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 |
|---|---|---|---|---|---|
2025/05/22 | Phase 1 | Not yet recruiting | LiteVax BV | ||
2025/03/03 | Phase 3 | Recruiting | |||
2025/02/03 | Phase 3 | Recruiting | |||
2024/12/18 | Phase 3 | Recruiting | |||
2024/11/18 | Phase 3 | Recruiting | |||
2023/09/21 | Phase 4 | Recruiting | |||
2023/05/30 | Phase 3 | Completed | |||
2022/06/21 | Phase 3 | Completed | |||
2022/04/15 | Phase 3 | Recruiting | |||
2021/01/11 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amneal Pharmaceuticals NY LLC | 69238-1791 | TOPICAL | 10 mg in 1 g | 7/31/2020 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3186 | TOPICAL | 10 mg in 1 g | 3/31/2019 | |
| Physicians Total Care, Inc. | 54868-4956 | TOPICAL | 10 mg in 1 g | 1/3/2011 | |
| Mylan Pharmaceuticals Inc. | 0378-0896 | TOPICAL | 10 mg in 1 g | 9/4/2019 | |
| Mylan Pharmaceuticals Inc. | 0378-9720 | TOPICAL | 10 mg in 1 g | 1/1/2018 | |
| 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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DENAVIR | novartis consumer health canada inc. | 02238848 | Cream - Topical | 1 % | 8/14/2006 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FENIVIR 10 mg/g CREMA | Perrigo Espana S.A. | 61462 | CREMA | Sin Receta | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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