Last reviewed 2026-05-14 · How we verify

Midazolam HCI

Eisai Inc. · Phase 3 active Small molecule

Midazolam HCI is a Benzodiazepine Small molecule drug developed by Eisai Inc.. It is currently in Phase 3 development for Preoperative sedation and anxiolysis, Induction of general anesthesia, Acute seizure management.

Midazolam is a benzodiazepine that enhances the inhibitory effects of GABA at GABA-A receptors in the central nervous system, producing sedation, anxiolysis, and muscle relaxation.

Midazolam is a benzodiazepine that enhances the inhibitory effects of GABA at GABA-A receptors in the central nervous system, producing sedation, anxiolysis, and muscle relaxation. Used for Preoperative sedation and anxiolysis, Induction of general anesthesia, Acute seizure management.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Midazolam HCI
Sponsor	Eisai Inc.
Drug class	Benzodiazepine
Target	GABA-A receptor
Modality	Small molecule
Therapeutic area	Neurology/Anesthesia
Phase	Phase 3

Mechanism of action

Midazolam binds to GABA-A receptors and potentiates the action of the inhibitory neurotransmitter GABA, increasing chloride ion influx and hyperpolarizing neuronal membranes. This results in depression of central nervous system activity, making it useful for sedation, anxiety relief, and preoperative anxiolysis. The drug has a rapid onset and short duration of action due to its high lipophilicity and rapid redistribution.

Approved indications

Preoperative sedation and anxiolysis
Induction of general anesthesia
Acute seizure management
Procedural sedation

Common side effects

Drowsiness
Dizziness
Headache
Respiratory depression
Hypotension
Amnesia

Key clinical trials

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:

Midazolam HCI CI brief — competitive landscape report
Midazolam HCI updates RSS · CI watch RSS
Eisai Inc. portfolio CI

Frequently asked questions about Midazolam HCI

What is Midazolam HCI?

Midazolam HCI is a Benzodiazepine drug developed by Eisai Inc., indicated for Preoperative sedation and anxiolysis, Induction of general anesthesia, Acute seizure management.

How does Midazolam HCI work?

Midazolam is a benzodiazepine that enhances the inhibitory effects of GABA at GABA-A receptors in the central nervous system, producing sedation, anxiolysis, and muscle relaxation.

What is Midazolam HCI used for?

Midazolam HCI is indicated for Preoperative sedation and anxiolysis, Induction of general anesthesia, Acute seizure management, Procedural sedation.

Who makes Midazolam HCI?

Midazolam HCI is developed by Eisai Inc. (see full Eisai Inc. pipeline at /company/eisai).

What drug class is Midazolam HCI in?

Midazolam HCI belongs to the Benzodiazepine class. See all Benzodiazepine drugs at /class/benzodiazepine.

What development phase is Midazolam HCI in?

Midazolam HCI is in Phase 3.

What are the side effects of Midazolam HCI?

Common side effects of Midazolam HCI include Drowsiness, Dizziness, Headache, Respiratory depression, Hypotension, Amnesia.

What does Midazolam HCI target?

Midazolam HCI targets GABA-A receptor and is a Benzodiazepine.

Drug class: All Benzodiazepine drugs
Target: All drugs targeting GABA-A receptor
Manufacturer: Eisai Inc. — full pipeline
Therapeutic area: All drugs in Neurology/Anesthesia
Indication: Drugs for Preoperative sedation and anxiolysis
Indication: Drugs for Induction of general anesthesia
Indication: Drugs for Acute seizure management

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing