Product Description
Ganciclovir capsules are used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people whose immune system is not working normally. Ganciclovir capsules are used to treat CMV retinitis after the condition has been controlled by intravenous (injected into a vein) ganciclovir. Ganciclovir is also used to prevent cytomegalovirus (CMV) disease in people who have acquired immunodeficiency syndrome (AIDS) or who have received an organ transplant and are at risk of CMV disease. Ganciclovir 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/a605011.html)
Mechanisms of Action: DNA Polymerase Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous,Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Czech | Denmark | Dominican Republic | Ecuador | Egypt | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Retinitis | Acquired Immunodeficiency Syndrome | Keratitis | Keratitis, Dendritic | Keratitis, Herpetic | Retinitis | Cytomegalovirus Retinitis | Acquired Immunodeficiency Syndrome
Known Adverse Events: Anemia | Leukopenia | Sepsis | Diarrhea | Hyperemia | Keratitis | Pregnancy Outcomes | Keratitis, Herpetic | Abdominal Pain | Headache | Labor Pain | Pain Unspecified | Hyperhidrosis | Dyspnea | Asthenia
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China, Japan, Spain
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Allogeneic Stem Cell Transplant|Communicable Diseases|Cytomegalovirus Infections|Hematopoietic Stem Cell Transplant|Liver Cancer|Liver Transplant|Lung Transplant
Phase 2: Herpes Simplex|Keratitis
Phase 1: Autism Spectrum Disorder
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| BD-HSK-111002-â ¡a | P2 |
Not yet recruiting |
Herpes Simplex|Keratitis |
2025-12-01 |
|
| CYTOCOR | P3 |
Completed |
Communicable Diseases|Cytomegalovirus Infections |
2023-05-29 |
|
| jRCT2051210064 | P3 |
Active, not recruiting |
Unknown |
2022-12-31 |
|
| CYTOCOR | P3 |
Active, not recruiting |
Lung Transplant |
2022-11-02 |