Ganciclovir

Overview

An acyclovir analog that is a potent inhibitor of the Herpesvirus family including cytomegalovirus. Ganciclovir is used to treat complications from AIDS-associated cytomegalovirus infections.

Indication

For induction and maintenance in the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). Also used in the treatment of severe cytomegalovirus (CMV) disease, including CMV pneumonia, CMV gastrointestinal disease, and disseminated CMV infections, in immunocompromised patients.

Associated Conditions

CMV colitis
Cytomegalovirus (CMV) Infections
Cytomegalovirus Retinitis
Cytomegalovirus gastroesophagitis
Varicella-zoster Progressive outer retinal necrosis
Acute Herpetic keratitis
Cytomegalovirus neurological disease
Varicella-zoster virus acute retinal necrosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia	2025/05/14	NCT06971913	Phase 2	Not yet recruiting	Peking University People's Hospital
Study Evaluating the Efficacy and Safety of Artesunate	2025/02/28	NCT06853184	Phase 2	Not yet recruiting	Amivas Inc.
Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis	2025/01/03	NCT06757907	Not Applicable	Completed	Al-Azhar University
Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis	2024/05/31	NCT06436534	Not Applicable	Recruiting	Wuhan Union Hospital, China
Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection	2024/04/02	NCT06341686	Phase 3	Not yet recruiting	Hospital do Rim e Hipertensão
Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid	2022/10/13	NCT05578820	Phase 1	Completed	Gene Surgery LLC
Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis	2021/01/12	NCT04706507	Phase 3	Active, not recruiting	Fred Hutchinson Cancer Center
Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients	2020/07/20	NCT04478474	N/A	Completed	New York Medical College
Treatment of Low Dose IL-2 and Ganciclovir in Cytomegalovirus Infection	2020/01/13	NCT04225780	Phase 1	UNKNOWN	Peking University People's Hospital
Optimized Antibiotic Therapy in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)	2019/10/18	NCT04132115	N/A	UNKNOWN	Azienda Sanitaria-Universitaria Integrata di Udine

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ganciclovir	Fresenius Kabi USA, LLC	63323-315	INTRAVENOUS	500 mg in 10 mL	9/30/2022
Ganciclovir	Hainan Poly Pharm. Co., Ltd.	14335-030	INTRAVENTRICULAR	50 mg in 1 mL	1/30/2019
Ganciclovir	Par Pharmaceutical, Inc.	42023-173	INTRAVENOUS	500 mg in 10 mL	9/17/2018
GANCICLOVIR	Ranbaxy Pharmaceuticals Inc.	63304-636	ORAL	250 mg in 1 1	10/20/2011
Ganciclovir	Hikma Pharmaceuticals USA Inc.	0143-9299	INTRAVENOUS	50 mg in 1 mL	7/1/2021
GANCICLOVIR	Ranbaxy Pharmaceuticals Inc.	63304-637	ORAL	500 mg in 1 1	10/20/2011
Ganciclovir	Fresenius Kabi USA, LLC	63323-315	INTRAVENOUS	500 mg in 10 mL	8/31/2019
Ganciclovir	Slate Run Pharmaceuticals, LLC	70436-089	INTRAVENTRICULAR	500 mg in 10 mL	8/31/2021
ZIRGAN	Bausch & Lomb Incorporated	24208-535	OPHTHALMIC	1.5 mg in 1 g	2/27/2024
GANCICLOVIR	EXELA PHARMA SCIENCES, LLC	51754-2500	INTRAVENOUS	2 mg in 1 mL	9/19/2017

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
VIRGAN EYE GEL 1.5 mg/g	FARMILA-THEA FARMACEUTICI S.P.A	SIN11778P	OINTMENT	0.15g/ 100g	1/18/2002
CYMEVENE FOR INJECTION 500 mg	BSP Pharmaceuticals S.P.A. (DP + Primary Packager), Valdepharm (DP + Primary Packager)	SIN05051P	INJECTION, POWDER, FOR SOLUTION	500 mg	9/6/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Ganciclovir and Sodium Chloride Injection	武汉华龙生物制药有限公司	国药准字H20020294	化学药品	注射剂	9/4/2020
Ganciclovir and Sodium Chloride Injection	宜昌三峡制药有限公司	国药准字H20060433	化学药品	注射剂	7/8/2020
Ganciclovir and Sodium Chloride Injection	武汉华龙生物制药有限公司	国药准字H20020295	化学药品	注射剂	9/4/2020
Ganciclovir and Sodium Chloride Injection	宜昌三峡制药有限公司	国药准字H20060434	化学药品	注射剂	7/8/2020
Ganciclovir and Sodium Chloride Injection	宜昌三峡制药有限公司	国药准字H20060432	化学药品	注射剂	7/8/2020
Ganciclovir Sodium Injection	江苏苏中药业集团生物制药有限公司	国药准字H20050158	化学药品	注射剂	7/28/2020
Ganciclovir Tablets	山东罗欣药业集团股份有限公司	国药准字H20100030	化学药品	片剂	2/3/2020
Ganciclovir Dispersible Tablets	海南全星制药有限公司	国药准字H20090066	化学药品	片剂	11/2/2023
Ganciclovir Dispersible Tablets	海口奇力制药股份有限公司	国药准字H20090128	化学药品	片剂	1/18/2024
Ganciclovir Dispersible Tablets	湖北东信药业有限公司	国药准字H20110082	化学药品	片剂	4/7/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CYMEVENE 500mg (as sodium) powder for injection vial	10047	Pharmaco Australia Ltd	Medicine	A	6/11/1991
GANCICLOVIR MYLAN ganciclovir 500mg powder for injection vial	233584	MedTAS Pty Ltd	Medicine	A	1/14/2022
GANCICLOVIR HHH ganciclovir (as sodium) 500 mg powder for injection vial	280239	Southern Cross Pharma Pty Ltd	Medicine	A	8/31/2017
GANCICLOVIR ALPHAPHARM ganciclovir 500mg powder for injection vial	233585	MedTAS Pty Ltd	Medicine	A	1/14/2022
GANCICLOVIR AGILA ganciclovir 500mg powder for injection vial	233583	MedTAS Pty Ltd	Medicine	A	1/14/2022
GANCICLOVIR LUPIN ganciclovir (as sodium) 500 mg powder for injection vial	280238	Southern Cross Pharma Pty Ltd	Medicine	A	8/31/2017

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access