Acyclovir
Acyclovir, Sitavig, Xerese, Zovirax (acyclovir) is a small molecule pharmaceutical. Acyclovir was first approved as Zovirax on 1982-03-29. It is used to treat aids-related opportunistic infections, chickenpox, epstein-barr virus infections, herpes genitalis, and herpes labialis amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Acyclovir, Zovirax (discontinued: Acyclovir, Avaclyr, Sitavig, Zovirax)
CombinationsXerese
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acyclovir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZOVIRAX | Bausch Health Companies | N-018604 RX | 1982-03-29 | 1 products, RLD, RS |
| ZOVIRAX | Bausch Health Companies | N-021478 RX | 2002-12-30 | 1 products, RLD |
Show 5 discontinued
Acyclovir sodium
Acyclovir
+
Hydrocortisone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XERESE | Bausch Health Companies | N-022436 RX | 2009-07-31 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acyclovir | ANDA | 2025-12-04 |
| acyclovir sodium | ANDA | 2025-07-18 |
| acyclovir suspension | ANDA | 2023-11-03 |
| acyclovir valacyclovir valacyclovir hydrochloride | ANDA | 2023-06-29 |
| averteax | OTC monograph not final | 2014-03-08 |
| lornamead | OTC monograph final | 2013-03-06 |
| lypsyl honeyberry | OTC monograph final | 2018-12-27 |
| lypsyl vanilla plum | OTC monograph not final | 2013-12-13 |
| sitavig | New Drug Application | 2020-06-11 |
| sitivig | New Drug Application | 2014-03-13 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ACYCLOVIR, AVACLYR, FERA PHARMS LLC | |||
| 2026-03-29 | ODE-235 | ||
ACYCLOVIR, ACYCLOVIR, ALEMBIC | |||
| 2024-06-12 | CGT | ||
ATC Codes
D: Dermatologicals
— D06: Antibiotics and chemotherapeutics for dermatological use
— D06B: Chemotherapeutics for topical use
— D06BB: Antivirals, topical
— D06BB03: Aciclovir
— D06BB53: Aciclovir, combinations
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors
— J05AB01: Aciclovir
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AD: Antivirals, ophthalmologic
— S01AD03: Aciclovir
HCPCS
Code | Description |
|---|---|
| J0133 | Injection, acyclovir, 5 mg |
Clinical
Clinical Trials
454 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 | 13 | 24 | 28 | 12 | 25 | 98 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 12 | 15 | 21 | 6 | 40 | 91 |
| Infections | D007239 | EFO_0000544 | — | 14 | 7 | 21 | 10 | 27 | 75 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | 6 | 18 | 27 | 12 | 18 | 75 |
| Communicable diseases | D003141 | — | — | 9 | 5 | 14 | 8 | 18 | 51 |
| Cytomegalovirus retinitis | D017726 | EFO_1001302 | — | 4 | 4 | 7 | 1 | 14 | 30 |
| Retinitis | D012173 | — | H30.9 | 4 | 4 | 7 | 1 | 14 | 30 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | 2 | 6 | 4 | 4 | 10 | 26 |
| Herpes genitalis | D006558 | EFO_0007282 | A60 | — | 6 | 5 | 8 | 7 | 26 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 3 | 7 | 1 | 9 | 20 |
Show 47 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 4 | 3 | 1 | — | 1 | 9 |
| Keratitis | D007634 | — | H16 | 1 | 1 | 2 | — | 4 | 8 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | 1 | — | 5 | 6 |
| Postherpetic neuralgia | D051474 | — | — | — | 1 | 1 | — | 3 | 5 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | 1 | — | 3 | 5 |
| Carcinoma | D002277 | — | C80.0 | 2 | 2 | 1 | — | — | 5 |
| Cytomegalovirus | D003587 | — | — | — | 1 | 5 | — | — | 5 |
| Chickenpox | D002644 | EFO_0007204 | B01 | 1 | 1 | 1 | — | 2 | 5 |
| Prostatic neoplasms | D011471 | — | C61 | — | 3 | 1 | — | — | 4 |
| Nasopharyngeal carcinoma | D000077274 | — | — | 2 | 1 | 1 | — | — | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 3 | 8 | — | — | 2 | 12 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 2 | 6 | — | — | 1 | 8 |
| Epstein-barr virus infections | D020031 | EFO_0000769 | — | 2 | 8 | — | — | — | 8 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | 3 | — | — | 1 | 7 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | 4 | — | — | — | 6 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 3 | — | — | 2 | 6 |
| Plasma cell neoplasms | D054219 | — | — | 1 | 2 | — | — | 2 | 5 |
| Glioma | D005910 | EFO_0000520 | — | 4 | 1 | — | — | — | 5 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 4 | — | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | 1 | 4 |
Show 76 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | 1 | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | 2 | 3 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | 3 | — | — | — | — | 3 |
| Paralysis | D010243 | — | — | 1 | — | — | — | 2 | 3 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 3 | — | — | — | — | 3 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | 1 | — | — | — | 2 | 3 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | — | — | — | 1 | 2 |
| Nasopharyngeal neoplasms | D009303 | — | — | 2 | — | — | — | — | 2 |
| Mesothelioma | D008654 | — | C45 | 2 | — | — | — | — | 2 |
| Liver transplantation | D016031 | EFO_0010682 | — | 1 | — | — | — | — | 1 |
Show 32 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphatic diseases | D008206 | — | — | — | — | — | — | 3 | 3 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | — | — | — | 2 | 2 |
| Hematologic neoplasms | D019337 | — | — | — | — | — | — | 2 | 2 |
| Recurrence | D012008 | — | — | — | — | — | — | 2 | 2 |
| Preleukemia | D011289 | — | — | — | — | — | — | 2 | 2 |
| Cesarean section | D002585 | — | — | — | — | — | — | 2 | 2 |
| Death | D003643 | PATO_0001422 | — | — | — | — | — | 1 | 1 |
| Papillomaviridae | D027383 | — | — | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Cerebral hemorrhage | D002543 | — | — | — | — | — | — | 1 | 1 |
Show 86 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Acyclovir |
| INN | aciclovir |
| Description | Aciclovir, also known as acyclovir, is an antiviral medication. It is primarily used for the treatment of herpes simplex virus infections, chickenpox, and shingles. Other uses include prevention of cytomegalovirus infections following transplant and severe complications of Epstein–Barr virus infection. It can be taken by mouth, applied as a cream, or injected.
|
| Classification | Small molecule |
| Drug class | antivirals: antivirals (acyclovir type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nc2c(ncn2COCCO)c(=O)[nH]1 |
Identifiers
| PDB | — |
| CAS-ID | 59277-89-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL184 |
| ChEBI ID | 2453 |
| PubChem CID | 2022 |
| DrugBank | DB00787 |
| UNII ID | X4HES1O11F (ChemIDplus, GSRS) |
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Acyclovir
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Safety
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Adverse Events
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38,464 adverse events reported
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