Valacyclovir
Valacyclovir, Valtrex (valacyclovir) is a small molecule pharmaceutical. Valacyclovir was first approved as Valtrex on 1995-06-23. It is used to treat chickenpox, herpes genitalis, herpes labialis, herpes simplex, and herpes zoster in the USA.
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Commercial
Therapeutic Areas
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Valacyclovir, Valtrex (discontinued: Valacyclovir)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acyclovir valacyclovir valacyclovir hydrochloride | ANDA | 2023-06-29 |
| direct rx | ANDA | 2015-11-09 |
| valacyclovir | ANDA | 2024-10-29 |
| valacyclovir hydrochloride | ANDA | 2024-11-05 |
| valacyclovir valacyclovir | ANDA | 2024-02-15 |
| valacyclovir valacyclovir hydrochloride | ANDA | 2020-06-17 |
| valtrex | New Drug Application | 2024-08-08 |
Indications
FDA
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Agency Specific
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Clinical
Clinical Trials
137 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Herpes simplex | D006561 | — | B00 | 9 | 13 | 11 | 11 | 11 | 55 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | 2 | 5 | 4 | 3 | 7 | 21 |
| Infections | D007239 | EFO_0000544 | — | 5 | 3 | 5 | 4 | 5 | 20 |
| Communicable diseases | D003141 | — | — | 5 | 3 | 3 | 4 | 5 | 18 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 2 | 6 | 3 | 6 | 18 |
| Herpes genitalis | D006558 | EFO_0007282 | A60 | — | 4 | 2 | 5 | 4 | 15 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | — | 3 | 3 | 2 | 1 | 8 |
| Virus diseases | D014777 | — | B34 | 2 | — | — | 3 | 2 | 7 |
| Varicella zoster virus infection | D000073618 | — | — | 1 | — | — | 1 | 2 | 4 |
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | — | — | 1 | 3 | 4 |
Show 16 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 1 | 3 | 1 | — | — | 4 |
| Chickenpox | D002644 | EFO_0007204 | B01 | 1 | — | 1 | — | 2 | 4 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | 3 | — | — | 3 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | 1 | — | 1 | 3 |
| Postherpetic neuralgia | D051474 | — | — | — | 1 | 1 | — | 1 | 3 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 2 | 1 | — | — | 3 |
| Hiv | D006678 | — | — | — | — | 1 | — | 2 | 3 |
| Neoplasms | D009369 | — | C80 | — | 1 | 1 | — | — | 2 |
| Sexually transmitted diseases | D012749 | — | A50-A64 | — | — | 2 | — | — | 2 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | — | 1 | — | — | 2 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | 4 | 1 | — | — | — | 5 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | 3 | — | — | — | 5 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | 3 | — | — | — | 5 |
| Astrocytoma | D001254 | EFO_0000271 | — | 3 | 3 | — | — | — | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 3 | — | — | — | 3 |
| Epstein-barr virus infections | D020031 | EFO_0000769 | — | — | 2 | — | — | 1 | 3 |
| Hepatitis c | D006526 | — | B19.2 | 2 | 1 | — | — | — | 3 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 2 | 1 | — | — | — | 3 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 2 | 1 | — | — | — | 3 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 2 | 1 | — | — | — | 3 |
Show 25 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | 3 | 11 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | 1 | 3 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Infectious pregnancy complications | D011251 | — | — | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Pleural effusion | D010996 | HP_0002202 | J90 | 1 | — | — | — | — | 1 |
| Mesothelioma | D008654 | — | C45 | 1 | — | — | — | — | 1 |
| Malignant pleural effusion | D016066 | — | J91.0 | 1 | — | — | — | — | 1 |
| Hepatitis b | D006509 | — | — | 1 | — | — | — | — | 1 |
| Coinfection | D060085 | — | — | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Paralysis | D010243 | HP_0003470 | — | — | — | — | — | 2 | 2 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | — | 1 | 1 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | — | — | 1 | 1 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | — | — | — | — | 1 | 1 |
| Vaginal diseases | D014623 | — | — | — | — | — | — | 1 | 1 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | — | — | — | 1 | 1 |
| Oncogenes | D009857 | — | — | — | — | — | — | 1 | 1 |
| Electroacupuncture | D015671 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Valacyclovir |
| INN | valaciclovir |
| Description | Valacyclovir is a L-valyl ester. It has a role as an antiviral drug. It is functionally related to a guanine. |
| Classification | Small molecule |
| Drug class | antivirals: antivirals (acyclovir type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21 |
Identifiers
| PDB | — |
| CAS-ID | 124832-26-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1349 |
| ChEBI ID | 35854 |
| PubChem CID | 135398742 |
| DrugBank | DB00577 |
| UNII ID | MZ1IW7Q79D (ChemIDplus, GSRS) |
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Financial
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Estimated US medical usage
Valacyclovir
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
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Adverse Events
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20,844 adverse events reported
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