Overview
Vismodegib is an orally active small molecule that inhibits the hedgehog signaling pathway by binding to and inhibiting the transmembrane protein smoothened homologue (SMO). It was discovered by high-throughput screening of a library of small-molecule compounds and subsequent optimization through medicinal chemistry. Since it targets the hedgehog signaling pathway, vismodegib has anti-tumor activity in basal-cell carcinoma. The Hedgehog signaling pathway plays an important role in the development of organs and tissues during embryogenesis. Afterwards, it is silenced in all cells and tissues, except for hair, skin and stem cells. However, dysregulated or aberrant Hedgehog signaling has been associated with basal cell carcinoma pathogenesis. In January 2012, vismodegib was approved by the FDA for the treatment of adult basal cell carcinoma. In July 2013, it was approved by the EMA, and since then, it has been approved by several other countries.
Background
Vismodegib is an orally active small molecule that inhibits the hedgehog signaling pathway by binding to and inhibiting the transmembrane protein smoothened homologue (SMO). It was discovered by high-throughput screening of a library of small-molecule compounds and subsequent optimization through medicinal chemistry. Since it targets the hedgehog signaling pathway, vismodegib has anti-tumor activity in basal-cell carcinoma. The Hedgehog signaling pathway plays an important role in the development of organs and tissues during embryogenesis. Afterwards, it is silenced in all cells and tissues, except for hair, skin and stem cells. However, dysregulated or aberrant Hedgehog signaling has been associated with basal cell carcinoma pathogenesis. In January 2012, vismodegib was approved by the FDA for the treatment of adult basal cell carcinoma. In July 2013, it was approved by the EMA, and since then, it has been approved by several other countries.
Indication
用于不能手术或放疗的局部晚期皮肤基底细胞癌患者和肿瘤已转移的患者。
Associated Conditions
- Locally Advanced Basal Cell Carcinoma
- Metastatic Basal cell carcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/27 | Phase 1 | Recruiting | Dwight Owen | ||
2024/04/10 | Phase 2 | Active, not recruiting | |||
2024/04/03 | Phase 2 | Recruiting | |||
2022/12/15 | Early Phase 1 | Recruiting | |||
2022/09/30 | Phase 2 | Not yet recruiting | University Hospital, Lille | ||
2022/09/13 | Phase 2 | Recruiting | Ronald Buckanovich | ||
2022/07/19 | N/A | Recruiting | |||
2022/02/14 | Early Phase 1 | Withdrawn | |||
2021/12/16 | Phase 2 | Recruiting | |||
2020/04/10 | Phase 2 | Recruiting | Ulrik Lassen |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genentech, Inc. | 50242-140 | ORAL | 150 mg in 1 1 | 3/27/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/12/2013 | ||
Authorised | 7/12/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ERIVEDGE CAPSULES 150MG | N/A | N/A | N/A | 7/7/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ERIVEDGE vismodegib 150 mg hard capsule bottle | 214475 | Medicine | A | 12/3/2013 |