> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/acyclovir-69352556-3ccf-40be-9470-76b950dab32b
> Record changed: 2026-10-13

# Acyclovir

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

First approval year

1982

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

## Development status

**First approval year**

1982

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

**Drug name**

Acyclovir

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

**Molecular weight**

225.21

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

**Structure (SMILES)**

Nc1nc2c(ncn2COCCO)c(=O)\[nH\]1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

### Brand names (42)

- acycloguanosine
- Acycloguanosine
- acyclovir
- Acyclovir
- acyclovir component of xerese
- Acyclovir component of xerese
- avaclyr
- Avaclyr
- avert
- Avert
- clearsore
- Clearsore
- cymex ultra
- Cymex ultra
- duvimex
- Duvimex
- herpetad
- Herpetad
- lipsore
- Lipsore
- lypsyl
- Lypsyl
- ranovir
- Ranovir
- sitavig

And 17 more, listed on the interactive page.

### Other names (48)

- aciclovir
- Aciclovir
- ACICLOVIR \[EP MONOGRAPH\]
- ACICLOVIR \[IARC\]
- aciclovir \[INN\]
- ACICLOVIR \[JAN\]
- ACICLOVIR \[MART.\]
- Aciclovir \[WHO-DD\]
- ACICLOVIR \[WHO-IP\]
- aciclovir ep monograph
- aciclovir iarc
- aciclovir inn
- aciclovir jan
- aciclovir mart
- aciclovir who dd
- aciclovir who ip
- aciclovirum
- Aciclovirum
- ACICLOVIRUM \[WHO-IP\]
- aciclovirum who ip
- acyclovir
- Acyclovir
- ACYCLOVIR \[HSDB\]
- ACYCLOVIR \[MI\]
- ACYCLOVIR \[ORANGE BOOK\]

And 23 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 59277-89-3

**ChEMBL ID**

CHEMBL184

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

**InChIKey**

MKUXAQIIEYXACX-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

**PubChem compound IDs**

- 135398513

**RxNorm IDs (RxCUI)**

- 281

**FDA ingredient codes (UNII)**

- X4HES1O11F

### ATC classification codes (4)

- D06BB03
- D06BB53
- J05AB01
- S01AD03

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL184)

## Regulatory information

### United States

**Applicant**

BAUSCH

**Approval date**

29 Mar 1982

**Application number**

NDA018604

### Other regulatory facts

**Patents**

3

**Designations**

2

**Earliest recorded loss of exclusivity**

16 Jun 2030

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

aciclovir

**Type**

Synthetic organic

**Drug name stem**

\-vir

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral
- Parenteral
- topical

### Mechanisms of action

- **Mechanism**  
Human herpesvirus 1 DNA polymerase inhibitor

**Action type**  
Inhibitor

**Target**  
DNA polymerase catalytic subunit

**Protein identifier**  
P04293

### Open Targets mechanisms

- **Mechanism**  
Human herpesvirus 1 DNA polymerase inhibitor

**Action type**  
Inhibitor

**Target**  
DNA polymerase catalytic subunit

### DrugCentral mechanisms (4)

- **Action type**  
Inhibitor

**Protein identifier**  
P04293

**Organism**  
Human herpesvirus 1 (strain 17)
- **Action type**  
Inhibitor

**Gene symbol**  
TK

**Protein identifier**  
P04407

**Organism**  
Human herpesvirus 2 (strain 333)
- **Action type**  
Inhibitor

**Protein identifier**  
P09252

**Organism**  
Varicella-zoster virus (strain Dumas)
- **Action type**  
Inhibitor

**Gene symbol**  
TK

**Protein identifier**  
Q9QNF7

**Organism**  
Human herpesvirus 1

### Investigated indications (10)

- **Condition**  
Virus Diseases

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000763

**Subject identifier**  
D014777
- **Condition**  
HIV Infections

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000764

**Subject identifier**  
D015658
- **Condition**  
Cytomegalovirus Infections

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001062

**Subject identifier**  
D003586
- **Condition**  
Herpes Zoster

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0006510

**Subject identifier**  
D006562
- **Condition**  
Chickenpox

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0007204

**Subject identifier**  
D002644
- **Condition**  
Herpes Genitalis

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0007282

**Subject identifier**  
D006558
- **Condition**  
Herpes Labialis

**Highest recorded phase**  
4

**Condition identifier**  
EFO:1001347

**Subject identifier**  
D006560
- **Condition**  
Eye Infections

**Highest recorded phase**  
4

**Condition identifier**  
EFO:1001888

**Subject identifier**  
D015817
- **Condition**  
Herpes Simplex

**Highest recorded phase**  
4

**Condition identifier**  
EFO:1002022

**Subject identifier**  
D006561
- **Condition**  
Herpes Labialis

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0043653

**Subject identifier**  
D006560

### Open Targets indications (34)

- **Condition identifier**  
EFO\_0000763
- **Condition identifier**  
EFO\_0000764

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0001062

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0004352
- **Condition identifier**  
EFO\_0006510
- **Condition identifier**  
EFO\_0007204
- **Condition identifier**  
EFO\_0007282
- **Condition identifier**  
EFO\_0007309
- **Condition identifier**  
EFO\_1001231
- **Condition identifier**  
EFO\_1001360
- **Condition identifier**  
EFO\_1001888
- **Condition identifier**  
EFO\_1001888

**Highest recorded phase**  
4
- **Condition identifier**  
EFO\_1002022
- **Condition identifier**  
EFO\_1002023
- **Condition identifier**  
HP\_0010628
- **Condition identifier**  
MONDO\_0000878
- **Condition identifier**  
MONDO\_0001795

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004609

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005108

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005609

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005665
- **Condition identifier**  
MONDO\_0005700

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005770

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005855

And 9 more, listed on the interactive page.

### Reported adverse events (37)

- **Event**  
acute generalised exanthematous pustulosis

**Reports**  
91

**Reporting signal score**

167.423
- **Event**  
acute kidney injury

**Reports**  
599

**Reporting signal score**

781.848
- **Event**  
altered state of consciousness

**Reports**  
97

**Reporting signal score**

122.98
- **Event**  
blood creatinine increased

**Reports**  
186

**Reporting signal score**

171.264
- **Event**  
blood urea increased

**Reports**  
74

**Reporting signal score**

91.1867
- **Event**  
confusional state

**Reports**  
277

**Reporting signal score**

197.647
- **Event**  
crystal urine present

**Reports**  
35

**Reporting signal score**

123.368
- **Event**  
crystalluria

**Reports**  
46

**Reporting signal score**

176.895
- **Event**  
depressed level of consciousness

**Reports**  
108

**Reporting signal score**

89.663
- **Event**  
dilatation intrahepatic duct acquired

**Reports**  
27

**Reporting signal score**

110.862
- **Event**  
disorientation

**Reports**  
105

**Reporting signal score**

99.6363
- **Event**  
drug reaction with eosinophilia and systemic symptoms

**Reports**  
113

**Reporting signal score**

121.092
- **Event**  
drug resistance

**Reports**  
173

**Reporting signal score**

281.271
- **Event**  
encephalitis

**Reports**  
60

**Reporting signal score**

119.703
- **Event**  
encephalopathy

**Reports**  
159

**Reporting signal score**

244.531
- **Event**  
hallucination, visual

**Reports**  
86

**Reporting signal score**

110.576
- **Event**  
herpes simplex

**Reports**  
83

**Reporting signal score**

202.304
- **Event**  
lymphocyte count decreased

**Reports**  
83

**Reporting signal score**

97.2768
- **Event**  
myoclonus

**Reports**  
80

**Reporting signal score**

120.141
- **Event**  
nephropathy toxic

**Reports**  
143

**Reporting signal score**

302.922
- **Event**  
neurotoxicity

**Reports**  
324

**Reporting signal score**

812.112
- **Event**  
ophthalmic herpes simplex

**Reports**  
25

**Reporting signal score**

86.1935
- **Event**  
organic brain syndrome

**Reports**  
22

**Reporting signal score**

97.1394
- **Event**  
pathogen resistance

**Reports**  
153

**Reporting signal score**

381.029
- **Event**  
rash maculo-papular

**Reports**  
111

**Reporting signal score**

131.121

And 12 more, listed on the interactive page.

### Trial references (10)

- NCT00194519  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00194519)
- NCT01281007  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01281007)
- NCT00467662  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00467662)
- NCT00469300  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00469300)
- NCT00769314  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00769314)
- NCT01574612  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01574612)
- NCT02265913  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02265913)
- NCT02483182  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02483182)
- NCT01327144  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01327144)
- NCT03443869  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03443869)

## Dosing

**Dose**

Approximate a one-half inch ribbon of ointment per 4 square inches of surface area

**Route**

Topical

**How often**

Every 3 hours, 6 times per day for 7 days

### Conditions of use

- Use a finger cot or rubber glove during application

## Chemical properties

**Hydrogen bond acceptors**

7

**Hydrogen bond donors**

3

**Polar surface area**

119.05

**Calculated partition coefficient (ALogP)**

\-1.33

**Calculated partition coefficient (XLogP)**

\-1.9

**Prodrug**

Yes

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

4

**Heavy atoms**

16

**Molecular formula**

C8H11N5O3

**Monoisotopic mass**

225.08618923

**Natural product**

Yes

## National Drug Codes

- 0093-3630
- 0187-0993
- 0187-0994
- 0187-5104
- 0472-0082
- 0591-1159
- 0904-7507
- 0904-7519
- 13668-515
- 16714-885
- 23155-227
- 23155-228
- 23155-229
- 23155-962
- 31722-681
- 31722-777
- 31722-778
- 33342-439
- 43063-589
- 43063-928
- 43547-499
- 45802-044
- 48102-028
- 50268-061
- 50268-062

And 163 more, listed on the interactive page.

## Evidence counts

**Recorded assays**

8,599

**Active assays**

563

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

- Antiviral Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000998.html)

## Biological measurements

### Observed measurements

#### Distribution coefficient (LogD)

**Median**

\-2

**Mean**

\-2

**Minimum**

\-2

**Maximum**

\-2

**Unit**

unitless

**Assays**

1

**Standard deviation**

0

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- LogD

#### Solubility

**Median**

1,895

**Mean**

2,177.5

**Minimum**

1,000

**Maximum**

3,920

**Unit**

ug/mL

**Assays**

4

**Standard deviation**

1,330.97

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- Solubility

#### Oral bioavailability

**Median**

48

**Mean**

37.8808

**Minimum**

2.8

**Maximum**

83

**Unit**

%

**Assays**

13

**Standard deviation**

27.72

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- F

## Related records

### Trials (96)

- A Clinical Trial of Acyclovir for Viral Uveitis
- A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
- A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
- A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
- A Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3
- A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
- A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
- A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
- A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
- A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
- A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
- A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients
- A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis
- [A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally](https://trialight.com/data/trial/a-study-to-compare-sitavig-acyclovir-buccal-tablet-with-a-2732ad1a-7ae1-4747-b803-17669f43e29d.md)
- A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
- A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN\_Acyclo)
- A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT
- Aciclovir Versus Placebo for HSV-2 Meningitis
- Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates
- Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth

### Approved for (7)

- [Chickenpox](https://trialight.com/data/condition/chickenpox-4213f806-c779-5b01-9e52-7179e9edebeb.md)
- Eye infectious disorder
- [Genital herpes](https://trialight.com/data/condition/genital-herpes-07f6bf40-9937-5924-bf15-bb89bedc2b84.md)
- [Herpes labialis](https://trialight.com/data/condition/herpes-labialis-fa943de0-4b97-5737-b852-caaa6e54d250.md)
- [Herpes simplex infectious disease](https://trialight.com/data/condition/herpes-simplex-infectious-disease-e68e9e47-8d4d-542b-bba5-bb8aaa1ebd60.md)
- [Herpes zoster](https://trialight.com/data/condition/herpes-zoster-b5c04cf4-ae28-5154-8254-f4f1fde4c3c9.md)
- [Viral infectious disease](https://trialight.com/data/condition/viral-infectious-disease-43db42a3-adad-5b9d-b74c-f17df0674c21.md)

### In development for (2)

- [Cytomegalovirus infection](https://trialight.com/data/condition/cytomegalovirus-infection-33aa640c-a359-5979-84a0-c70ac00df24d.md) Phase 3
- [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 3

### Other linked conditions (3)

- [Herpesviridae infectious disease](https://trialight.com/data/condition/herpesviridae-infectious-disease-aebfcafe-83be-52c0-b83f-f857b2e24dba.md)
- Plantar wart
- Uveitis

---

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