Zovirax

(Acyclovir)

ApprovedSmall molecule

Acyclovir is used to treat infections caused by herpes viruses, including cold sores, genital herpes, and shingles. It works by slowing down the virus's ability to spread in your body.[2] Zovirax is currently approved and in use across 21 indications[4].[1]

Zovirax is one of 279 small molecule programs targeting Herpesviridae infectious disease. It is currently in Approved.

Indications

Total Trials

Active Trials

278

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Herpesviridae Infectious DiseaseActive, not recruiting

HIV InfectionApproved

Herpes Simplex InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

Cytomegalovirus RetinitisActive, not recruiting

Rheumatic DiseaseActive, not recruiting

Herpes LabialisActive, not recruiting

ChickenpoxActive, not recruiting

KeratitisActive, not recruiting

Eye InfectionActive, not recruiting

Herpesviridae Infectious DiseasePreclinical

Active, not recruiting

HIV InfectionApproved

Approved

Herpes Simplex InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

Cytomegalovirus RetinitisPreclinical

Active, not recruiting

Rheumatic DiseaseApproved

Active, not recruiting

Herpes LabialisApproved

Active, not recruiting

ChickenpoxApproved

Active, not recruiting

KeratitisPreclinical

Active, not recruiting

Eye InfectionApproved

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

123 competitors in HIV Infection

#DrugCompanyPhaseTrials

Retrovir

BBp Consulting, Inc

Approved

36 2

Videx

Bristol-Myers Squibb

Approved

14 3

Norvir

AbbVie

Approved

10 4

Tivicay

GSK

Approved

7 5

Epivir

GGlaxo Dba Glaxosmithkline

Approved

16 6

Ziagen

GSK

Approved

4 7

Viramune

Boehringer Ingelheim

Approved

11 8

Sustiva

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

10 9

Olumiant

Eli Lilly

Approved

1 10

Vemlidy

Gilead

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Obese Patients

NCT05589688

Phase 3Recruiting

Pneumonia, Viral

NCT06134492

Q1 2027

N/ANot yet recruiting

Mechanically Ventilated Patients

NCT06217406

Q4 2027

Phase 1Recruiting

Age-Related Macular Degeneration

NCT03178149

Q2 2028

ApprovedRecruiting

Autoimmune Rheumatic Diseases

NCT07341386

Clinical

Trials by Indication[1]

Treatment6 trials

Effect of Various Treatment Modalities on Dendritic Vial Ulcer

Unknown status·SSohag University··NCT05313828·40 enrolled

HSV-2 Shedding Resolution After Acyclovir Treatment

Completed·UUniversity of Washington··NCT00495573·36 enrolled

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000712·400 enrolled

Show 3 more trials

Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000953·180 enrolled

Anti-Herpetic Treatment of Genital Ulcer : Effect on HIV & Herpes Shedding (ANRS 1212)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00158483·449 enrolled

Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000985·26 enrolled

Herpes Simplex Virus6 trials

Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

Completed·UUniversity of Washington·Phase 4·NCT00527618·28 enrolled

Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00006135·66 enrolled

Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004757

Show 3 more trials

The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001115·75 enrolled

Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00031447·29 enrolled

Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00371592·50 enrolled

Genital Herpes5 trials

A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients

Completed· GSK logo

GSK·N/A·NCT00002084

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

Completed· GSK logo

GSK·N/A·NCT00002000

Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT02053142·74 enrolled

Show 2 more trials

A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00076232·3,682 enrolled

Melatonin Effects on Genital Herpes in Brazilian Women

Completed·UUniversity of Sao Paulo General Hospital·Phase 4·NCT03831165·90 enrolled

Multiple Sclerosis4 trials

A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 1·NCT02583594·24 enrolled

A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 1·NCT02977533·20 enrolled

A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 1·NCT02282826·48 enrolled

Show 1 more trial

A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)

Terminated· Sanofi logo

Sanofi·Phase 3·NCT03368664·16 enrolled

Central Nervous System3 trials

Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00031460·46 enrolled

Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System

Unknown status·NNational Center for Research Resources (NCRR)·Phase 3·NCT00006132·132 enrolled

Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection

Completed·NNational Center for Research Resources (NCRR)·Phase 1/2·NCT00004644·25 enrolled

41 more indications

Herpes Zoster3 trials

Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection in Patients With Herpes Zoster

Completed·CCttq·Phase 4·NCT02151240·94 enrolled

A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems

Completed· GSK logo

GSK·Phase 3·NCT00002315·400 enrolled

Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster Virus Infection After Bone Marrow Transplant

Completed·FFred Hutchinson Cancer Center·Phase 3·NCT00209352·120 enrolled

HIV-12 trials

Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons

Completed·UUniversity of Washington·Phase 4·NCT01026454·32 enrolled

Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon

Completed·FFred Hutchinson Cancer Center·Phase 2/3·NCT00209313·40 enrolled

Randomized2 trials

Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

Completed·UUniversity of Washington·Phase 4·NCT00362297·31 enrolled

A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation

Completed·UUniversity of Washington·Phase 4·NCT00723229·48 enrolled

Eye Disease2 trials

Herpetic Eye Disease Study (HEDS) I

Unknown status·NNational Eye Institute (NEI)·Phase 3·NCT00000138

Herpetic Eye Disease Study (HEDS) II

Completed·NNational Eye Institute (NEI)·Phase 3·NCT00000139

Kidney Transplant2 trials

Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

Completed·UUniversity of Wisconsin, Madison·Phase 1/2·NCT00078559·10 enrolled

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03443869·601 enrolled

Nasopharyngeal Carcinoma1 trial

EBV Positive Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug

Unknown status·KKuwait Cancer Control Center·Phase 3·NCT03656965·50 enrolled

Completed·UUniversity of Washington·N/A·NCT00808405·88 enrolled

Effectiveness1 trial

The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children

Unknown status·DDalia Mahran·N/A·NCT04476186·35 enrolled

Immunodeficiency1 trial

Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)

Completed·SShaman Pharmaceuticals·N/A·NCT00002186·400 enrolled

Prophylaxis1 trial

Antiviral Prophylaxis in a Burn Population

Withdrawn·SSouthern Illinois University·Phase 2/3·NCT02349828

ESS1 trial

Effect of HSV-2 Suppressive Therapy on Sexual Behavior

Terminated·UUniversity of Washington·Phase 4·NCT00495716·72 enrolled

Uveitis1 trial

A Clinical Trial of Acyclovir for Viral Uveitis

Unknown status·XXiaomin Zhang·N/A·NCT03389191·30 enrolled

Cytomegalovirus Retinitis1 trial

Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000693·25 enrolled

HIV infection1 trial

The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection

Completed· GSK logo

GSK·N/A·NCT00002290

Randomized Controlled Trial1 trial

A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand

Completed·CCenters for Disease Control and Prevention·Phase 4·NCT00362596·67 enrolled

Cytomegalovirus Infection1 trial

Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation

Completed·FFred Hutchinson Cancer Center·Phase 3·NCT00045292

Obese Patients1 trial

Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir

Recruiting·UUniversity Hospital, Toulouse·Phase 1·NCT05589688·20 enrolled

HIV1 trial

A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001010·72 enrolled

Plantar Wart1 trial

Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts

Unknown status·—·N/A·NCT05324904·44 enrolled

Encephalitis1 trial

Aseptic Meningoencephalitis in Slovenia

Unknown status·UUniversity Medical Centre Ljubljana··NCT02328469·800 enrolled

Stem Cell Transplantation1 trial

Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)

Completed·HHadassah Medical Organization·Phase 3·NCT00330018·40 enrolled

Vertigo1 trial

Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease

Unknown status·TTehran University of Medical Sciences·Phase 2/3·NCT01729767·80 enrolled

Cytomegalovirus Disease1 trial

A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001038·1,200 enrolled

Non-Small Cell Lung Cancer1 trial

Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01833143·17 enrolled

Premature Infants1 trial

A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)

Completed·PPhillip Brian Smith·Phase 1·NCT00942084·32 enrolled

Infection1 trial

Antimicrobial PK in Infants With Suspected or Confirmed Infection

Completed·—··NCT00491426·450 enrolled

Leukoplakia1 trial

Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)

Completed· GSK logo

GSK·N/A·NCT00002026

Mechanically Ventilated Patients1 trial

Preemptive Treatment With Acyclovir in Intubated and Mechanically Ventilated Patients With Herpes (PTH2)

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·N/A·NCT06217406·246 enrolled

Hematological Malignancies1 trial

Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies

Completed·AAzienda Ospedaliero, Universitaria Pisana·Phase 2·NCT03159845·20 enrolled

Pediatric Burns1 trial

Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns

Completed·KKing Edward Medical University·N/A·NCT06380647·64 enrolled

Fasting Conditions1 trial

The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting Conditions

Unknown status·IInternational Bio service·Phase 1·NCT06228430·40 enrolled

Keratitis1 trial

Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis

Completed·—·N/A·NCT06757907·20 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Carfilzomib, Rituximab, and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Lymphoma

Completed·—·Phase 1/2·NCT02073097·48 enrolled

Acute Lymphoblastic Leukemia1 trial

Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00061945·302 enrolled

Prostate Cancer1 trial

Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT02047253·28 enrolled

Age-Related Macular Degeneration1 trial

A Phase 1b, Multicenter, Dose Escalation, Evaluation of Safety and Tolerability of ASP7317 for Geographic Atrophy Secondary to Age-related Macular Degeneration

Recruiting· Astellas logo

Astellas·Phase 1·NCT03178149·42 enrolled

Autoimmune Rheumatic Diseases1 trial

Prevention of Recurrence of Herpes Simplex in Patients With Autoimmune Rheumatic Diseases

Recruiting·UUniversity of Sao Paulo General Hospital·Approved·NCT07341386·62 enrolled

Pneumonia, Viral1 trial

Effect of Acyclovir Therapy on the Outcome of Ventilated Patients With Lower Respiratory Tract Infection and Detection of Herpes Simplex Virus in Bronchoalveolar Lavage

Recruiting·JJena University Hospital·Phase 3·NCT06134492·616 enrolled

Unspecified3 trials

Bioequivalence of Two Formulations of Acyclovir

Completed·YYung Shin Pharm. Ind. Co., Ltd.·Phase 4·NCT02255734·14 enrolled

Episodic Acyclovir Therapy for Genital Ulcers

Completed·CCenters for Disease Control and Prevention·Phase 2/3·NCT00164424·613 enrolled

Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject

Completed·PPT. Kimia Farma (Persero) Tbk·N/A·NCT04988646·56 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 29, 1982

ZOVIRAX

NDA NDA018604

Mar 29, 1982

ZOVIRAX

NDA NDA018604

Jun 14, 1982

ZOVIRAX

NDA NDA018604

Jul 21, 1982

ZOVIRAX

NDA NDA018604

Dec 16, 1982

ZOVIRAX

NDA NDA018604

Jan 25, 1985

ZOVIRAX

NDA NDA018828

Apr 2, 1985

ZOVIRAX

NDA NDA018604

Nov 12, 1986

ZOVIRAX

NDA NDA018604

Jun 29, 1989

ZOVIRAX

NDA NDA018603

Dec 22, 1989

ZOVIRAX

NDA NDA019909

Apr 30, 1991

ZOVIRAX

NDA NDA020089

Jul 23, 1992

ZOVIRAX

NDA NDA018604

Jan 21, 1993

ZOVIRAX

NDA NDA018604

Jan 21, 1993

ZOVIRAX

NDA NDA018604

Nov 9, 1993

ZOVIRAX

NDA NDA018604

Oct 29, 1996

ZOVIRAX

NDA NDA018604

Jan 8, 1997

ZOVIRAX

NDA NDA018604

Feb 3, 1999

ZOVIRAX

NDA NDA018604

Jul 12, 2000

ZOVIRAX

NDA NDA018604

May 30, 2001

ZOVIRAX

NDA NDA018604

May 30, 2001

ZOVIRAX

NDA NDA018604

Nov 22, 2002

ZOVIRAX

NDA NDA018604

Dec 30, 2002

ZOVIRAX

NDA NDA021478

Dec 30, 2002

ZOVIRAX

NDA NDA021478

Jan 23, 2004

ZOVIRAX

NDA NDA021478

Apr 12, 2013

SITAVIG

NDA NDA203791

Apr 1, 2014

ZOVIRAX

NDA NDA021478

Sep 29, 2014

ZOVIRAX

NDA NDA018604

Feb 3, 2015

ZOVIRAX

NDA NDA021478

Mar 29, 2019

AVACLYR

NDA NDA202408

Dec 23, 2020

ZOVIRAX

NDA NDA021478

Sources

References

[1]
ClinicalTrials.gov — 73 trial records for Acyclovir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zovirax drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Acyclovir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Acyclovir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021478). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Zovirax. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bp Consulting, Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Herpesvirus 1 DNA Polymerase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBp Consulting, Inc

Patent Landscape[6]

Patent Cliff

Mar 23, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8791127Mar 23, 2027

8747896Jun 3, 2027

8592434Jun 16, 2030

Zovirax

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q2 2028

Trials by Indication[1]

Treatment6 trials

Herpes Simplex Virus6 trials

Genital Herpes5 trials

Multiple Sclerosis4 trials

Central Nervous System3 trials

Herpes Zoster3 trials

HIV-12 trials

Randomized2 trials

Eye Disease2 trials

Kidney Transplant2 trials

Nasopharyngeal Carcinoma1 trial

Virus1 trial

Antibiotic Therapy1 trial

Women1 trial

Effectiveness1 trial

Immunodeficiency1 trial

Prophylaxis1 trial

ESS1 trial

Uveitis1 trial

Cytomegalovirus Retinitis1 trial

HIV infection1 trial

Randomized Controlled Trial1 trial

Cytomegalovirus Infection1 trial

Obese Patients1 trial

HIV1 trial

Plantar Wart1 trial

Encephalitis1 trial

Stem Cell Transplantation1 trial

Vertigo1 trial

Cytomegalovirus Disease1 trial

Non-Small Cell Lung Cancer1 trial

Premature Infants1 trial

Infection1 trial

Leukoplakia1 trial

Mechanically Ventilated Patients1 trial

Hematological Malignancies1 trial

Pediatric Burns1 trial

Fasting Conditions1 trial

Keratitis1 trial

Diffuse Large B-Cell Lymphoma1 trial

Acute Lymphoblastic Leukemia1 trial

Prostate Cancer1 trial

Age-Related Macular Degeneration1 trial

Autoimmune Rheumatic Diseases1 trial

Pneumonia, Viral1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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