Acyclovir

Overview

Acyclovir is a nucleotide analog antiviral used to treat herpes simplex, Varicella zoster, herpes zoster, herpes labialis, and acute herpetic keratitis. Acyclovir is generally used first line in the treatment of these viruses and some products are indicated for patients as young as 6 years old. Acyclovir was granted FDA approval on 29 March 1982.

Indication

An acyclovir topical cream is indicated to treat recurrent herpes labialis in immunocompetent patients 12 years and older. Acyclovir oral tablets, capsules, and suspensions are indicated to treat herpes zoster, genital herpes, and chickenpox. An acyclovir topical ointment is indicated to treat initial genital herpes and limited non-life-threatening mucocutaneous herpes simplex in immunocompromised patients. An acyclovir cream with hydrocortisone is indicated to treat recurrent herpes labialis, and shortening lesion healing time in patients 6 years and older. An acyclovir buccal tablet is indicated for the treatment of recurrent herpes labialis. An acyclovir ophthalmic ointment is indicated to treat acute herpetic keratitis.

Associated Conditions

Bell's Palsy
Chickenpox
Cytomegalovirus (CMV) Infections
Herpes Simplex Infections
Herpes Zoster
Herpes simplex encephalitis
Herpes simplex of the oral-labial
Herpes simplex type I reactivation
Recurrent Genital Herpes (RGH)
Recurrent Herpes Labialis
VZV re-activation
Acute Genital herpes
Acute Herpes labialis
Acute Herpetic keratitis
Severe Genital herpes

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis	2025/01/03	NCT06757907	Not Applicable	Completed	Al-Azhar University
Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns	2024/04/24	NCT06380647	Not Applicable	Completed	King Edward Medical University
Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.	2024/02/15	NCT06261684	Phase 2	Recruiting	Cairo University
The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting Conditions	2024/01/29	NCT06228430	Phase 1	Not yet recruiting	International Bio service
Preemptive Treatment With Acyclovir in Intubated and Mechanically Ventilated Patients With Herpes (PTH2)	2024/01/22	NCT06217406	Not Applicable	Not yet recruiting	Assistance Publique - Hôpitaux de Paris
Acyclovir in Ventilated Patients With Pneumonia and HSV-1 in BAL	2023/11/18	NCT06134492	Phase 3	Recruiting	Jena University Hospital
Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir	2022/10/21	NCT05589688	Phase 1	Recruiting	University Hospital, Toulouse
Aciclovir Versus Placebo for HSV-2 Meningitis	2022/07/12	NCT05452928	Phase 4	Not yet recruiting	Jacob Bodilsen
Intralesional Injection of Acyclovir Versus Candida Antigen in Treatment of Plantar Warts	2022/06/23	NCT05429151	Phase 4	UNKNOWN	Sohag University
Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts	2022/04/13	NCT05324904	Not Applicable	UNKNOWN	Assiut University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Acyclovir	NuCare Pharmaceuticals,Inc.	68071-3573	ORAL	400 mg in 1 1	2/15/2024
Acyclovir	Preferred Pharmaceuticals Inc.	68788-8434	ORAL	800 mg in 1 1	4/27/2023
ACYCLOVIR	RedPharm Drug Inc.	67296-0375	ORAL	400 mg in 1 1	6/29/2011
ACYCLOVIR	RedPharm Drug, Inc.	67296-1108	ORAL	200 mg in 1 1	1/20/2022
acyclovir	NuCare Pharmaceuticals,Inc.	68071-2287	ORAL	400 mg in 1 1	1/14/2022
acyclovir	Zydus Lifesciences Limited	65841-803	ORAL	800 mg in 1 1	10/24/2023
Acyclovir	A-S Medication Solutions	50090-5610	ORAL	200 mg in 1 1	12/20/2022
ACYCLOVIR	DIRECT RX	72189-232	ORAL	800 mg in 1 1	6/29/2023
Sitavig	EPI Health, Inc	71403-049	BUCCAL	50 mg in 1 1	12/1/2019
acyclovir	Zydus Pharmaceuticals (USA) Inc.	68382-791	ORAL	400 mg in 1 1	10/24/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
VILERM TABLET 200 mg	SIAM BHEASACH CO LTD	SIN09451P	TABLET	200 mg	7/16/1997
AVORAX CREAM 5%	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN09254P	CREAM	5% w/w	3/18/1997
DBL ACICLOVIR INTRAVENOUS INFUSION 250mg/10ml	HOSPIRA AUSTRALIA PTY LTD	SIN09367P	INJECTION	250mg	6/13/1997
VIRLESS TABLET 800 mg	Y S P INDUSTRIES (M) SDN BHD	SIN10084P	TABLET	800 mg	9/29/1998
LOVIR TABLETS 400 mg	RANBAXY (MALAYSIA) SDN BHD	SIN09629P	TABLET	400 mg	2/12/1998
ZOVIRAX SUSPENSION 200 mg/5 ml	ASPEN BAD OLDESLOE GMBH	SIN01192P	SUSPENSION	200 mg/5 ml	5/14/1988
VACRAX I.V. FOR INFUSION 250 mg/vial	Aprogen Pharmaceuticals, Inc.	SIN10874P	INJECTION, POWDER, FOR SOLUTION	250 mg/vial	4/13/1999
VIRLESS TABLET 200 mg	Y S P INDUSTRIES (M) SDN BHD	SIN08532P	TABLET	200 mg	1/29/1996
MEDOVIR 800 TABLET 800 mg	MEDOCHEMIE LTD, MEDOCHEMIE (FAR EAST) LTD -ORAL FACILITY	SIN08762P	TABLET, FILM COATED	800 mg	7/3/1996
HERPERAX-800 TABLET 800 mg	MICRO LABS LTD	SIN10468P	TABLET	800 mg	11/27/1998

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Aciclovir Eye Ointment	唐山红星药业有限责任公司	国药准字H19999320	化学药品	眼膏剂	9/22/2020
Aciclovir Eye Ointment	山东博士伦福瑞达制药有限公司	国药准字H20063903	化学药品	眼膏剂	2/3/2021
Aciclovir Eye Ointment	湖北科益药业股份有限公司	国药准字H42021733	化学药品	眼用制剂	8/31/2022
Aciclovir Eye Ointment	上海正大通用药业股份有限公司	国药准字H19999162	化学药品	眼膏剂	1/21/2020
Aciclovir Chewable Tablets	山东淄博新达制药有限公司	国药准字H20020113	化学药品	片剂	2/12/2020
Aciclovir Chewable Tablets	山东淄博新达制药有限公司	国药准字H20020112	化学药品	片剂	2/12/2020
Aciclovir and Glucose Injection	福州海王福药制药有限公司	国药准字H20050089	化学药品	注射剂	6/26/2024
Aciclovir and Glucose Injection	锦州九泰药业有限责任公司	国药准字H20031027	化学药品	注射剂	7/23/2020
Aciclovir and Glucose Injection	黑龙江羽迪药业有限责任公司	国药准字H20031273	化学药品	注射剂	1/31/2023
Aciclovir and Glucose Injection	辅仁药业集团有限公司	国药准字H20040923	化学药品	注射剂	10/11/2023

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ACLOVIR CREAM 5%	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	2/8/1996
RIPIK CREAM 5%	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	5/21/1998
ZOVIRAX COLD SORE CREAM 5%	N/A	Haleon Hong Kong Limited	N/A	N/A	11/23/2000
EUROCLOVIR TAB 400MG	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	1/26/1998
TOVIRA CREAM 5% W/W	N/A	Mediline (Hong Kong) Company Limited	N/A	N/A	7/8/2020
MEDOVIR 800 TAB 800MG	N/A	STAR MEDICAL AND GENERAL SUPPLIES (PTY) LTD	N/A	N/A	3/1/1996
GYNOVIR CREAM 5%	N/A	GAILY PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	12/7/2009
VIROX TAB 400MG	N/A	Kai Yuen Pharmaceutical Co	N/A	N/A	7/8/2004
VIRLESS CREAM 5%	N/A	PT. YUNG SHIN PHARMACEUTICAL INDONESIA	N/A	N/A	5/15/2008
HERAX 400 TAB 400MG	N/A	HANG LUNG TRADING CO	N/A	N/A	2/11/2006

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Hospira Aciclovir 25 mg/mL Sterile Concentrate 1g /40mL vial	61660	Hospira Australia Pty Ltd	Medicine	A	10/1/1997
TERRYWHITE CHEMMART COLD SORE CREAM aciclovir 5% w/w tube	309839	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	9/27/2018
Hospira Aciclovir 25 mg/mL Injection 250 mg/10 mL vial	376427	Hospira Australia Pty Ltd	Medicine	A	10/15/2021
ACICLOVIR SANDOZ aciclovir 800mg tablet blister pack	99421	Sandoz Pty Ltd	Medicine	A	2/3/2004
ACIVIR 5% CREAM aciclovir 5% w/w tube	66076	Cipla Australia Pty Ltd	Medicine	A	10/14/1998
ALINIVIR aciclovir 400 mg tablet blister pack	202876	Strides Pharma Science Pty Ltd	Medicine	A	5/22/2013
EXIVIR Aciclovir 400 mg tablet blister pack	202873	Strides Pharma Science Pty Ltd	Medicine	A	5/22/2013
ACICLOVIR INTAS aciclovir 250 mg/10 mL injection vial	313545	Accord Healthcare Pty Ltd	Medicine	A	6/17/2020
Pharmacy Action Cold Sore Cream aciclovir 5% tube	194405	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	2/7/2012
Aciclovir 25 mg/mL concentrate for solution for infusion, 500 mg/20 mL Vial	490908	Hospira Australia Pty Ltd	Medicine	A	6/5/2025

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