Product Description
Valganciclovir is used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people who have acquired immunodeficiency syndrome (AIDS). Valganciclovir is also used to prevent cytomegalovirus (CMV) disease in people who have received a heart, kidney, or kidney-pancreas transplant and who have a chance of getting CMV disease. Valganciclovir is in a class of medications called antivirals. It works by preventing the spread of CMV disease or slowing the growth of CMV. (Sourced from: https://medlineplus.gov/druginfo/meds/a605021.html)
Mechanisms of Action: DNA Polymerase Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Retinitis | Heart Transplant | Kidney Transplant | Liver Transplant | Pancreas Transplant | Transplantation Unspecified | Kidney Diseases | Cytomegalovirus Retinitis | Acquired Immunodeficiency Syndrome
Known Adverse Events: Hypertension | Tremor | Anemia | Thrombocytopenia | Respiratory Tract Infections | Transplantation Unspecified | Constipation | Diarrhea
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, Canada, France, Germany, Hong Kong, Israel, Italy, Korea, Malaysia, Singapore, Spain, Taiwan, United Kingdom, United States
Active Clinical Trial Count: 7
Highest Development Phases
Phase 2: Deafness|Diffuse Large B-Cell Lymphoma|Epstein-Barr Virus Infections|Gastrointestinal Cancer|Hearing Loss, Sensorineural|Leiomyosarcoma|Lymphoma|Lymphoma, Non-Hodgkin|Lymphoproliferative Disorders|Nasopharyngeal Cancer|Relapsed/Refractory Lymphoma|T-Cell Peripheral Lymphoma
Phase 1: Colorectal Cancer|Suicidality
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| Protocol GVO-1102 | P1 |
Recruiting |
Suicidality|Colorectal Cancer |
2027-03-01 |
43% |
| NAVAL-1 | P2 |
Active, not recruiting |
Relapsed/Refractory Lymphoma |
2025-10-01 |
|
| NAVAL-1 | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Lymphoproliferative Disorders|T-Cell Peripheral Lymphoma|Epstein-Barr Virus Infections|Diffuse Large B-Cell Lymphoma |
2025-07-01 |
|
| VT3996-202 | P2 |
Unknown Status |
Relapsed/Refractory Lymphoma |
2025-06-14 |