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: United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 2: Basal Cell Carcinoma|Bladder Cancer|Fallopian Tube Cancer|Nose Cancer|Ovarian Cancer|Peritoneal Cancer
Phase 1: Non-Small-Cell Lung Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| MCC 21997 | P1 |
Recruiting |
Basal Cell Carcinoma |
2028-12-01 |
|
| HCC 22-017 | P2 |
Recruiting |
Fallopian Tube Cancer|Ovarian Cancer|Peritoneal Cancer|Nose Cancer |
2028-04-01 |
|
| ML43922 | P1 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2026-12-31 |
|
| SP-002-004 | P2 |
Recruiting |
Basal Cell Carcinoma |
2026-09-30 |