Diazepam
Diastat, Valium, Valtoco (diazepam) is a small molecule pharmaceutical. Diazepam was first approved as Valium on 1982-01-01. It is used to treat alcohol withdrawal delirium, muscle spasticity, panic disorder, and status epilepticus in the USA. The pharmaceutical is active against gamma-aminobutyric acid receptor subunit alpha-3, gamma-aminobutyric acid receptor subunit alpha-2, and gamma-aminobutyric acid receptor subunit alpha-1. In addition, it is known to target alpha-1A adrenergic receptor, thyrotropin-releasing hormone receptor, and albumin.
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Commercial
Trade Name
FDA
EMA
Diastat, Diastat acudial, Valium, Valtoco (generic drugs available since 1985-09-04, discontinued: Dizac, Q-pam, Valrelease)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Diazepam
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DIASTAT ACUDIAL | Bausch Health Companies | N-020648 RX | 2005-09-15 | 2 products, RLD, RS |
| DIASTAT | Bausch Health Companies | N-020648 RX | 1997-07-29 | 1 products, RLD, RS |
| VALTOCO | Neurelis | N-211635 RX | 2020-01-10 | 3 products, RLD, RS |
| VALIUM | Waylis Therapeutics | N-013263 RX | 1982-01-01 | 3 products, RLD, RS |
Show 5 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| alcohol withdrawal delirium | EFO_1000800 | D000430 | — |
| muscle spasticity | HP_0001257 | D009128 | — |
| panic disorder | EFO_0004262 | D016584 | F41.0 |
| status epilepticus | EFO_0008526 | D013226 | G41 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DIAZEPAM, VALTOCO, NEURELIS INC | |||
| 2027-01-10 | ODE-279 | ||
| 2023-01-10 | NP | ||
HCPCS
Code | Description |
|---|---|
| J3360 | Injection, diazepam, up to 5 mg |
Clinical
Clinical Trials
122 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | 4 | 1 | 1 | — | 5 |
| Alcohol withdrawal delirium | D000430 | EFO_1000800 | — | — | — | 2 | 2 | 4 | |
| Seizures | D012640 | G40.4 | — | 1 | 2 | 1 | — | 4 | |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | 1 | 2 | 3 |
| Postoperative pain | D010149 | G89.18 | — | — | — | 1 | 1 | 2 | |
| Febrile seizures | D003294 | HP_0002373 | R56.0 | — | — | — | 1 | 1 | 2 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | 1 | 1 | — | 2 | |
| Infertility | D007246 | EFO_0000545 | — | — | — | 1 | — | 1 | |
| Substance-induced psychoses | D011605 | EFO_1000902 | — | — | — | 1 | — | 1 | |
| Cerebral palsy | D002547 | G80 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 3 | 7 | 2 | — | — | 10 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 2 | 3 | — | — | 3 |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | 1 | 1 | — | 1 | 2 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 1 | 1 | — | — | 1 |
| Respiratory tract infections | D012141 | J06.9 | — | 1 | 1 | — | — | 1 | |
| Anterior cruciate ligament injuries | D000070598 | — | 1 | 1 | — | — | 1 | ||
| Dementia | D003704 | F03 | — | — | 1 | — | — | 1 | |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | — | — | 1 |
| Depression | D003863 | F33.9 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | 2 | 3 |
| Rotator cuff injuries | D000070636 | M75.1 | — | 1 | — | — | — | 1 | |
| Abdominal pain | D015746 | R10.9 | — | 1 | — | — | — | 1 | |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | — | 1 | — | — | — | 1 |
| Pelvic pain | D017699 | — | 1 | — | — | — | 1 | ||
| Pelvic floor disorders | D059952 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | 5 | 8 | ||
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | 3 | 4 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 4 | 4 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | — | — | — | 3 | 3 |
| Labor pain | D048949 | — | — | — | — | 2 | 2 | ||
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | — | 2 | 2 |
| Tobacco use disorder | D014029 | F17 | — | — | — | — | 2 | 2 | |
| Tobacco use | D064424 | Z72.0 | — | — | — | — | 2 | 2 | |
| Tobacco smoking | D000073869 | — | — | — | — | 2 | 2 | ||
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 2 | 2 |
| Otitis | D010031 | — | — | — | — | 2 | 2 | ||
| Laparoscopic cholecystectomy | D017081 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DIAZEPAM |
| INN | diazepam |
| Description | Diazepam is a 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one substituted by a chloro group at position 7, a methyl group at position 1 and a phenyl group at position 5. It has a role as a xenobiotic, an environmental contaminant, an anxiolytic drug, an anticonvulsant and a sedative. It is a 1,4-benzodiazepinone and an organochlorine compound. |
| Classification | Small molecule |
| Drug class | antianxiety agents (diazepam type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN1C(=O)CN=C(c2ccccc2)c2cc(Cl)ccc21 |
Target
Agency Approved
GABRA3
GABRA3
GABRA2
GABRA2
GABRA1
GABRA1
Organism
Homo sapiens
Gene name
GABRA3
Gene synonyms
NCBI Gene ID
Protein name
gamma-aminobutyric acid receptor subunit alpha-3
Protein synonyms
GABA(A) receptor subunit alpha-3, GABA(A) receptor, alpha 3, gamma-aminobutyric acid (GABA) A receptor, alpha 3, gamma-aminobutyric acid type A receptor alpha3 subunit, gamma-animobutyric acid (GABA) A receptor, alpha 3
Uniprot ID
Mouse ortholog
Gabra3 (14396)
gamma-aminobutyric acid receptor subunit alpha-3 (P26049)
Alternate
ADRA1A
ADRA1A
TRHR
TRHR
ALB
ALB
Organism
Homo sapiens
Gene name
ADRA1A
Gene synonyms
ADRA1C
NCBI Gene ID
Protein name
alpha-1A adrenergic receptor
Protein synonyms
Alpha-1A adrenoceptor, Alpha-1A adrenoreceptor, Alpha-1C adrenergic receptor, Alpha-adrenergic receptor 1c, G protein coupled receptor
Uniprot ID
Mouse ortholog
Adra1a (11549)
alpha-1A adrenergic receptor (Q8BV77)
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: Diastat, Diazepam, Valium, Valtoco
Adverse Events
Top Adverse Reactions
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1,959 adverse events reported
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