ClinicalTrials.gg
Drug

Midazolam clinical trials

Also written Versed, Dormicum, USL261 and SHP615.

studies test it
423
open now
55
in phase 3
46
first study started
1996

How each study uses Midazolam is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study

Get an email when these change. Save the Midazolam studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.

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Approvals

The first approval found in each region, with its record

United States
20 Dec 1985 · VERSED · NDA 018654 (FDA, Drugs@FDA)
European Union
4 Sept 2011 · Buccolam · EMEA/H/C/002267 (EMA)

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Name

Midazolam
267
Intranasal Midazolam
9
Midazolam injection
9
Midazolam oral solution
8
Oral midazolam
6

Brand

Versed
35
Dormicum
22
Buccolam
1

Development codes

USL261
4
SHP615
2

In one entry with another drug

Given together, or one or the other

Drug cocktail
3
Dexmedetomidine and Midazolam
3
fentanyl and midazolam
2
ketamine and midazolam
2
midazolam with fentanyl
2
Ketamine/Midazolam
2

Studies by the year they started

423 studies that test it; most in 2017 (27)

Studies that test Midazolam, by start year
YearStudies
19961
20001
20011
20032
20043
20057
20069
200711
200814
200914
201013
201117
201213
201321
201418
201525
201618
201727
201824
201923
202016
202127
202227
202322
202420
202525
202624

By phase

A phase 1/2 study counts in both.

Early Phase 1
12
Phase 1
109
Phase 2
45
Phase 3
46
Phase 4
123
No phase
108

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Who runs them

Industry 96 · Other 327

Assiut University (10) · Ain Shams University (8) · Seoul National University Hospital (8) · Tanta University (7) · Pfizer (7) · Eli Lilly and Company (7) · Boehringer Ingelheim (7) · Zagazig University (6)

Often tested with

Tested in the same studies.

Dexmedetomidine (84) · Propofol (52) · Ketamine (38) · Fentanyl (33) · Omeprazole (13) · Caffeine (11) · Remifentanil (10) · Sevoflurane (9)

Related medicines

As reviewed, each with the page that says it.

Coming up

From the study records. Dates are the sponsors’ own estimates and often move.

Tested against it · 8 phase 3 studies under way

Midazolam is the comparator. A study of two new drugs counts under both.

  • 3Dexmedetomidine · University Hospital, Tours, Post Graduate Institute of Medical Education and Research, Chandigarh · next primary completion Dec 2027
  • 2Ketamine · Abraham Nunes, Theresa Jacob, PhD, MPH · next primary completion Sep 2027
  • 1Nitrous Oxide · Women's College Hospital · next primary completion Feb 2027
  • 1Remimazolam · Guy's and St Thomas' NHS Foundation Trust
Reaching primary completion within a year · 25, 4 in phase 3

Studies that test Midazolam, phase 3 first.

Studies

Open first, then newest update. How each study uses Midazolam is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.

Testing it · 423

See all 423 studies that test Midazolam →

Given beside what is tested · 287 — Midazolam is usual care or a partner of the new treatment

Showing 20 of 287.

As the comparator · 158 — what is tested is compared with Midazolam

Showing 20 of 158.

Codes

What other systems call Midazolam · ClinicalTrials.gg INT007834

  • MeSH (NLM) D008874MidazolamConfirmed ClinicalTrials.gov, NLM, Wikidata
  • UNII (FDA) R60L0SM5BCMIDAZOLAMConfirmed FDA, NLM, Wikidata
  • RxNorm 6960Confirmed FDA, Wikidata
  • Wikidata Q423071midazolamConfirmed FDA, NLM, Wikidata
  • NCI Thesaurus C62049MidazolamOne source FDA
  • DrugBank DB00683One source Wikidata

Also registered as midazolam hydrochloride (UNII W7TTW573JJ · RxNorm 203128) and midazolam maleate (UNII 77520S18SE · RxNorm 142441).

“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.