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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| stomatognathic diseases | D009057 |
| urogenital diseases | D000091642 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Valtrex (generic drugs available since 2007-01-31)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Valacyclovir hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VALTREX | GSK | N-020487 RX | 1995-06-23 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| valacyclovir hydrochloride | ANDA | 2023-06-07 |
| valtrex | New Drug Application | 2022-11-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chickenpox | EFO_0007204 | D002644 | B01 |
| herpes genitalis | EFO_0007282 | D006558 | A60 |
| herpes labialis | EFO_1001347 | D006560 | B00.1 |
| herpes simplex | — | D006561 | B00 |
| herpes zoster | EFO_0006510 | D006562 | B02 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
101 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biliary liver cirrhosis | D008105 | K74.3 | 1 | 2 | 5 | 4 | 4 | 16 | |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | 2 | 1 | 4 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | 1 | — | 3 |
| Chemical and drug induced liver injury | D056486 | — | 1 | — | 1 | — | 2 | ||
| Autoimmune hepatitis | D019693 | K75.4 | — | — | — | 1 | 1 | 2 | |
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | — | 1 | 1 | — | 2 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | 2 | — | 2 |
| Gallstones | D042882 | EFO_0004210 | — | — | — | 1 | 1 | 2 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
| Gestational diabetes | D016640 | HP_0009800 | O24.4 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cholestasis | D002779 | K83.1 | — | 3 | 2 | — | 4 | 8 | |
| Healthy volunteers/patients | — | 6 | — | 1 | — | — | 7 | ||
| Intrahepatic cholestasis | D002780 | — | 2 | 2 | — | — | 3 | ||
| Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | 1 | 2 | 1 | — | — | 3 |
| Adenomatous polyposis coli | D011125 | — | 2 | 2 | — | — | 2 | ||
| Duodenal neoplasms | D004379 | — | 1 | 1 | — | — | 1 | ||
| Pregnancy complications | D011248 | — | 1 | 1 | — | — | 1 | ||
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | — | 1 |
| Sepsis | D018805 | A41.9 | — | 1 | 1 | — | — | 1 | |
| Child nutrition disorders | D015362 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | 1 | 2 | — | — | — | 3 | ||
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 3 | — | — | — | 3 |
| Cholangitis | D002761 | K83.0 | — | 1 | — | — | 1 | 2 | |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 1 | — | — | — | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | 1 | 2 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | 1 | — | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | 1 | — | — | — | 1 |
| Biliary tract diseases | D001660 | EFO_0009534 | K83.9 | — | 1 | — | — | — | 1 |
| Bile duct diseases | D001649 | — | 1 | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 2 | 2 | |
| Zellweger syndrome | D015211 | Orphanet_912 | E71.510 | — | — | — | — | 1 | 1 |
| Infantile refsum disease | D052919 | Orphanet_772 | G60.1 | — | — | — | — | 1 | 1 |
| Adrenoleukodystrophy | D000326 | Orphanet_43 | E71.52 | — | — | — | — | 1 | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | — | — | 1 | 1 |
| Sarcoma | D012509 | — | — | — | — | 1 | 1 | ||
| Germ cell and embryonal neoplasms | D009373 | — | — | — | — | 1 | 1 | ||
| Medulloblastoma | D008527 | — | — | — | — | 1 | 1 | ||
| Retinoblastoma | D012175 | — | — | — | — | 1 | 1 |
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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 | 73645 |
| ChEMBL ID | CHEMBL1349 |
| ChEBI ID | 35854 |
| PubChem CID | 135398742 |
| DrugBank | DB00577 |
| UNII ID | MZ1IW7Q79D (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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Additional graphs summarizing 6,329 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,637 adverse events reported
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