Versed, Buccolam(midazolam maleate)
Buccolam, Nayzilam, Seizalam (midazolam maleate) is a small molecule pharmaceutical. Midazolam maleate 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.
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Commercial
Trade Name
FDA
EMA
Nayzilam, Seizalam (generic drugs available since 2000-06-20, discontinued: Midozalam, Versed)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Midazolam
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| midazolam | ANDA | 2023-05-16 |
| nayzilam | New Drug Application | 2021-02-11 |
| seizalam | New Drug Application | 2021-11-26 |
| versed spf 30 replenishing body mineral | OTC monograph final | 2023-05-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anxiety disorders | EFO_0006788 | D001008 | F41.1 |
| psychomotor agitation | — | D011595 | — |
| status epilepticus | EFO_0008526 | D013226 | G41 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MIDAZOLAM, NAYZILAM, UCB INC | |||
| 2026-05-17 | ODE-243 | ||
MIDAZOLAM HYDROCHLORIDE, SEIZALAM, MMT | |||
| 2025-09-14 | ODE-207 | ||
HCPCS
No data
Clinical
Clinical Trials
922 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 141 | 1 | — | 2 | 2 | 146 | ||
| Anesthesia | D000758 | 3 | 1 | 4 | 11 | 10 | 28 | ||
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | 4 | 1 | 11 | 11 | 27 |
| Neoplasms | D009369 | C80 | 23 | 2 | — | 1 | 2 | 26 | |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 5 | 8 | 3 | 5 | 3 | 21 |
| Pain | D010146 | EFO_0003843 | R52 | 4 | 3 | — | 5 | 7 | 19 |
| Postoperative pain | D010149 | G89.18 | 2 | 6 | 2 | 2 | 7 | 15 | |
| Delirium | D003693 | R41.0 | — | 1 | 1 | 5 | 4 | 11 | |
| Critical illness | D016638 | — | 2 | 4 | 4 | 3 | 11 | ||
| Conscious sedation | D016292 | 1 | — | 2 | 5 | 2 | 10 |
Show 129 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 2 | 1 | — | 1 | 8 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 6 | 3 | — | 1 | 8 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | 1 | 1 | 1 | — | 4 | 7 |
| Acute pain | D059787 | R52 | — | 1 | 1 | — | 3 | 4 | |
| Low back pain | D017116 | HP_0003419 | M54.5 | 1 | — | 2 | — | — | 3 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | 1 | — | 1 | — | — | 2 |
| Chronic pain | D059350 | HP_0012532 | 1 | — | 1 | — | — | 2 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | 1 | — | — | 2 |
| Procedural pain | D000073818 | — | — | 2 | — | — | 2 | ||
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 1 | — | 1 | 2 |
Show 22 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | 1 | 3 | — | — | 1 | 4 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 2 | 1 | — | — | — | 3 |
| Candidiasis | D002177 | B37 | — | 2 | — | — | — | 2 | |
| Male breast neoplasms | D018567 | — | 1 | — | — | 1 | 2 | ||
| Tonsillitis | D014069 | HP_0011110 | J03 | — | 1 | — | — | 1 | 2 |
| Myeloid leukemia acute | D015470 | C92.0 | 2 | 2 | — | — | — | 2 | |
| Status epilepticus | D013226 | EFO_0008526 | G41 | 1 | 1 | — | — | — | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | 1 | — | — | 1 | 2 |
| Radical mastectomy | D015409 | 1 | 1 | — | — | — | 1 | ||
| Liposarcoma | D008080 | 1 | 1 | — | — | — | 1 |
Show 29 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | 15 | — | — | — | 2 | 17 | ||
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 7 | — | — | — | — | 7 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 6 | — | — | — | — | 6 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 6 | — | — | — | — | 6 |
| Melanoma | D008545 | 3 | — | — | — | — | 3 | ||
| Non-hodgkin lymphoma | D008228 | C85.9 | 3 | — | — | — | — | 3 | |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 3 | — | — | — | — | 3 |
| Amnesia | D000647 | EFO_1001454 | F44.0 | 3 | — | — | — | — | 3 |
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 3 | — | — | — | — | 3 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | — | — | 2 | 3 |
Show 60 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psychomotor agitation | D011595 | — | — | — | — | 5 | 5 | ||
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 2 | 2 |
| Spine osteoarthritis | D055013 | EFO_1000787 | — | — | — | — | 1 | 1 | |
| Rhytidoplasty | D015361 | — | — | — | — | 1 | 1 | ||
| Acrodynia | D000170 | EFO_1001756 | — | — | — | — | 1 | 1 | |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | 1 | 1 | |
| Alpha 1-antitrypsin deficiency | D019896 | E88.01 | — | — | — | — | 1 | 1 | |
| Argininosuccinic aciduria | D056807 | — | — | — | — | 1 | 1 | ||
| Perioperative period | D059035 | — | — | — | — | 1 | 1 | ||
| Sepsis-associated encephalopathy | D065166 | G93.41 | — | — | — | — | 1 | 1 |
Show 48 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MIDAZOLAM MALEATE |
| INN | midazolam |
| 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 class | Benzodiazepine |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2.O=C(O)/C=C\C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 59467-70-8 |
| RxCUI | 6960 |
| ChEMBL ID | CHEMBL2106922 |
| ChEBI ID | — |
| PubChem CID | 4192 |
| DrugBank | DB00683 |
| UNII ID | R60L0SM5BC (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Midazolam
, Nayzilam, Seizalam
Adverse Events
Top Adverse Reactions
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1 adverse events reported
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