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Erivedge

(Vismodegib)

ApprovedSmall molecule

Vismodegib is used to treat certain types of skin cancer called basal cell carcinoma, particularly in patients with advanced disease or those who cannot undergo surgery or radiation therapy.[2] Erivedge is currently approved and in use across 33 indications[4].[1]

Erivedge is one of 721 small molecule programs targeting Glioma. It is currently in Approved.

33

Indications

75

Total Trials

16

Active Trials

720

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

2

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

Nevoid Basal Cell Carcinoma SyndromeApproved

ParagangliomaApproved

Basal Cell CarcinomaActive, not recruiting

Gastric AdenocarcinomaActive, not recruiting

Skin CancerActive, not recruiting

Adult GlioblastomaApproved

ChondrosarcomaActive, not recruiting

Adult MedulloblastomaApproved

Intracranial MeningiomaRecruiting

GliomaPhase 2

Active, not recruiting

Nevoid Basal Cell Carcinoma SyndromeApproved

Approved

ParagangliomaApproved

Approved

Basal Cell CarcinomaApproved

Active, not recruiting

Gastric AdenocarcinomaPhase 2

Active, not recruiting

Skin CancerPhase 1

Active, not recruiting

Adult GlioblastomaApproved

Approved

ChondrosarcomaPhase 2

Active, not recruiting

Adult MedulloblastomaApproved

Approved

Intracranial MeningiomaPhase 2

Recruiting

Showing 10 of 33 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Erivedge

Zinecard

CChildren's Oncology Group

Recentin

NNational Cancer Institute (NCI)

Spravato

Tricor

Avastin

Perflutren Lipid Microsphere

IImaRx Therapeutics

Diuretic

RReprieve Cardiovascular, Inc

Perflutren Lipid Microcpheres

TThomas Jefferson University

Gadolinium-Chelate

MM.D. Anderson Cancer Center

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Chondrosarcoma

NCT01267955

Q4 2026

Phase 2Recruiting

Cancer

NCT05159245

Basal Cell Carcinoma

NCT05463757

Phase 2Active, not recruiting

Treatment

NCT06357988

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Q1 2027

Phase 2Recruiting

Trial

NCT03297606

Clinical

Trials by Indication[1]

Basal Cell Carcinoma21 trials

Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas

Completed·UUCSF Benioff Children's Hospital Oakland·Phase 2·NCT01556009·24 enrolled

Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma

Completed·SSue Yom·Phase 2·NCT01835626·24 enrolled

To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma

Terminated·IIstituto Clinico Humanitas·Phase 2·NCT02956889·14 enrolled

Show 18 more trials

Vismodegib for Treatment of Basal Cell Carcinoma

Completed·—·Phase 2·NCT01543581·3 enrolled

Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC)

Completed·SStanford University·Phase 1·NCT01631331·15 enrolled

VISmodegib for ORbital and Periocular Basal Cell Carcinoma

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 4·NCT02436408·35 enrolled

To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma

Recruiting·SStamford Pharmaceuticals, Inc.·Phase 2·NCT06344052·80 enrolled

STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Completed· Roche logo

Roche·Phase 2·NCT01367665·1,232 enrolled

Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)

Completed· Roche logo

Roche··NCT02674009·67 enrolled

A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Completed· Roche logo

Roche·Phase 2·NCT01815840·229 enrolled

Neoadjuvant Vismodegib in Patients With Large and/or Recurrent Resectable Basal Cell Carcinoma

Completed·SSRH Wald-Klinikum Gera GmbH·Phase 2·NCT03035188·40 enrolled

Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT05651828·34 enrolled

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma

Completed· Roche logo

Roche·Phase 2·NCT00833417·104 enrolled

A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Approved for marketing· Roche logo

Roche··NCT01160250

Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study

Recruiting·MMaastricht University Medical Center··NCT05463757·80 enrolled

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma

Completed· Roche logo

Roche·Phase 2·NCT01201915·74 enrolled

Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas

Completed·UUniversity of Arizona·Phase 1·NCT02639117·4 enrolled

A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)

Completed· Roche logo

Roche··NCT02371967·50 enrolled

Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention

Terminated·UUniversity of Arizona·Phase 2·NCT02067104·9 enrolled

A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma

Terminated· Roche logo

Roche·Phase 2·NCT01898598·18 enrolled

Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Recruiting·UUniversity Hospital, Lille·Phase 2·NCT05561634·82 enrolled

Medulloblastoma5 trials

A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT01878617·660 enrolled

Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway

Terminated·CCentre Leon Berard·Phase 1/2·NCT01601184·24 enrolled

Vismodegib in Treating Patients With Recurrent or Refractory Medulloblastoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00939484·31 enrolled

Show 2 more trials

GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00822458·34 enrolled

Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01239316·12 enrolled

Pancreatic Cancer5 trials

Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Vismodegib Before Surgery in Pancreatic Cancer

Unknown status·JJean-Luc Van Laethem·Phase 1·NCT01713218·21 enrolled

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT00878163·55 enrolled

Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01064622·118 enrolled

Show 2 more trials

Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery

Completed·MMayo Clinic·Phase 1·NCT01537107·31 enrolled

Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01195415·25 enrolled

Trial3 trials

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03297606·720 enrolled

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Idiopathic Pulmonary Fibrosis2 trials

A Study of Oral Vismodegib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

Withdrawn· Roche logo

Roche·Phase 2·NCT02168530

A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis

Completed· Roche logo

Roche·Phase 1·NCT02648048·21 enrolled

36 more indications

Treatment2 trials

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06357988·35 enrolled

Breast Cancer2 trials

RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT01071564·13 enrolled

Addition of Vismodegib to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients

Unknown status·—·Phase 2·NCT02694224·40 enrolled

Cancer2 trials

A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study

Completed· Roche logo

Roche·Phase 2·NCT00959647·19 enrolled

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

Metastatic Sarcoma1 trial

Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01154452·78 enrolled

Interaction1 trial

A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib

Completed· Roche logo

Roche·Phase 1·NCT01772290·92 enrolled

Keratocystic odontogenic tumor1 trial

A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors

Completed·NNYU College of Dentistry·Phase 2·NCT02366312·2 enrolled

Tics1 trial

Evaluation of Food Effect on Pharmacokinetics of Vismodegib

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01174264·63 enrolled

Clinical Trial1 trial

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

Recruiting·UUlrik Lassen·Phase 2·NCT04341181·300 enrolled

Multiple Myeloma1 trial

Vismodegib After Stem Cell Transplant in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01330173·50 enrolled

Prostate Cancer1 trial

Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT01163084·10 enrolled

Cancer of Unknown Primary Site1 trial

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Completed· Roche logo

Roche·Phase 2·NCT03498521·529 enrolled

Myelofibrosis1 trial

A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination With Ruxolitinib for the Treatment of Intermediate- or High-Risk Myelofibrosis (MF)

Completed· Roche logo

Roche·Phase 1·NCT02593760·10 enrolled

Gastroesophageal Junction Cancer1 trial

Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00982592·124 enrolled

Myelodysplastic Syndrome1 trial

A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome

Terminated· Roche logo

Roche·Phase 2·NCT01880437·38 enrolled

Advanced Solid Tumors1 trial

My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

Completed· Roche logo

Roche·Phase 2·NCT02091141·673 enrolled

AML1 trial

Ribavirin and Hedgehog Inhibitor With or Without Decitabine in AML

Completed·SSarit Assouline·Phase 2·NCT02073838·23 enrolled

Non-Small Cell Lung Cancer1 trial

Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer

Recruiting·DDwight Owen·Phase 1·NCT06616623·24 enrolled

Metastatic1 trial

A Study of Vismodegib in Men With Metastatic CRPC With Accessible Metastatic Lesions for Tumor Biopsy

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02115828·9 enrolled

Locally Advanced or Metastatic Solid Tumors1 trial

A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

Completed· Roche logo

Roche·Phase 1·NCT01209143·52 enrolled

Basal Cell Nevus Syndrome1 trial

Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome

Withdrawn·—·Phase 2·NCT03767439

Hepatocellular Carcinoma1 trial

A Study of Vismodegib in Patients With Advanced Solid Malignancies Including Hepatocellular Carcinoma With Varying Degrees of Renal or Hepatic Function

Completed· Roche logo

Roche·Phase 1·NCT01546519·31 enrolled

Chronic Graft Versus Host Disease1 trial

Vismodegib in Treating Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT02337517·6 enrolled

Gastric Adenocarcinoma1 trial

Study of Vismodegib in Advanced Gastric Adenocarcinoma Patients With SMO Overexpression

Completed·SSamsung Medical Center·Phase 2·NCT03052478·10 enrolled

Metastatic Colorectal Cancer1 trial

A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer

Completed· Roche logo

Roche·Phase 2·NCT00636610·199 enrolled

Efficacy1 trial

Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes

Completed·MMayo Clinic·Phase 2·NCT01700049·28 enrolled

Ovarian Cancer1 trial

A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

Completed· Roche logo

Roche·Phase 2·NCT00739661·104 enrolled

Chronic Lymphocytic Leukemia1 trial

Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia

Terminated·TThe Lymphoma Academic Research Organisation·Phase 2·NCT01944943·31 enrolled

Chondrosarcoma1 trial

Vismodegib in Treating Patients With Advanced Chondrosarcomas

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT01267955·45 enrolled

Skin Cancer1 trial

Pembrolizumab With or Without Vismodegib in Treating Metastatic or Unresectable Basal Cell Skin Cancer

Completed·AAnne Chang·Phase 1/2·NCT02690948·16 enrolled

Primary Peritoneal Cancer1 trial

Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Recruiting·RRonald Buckanovich·Phase 2·NCT05538091·48 enrolled

Glioma1 trial

Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma

Terminated·GGiselle Sholler·Phase 2·NCT01774253·9 enrolled

Glioblastoma Multiforme1 trial

GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00980343·44 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Intracranial Meningioma1 trial

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

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT02523014·124 enrolled

Extensive-stage Small-cell Lung Cancer1 trial

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

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00887159·168 enrolled

Unspecified1 trial

NCT Neuro Master Match - N²M² (NOA-20)

Completed·UUniversity Hospital Heidelberg·Phase 1/2·NCT03158389·228 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 30, 2012

ERIVEDGE

NDA NDA203388

Sources

References

[1]
ClinicalTrials.gov — 75 trial records for Vismodegib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Erivedge drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Vismodegib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Vismodegib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA203388). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Erivedge. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Smoothened Homolog Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Roche

Patent Landscape[6]

Patent Cliff

Nov 11, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7888364Nov 11, 2028

9278961Dec 15, 2028

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