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Erivedge (vismodegib)
Vismodegib inhibits the Hedgehog pathway by binding to and blocking Smoothened, a key protein in the pathway.
Erivedge (vismodegib) is a small molecule Hedgehog Pathway Inhibitor developed by Genentech, targeting the sonic hedgehog protein. It was FDA-approved in 2012 for the treatment of basal cell carcinoma of the skin. Erivedge is a patented medication with no generic manufacturers available. Key safety considerations include its potential to cause muscle spasms, taste disturbances, and alopecia. As a potent inhibitor of the hedgehog pathway, Erivedge has a half-life of 245 hours.
At a glance
| Generic name | vismodegib |
|---|---|
| Sponsor | Roche |
| Drug class | Hedgehog Pathway Inhibitor [EPC] |
| Target | Smoothened |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2012 |
Mechanism of action
Vismodegib works by targeting the Hedgehog signaling pathway, which is important in cell growth and development. It specifically binds to and inhibits Smoothened, a protein that helps transmit signals within this pathway, thereby blocking the pathway's activity.
Approved indications
- Basal cell carcinoma of skin
Boxed warnings
- WARNING: EMBRYO-FETAL TOXICITY ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE [ see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] . Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. ( 5.1 , 8.1 ) Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE. ( 2.1 , 5.1 , 8.1 , 8.3 ) Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. ( 5.1 , 8.3 )
Common side effects
- muscle spasms
- alopecia
- dysgeusia
- weight loss
- fatigue
- nausea
- diarrhea
- constipation
- decreased appetite
- arthralgias
- vomiting
- ageusia
Key clinical trials
- Vismodegib in Treating Patients With Advanced Chondrosarcomas (PHASE2)
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (PHASE2)
- GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery (PHASE1)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas (PHASE2)
- Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (PHASE1)
- Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma (EARLY_PHASE1)
- Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Erivedge CI brief — competitive landscape report
- Erivedge updates RSS · CI watch RSS
- Roche portfolio CI