Midazolam
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1985
- First approval year
- 1985
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Midazolam
- Molecular weight
- 325.77
- Structure (SMILES)
- Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
- midazolam in 0 8 sodium chloride
- midazolam in 0 9 sodium chloride
- Midazolam in 0.8% sodium chloride
- Midazolam in 0.9% sodium chloride
- nayzilam
- Nayzilam
- 4h imidazo 1 5 a 1 4 benzodiazepine 8 chloro 6 2 fluorophenyl 1 methyl
- 4H-IMIDAZO(1,5-A)(1,4)BENZODIAZEPINE, 8-CHLORO-6-(2-FLUOROPHENYL)-1-METHYL
- dormicum
- DORMICUM
- midazolam
- Midazolam
- MIDAZOLAM [EP MONOGRAPH]
- midazolam [INN]
- MIDAZOLAM [JAN]
- MIDAZOLAM [MART.]
- MIDAZOLAM [MI]
- MIDAZOLAM [ORANGE BOOK]
- MIDAZOLAM [USP MONOGRAPH]
- MIDAZOLAM [VANDF]
- Midazolam [WHO-DD]
- midazolam civ
- Midazolam civ
- MIDAZOLAM CIV [USP-RS]
- midazolam civ usp rs
- midazolam ep monograph
- midazolam inn
- midazolam jan
- midazolam mart
- midazolam mi
- midazolam orange book
And 7 more, listed on the interactive page.
- ATC classification codes
- N05CD08
Sources for recorded values
- CAS registry numbers
- 59467-70-8
- ChEMBL ID
- CHEMBL655
- InChIKey
- DDLIGBOFAVUZHB-UHFFFAOYSA-N
- PubChem compound IDs
- 4192
- FDA ingredient codes (UNII)
- R60L0SM5BC
- 6960
- 142441
- Applicant
- UCB INC
- Approval date
- 17 May 2019
- Application number
- NDA211321
- Status
- Authorised
- Status date
- 4 Sept 2011
- Authorisation date
- 4 Sept 2011
- Approved indications
- 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.
- Product number
- EMEA/H/C/002267
- Authorisation holder
- Neuraxpharm Pharmaceuticals S.L.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Epilepsy
European medicines record
- Patents
- 5
- Designations
- 1
- Earliest recorded loss of exclusivity
- 20 Jun 2038
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- midazolam
- Type
- Synthetic organic
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Parenteral
- topical
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- O00591
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- O14764
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P14867
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P18505
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P18507
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P28472
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P31644
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P34903
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P47869
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P47870
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P48169
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- P78334
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- Q16445
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- Q8N1C3
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- Q99928
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE_ALLOSTERIC_MODULATOR
- Target
- GABA-A receptor; anion channel
- Protein identifier
- Q9UN88
Open Targets mechanisms
- Mechanism
- GABA-A receptor; anion channel positive allosteric modulator
- Action type
- POSITIVE ALLOSTERIC MODULATOR
- Target
- GABA-A receptor; anion channel
- Action type
- POSITIVE ALLOSTERIC MODULATOR
- Gene symbol
- GABRA1|GABRG2|GABRB2
- Protein identifier
- P14867|P18507|P47870
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- POSITIVE ALLOSTERIC MODULATOR
- Gene symbol
- GABRA1|GABRB2|GABRG3
- Protein identifier
- P14867|P47870|Q99928
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- POSITIVE ALLOSTERIC MODULATOR
- Gene symbol
- GABRG2|GABRB3|GABRA5
- Protein identifier
- P18507|P28472|P31644
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- POSITIVE ALLOSTERIC MODULATOR
- Gene symbol
- GABRG2|GABRA5|GABRB2
- Protein identifier
- P18507|P31644|P47870
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- POSITIVE ALLOSTERIC MODULATOR
- Gene symbol
- GABRG2|GABRA3|GABRB2
- Protein identifier
- P18507|P34903|P47870
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- POSITIVE ALLOSTERIC MODULATOR
- Gene symbol
- GABRB3|GABRA5|GABRG3
- Protein identifier
- P28472|P31644|Q99928
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- POSITIVE ALLOSTERIC MODULATOR
- Gene symbol
- GABRA5|GABRB2|GABRG3
- Protein identifier
- P31644|P47870|Q99928
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- POSITIVE ALLOSTERIC MODULATOR
- Gene symbol
- GABRA3|GABRB2|GABRG3
- Protein identifier
- P34903|P47870|Q99928
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Trypanosomiasis
- Highest recorded phase
- 1
- Condition identifier
- DOID:10113
- Subject identifier
- D014352
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Dermatitis, Atopic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000274
- Subject identifier
- D003876
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Crohn Disease
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Epilepsy
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000474
- Subject identifier
- D004827
- Condition
- Hypertension
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Infertility
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000545
- Subject identifier
- D007246
- Condition
- Wounds and Injuries
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000546
- Subject identifier
- D014947
- Condition
- Mesothelioma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Psoriasis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000676
- Subject identifier
- D011565
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Skin Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000701
- Subject identifier
- D012871
- Condition
- Subarachnoid Hemorrhage
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000713
- Subject identifier
- D013345
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Melanoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- HIV Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Endometriosis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001065
- Subject identifier
- D004715
- Condition
- Malaria
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001068
- Subject identifier
- D008288
- Condition
- Obesity
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
And 90 more, listed on the interactive page.
- Condition identifier
- DOID_10113
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000222
- Condition identifier
- EFO_0000341
- Condition identifier
- EFO_0000474
- Condition identifier
- EFO_0000537
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000545
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000546
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000676
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001065
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001073
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001358
- Condition identifier
- EFO_0001422
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001645
- Condition identifier
- EFO_0003015
- Condition identifier
- EFO_0003015
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003103
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003144
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003768
And 125 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Warning
- Black Box Warning
- Country
- United States
- Warning
- Black Box Warning
- Effect
- misuse
- Country
- United States
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Country
- United States
- Event
- acidosis hyperchloraemic
- Reports
- 19
- Reporting signal score
- 68.1958
- Event
- agitation
- Reports
- 135
- Reporting signal score
- 134.276
- Event
- anaesthetic complication neurological
- Reports
- 29
- Reporting signal score
- 119.144
- Event
- anaphylactic reaction
- Reports
- 179
- Reporting signal score
- 232.407
- Event
- anaphylactic shock
- Reports
- 92
- Reporting signal score
- 138.832
- Event
- anorectal ulcer
- Reports
- 10
- Reporting signal score
- 53.9605
- Event
- apnoea
- Reports
- 52
- Reporting signal score
- 104.801
- Event
- bradycardia
- Reports
- 124
- Reporting signal score
- 103.023
- Event
- cardiac arrest
- Reports
- 104
- Reporting signal score
- 146.888
- Event
- circulatory collapse
- Reports
- 47
- Reporting signal score
- 64.8312
- Event
- cognitive disorder
- Reports
- 71
- Reporting signal score
- 70.1201
- Event
- coma
- Reports
- 101
- Reporting signal score
- 112.428
- Event
- congenital visual acuity reduced
- Reports
- 11
- Reporting signal score
- 55.7619
- Event
- delayed recovery from anaesthesia
- Reports
- 26
- Reporting signal score
- 85.5134
- Event
- delirium
- Reports
- 145
- Reporting signal score
- 226.052
- Event
- depressed level of consciousness
- Reports
- 78
- Reporting signal score
- 70.3447
- Event
- diabetes insipidus
- Reports
- 30
- Reporting signal score
- 76.7161
- Event
- drug reaction with eosinophilia and systemic symptoms
- Reports
- 120
- Reporting signal score
- 179.308
- Event
- drug resistance
- Reports
- 59
- Reporting signal score
- 60.8368
- Event
- drug withdrawal syndrome neonatal
- Reports
- 33
- Reporting signal score
- 52.2404
- Event
- encephalopathy
- Reports
- 55
- Reporting signal score
- 52.9665
- Event
- fatigue
- Reports
- 31
- Reporting signal score
- 85.1241
- Event
- female genital tract fistula
- Reports
- 21
- Reporting signal score
- 58.6956
- Event
- generalised tonic-clonic seizure
- Reports
- 74
- Reporting signal score
- 122.967
- Event
- haemodynamic instability
- Reports
- 33
- Reporting signal score
- 59.5209
And 32 more, listed on the interactive page.
- NCT00030004
- NCT00176670
- NCT00290082
- NCT00942539
- NCT02096900
- NCT02374567
- NCT03069677
- NCT03165500
- NCT04586504
- NCT05610969
- NCT00221520
- NCT00248729
- NCT00258050
- NCT00326612
- NCT00534378
- NCT06271096
- NCT00336882
- NCT05340803
- NCT00416039
- NCT00443170
- NCT00467779
- NCT01287598
- NCT01517399
- NCT01585623
- NCT01596647
And 214 more, listed on the interactive page.
- Dose
- Up to 2.5mg
- Route
- Intravenous
- Administer slowly over at least 2 minutes
- Total dose usually not exceeding 5mg
- Wait 2 minutes between doses
- Hydrogen bond acceptors
- 3
- Hydrogen bond donors
- 0
- Polar surface area
- 30.18
- Calculated partition coefficient (ALogP)
- 4.32
- Calculated partition coefficient (XLogP)
- 2.5
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 1
- Heavy atoms
- 23
- Molecular formula
- C18H13ClFN3
- Monoisotopic mass
- 325.0782033
- Natural product
- No
- 0264-8002
- 0264-8005
- 44567-610
- 44567-611
- 50474-500
- 71053-595
- Recorded assays
- 638
- Active assays
- 83
- Confirmatory
- Other
- Adjuvants, Anesthesia
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- Anesthetics, Intravenous
- GABA Modulators
These details could not be displayed.
Related records
Trials (1,034)
- (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
- 28-day Repeat Dose and Drug Interaction Study With Orvepitant (GW823296)
- A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion
- A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone
- A Clinical Study to Evaluate the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Healthy Volunteers and Renal Impairment Patients
- A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam
- A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)
- A Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury
- A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
- A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia
- A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit
- A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation
- A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
- A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
- A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration
- A Comparison of the Sedation During Endoscopy in Children
- A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors
- A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
- A Dose Escalation Study of ASP8273 in Subjects With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations
- A Double-Blind Pharmacokinetic Interaction Study Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure
Approved for (1)
- Epilepsy
In development for (92)
- Acute myeloid leukemia Phase 1
- Alzheimer disease Phase 1
- Amyotrophic lateral sclerosis Phase 1
- Anemia Phase 1
- Anti-neutrophil antibody associated vasculitis Phase 1
- Anxiety Phase 3
- Aspergillosis Phase 1
- Atherosclerosis Phase 1
- Atopic eczema Phase 1
- Autosomal dominant polycystic kidney disease Phase 1
- B-cell chronic lymphocytic leukemia Phase 1
- Bipolar disorder Phase 2
- Bone fracture Phase 3
- Borderline personality disorder Phase 2
- Brain injury Phase 3
- Breast cancer Phase 2
- Breast neoplasm Phase 2
- Burn Phase 1
- Cancer Phase 1
- Cardiovascular disorder Phase 1
Other linked conditions (5)
- Coronary artery disorder
- Female breast carcinoma
- Glioma
- Insomnia
- Vesicoureteral reflux
Targets (16)
- GABRA1 GABA-A receptor; anion channel positive allosteric modulator
- GABRA2 GABA-A receptor; anion channel positive allosteric modulator
- GABRA3 GABA-A receptor; anion channel positive allosteric modulator
- GABRA4 GABA-A receptor; anion channel positive allosteric modulator
- GABRA5 GABA-A receptor; anion channel positive allosteric modulator
- GABRA6 GABA-A receptor; anion channel positive allosteric modulator
- GABRB1 GABA-A receptor; anion channel positive allosteric modulator
- GABRB2 GABA-A receptor; anion channel positive allosteric modulator
- GABRB3 GABA-A receptor; anion channel positive allosteric modulator
- GABRD GABA-A receptor; anion channel positive allosteric modulator
- GABRE GABA-A receptor; anion channel positive allosteric modulator
- GABRG1 GABA-A receptor; anion channel positive allosteric modulator
- GABRG2 GABA-A receptor; anion channel positive allosteric modulator
- GABRG3 GABA-A receptor; anion channel positive allosteric modulator
- GABRP GABA-A receptor; anion channel positive allosteric modulator
- GABRQ GABA-A receptor; anion channel positive allosteric modulator