PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
AboutPricing
Drug ReportsMidazolam
Midazolam
Buccolam, Midazolam, Midozalam, Nayzilam, Seizalam (midazolam) is a small molecule pharmaceutical. Midazolam was first approved as Versed on 1985-12-20. It is used to treat anxiety disorders, psychomotor agitation, and status epilepticus in the USA. It has been approved in Europe to treat epilepsy. It is known to target alpha-1B adrenergic receptor and thyrotropin-releasing hormone receptor.
Download report
Favorite
Searched
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Plot placeholder
Mock data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
behavior and behavior mechanismsD001520
mental disordersD001523
Trade Name
FDA
EMA
Midazolam, Nayzilam (discontinued: Midazolam, Seizalam, Versed)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Midazolam
Tradename
Company
Number
Date
Products
MIDAZOLAM IN 0.9% SODIUM CHLORIDEInfoRLifeN-211844 RX2021-03-22
2 products, RLD, RS
NAYZILAMUCBN-211321 RX2019-05-17
1 products, RLD, RS
Show 1 discontinued
Midazolam hydrochloride
Tradename
Company
Number
Date
Products
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)Rafa LaboratoriesN-216359 RX2022-08-08
1 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
midazolamANDA2025-10-02
midazolam hclunapproved drug other2016-04-06
midazolam hydrochlorideANDA2025-08-15
midazolam in 0.8% sodium chlorideANDA2025-05-19
midazolam in sodium chlorideANDA2025-03-02
mkh dose packunapproved drug other2019-03-05
mko melt dose packunapproved drug other2019-03-04
n/aNew Drug Application2024-05-09
nayzilamNew Drug Application2023-01-19
seizalamNew Drug Application2023-01-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
psychomotor agitation—D011595—
status epilepticusEFO_0008526D013226G41
anxiety disordersEFO_0006788D001008F41.1
Agency Specific
FDA
EMA
Expiration
Code
MIDAZOLAM, NAYZILAM, UCB INC
2026-05-17ODE-243
MIDAZOLAM HYDROCHLORIDE, SEIZALAM, MMT
2025-09-14ODE-207
Patent Expiration
Patent
Expires
Flag
FDA Information
Midazolam, Midazolam In 0.9% Sodium Chloride, Inforlife
109669902038-06-20DP
Midazolam, Nayzilam, Ucb Inc
82170332028-01-18DPU-2526
88093222028-01-18DP
92894322028-01-18DPU-2526
96874952028-01-18DPU-2526
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CD: Benzodiazepine derivative hypnotics and sedatives
— N05CD08: Midazolam
HCPCS
Code
Description
J2250
Injection, midazolam hydrochloride, per 1 mg
Clinical
Clinical Trials
1628 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
MelanomaD008545——1————1
NeoplasmsD009369—C801————1
Muscular atrophyD009133——1————1
Spinal muscular atrophyD009134EFO_0003823G12.11————1
Hepatitis bD006509——1————1
Chronic hepatitis bD019694EFO_0004239B18.11————1
HepatitisD006505—K75.91————1
Hepatitis aD006506EFO_0007305B151————1
Developmental disabilitiesD002658EFO_0003852F891————1
Show 5 more
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameMidazolam
INNmidazolam
Description
Midazolam is an imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. It has a role as a GABAA receptor agonist, an anticonvulsant, an anxiolytic drug, an apoptosis inducer, an antineoplastic agent, a muscle relaxant, a sedative, a general anaesthetic and a central nervous system depressant. It is an organochlorine compound, an imidazobenzodiazepine and a member of monofluorobenzenes.
Classification
Small molecule
Drug classBenzodiazepine
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Identifiers
PDB—
CAS-ID59467-70-8
RxCUI—
ChEMBL IDCHEMBL655
ChEBI ID6931
PubChem CID4192
DrugBankDB00683
UNII IDR60L0SM5BC (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP3A4
CYP3A4
Organism
Homo sapiens
Gene name
CYP3A4
Gene synonyms
CYP3A3
NCBI Gene ID
1576
Protein name
cytochrome P450 3A4
Protein synonyms
1,4-cineole 2-exo-monooxygenase, 1,8-cineole 2-exo-monooxygenase, Albendazole monooxygenase (sulfoxide-forming), Albendazole sulfoxidase, Cholesterol 25-hydroxylase, CYPIIIA3, CYPIIIA4, Cytochrome P450 3A3, Cytochrome P450 HLp, Cytochrome P450 NF-25, cytochrome P450, family 3, subfamily A, polypeptide 4, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 3, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 4, Cytochrome P450-PCN1, glucocorticoid-inducible P450, Nifedipine oxidase, P450-III, steroid inducible, Quinine 3-monooxygenase, taurochenodeoxycholate 6-alpha-hydroxylase
Uniprot ID
P08684
Mouse ortholog
—
—
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Midazolam
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 59,660 documents
View more details
Safety
Black-box Warning
Black-box warning for: Midazolam, Midazolam hydrochloride, Midazolam in 0.8% sodium chloride, Midazolam in sodium chloride, N/a, Nayzilam, Seizalam
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
15,917 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use