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Drug

Vismodegib

Approved · EMA
Emerging researchLate-stage development

Also known as 2-chloro-N-(4-chloro-3-pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide, Benzamide, 2-chloro-N-(4-chloro-3-(2-pyridinyl)phenyl)-4-(methylsulfonyl)-, Erivedge, Vismodegibum.

RxNorm1242987ChEMBLCHEMBL473417UNII25X868M3DS
2
Research papers
15
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Molecular Analysis for Therapy Choice (MATCH)

Clinical trial2026-07-31Results expected Q4 2026 · ClinicalTrials.gov

Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas With SMO/ AKT/ NF2/CDK Pathway Mutations

Clinical trial2026-07-02Results expected Q1 2027 · ClinicalTrials.gov

A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage Small Cell Lung Cancer

Clinical trial2026-06-24Results posted · ClinicalTrials.gov

Phase II Clinical Trial Combining the Hedgehog Inhibitor Vismodegib With the PD-L1 Inhibitor Atezolizumab in Patients With Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Clinical trial2026-06-18Results expected Q3 2031 · ClinicalTrials.gov

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT)

Clinical trial2026-05-31Withdrawn · ClinicalTrials.gov

MATCH Treatment Subprotocol T: GDC-0449 (Vismodegib) in Patients With Tumors (Except Basal Cell Skin Carcinoma) With Smoothened (SMO) or Patched 1 (PTCH1) Mutations

Clinical trial2026-05-28Results posted · ClinicalTrials.gov

A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma

Clinical trial2026-05-11Results posted · ClinicalTrials.gov

An Open-Label, Multicenter Extension Study of GDC-0449 (Hedgehog Pathway Inhibitor) in Patients Treated With GDC-0449 in a Previous Genentech-sponsored Phase I or Phase II Cancer Study

Clinical trial2026-05-08Results posted · ClinicalTrials.gov

A Phase 2 Study of GDC-0449 in Patients With Advanced Chondrosarcomas

Clinical trial2026-04-13Results posted · ClinicalTrials.gov

Pharmacodynamic study of the oral hedgehog pathway inhibitor, vismodegib, in patients with metastatic castration-resistant prostate cancer.

Research2016-11-08Cancer chemotherapy and pharmacology

An investigator-initiated open-label clinical trial of vismodegib as a neoadjuvant to surgery for high-risk basal cell carcinoma.

Research2014-06-11Journal of the American Academy of Dermatology

Approval: Erivedge (EMA)

Regulatory2013-07-12EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Vismodegib
Aliases & brands
2-chloro-N-(4-chloro-3-pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamideBenzamide, 2-chloro-N-(4-chloro-3-(2-pyridinyl)phenyl)-4-(methylsulfonyl)-ErivedgeVismodegibum
RxNorm CUI
1242987
ChEMBL ID
CHEMBL473417
UNII
25X868M3DS
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-07-12
Latest approval
2013-07-12
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2013-07-12Approval
Approval: Erivedge (EMA)
Indication: Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or… Show full indication

Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

72 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
72
registered trials across all phases
LATEST COMPLETION 2024
15
Active studies
10
Recruiting
1
Late-stage (III+)
41
Completed
16
Discontinued
PHASE DISTRIBUTIONn = 72
Early Phase 15Phase 113Phase 1 / 26Phase 247Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)

CompletedPH IVUniversity of Michigan Rogel Cancer Centern=352020

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase II, Randomized, Active-Controlled, Multi-Center Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Guided by Genomic Profiling Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Who Have Received Three Cycles of Platinum Doublet Chemotherapy

CompletedPH IIHoffmann-La Rochen=5292024

My Pathway: An Open-Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents

CompletedPH IIGenentech, Inc.n=6732023

Umbrella Protocol for Phase I/IIa Trials of Molecularly Matched Targeted Therapies Plus Radiotherapy in Patients With Newly Diagnosed Glioblastoma Without MGMT Promoter Methylation: NCT Neuro Master Match - N²M² (NOA-20)

CompletedPH I/IIUniversity Hospital Heidelbergn=2282023

A Phase II, Multi-center, Open Label, Randomized Study of Ribavirin and Hedgehog Inhibitor With or Without Decitabine in Acute Myeloid Leukemia (AML)

CompletedPH IISarit Assoulinen=232022

A Phase II, Single-armed, Multicenter Trial of Neoadjuvant Vismodegib in Patients With Large and/or Recurrent Resectable Basal Cell Carcinoma

CompletedPH IISRH Wald-Klinikum Gera GmbHn=402021

Phase II, Single-arm Study of Vismodegib in Advanced Gastric Adenocarcinoma Patients With SMO Overexpression

CompletedPH IISamsung Medical Centern=102020

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20142016
Journals, researchers & institutions
Top journals
  • Cancer chemotherapy and pharmacology1
  • Journal of the American Academy of Dermatology1
Leading researchers
  • Aasi S1
  • Ally MS1
  • Anderson E1
  • Antonarakis ES1
  • Bailey-Healy I1
  • Boudadi K1
  • Chang AL1
  • Demarzo A1
Leading institutions
free-text, unnormalised
  • Center for Drug Evaluation and Research1
  • Huntsman Cancer Center1
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center1
  • School of Medicine1
  • Stanford University1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.