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Drug

Midazolam

Approved · EMA
ClassGABA-A receptor; anion channel positive allosteric modulatorEmerging researchLate-stage developmentRising momentum

Also known as Nayzilam, Versed, Midazolam Hydrochloride, Midazolamum.

9
Research papers
16
Active clinical trials
16
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Sex Differences in Organophosphate Model of Benzodiazepine-Refractory Status Epilepticus and Neuronal Damage.

Research2024-01-17The Journal of pharmacology and experimental therapeutics

Approval: Buccolam (EMA)

Regulatory2011-09-04EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Midazolam
Aliases & brands
NayzilamVersedMidazolam HydrochlorideMidazolamum
RxNorm CUI
6960
ChEMBL ID
CHEMBL655
ATC codes
N05CD08
UNII
R60L0SM5BC
Primary mechanism
GABA-A receptor; anion channel positive allosteric modulator
Regulatory jurisdictions
ema

Pharmacology & targets

16 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORGABA-A receptor; anion channel positive allosteric modulator

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2011-09-04
Latest approval
2011-09-04
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2011-09-04Approval
Approval: Buccolam (EMA)
Indication: Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults.BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to haveShow full indication

Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults.BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have epilepsy.For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. See section 4.2.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

193 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
193
registered trials across all phases
LATEST COMPLETION 2026
16
Active studies
11
Recruiting
91
Late-stage (III+)
126
Completed
51
Discontinued
PHASE DISTRIBUTIONn = 193
Early Phase 13Phase 186Phase 1 / 26Phase 27Phase 2 / 34Phase 39Phase 442Phase N / A36

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

9 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20032024
Most influential
Recent papers
Major research themes8
Organophosphate Poisoning2Status Epilepticus2Brain Injuries1Colonoscopy1Length of Stay1Nerve Agents1Neuroprotective Agents1Neurosteroids1
Journals, researchers & institutions
Top journals
  • Annals of emergency medicine2
  • The Journal of pharmacology and experimental therapeutics2
  • Anesthesia and analgesia1
  • Chest1
  • Gastrointestinal endoscopy1
  • Nature communications1
Leading researchers
  • Ramakrishnan S2
  • Reddy DS2
  • Singh T2
  • Wu X2
  • Abrahao A1
  • Akulian J1
  • Aubert I1
  • Barish CF1
Leading institutions
free-text, unnormalised
  • Advanced Clinical Research Institute1
  • Advocate Christ Medical Center1
  • Borland-Groover Clinic1
  • Department of Laboratory Medicine and Pathobiology1
  • Department of Neuroscience and Experimental Therapeutics and Institute of Pharmacology and Neurotherapeutics1
  • Duke University Medical Center1

Related diseases

4 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Midazolam, with 4 overlapping disease areas.

16 shared targets4 shared diseases1 shared paper

Studied across 7 of the same disease areas as Midazolam in the shared literature.

7 shared diseases2 shared papers

Studied across 4 of the same disease areas as Midazolam in the shared literature.

4 shared diseases1 shared paper

Studied across the same disease area as Midazolam in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.