Penciclovir

Overview

Penciclovir is a synthetic acyclic guanine derivative with antiviral activity used for the treatment of various herpes simplex virus (HSV) infections. Displaying low toxicity and good selectivity, penciclovir is a nucleoside analogue.

Indication

Used to treat recurrent cold sores on the lips and face from various herpesvirus invections.

Associated Conditions

Cold Sore

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Immunogenicity of PCV-LITE, a Low-dose of Pneumococcal Conjugate Vaccine With LiteVax Adjuvant	2025/05/22	NCT06986239	Phase 1	Not yet recruiting	LiteVax BV
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age	2025/03/03	NCT06855160	Phase 3	Recruiting	GlaxoSmithKline
A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age	2025/02/03	NCT06806137	Phase 3	Recruiting	GlaxoSmithKline
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age	2024/12/18	NCT06740630	Phase 3	Recruiting	GlaxoSmithKline
A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age	2024/11/18	NCT06693895	Phase 3	Recruiting	GlaxoSmithKline
Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy	2023/09/21	NCT06049134	Phase 4	Recruiting	M.D. Anderson Cancer Center
Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults	2023/05/30	NCT05879107	Phase 3	Completed	GlaxoSmithKline
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)	2022/06/21	NCT05425732	Phase 3	Completed	Merck Sharp & Dohme LLC
A Clinical Study to Improve Brain Function and Quality of Life of Patients With Newly Diagnosed Brain Tumors (Gliomas).	2022/04/15	NCT05331521	Phase 3	Recruiting	University Hospital Heidelberg
A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery	2021/01/11	NCT04702581	Phase 3	Recruiting	Hospices Civils de Lyon

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Penciclovir	Teva Pharmaceuticals USA, Inc.	0093-3186	TOPICAL	10 mg in 1 g	3/31/2019
Denavir	Physicians Total Care, Inc.	54868-4956	TOPICAL	10 mg in 1 g	1/3/2011
Penciclovir	Mylan Pharmaceuticals Inc.	0378-0896	TOPICAL	10 mg in 1 g	9/4/2019
Denavir	Mylan Pharmaceuticals Inc.	0378-9720	TOPICAL	10 mg in 1 g	1/1/2018
Penciclovir	Torrent Pharmaceuticals Limited	13668-661	TOPICAL	10 mg in 1 g	8/8/2023

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
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Penciclovir Gel	丽珠集团丽珠制药厂	国药准字H20100085	化学药品	凝胶剂	4/9/2024
Penciclovir for Injection	浙江尖峰药业有限公司	国药准字H20070186	化学药品	注射剂	4/6/2022
Penciclovir Cream	武汉长联来福制药股份有限公司	国药准字H20000170	化学药品	乳膏剂	6/16/2020
Penciclovir Cream	湖北科田药业有限公司	国药准字H20133072	化学药品	乳膏剂	9/26/2022
Penciclovir Cream	丽珠集团丽珠制药厂	国药准字H20000166	化学药品	乳膏剂	1/8/2020
Penciclovir Cream	湖北恒安芙林药业股份有限公司	国药准字H20103385	化学药品	乳膏剂	5/19/2020
Penciclovir Cream	上海朝晖药业有限公司	国药准字H20000168	化学药品	乳膏剂	1/8/2020
Penciclovir Cream	湖北科益药业股份有限公司	国药准字H20000172	化学药品	乳膏剂	8/31/2020
Penciclovir Cream	重庆华邦制药有限公司	国药准字H20000189	化学药品	乳膏剂	8/23/2024
Penciclovir Cream	武汉诺安药业有限公司	国药准字H20153275	化学药品	乳膏剂	6/29/2020

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
No TGA approvals found for this drug.

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