surgery (NA)
- Propofol Versus Sevoflurane Anesthesia on the Intraocular Pressure and Hemodynamics in Patient Undergoing Cyclophotocoagulation (NA)
- Actualities in Procedural Sedation: Remimazolam (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- propofol (drug) CI brief — competitive landscape report
- propofol (drug) updates RSS · CI watch RSS
- B. Braun Melsungen AG portfolio CI
Frequently asked questions about propofol (drug)
What is propofol (drug)?
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What development phase is propofol (drug) in?
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What does propofol (drug) target?
Related
- Drug class: All GABA receptor agonist drugs
- Target: All drugs targeting GABA_A receptor
- Manufacturer: B. Braun Melsungen AG — full pipeline
- Therapeutic area: All drugs in Anesthesiology
- Indication: Drugs for General anesthesia
- Indication: Drugs for Sedation for mechanical ventilation
- Indication: Drugs for Sedation for diagnostic or surgical procedures
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing