Overview
Valaciclovir (valacyclovir), also known as Valtrex, is an antiviral drug that has been used to manage and treat various herpes infections for more than 2 decades. It was initially approved by the FDA in 1995 and marketed by GlaxoSmithKline . Valacyclovir is the L-valine ester of aciclovir. It is a member of the purine (guanine) nucleoside analog drug class . This class of drugs forms an important part of hepatitis, HIV, and cytomegalovirus drug regimens . One major use of valacyclovir is the treatment of genital herpes episodes or outbreaks. Genital herpes is a frequently diagnosed sexually transmitted disease which currently affects more than 400 million individuals worldwide. It is caused by infection with the herpes simplex virus (HSV). Infection with this virus is lifelong with periodic episodes of reactivation .
Background
Valaciclovir (valacyclovir), also known as Valtrex, is an antiviral drug that has been used to manage and treat various herpes infections for more than 2 decades. It was initially approved by the FDA in 1995 and marketed by GlaxoSmithKline . Valacyclovir is the L-valine ester of aciclovir. It is a member of the purine (guanine) nucleoside analog drug class . This class of drugs forms an important part of hepatitis, HIV, and cytomegalovirus drug regimens . One major use of valacyclovir is the treatment of genital herpes episodes or outbreaks. Genital herpes is a frequently diagnosed sexually transmitted disease which currently affects more than 400 million individuals worldwide. It is caused by infection with the herpes simplex virus (HSV). Infection with this virus is lifelong with periodic episodes of reactivation .
Indication
Valacyclovir is a nucleoside analog DNA polymerase inhibitor indicated for : Adults • Cold Sores (Herpes Labialis) • Genital Herpes • Treatment of genital herpes lesions in immunocompetent patients (initial or recurrent episode) • Suppression of genital herpes lesions in immunocompetent or HIV-infected patients • Reduction of viral transmission • Herpes Zoster Pediatric Patients • Cold Sores (Herpes Labialis) • Chickenpox Limitations of use The efficacy and safety of valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.
Associated Conditions
- Chickenpox
- Genital Herpes
- Genital herpes, initial episode
- Herpes Labialis
- Herpes Zoster
- Recurrent Genital Herpes (RGH)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/10/26 | Phase 1 | UNKNOWN | Buddhist Tzu Chi General Hospital | ||
2021/01/14 | Phase 2 | Completed | |||
2020/12/11 | N/A | Completed | Nearmedic Plus LLC | ||
2020/06/25 | Phase 1 | Completed | |||
2019/11/15 | Phase 2 | Completed | |||
2019/09/09 | Not Applicable | Terminated | |||
2018/10/09 | Phase 2 | Terminated | |||
2018/07/03 | Phase 1 | Completed | |||
2018/05/31 | Phase 2 | UNKNOWN | |||
2018/05/02 | Not Applicable | Completed | David Smart |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| TIME CAP LABORATORIES, INC. | 49483-691 | ORAL | 1 g in 1 1 | 7/17/2021 | |
| Rising Pharma Holdings, Inc. | 57237-043 | ORAL | 1 g in 1 1 | 1/8/2024 | |
| Cipla USA Inc. | 69097-153 | ORAL | 500 mg in 1 1 | 12/25/2022 | |
| Zydus Lifesciences Limited | 65841-630 | ORAL | 1000 mg in 1 1 | 11/5/2022 | |
| A-S Medication Solutions | 50090-6581 | ORAL | 500 mg in 1 1 | 2/13/2023 | |
| Unit Dose Services | 50436-0154 | ORAL | 1000 mg in 1 1 | 12/12/2018 | |
| Cardinal Health 107, LLC | 55154-7985 | ORAL | 500 mg in 1 1 | 11/28/2022 | |
| Redpharm Drug | 67296-2146 | ORAL | 1000 mg in 1 1 | 6/10/2025 | |
| Life Line Home Care Services, Inc. | 75921-208 | ORAL | 500 mg in 1 1 | 3/22/2012 | |
| Preferred Pharmaceuticals, Inc. | 68788-7587 | ORAL | 1 g in 1 1 | 10/9/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Valacyclovir Hydrochloride Tablets | 国药准字H20258047 | 化学药品 | 片剂 | 3/28/2025 | |
| Valacyclovir Hydrochloride Tablets | 国药准字H20045266 | 化学药品 | 片剂 | 5/14/2024 | |
| Valacyclovir Hydrochloride Tablets | 国药准字H20258039 | 化学药品 | 片剂 | 3/24/2025 | |
| Valacyclovir Hydrochloride Tablets | 国药准字HJ20150209 | 化学药品 | 片剂 | 9/18/2023 | |
| Valacyclovir Hydrochloride Tablets | 国药准字H20217017 | 化学药品 | 片剂 | 2/7/2021 | |
| Valacyclovir Hydrochloride Tablets | 国药准字H20065583 | 化学药品 | 片剂 | 8/24/2021 | |
| Valacyclovir Hydrochloride Tablets | 国药准字H20237057 | 化学药品 | 片剂 | 5/24/2023 | |
| Valacyclovir Hydrochloride Tablets | 国药准字H20057723 | 化学药品 | 片剂（薄膜衣） | 5/18/2020 | |
| Valacyclovir Hydrochloride Tablets | 国药准字H20056932 | 化学药品 | 片剂 | 5/14/2024 | |
| Valacyclovir Hydrochloride Tablets | 国药准字H20234312 | 化学药品 | 片剂 | 10/18/2023 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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