Product Description
Vismodegib (Erivedge®) is the first-in-class, oral small molecule inhibitor of the Hedgehog (Hh) pathway, abnormal activation of which is associated with basal cell carcinoma (BCC). In the USA, vismodegib is indicated for the treatment of adults with metastatic BCC (mBCC) or with locally-advanced BCC (LaBCC) that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/30030732/)
Mechanisms of Action: Hh Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lebanon | Lithuania | Luxembourg | Mexico | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Serbia | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: Basal Cell Carcinoma | Oncology Unspecified
Known Adverse Events: Ageusia | Dysgeusia | Spasm | Alopecia | Arthralgia | Constipation | Diarrhea | Weight Loss
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Latvia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Spain, Switzerland, Thailand, Turkey, United Kingdom, United States
Active Clinical Trial Count: 12
Highest Development Phases
Phase 2: Abnormalities, Multiple|Basal Cell Carcinoma|Bladder Cancer|Breast Cancer|Fallopian Tube Cancer|Glioblastoma|Hodgkin Lymphoma|Intestinal Cancer|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Multiple Myeloma|Non-Small-Cell Lung Cancer|Nose Cancer|Oncology Solid Tumor Unspecified|Oncology Unspecified|Ovarian Cancer|Peritoneal Cancer|Vision, Low
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| MCC 21997 | P1 |
Recruiting |
Basal Cell Carcinoma |
2028-12-01 |
|
| RADIOSONIC | P2 |
Not yet recruiting |
Basal Cell Carcinoma |
2028-07-01 |
|
| ProTarget | P2 |
Active, not recruiting |
Oncology Unspecified |
2028-04-28 |
|
| HCC 22-017 | P2 |
Recruiting |
Ovarian Cancer|Nose Cancer|Fallopian Tube Cancer|Peritoneal Cancer |
2028-04-01 |