aciclovir
Trade name: zovirax
Approved
Mar 29, 1982
Acyclovir is a synthetic antiviral nucleoside analogue. A screening program for antiviral drugs begun at Burroughs Wellcome in the 1960s resulted in the discovery of acyclovir in 1974. Preclinical investigation brought the drug to clinical trials in 1977 and the first form of the drug (topical) was available to physicians in 1982. Activity of acyclovir is greatest against herpes 1 and herpes 2, less against varicella zoster, still less against Epstein-Barr, and very little against cytomegalovirus. Acyclovir is an antiviral agent only after it is phosphorylated in infected cells by a viral-induced thymidine kinase. Acyclovir monophosphate is phosphorylated to diphosphate and triphosphate forms by cellular enzymes in the infected host cell where the drug is concentrated. Acyclovir triphosphate inactivates viral deoxyribonucleic acid polymerase. — NCATS
Clinical trial activity
98 trials · 86 clinical orgs · 66 marketing orgs
Earliest trial started Jun 1, 1985 (NCT00209352)
Timeline
1980s
- Mar 29, 1982
Bausch Health Companies — Earliest FDA Approval
- Mar 29, 1982
Bausch Health Companies — NDA Organization
- Mar 29, 1982
Bausch Health Companies — NDA Secondary Org
- Oct 22, 1982
GlaxoSmithKline — NDA Secondary Org
- Jan 1, 1985
Earliest Phase 3 Sponsor(trial)
- Jan 25, 1985
Mylan — NDA Secondary Org
1990s
- Jan 1, 1995
Earliest Phase 1 Sponsor(trial)
- Aug 30, 1996
Roxane Laboratories — Marketing Organization
- Aug 30, 1996
Boehringer Ingelheim — Marketing Organization
- Mar 21, 1997
Lek Pharmaceuticals — Marketing Organization
- Apr 22, 1997
Strides Pharma Science — Marketing Organization
- Apr 22, 1997
Hospira — Marketing Organization
- Apr 22, 1997
Athenex, Inc. — Marketing Organization
- Apr 22, 1997
Chartwell Pharmaceuticals — Marketing Organization
- Apr 22, 1997
DAVA Pharmaceuticals — Marketing Organization
- Apr 22, 1997
Teva — Marketing Organization
- Apr 22, 1997
Mylan — Marketing Organization
- Jun 5, 1997
Actavis — Marketing Organization
- Oct 15, 1997
Eurohlth Intl Sarl — Marketing Organization
- Oct 31, 1997
Heritage Pharma — Marketing Organization
- Dec 10, 1997
Apothecon — Marketing Organization
- Apr 15, 1998
Watson Pharmaceuticals — Marketing Organization
- Apr 30, 1998
Fresenius — Marketing Organization
- Sep 30, 1998
Ranbaxy — Marketing Organization
- Sep 30, 1998
Sun Pharmaceuticals — Marketing Organization
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
- Jan 26, 1999
Kenton — Marketing Organization
- Jan 26, 1999
Boscogen — Marketing Organization
- Apr 30, 1999
Ionis Pharmaceuticals, Inc. — Marketing Organization
- Jul 26, 1999
AbbVie — Marketing Organization
2000s
- Jun 7, 2005
Hi Tech Pharmaceuticals — Marketing Organization
- Jun 7, 2005
Akorn, Inc. — Marketing Organization
- Sep 28, 2005
Apotex — Marketing Organization
2010s
- Apr 12, 2013
Epi Health — NDA Secondary Org
- Oct 11, 2013
Aurobindo Pharma — Marketing Organization
- Oct 11, 2013
Eugia Pharma — Marketing Organization
- Oct 29, 2013
Hetero Labs Ltd — Marketing Organization
- Nov 15, 2013
Cadila Healthcare — Marketing Organization
- Jun 18, 2014
Amneal Pharmaceuticals — Marketing Organization
- Aug 19, 2014
Zydus Discovery DMCC — Marketing Organization
- Feb 29, 2016
Hikma — Marketing Organization
- May 11, 2016
Fougera — Marketing Organization
- May 11, 2016
Novartis — Marketing Organization
- Dec 21, 2016
Taro Pharmaceuticals — Marketing Organization
- Jul 31, 2017
ANDA Repository — Marketing Organization
- Jul 31, 2017
Glenmark Pharmaceuticals — Marketing Organization
- Jul 31, 2017
Tolmar Inc. — Marketing Organization
- Aug 16, 2017
Carlsbad Technology — Marketing Organization
- Nov 13, 2017
ACP Nimble — Marketing Organization
- Nov 13, 2017
Cosette — Marketing Organization
- Nov 13, 2017
G & W Laboratories Inc. — Marketing Organization
- Mar 7, 2018
Yiling Pharmaceutical Inc. — Marketing Organization
- Apr 6, 2018
Alembic — Marketing Organization
- Jan 11, 2019
Torrent Pharmaceuticals Limited — Marketing Organization
- Jan 18, 2019
Cipla — Marketing Organization
- Feb 4, 2019
Perrigo — Marketing Organization
- Feb 4, 2019
Padagis Us — Marketing Organization
- Mar 29, 2019
Fera Development, LLC — NDA Secondary Org
- Oct 7, 2019
Square Pharmaceuticals — Marketing Organization
2020s
- Jan 29, 2020
Exeltis — Marketing Organization
- Apr 7, 2020
Solaris Pharma Corp — Marketing Organization
- Apr 23, 2020
Emcure — Marketing Organization
- Jun 17, 2020
Exela Pharma Sciences, LLC. — Marketing Organization
- Jun 17, 2020
Namigen Llc — Marketing Organization
- Jun 17, 2020
Dr. Reddy's Laboratories — Marketing Organization
- Jul 10, 2020
Novitium Pharma — Marketing Organization
- Jan 11, 2021
VistaPharm, Inc. — Marketing Organization
- May 19, 2021
Macleods Pharmaceuticals, Ltd — Marketing Organization
- May 19, 2021
Neogen — Marketing Organization
- Nov 15, 2021
Prinston Inc — Marketing Organization
- Aug 18, 2022
Rubicon Research — Marketing Organization
- Mar 9, 2023
MSN Laboratories — Marketing Organization
Indications
Approved for
Studied for
- Acne Vulgaris · Phase 3
- Anesthesia and Analgesia · Phase 4
- Bell Palsy · Early Phase 1
- Bone Marrow Transplantation · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Chickenpox · Phase 3
- Community-Acquired Infections · Phase 3
- Critical Illness · Phase 2
- Cytomegalovirus · Phase 3
- Cytomegalovirus Infections · Phase 3
- Dermatitis, Atopic · Phase 2
- Healthcare-Associated Pneumonia · Phase 3
- Healthy Volunteers · Phase 4
- Hematopoietic Stem Cell Transplantation · Phase 2
- Herpes Genitalis · Phase 4
- Herpes Labialis · Phase 4
- Herpes Simplex · Phase 4
- Herpesvirus 2, Human · Phase 2
- Herpes Zoster · Phase 4
- HIV · Phase 4
- HIV Infections · Phase 4
- HIV Seronegativity · Phase 3
- Infections · Phase 1
- Keratitis, Herpetic · Phase 3
- Kidney Diseases · Phase 1/Phase 2
- Kidney Transplantation · Phase 1/Phase 2
- Leukemia · Phase 1/Phase 2
- Leukemia-Lymphoma, Adult T-Cell · Phase 1/Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 1/Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 1/Phase 2
- Meniere Disease · Phase 2/Phase 3
- Multiple Sclerosis · Phase 3
- Multiple Sclerosis, Relapsing-Remitting · Phase 4
- Neonatal Sepsis · Phase 1
- Neoplasms · Phase 3
- Obesity · Phase 1
- Pain · Phase 4
- Pharmacology · Phase 3
- Pneumonia, Ventilator-Associated · Phase 3
- Pneumonia, Viral · Phase 4
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1/Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 1/Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Sexually Transmitted Diseases · Phase 3
- Simplexvirus · Phase 1
- Ulcer · Phase 2/Phase 3
- Varicella Zoster Virus Infection · Phase 4
- Warts · Phase 4
Mechanism of action
- Human herpesvirus 1 DNA polymeraseINHIBITOR
Human herpesvirus 1 DNA polymerase inhibitor
Prodrug enzyme: Thymidine kinase
Combination products
xerese
with urea
Approval history
- approvedPriority reviewMar 29, 1982
Chemistry & pharmacology
SMILES
Nc1nc2c(ncn2COCCO)c(=O)[nH]1- Mol. weight
- 225.21 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
Yes
Sources
- ChEMBLCHEMBL184 ↗
- WikipediaAciclovir ↗
- NCATSX4HES1O11F ↗
- ChEMBLCHEMBL1200380 ↗
Also known as
- aciclostad
- aciclostad
- aciclovir
- aciclovir
- aciclovir
- aciclovir
- aciclovir
- aciclovir
- aciclovir
- aciclovir sodium
- aciclovir sodium
- aciclovirum
- aciclovirum
- acycloguanosine
- acycloguanosine
- acycloguanosine
- acyclovir
- acyclovir
- acyclovir
- acyclovir
- acyclovir
- acyclovir
- acyclovir
- acyclovir
- acyclovir
- acyclovir mixture with hydrocortisone
- acyclovir sodium
- acyclovir sodium
- acyclovir sodium
- acyclovir sodium
- acyclovir sodium
- avert
- bw-248u sodium
- bw-248u sodium
- clearsore
- cyclovir
- cyclovir
- cymex ultra
- duvimex
- herpetad
- herpetad
- lipsore
- lypsyl
- ranovir
- soothelip
- soraway
- viralief
- virasorb
- virovir 200
- virovir 400
- virovir 800
- zep-3
- zep-3
- zovirax
- zovirax
- zovirax
- zovirax
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07196670 | Phase 4 | Sep 30, 2025 | Cairo University |
| NCT06757907 | N/A | Oct 1, 2024 | Al Azhar University |
| NCT06217406 | N/A | Mar 1, 2024 | Assistance Publique - Hôpitaux de Paris |
| NCT06228430 | Phase 1 | Feb 12, 2024 | Mahidol University |
| NCT06134492 | Phase 3 | Jan 31, 2024 | Friedrich Schiller University |
| NCT06261684 | Phase 2/Phase 3 (Phase 3) | Oct 1, 2023 | Cairo University |
| NCT05589688 | Phase 1 | Nov 30, 2022 | University of Toulouse |
| NCT05324904 | N/A | Oct 31, 2022 | Assiut University |
| NCT05514197 | N/A | Sep 1, 2022 | Chimei Medical Center |
| NCT05429151 | Phase 4 | Jun 13, 2022 | Sohag University |
| NCT05098938 | Phase 3 | Oct 28, 2021 | Bayer |
| NCT04656821 | Phase 4 | Dec 5, 2020 | Tanta University |
| NCT04476186 | N/A | Jun 15, 2020 | Assiut University, Cairo University |
| NCT04988646 | N/A | Feb 21, 2020 | PT. Kimia Farma (Persero) Tbk, PT Pharma Metric Labs |
| NCT04307862 | Phase 2 | Dec 29, 2019 | Shulov Innovate for Science Ltd. |
| NCT06380647 | N/A | Oct 1, 2019 | King Edward Medical University |
| NCT03626376 | Phase 4 | Oct 31, 2018 | New York University |
| NCT03457025 | Early Phase 1 (Phase 1) | May 31, 2018 | New York University |
| NCT03443869 | Phase 3 | May 3, 2018 | Merck |
| NCT03656965 | Phase 3 | May 1, 2018 | Kuwait Cancer Control Center |
Organizations
Research & Development (86)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 17 | 12 | 5 | 1992 |
| University of Washington | Academic/Hospital | 13 | 10 | 4 | 1985 |
| Glaxo Wellcome | For profit | 7 | 5 | 3 | 1999 |
| National Institutes of Health (NIH) | Government | 6 | 0 | 5 | 1985 |
| Sanofi | For profit | 5 | 1 | 3 | 2014 |
| Genzyme | For profit | 4 | 4 | 3 | 2014 |
| Medivir | For profit | 4 | 4 | 2 | 1999 |
| National Center for Research Resources (NCRR) | Government | 4 | 4 | 2 | 1992 |
| Assiut University | Academic/Hospital | 3 | 3 | 1 | 2013 |
| Cairo University | Academic/Hospital | 3 | 2 | 3 | 2020 |
| EMS S/A | For profit | 3 | 3 | 1 | 2012 |
| National Cancer Institute (NCI) | Government | 3 | 1 | 2 | 2002 |
| Shulov Innovate for Science Ltd. | For profit | 3 | 3 | 2 | 2013 |
| University of Alabama, Birmingham | Academic/Hospital | 3 | 1 | 2 | 1997 |
| Centers for Disease Control and Prevention (CDC) | Government | 2 | 2 | 2 | 2005 |
| GlaxoSmithKline | For profit | 2 | 1 | 2 | 2007 |
| Hebrew University | Academic/Hospital | 2 | 2 | 2 | 2006 |
| National Eye Institute (NEI) | Government | 2 | 2 | 1 | 1989 |
| New York University | Academic/Hospital | 2 | 2 | 2 | 2018 |
| University of London | Academic/Hospital | 2 | 0 | 2 | 2003 |
Marketing (89)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | Nov 13, 2017 |
| ANDA Repository | For profit | MKTG | Jul 31, 2017 |
| AbbVie | For profit | MKTG | Jul 26, 1999 |
| Actavis | For profit | MKTG | Jun 5, 1997 |
| Actavis | For profit | SYN | Apr 28, 1997 |
| Akorn, Inc. | For profit | MKTG | Jun 7, 2005 |
| Alembic | For profit | MKTG | Apr 6, 2018 |
| Alembic | For profit | SYN | Apr 6, 2018 |
| Amneal Pharmaceuticals | For profit | SYN | Nov 9, 2020 |
| Amneal Pharmaceuticals | For profit | MKTG | Jun 18, 2014 |
| Apotex | For profit | SYN | Sep 28, 2005 |
| Apotex | For profit | MKTG | Sep 28, 2005 |
| Apothecon | For profit | MKTG | Dec 10, 1997 |
| Athenex, Inc. | For profit | MKTG | Apr 22, 1997 |
| Aurobindo Pharma | For profit | MKTG | Oct 11, 2013 |
| Aurobindo Pharma | For profit | SYN | Mar 31, 2022 |
| Aurobindo Pharma | For profit | SYN | Apr 22, 1997 |
| Bausch Health Companies | For profit | NDA | Mar 29, 1982 |
| Bausch Health Companies | For profit | NDA2 | Mar 29, 1982 |
| Boehringer Ingelheim | For profit | MKTG | Aug 30, 1996 |
| Boscogen | For profit | MKTG | Jan 26, 1999 |
| Cadila Healthcare | For profit | SYN | Mar 25, 2016 |
| Cadila Healthcare | For profit | MKTG | Nov 15, 2013 |
| Carlsbad Technology | For profit | MKTG | Aug 16, 2017 |
| Chartwell Pharmaceuticals | For profit | MKTG | Apr 22, 1997 |
| Chartwell Pharmaceuticals | For profit | SYN | Apr 22, 1997 |
| Chartwell Pharmaceuticals | For profit | SYN | Apr 7, 2020 |
| Cipla | For profit | MKTG | Jan 18, 2019 |
| Cosette | For profit | MKTG | Nov 13, 2017 |
| DAVA Pharmaceuticals | For profit | MKTG | Apr 22, 1997 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jun 17, 2020 |
| Emcure | For profit | MKTG | Apr 23, 2020 |
| Epi Health | For profit | NDA2 | Apr 12, 2013 |
| Eugia Pharma | For profit | MKTG | Oct 11, 2013 |
| Eurohlth Intl Sarl | For profit | MKTG | Oct 15, 1997 |
| Exela Pharma Sciences, LLC. | For profit | MKTG | Jun 17, 2020 |
| Exeltis | For profit | MKTG | Jan 29, 2020 |
| Exeltis | For profit | SYN | Jan 29, 2020 |
| Fera Development, LLC | For profit | NDA2 | Mar 29, 2019 |
| Fougera | For profit | MKTG | May 11, 2016 |
| Fresenius | For profit | MKTG | Apr 30, 1998 |
| G & W Laboratories Inc. | For profit | MKTG | Nov 13, 2017 |
| GlaxoSmithKline | For profit | NDA2 | Oct 22, 1982 |
| Glenmark Pharmaceuticals | For profit | SYN | Jul 31, 2017 |
| Glenmark Pharmaceuticals | For profit | MKTG | Jul 31, 2017 |
| Heritage Pharma | For profit | MKTG | Oct 31, 1997 |
| Heritage Pharma | For profit | SYN | Oct 31, 1997 |
| Hetero Labs Ltd | For profit | MKTG | Oct 29, 2013 |
| Hetero Labs Ltd | For profit | SYN | Jul 1, 2022 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Jun 7, 2005 |
| Hikma | For profit | MKTG | Feb 29, 2016 |
| Hikma | For profit | SYN | Feb 29, 2016 |
| Hospira | For profit | MKTG | Apr 22, 1997 |
| Ionis Pharmaceuticals, Inc. | For profit | MKTG | Apr 30, 1999 |
| Kenton | For profit | MKTG | Jan 26, 1999 |
| Lek Pharmaceuticals | For profit | MKTG | Mar 21, 1997 |
| MSN Laboratories | For profit | MKTG | Mar 9, 2023 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | May 19, 2021 |
| Mylan | For profit | NDA2 | Jan 25, 1985 |
| Mylan | For profit | MKTG | Apr 22, 1997 |
| Mylan | For profit | SYN | Mar 29, 2017 |
| Namigen Llc | For profit | MKTG | Jun 17, 2020 |
| Neogen | For profit | MKTG | May 19, 2021 |
| Novartis | For profit | MKTG | May 11, 2016 |
| Novitium Pharma | For profit | MKTG | Jul 10, 2020 |
| Padagis Us | For profit | MKTG | Feb 4, 2019 |
| Perrigo | For profit | MKTG | Feb 4, 2019 |
| Prinston Inc | For profit | MKTG | Nov 15, 2021 |
| Ranbaxy | For profit | MKTG | Sep 30, 1998 |
| Roxane Laboratories | For profit | MKTG | Aug 30, 1996 |
| Rubicon Research | For profit | MKTG | Aug 18, 2022 |
| Solaris Pharma Corp | For profit | MKTG | Apr 7, 2020 |
| Square Pharmaceuticals | For profit | SYN | Oct 7, 2019 |
| Square Pharmaceuticals | For profit | MKTG | Oct 7, 2019 |
| Strides Pharma Science | For profit | MKTG | Apr 22, 1997 |
| Sun Pharmaceuticals | For profit | MKTG | Sep 30, 1998 |
| Taro Pharmaceuticals | For profit | MKTG | Dec 21, 2016 |
| Teva | For profit | SYN | Nov 26, 1997 |
| Teva | For profit | MKTG | Apr 22, 1997 |
| Teva | For profit | SYN | Apr 22, 1997 |
| Teva | For profit | SYN | Aug 26, 1997 |
| Tolmar Inc. | For profit | MKTG | Jul 31, 2017 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Jan 11, 2019 |
| VistaPharm, Inc. | For profit | MKTG | Jan 11, 2021 |
| Watson Pharmaceuticals | For profit | MKTG | Apr 15, 1998 |
| Yiling Pharmaceutical Inc. | For profit | SYN | Mar 7, 2018 |
| Yiling Pharmaceutical Inc. | For profit | MKTG | Mar 7, 2018 |
| Zydus Discovery DMCC | For profit | MKTG | Aug 19, 2014 |
| Zydus Discovery DMCC | For profit | SYN | Feb 28, 2023 |