NDAORALCAPSULEPriority Review
Approved
Jan 2012
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
21
Data completeness
7/8 — Comprehensive
Priority Review
ERIVEDGE (vismodegib) by Roche is smoothened receptor antagonists [moa]. Approved for hedgehog pathway inhibitor [epc]. First approved in 2012.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ERIVEDGE (vismodegib) is an oral small-molecule Hedgehog pathway inhibitor approved in 2012 for treating basal cell carcinoma by blocking Smoothened receptor signaling. It represents a targeted approach to a rare but serious skin malignancy driven by aberrant Hedgehog pathway activation. The drug offers patients an alternative to surgery for advanced or metastatic disease.
$0.103BPart D
LOE Approaching2.2 years to LOEProduct is in late-stage lifecycle with modest Part D spending (~$103M in 2023), signaling a niche specialty oncology product with a small, focused commercial team.
Mechanism of Action
Smoothened Receptor Antagonists
Pharmacologic Class:
Hedgehog Pathway Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
Started Dec 2024
24 enrolled
Metastatic Lung Non-Small Cell CarcinomaRecurrent Lung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
Started Apr 2024
80 enrolled
Basal Cell Carcinoma
Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Started May 2023
48 enrolled
Platinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaPARP Inhibitor+1 more
Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
Started Mar 2023
34 enrolled
Advanced Basal Cell Carcinoma
Pembrolizumab With or Without Vismodegib in Treating Metastatic or Unresectable Basal Cell Skin Cancer
Started Feb 2016
16 enrolled
Skin Basal Cell Carcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.