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Sedation with midazolam
Sedation with midazolam is a Benzodiazepine Small molecule drug developed by Consorci Sanitari de l'Anoia. It is currently in Phase 3 development for Procedural sedation and anxiolysis, Induction of general anesthesia, Acute anxiety and agitation.
Midazolam is a benzodiazepine that enhances the inhibitory effects of GABA at the GABA-A receptor, depressing central nervous system activity to produce sedation.
Midazolam is a small molecule that acts as a positive allosteric modulator of the GABA-A receptor and anion channel. It is used for sedation in various medical procedures, including ERCP, dental sedation, and treatment of conditions such as choledocholithiasis, cholangiocarcinoma, pancreatitis, and pancreatic cancer.
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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 | Sedation with midazolam |
|---|---|
| Sponsor | Consorci Sanitari de l'Anoia |
| Drug class | Benzodiazepine |
| Target | GABA-A receptor |
| Modality | Small molecule |
| Therapeutic area | Anesthesia/Sedation |
| Phase | Phase 3 |
Mechanism of action
Midazolam binds to GABA-A receptors in the brain, potentiating the effect of the inhibitory neurotransmitter GABA. This increases chloride ion influx into neurons, hyperpolarizing the cell membrane and reducing neuronal excitability. The result is rapid onset sedation, anxiolysis, and amnesia, making it suitable for procedural sedation and anesthesia induction.
Approved indications
- Procedural sedation and anxiolysis
- Induction of general anesthesia
- Acute anxiety and agitation
Common side effects
- Respiratory depression
- Hypotension
- Oversedation
- Paradoxical reaction (agitation, disinhibition)
- Amnesia
Key clinical trials
- HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids (NA)
- Comparison Of The Effects Of Regional Anesthesia On Brain And Carotid Artery Oxygenation In Shoulder Surgery (NA)
- Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia (NA)
- Characteristic Electroencephalogram of General Anesthesia
- Virtual Reality to Improve Patient Experience During Endoscopic Mucosal and Submucosal Resection (NA)
- Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy (NA)
- Prospective IR-led Sedation Feasibility (PHASE1, PHASE2)
- Functional Outcomes After LumbOpenitoneal Shunt Placement UndeR Local Anesthesia for Patients With Idiopathic Normal preSsure Hydrocephalus (FLOURISH) Trial (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:
- Sedation with midazolam CI brief — competitive landscape report
- Sedation with midazolam updates RSS · CI watch RSS
- Consorci Sanitari de l'Anoia portfolio CI
Frequently asked questions about Sedation with midazolam
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What does Sedation with midazolam target?
Related
- Drug class: All Benzodiazepine drugs
- Target: All drugs targeting GABA-A receptor
- Manufacturer: Consorci Sanitari de l'Anoia — full pipeline
- Therapeutic area: All drugs in Anesthesia/Sedation
- Indication: Drugs for Procedural sedation and anxiolysis
- Indication: Drugs for Induction of general anesthesia
- Indication: Drugs for Acute anxiety and agitation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing