Overview
Valganciclovir hydrochloride (Valcyte, manufactured by Roche) is an antiviral medication used to treat cytomegalovirus infections. As the L-valyl ester of ganciclovir, it is actually a prodrug for ganciclovir. After oral administration, it is rapidly converted to ganciclovir by intestinal and hepatic esterases.
Background
Valganciclovir hydrochloride (Valcyte, manufactured by Roche) is an antiviral medication used to treat cytomegalovirus infections. As the L-valyl ester of ganciclovir, it is actually a prodrug for ganciclovir. After oral administration, it is rapidly converted to ganciclovir by intestinal and hepatic esterases.
Indication
Valganciclovir is an antiviral medication used for the treatment of cytomegalovirus infections.
Associated Conditions
- Cytomegalovirus (CMV) Infections
- Cytomegalovirus Retinitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/29 | Phase 3 | Not yet recruiting | |||
2024/04/30 | Phase 1 | Recruiting | |||
2024/03/28 | Phase 3 | Recruiting | |||
2023/09/13 | Phase 4 | Active, not recruiting | |||
2023/02/01 | Phase 2 | Not yet recruiting | |||
2022/02/14 | N/A | Completed | |||
2021/12/22 | Phase 1 | Terminated | |||
2021/09/13 | Phase 2 | Active, not recruiting | Fernanda P Silveira, MD, MS | ||
2021/01/26 | Phase 1 | Recruiting | |||
2019/10/04 | Phase 2 | Recruiting | Cecilia Soderberg-Naucler |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| McKesson Corporation DBA SKY Packaging | 63739-076 | ORAL | 450 mg in 1 1 | 9/8/2023 | |
| MAJOR PHARMACEUTICALS | 0904-7419 | ORAL | 50 mg in 1 mL | 12/28/2023 | |
| Somerset Therapeutics, LLC | 70069-810 | ORAL | 50 mg in 1 mL | 1/5/2022 | |
| H2-Pharma, LLC | 61269-480 | ORAL | 450 mg in 1 1 | 4/14/2023 | |
| Ajanta Pharma USA Inc. | 27241-159 | ORAL | 50 mg in 1 mL | 1/10/2022 | |
| American Health Packaging | 68084-965 | ORAL | 450 mg in 1 1 | 10/14/2022 | |
| Florida Pharmaceutical Products, LLC | 71921-210 | ORAL | 50 mg in 1 mL | 6/20/2023 | |
| Novadoz Pharmaceuticals LLC | 72205-019 | ORAL | 50 mg in 1 mL | 9/14/2022 | |
| Genentech, Inc. | 0004-0038 | ORAL | 450 mg in 1 1 | 1/11/2024 | |
| Strides Pharma Science Limited | 64380-153 | ORAL | 450 mg in 1 1 | 1/26/2024 |
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 |
|---|---|---|---|---|---|
| VALGANCICLOVIR SANDOZ FILM COATED TABLET 450MG | SIN15985P | TABLET, FILM COATED | 450mg | 8/7/2020 | |
| VALCYTE TABLET 450 mg | SIN12393P | TABLET, FILM COATED | 450 mg | 8/15/2003 | |
| VALGAN 450 VALGANCICLOVIR FILM-COATED TABLET 450 MG | SIN15779P | TABLET, FILM COATED | 450 MG | 8/14/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Valganciclovir Hydrochloride Tablets | 国药准字HJ20230121 | 化学药品 | 片剂 | 10/24/2023 | |
| Valganciclovir Hydrochloride Tablets | 国药准字HJ20230002 | 化学药品 | 片剂 | 1/19/2023 | |
| Valganciclovir Hydrochloride Tablets | 国药准字H20244281 | 化学药品 | 片剂 | 6/28/2024 | |
| Valganciclovir Hydrochloride Tablets | 国药准字HJ20150330 | 化学药品 | 片剂 | 9/3/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||