Acyclovir
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed herpes labialis 1 milestone | |||||
| Filed | EU (EMA) | Sitavig | herpes labialis | — | “the submission of a European registration dossier for Sitavir®/Sitavig® are particularly key milestones” valeriotx.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| 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
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Products Approvals For the Qtr ended 31st Dec, 2023 alembicpharmaceuticals.com ↗ |
| 2023-03-02 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Acyclovir Cream zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Acyclovir Cream, 5% (USRLD: Zovirax® Cream). |
| 2020-11-11 | Impax Laboratories, LLC | Regulatory Amneal Receives Abbreviated New Drug Application Approval for Acyclovir Cream, 5% amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) today announced that it has received approval for its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Acyclovir Cream, 5%. |
| 2019-03-19 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Acyclovir Ointment zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Acyclovir Ointment USP (US RLD – Zovirax ®), 5%. |
| 2019-02-06 | Perrigo Company | Regulatory Perrigo Announces FDA Final Approval for its AB Rated Generic Version of Zovirax® Cream 5% perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Zovirax® Cream, 5% (acyclovir cream, 5%) developed in collaboration with Sol-Gel Technologies Ltd. (NASDAQ: SLGL). |
| 2014-03-19 | Valerio Therapeutics | Regulatory Sitavig® Licensing Strategy: Execution of licensing agreement with Innocutis for North America and Positive opinion from French and German Health Authorities for Marketing Authorization valeriotx.com ↗
In Europe, the Company received a positive opinion from the Health Authorities in France and Germany for the Market Authorization of the drug. |
| 2010-10-26 | Medivir | Results Medivir’s U.S. commercialisation partner Meda presents positive Xerese™ data at the AOA's Osteopathic Medical Conference and Exposition medivir.com ↗
The study found that the combination was well tolerated and had a favourable safety profile. |
| 2008-03-19 | Medivir | Results Lipsovir® prevents cold sores. Phase III clinical trial results first to show prevention by early treatment. medivir.com ↗
Treatment with Lipsovir® prevented the development of cold sores in 42% of patients. |
All press releases naming this drug 12 releases
Evidence & citations 40 cited values
Every value below carries the sentence it was read from. 107 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 ↗96“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)” NCT07341386 ↗ “Acyclovir (ACV)” NCT00158483 ↗ “Acyclovir (ACV)” NCT03443869 ↗ “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 ↗ |