Diazepam
Diastat, Diazepam, 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-1, gamma-aminobutyric acid receptor subunit alpha-3, and gamma-aminobutyric acid receptor subunit alpha-2. In addition, it is known to target thyrotropin-releasing hormone receptor.
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Commercial
Trade Name
FDA
EMA
Diastat acudial, Diazepam, Libervant, Valium, Valtoco (discontinued: Diastat acudial, Diazepam, Dizac, Valium, 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 |
|---|---|---|---|---|
| LIBERVANT | Aquestive Therapeutics | N-218623 RX | 2024-04-26 | 5 products, RLD, RS |
| DIASTAT | Bausch Health Companies | N-020648 RX | 1997-07-29 | 1 products, RLD, RS |
| DIASTAT ACUDIAL | Bausch Health Companies | N-020648 RX | 2005-09-15 | 2 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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| diazepam | ANDA | 2025-11-18 |
| diazepam diazepam intensol | ANDA | 2016-07-05 |
| diazepam intensol | ANDA | 2022-11-17 |
| gabavale-5 | unapproved drug other | 2011-08-01 |
| libervant | New Drug Application | 2024-11-13 |
| valium | New Drug Application | 2025-01-06 |
| valtoco | New Drug Application | 2025-09-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| muscle spasticity | — | D009128 | — |
| status epilepticus | EFO_0008526 | D013226 | G41 |
| alcohol withdrawal delirium | EFO_1000800 | D000430 | — |
| panic disorder | EFO_0004262 | D016584 | F41.0 |
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
191 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 5 | 8 | 3 | 2 | 2 | 17 |
| Seizures | D012640 | — | G40.4 | 2 | 2 | 2 | 3 | 4 | 13 |
| Pain | D010146 | EFO_0003843 | R52 | — | 5 | 1 | 3 | 1 | 9 |
| Postoperative pain | D010149 | — | G89.18 | — | 2 | — | 1 | 4 | 7 |
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | — | — | 1 | 1 | 5 | 7 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | 1 | 1 | 2 | 6 |
| Syndrome | D013577 | — | — | — | 1 | 2 | 1 | 3 | 6 |
| Alcohol withdrawal delirium | D000430 | EFO_1000800 | — | — | — | — | 2 | 3 | 5 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | 1 | 3 | 4 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | 1 | 1 | — | 1 | 1 | 4 |
Show 37 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | 2 | 4 | — | 1 | 7 |
| Head and neck neoplasms | D006258 | — | — | 1 | 1 | 3 | — | 1 | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | 4 | — | 1 | 6 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 5 | — | — | 5 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 2 | 3 | — | 2 | 5 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 1 | — | 2 | — | 1 | 4 |
| Squamous cell carcinoma | D002294 | — | — | — | 2 | 1 | — | 1 | 4 |
| Low back pain | D017116 | — | M54.5 | — | 1 | 1 | — | 2 | 3 |
| Back pain | D001416 | — | M54 | — | 1 | 1 | — | 2 | 3 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | 1 | — | — | 2 |
Show 32 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | — | 1 | — | — | 4 | 5 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | 1 | — | — | 3 | 4 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 1 | — | — | — | 2 |
| Drug resistant epilepsy | D000069279 | — | — | — | 1 | — | — | 1 | 2 |
| Abdominal pain | D015746 | EFO_0003766 | R10.9 | — | 1 | — | — | 1 | 2 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | 1 | 2 |
| Fibrosis | D005355 | — | — | 1 | 1 | — | — | — | 2 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 1 | 1 | — | — | — | 2 |
| Pulmonary fibrosis | D011658 | — | J84.10 | 1 | 1 | — | — | — | 2 |
| Poisoning | D011041 | EFO_0008546 | T65.91 | — | 2 | — | — | — | 2 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | 2 | 7 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | 2 | 3 |
| Leukemia | D007938 | — | C95 | 2 | — | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | 1 | 2 |
| Delirium | D003693 | — | R41.0 | 1 | — | — | — | 1 | 2 |
| Emergence delirium | D000071257 | — | — | 1 | — | — | — | 1 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
Show 18 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Labor pain | D048949 | — | — | — | — | — | — | 4 | 4 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 2 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 2 | 2 |
| Recurrence | D012008 | — | — | — | — | — | — | 2 | 2 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 1 | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 1 | 1 |
| Analgesia | D000698 | — | — | — | — | — | — | 1 | 1 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 1 | 1 |
| Video-assisted thoracic surgery | D020775 | — | — | — | — | — | — | 1 | 1 |
Show 41 more
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 |
Identifiers
| PDB | — |
| CAS-ID | 439-14-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL12 |
| ChEBI ID | 49575 |
| PubChem CID | 3016 |
| DrugBank | DB00829 |
| UNII ID | Q3JTX2Q7TU (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
ADRA1A
ADRA1A
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
No data
Financial
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Estimated US medical usage
Diazepam
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
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Additional graphs summarizing 1,400,078 documents
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Safety
Black-box Warning
Black-box warning for: Diazepam, Diazepam intensol, Libervant, Valium, Valtoco
Adverse Events
Top Adverse Reactions
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52,557 adverse events reported
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