Acyclovir
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | ZOVIRAX | — | 1989-12-22 – 1998-06-02 | fda.gov ↗ |
| Approved | US (FDA) | ZOVIRAX | — | 1982-03-29 | fda.gov ↗ |
Trials 52 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 50 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03457025 Background | Aug 2019 → Jun 2020 | Bell's palsy | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT03178149 Background | Jul 2018 → Jun 2026 overdue | age-related macular degeneration | Astellas Institute for Regenerative Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT02977533 Background | Dec 2016 → May 2018 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02583594 Background | Dec 2015 → Mar 2016 | multiple sclerosis | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT02282826 Background | Oct 2014 → Mar 2016 | multiple sclerosis | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT01042704 Background | Feb 2008 → Jan 2011 | plasma cell myeloma | Robert Redner, MD | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02073097 Background | Jan 2015 → Jul 2021 | diffuse large B-cell lymphoma | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00078559 Background | Nov 2003 → Feb 2010 | kidney disorder | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1/2 | NCT00061945 Background | Jun 2003 → Dec 2007 | B-cell adult acute lymphocytic leukemia, B-cell childhood acute lymphoblastic leukemia, T-cell adult acute lymphocytic leukemia, T-cell childhood acute lymphocytic leukemia +1 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT05112354 Background | Dec 2019 → Jun 2021 | sudden sensorineural hearing loss | Assiut University | Completed | No outcome recorded |
| Phase 2 | NCT02871492 Comparator | Nov 2016 → Sep 2017 | herpes labialis | AiCuris Anti-infective Cures AG | Completed | No outcome recorded |
| Phase 2 | NCT02483182 Comparator | Sep 2015 → Jun 2018 | herpes labialis | Shulov Innovate for Science Ltd. 2012 | Completed | No outcome recorded |
| Phase 2 | NCT02047253 Background | Apr 2014 → Jun 2017 | castration-resistant prostate carcinoma | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT03159845 Background | Jan 2014 → Sep 2019 | disease related to hematopoietic stem cell transplant | Azienda Ospedaliero, Universitaria Pisana | Completed | No outcome recorded |
| Phase 2 | NCT01833143 Background | Apr 2013 → Aug 2019 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01114048 Background | Mar 2010 → Mar 2012 | plasma cell myeloma | Chonnam National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT00405821 Comparator | Nov 2006 → Oct 2010 | HIV infectious disease, genital herpes | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00492050 Background | Aug 2006 → Feb 2021 overdue | Waldenstrom macroglobulinemia | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02349828 Comparator | Sep 2015 → Apr 2016 | herpes simplex infectious disease | Southern Illinois University | Withdrawn | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03443869 Background | May 2018 → Apr 2022 | cytomegalovirus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03368664 Background | Oct 2017 → May 2021 | multiple sclerosis | Genzyme, a Sanofi Company | Terminated | No outcome recorded |
| Phase 3 | NCT01281007 Comparator | Jul 2012 → Jan 2015 | genital herpes | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01327144 Comparator | Jun 2012 → May 2017 | herpes zoster | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01257074 Comparator | Feb → Mar 2012 | herpes labialis | EMS | Completed | No outcome recorded |
| Phase 3 | NCT00735761 Comparator | Dec 2006 → Sep 2007 | herpes labialis | Medivir | Completed | No outcome recorded |
| Phase 3 | NCT00361881 Comparator | Jul 2006 → Aug 2007 | herpes labialis | Medivir | Completed | No outcome recorded |
| Phase 3 | NCT00330018 Comparator | Feb 2006 → Apr 2010 | cytomegalovirus infection | Hadassah Medical Organization | Completed | No outcome recorded |
| Phase 3 | NCT00194519 Comparator | Nov 2004 → Nov 2009 | HIV infectious disease, genital herpes | University of Washington | Completed | No outcome recorded |
| Phase 3 | NCT00045292 Background | Apr 2002 → Oct 2004 | cancer | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00000985 Background | ? → Oct 1990 | HIV infectious disease, herpes simplex infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT05452928 Comparator | Jun 2026 → Jun 2028 expected | herpes simplex type 2 infectious disease, viral meningitis | Jacob Bodilsen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07341386 Comparator | Apr 2026 → Apr 2027 expected | herpes simplex infectious disease, rheumatic disorder | University of Sao Paulo General Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07196670 Comparator | Sep → Dec 2025 overdue | plantar wart | Cairo University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05429151 Comparator | Jun → Nov 2022 | — | Sohag University | Unknown | No outcome recorded |
| Phase 4 | NCT04656821 Comparator | Dec 2020 → Jun 2021 | herpes zoster | Tanta University | Unknown | No outcome recorded |
| Phase 4 | NCT03626376 Comparator | Dec 2019 → Mar 2021 | herpes simplex virus keratitis | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 4 | NCT02205489 Background | Oct 2014 → Apr 2016 | relapsing-remitting multiple sclerosis | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT02151240 Comparator | May 2014 → May 2015 | herpes zoster | Cttq | Completed | No outcome recorded |
| Phase 4 | NCT02152358 Comparator | Feb 2014 → Apr 2018 | viral pneumonia | Assistance Publique Hopitaux De Marseille | Completed | No outcome recorded |
| Phase 4 | NCT01026454 Comparator | Feb → Nov 2010 | HIV infectious disease, herpes simplex type 2 infectious disease | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT00723229 Comparator | Aug 2008 → Jul 2010 | genital herpes simplex type 2 infectious disorder | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT00495716 Comparator | Jan 2008 → Jun 2010 | genital herpes | University of Washington | Terminated | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT06757907 Comparator | Oct → Dec 2024 | herpes simplex virus keratitis | Al-Azhar University | Completed | No outcome recorded |
| — | NCT05324904 Comparator | Oct 2022 → Oct 2023 | plantar wart | Assiut University | Unknown | No outcome recorded |
| — | NCT04546334 Background | Sep 2020 → Jun 2021 | postherpetic neuralgia | Tanta University | Completed | No outcome recorded |
| — | NCT04476186 Comparator | Jun 2020 → Dec 2021 | molluscum contagiosum | Dalia Mahran | Unknown | No outcome recorded |
| — | NCT02328079 Comparator | Apr 2013 → Nov 2014 | facial paralysis | Assiut University | Completed | No outcome recorded |
| — | NCT00808405 Comparator | Jan → Dec 2009 | genital herpes | University of Washington | Completed | No outcome recorded |
| — | NCT00002186 Background | — | HIV infectious disease, herpes simplex infectious disease | Shaman Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 40 cited values
Every value below carries the sentence it was read from. 106 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Acyclovir | “Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine...” NCT05894954 ↗95“standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours” NCT04656821 ↗ “In case of history of zoster or fungal infection a prophylaxis with Acyclovir or Diflucan should be also considered.” NCT01042704 ↗ “routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol)” NCT04546334 ↗ “All patients will receive antiviral therapy in the form of acyclovir,valcyclovir” NCT05112354 ↗ “Acyclovir prophylaxis during velcade administration” NCT01114048 ↗ “acyclovir 400mg: one pill 4 times daily for 7 days” NCT03457025 ↗ “Acyclovir (ACV)” NCT03443869 ↗ |
| Known as | aciclovir | “Acyclovir (aciclovir) is a nucleoside antiviral drug with antiviral activity in vitro against members of the herpes group of DNA viruses.” PMID 2653790 ↗ Mar 19896“We investigated the effect of daily suppressive aciclovir on HIV-1 disease progression in Rakai, Uganda.” PMID 22433279 ↗ Mar 2012 |
| Known as | Aciclovir sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Aciclovirum | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | ACV | “OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin lesions and improves neurologic outcome in neonates with localized herpes simplex...” NCT00004757 ↗10“To study the use of acyclovir (ACV) and zidovudine (AZT) in the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS who would otherwise be treated with...” NCT00000693 ↗ “Earlier studies during the era of zidovudine (Retrovir) monotherapy showed a survival advantage when acyclovir (ACV, Zovirax) was added to the treatment of patients with HIV.” NCT00405821 ↗ “Part A: To evaluate the impact of HSV suppression with acyclovir ( ACV ) on HIV burden in patients with asymptomatic HSV infection and at high risk for HSV reactivation.” NCT00001115 ↗ “three separate phase III trials of acyclovir (ACV) for prevention of HIV-1 acquisition and transmission” PMID 20702659 ↗ Aug 2010 “Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)” NCT00002026 ↗ “concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy alone” NCT00002290 ↗ “Acyclovir (ACV)” NCT00158483 ↗ “Acyclovir (ACV)” NCT03443869 ↗ “Acyclovir (ACV)” NCT07341386 ↗ “acyclovir (ACV)” NCT00000712 ↗ |
| Known as | Acycloguanosine | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Acyclovir component of xerese | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | ACYCLOVIR SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Acyclovir sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Avaclyr | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Avert | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | BAYM008894 | “Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773” NCT05098938 ↗ |
| Known as | BW 248U | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | BW 248U SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Clearsore | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Cymex ultra | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Duvimex | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Gerpevir | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Herpetad | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Lipsore | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Lypsyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Novirus | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | NSC-645011 | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | NSC-758477 | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Ranovir | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Sitavig | “Sitavig® (Acyclovir) 50 mg Muco-adhesive Buccal Tablet” NCT05098938 ↗ |
| Known as | Sodium acyclovir | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Soothelip | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Soraway | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | UI1614773 | “Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773” NCT05098938 ↗ |
| Known as | Viralief | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Virasorb | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Virovir 200 | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Virovir 400 | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Virovir 800 | ChEMBL registry synonym — accepted as the source's own label CHEMBL184 ↗ |
| Known as | Zovirax | “A Multi-Center, Double-Blind Trial to Evaluate the Safety and Efficacy of Concurrent Retrovir (Zidovudine) and Zovirax (Acyclovir) Therapy in Patients With Early Symptomatic...” NCT00002290 ↗3“Earlier studies during the era of zidovudine (Retrovir) monotherapy showed a survival advantage when acyclovir (ACV, Zovirax) was added to the treatment of patients with HIV.” NCT00405821 ↗ “Acyclovir vial (Zovirax® vial, 250mg, ) will be diluted with 3.5 ml saline to get approximately 70 mg /ml solution.” NCT05324904 ↗ |
| Known as | Zovirax - Acyclovir | “Zovirax - Acyclovir” NCT04476186 ↗ |
| Action | Inhibit | “Acyclovir as antiviral drug act at two levels: as competitive alternative substrates, competing with GTP on the substrate-binding site, and as DNA chain terminators, by...” NCT03656965 ↗ |
| Modality | Small molecule | “Acyclovir (aciclovir) is a nucleoside antiviral drug with antiviral activity in vitro against members of the herpes group of DNA viruses.” PMID 2653790 ↗ Mar 1989 |
| Route | Oral | “oral treatment with 200 mg acyclovir capsules” NCT00000138 ↗ |