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Valcyte (VALGANCICLOVIR)
Valcyte (generic name: VALGANCICLOVIR) is a Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Small molecule drug developed by Cheplapharm. It is currently FDA-approved (first approved 2001) for CMV Retinitis in AIDS Patients, Congenital cytomegalovirus infection, Prevention of CMV Disease After Cardiac Transplantation.
Valcyte works by inhibiting the replication of cytomegalovirus DNA through its action as a nucleoside analog DNA polymerase inhibitor.
Valcyte, also known as valganciclovir, is a small molecule antiviral medication used to treat various conditions, including congenital CMV infection, nasopharyngeal carcinoma, EBV-related gastric carcinoma, EBV-related leiomyosarcoma, and EBV-related carcinoma. It is administered orally in a dose of 16 mg/kg, twice daily, for a treatment course of 4-6 months.
At a glance
| Generic name | VALGANCICLOVIR |
|---|---|
| Sponsor | Cheplapharm |
| Drug class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2001 |
Mechanism of action
Valganciclovir is an antiviral drug with activity against CMV [see Microbiology 12.4)].
Approved indications
- CMV Retinitis in AIDS Patients
- Congenital cytomegalovirus infection
- Prevention of CMV Disease After Cardiac Transplantation
- Prevention of CMV Disease After Kidney Transplantation
- Prevention of CMV Disease After Kidney-Pancreas Transplantation
Boxed warnings
- WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir for oral solution [see Warnings and Precautions ( 5.1 )]. Impairment of Fertility: Based on animal data and limited human data, valganciclovir for oral solution may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions ( 5.3 )]. Fetal Toxicity: Based on animal data, valganciclovir for oral solution has the potential to cause birth defects in humans [see Warnings and Precautions ( 5.4 )]. Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir for oral solution has the potential to cause cancers in humans [see Warnings and Precautions ( 5.5 )]. WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning. Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir. ( 5.1 ) Impairment of Fertility: Based on animal data and limited human data, valganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. ( 5.3 ) Fetal Toxicity: Based on animal data, valganciclovir has the potential to cause birth defects in humans. ( 5.4 ) Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir has the potential to cause cancers in humans. ( 5.5 )
Common side effects
- Diarrhea
- Pyrexia
- Fatigue
- Nausea
- Tremor
- Neutropenia
- Anemia
- Leukopenia
- Thrombocytopenia
- Headache
- Insomnia
- Urinary tract infection
Key clinical trials
- CMV CTLs in Neonates With CMV Infection (PHASE2)
- A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus (PHASE1)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (PHASE2)
- Breakthrough CMV Lung Transplant -Multicentre
- Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors (PHASE1)
- Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS) (PHASE2)
- Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (PHASE2,PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Valcyte CI brief — competitive landscape report
- Valcyte updates RSS · CI watch RSS
- Cheplapharm portfolio CI
Frequently asked questions about Valcyte
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Related
- Drug class: All Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor drugs
- Manufacturer: Cheplapharm — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for CMV Retinitis in AIDS Patients
- Indication: Drugs for Congenital cytomegalovirus infection
- Indication: Drugs for Prevention of CMV Disease After Cardiac Transplantation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing