ERIVEDGE (vismodegib)
Erivedge is a medication used for adults with advanced forms of basal cell carcinoma. It treats patients whose skin cancer has spread to other parts of the body or has returned after surgical procedures. It also provides an option for those with locally advanced disease who are not eligible for surgery or radiation therapy.
How ERIVEDGE Works
This medication works by targeting the Hedgehog signaling pathway. It binds to and inhibits a specific transmembrane protein called Smoothened. By blocking this protein, the drug interferes with the signal transduction process within the Hedgehog pathway.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-01-30
- Patent Cliff
- 2028
- Revenue
- $283M (FY-2022)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ERIVEDGE Approval History
What ERIVEDGE Treats
2 indicationsERIVEDGE is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Basal Cell Carcinoma
- Basal Cell Carcinoma
ERIVEDGE Boxed 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 ...
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 )
ERIVEDGE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ERIVEDGE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ERIVEDGE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ERIVEDGE
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
61 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT02523014 | A071401 NCI-2015-00546 | Ph 2 | recruiting | Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas |
| NCT00959647 results posted | SHH4437g GO01352 | Ph 2 | completed | A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study |
| NCT06357988 results posted | NCI-2024-01149 NCI-2024-01149, EAY131-T | Ph 2 | active not recruiting | Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T) |
| NCT02667574 VISMONEO | 2013_36 2013-004338-13 | Ph 2 | completed | Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC) |
| NCT00878163 | NCI-2011-01400 NCI-2011-01400, CDR0000638302 | Ph 1 | active not recruiting | 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 |
| NCT01267955 results posted | NCI-2011-02564 NCI-2011-02564, CDR0000691728 | Ph 2 | active not recruiting | Vismodegib in Treating Patients With Advanced Chondrosarcomas |
| NCT03297606 CAPTUR | PM1 ESR-17-12831, CA209-9DL | Ph 2 | recruiting | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) |
| NCT06616623 | OSU-23268 NCI-2024-07859 | Ph 1 | recruiting | Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer |
| NCT05538091 | HCC 22-017 | Ph 2 | recruiting | Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer |
| NCT03498521 CUPISCO results posted | MX39795 2017-003040-20 | Ph 2 | completed | 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 |
| NCT01878617 | SJMB12 NCI-2013-01125, R01CA187079 | Ph 2 | active not recruiting | A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma |
| NCT05561634 RADIOSONIC | 2021_0710 2022-A01424-39 | Ph 2 | recruiting | Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma |
| NCT04341181 ProTarget | ProTarget | Ph 2 | recruiting | ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling |
| NCT01064622 results posted | NCI-2011-01454 NCI-2011-01454, 10-00099 | Ph 2 | completed | Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer |
| NCT06344052 | SP-002-004 | Ph 2 | recruiting | To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma |
| NCT01774253 results posted | NMTRCPG007 | Ph 2 | terminated | Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma |
| NCT02091141 results posted | ML28897 PRO 02 | Ph 2 | completed | 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 |
| NCT05159245 FINPROVE | FINPROVE | Ph 2 | recruiting | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs |
| NCT03878524 | STUDY00015588 NCI-2020-02743, STUDY00015588 | Ph 1 | terminated | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial |
| NCT02925234 DRUP | M15DRU | Ph 2 | recruiting | The Drug Rediscovery Protocol (DRUP Trial) |
| NCT02073838 | Ribavirin=005 | Ph 2 | completed | Ribavirin and Hedgehog Inhibitor With or Without Decitabine in AML |
| NCT03158389 N²M² | NCT-2014-0235/N2M2 2015-002752-27 | Ph 1, Ph 2 | completed | NCT Neuro Master Match - N²M² (NOA-20) |
| NCT03035188 NICCI | ADO-EP02 (ML29328) | Ph 2 | completed | Neoadjuvant Vismodegib in Patients With Large and/or Recurrent Resectable Basal Cell Carcinoma |
| NCT02436408 VISORB results posted | UMCC 2014.022 HUM00082579 | Ph 4 | completed | VISmodegib for ORbital and Periocular Basal Cell Carcinoma |
| NCT02337517 results posted | NCI-2014-02672 NCI-2014-02672, IIT 9664 | Ph 2 | terminated | Vismodegib in Treating Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease |
| NCT01835626 results posted | 122011 NCI-2013-00871 | Ph 2 | completed | Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma |
| NCT02366312 KCOT results posted | 15-00254 ML28859 | Ph 2 | completed | A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors |
| NCT00887159 results posted | NCI-2011-01917 NCI-2011-01917, 09-0679 | Ph 2 | completed | 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 |
| NCT01556009 Vismodegib results posted | 2011-077 ML28244 | Ph 2 | completed | Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas |
| NCT02956889 virgilio | ONC-2015-001 | Ph 2 | terminated | To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma |
| NCT03767439 | AAAS1021 | Ph 2 | withdrawn | Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome |
| NCT02067104 results posted | 1401183410 ML28585 | Ph 2 | terminated | Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention |
| NCT01367665 results posted | MO25616 2011-000195-34 | Ph 2 | completed | STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma |
| NCT01601184 | MEVITEM 2011-003372-37 | Ph 1, Ph 2 | terminated | Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway |
| NCT01537107 | MC1111 NCI-2011-03809 | Ph 1 | completed | Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery |
| NCT02690948 results posted | IRB-34925 NCI-2015-01869, 350 | Ph 1, Ph 2 | completed | Pembrolizumab With or Without Vismodegib in Treating Metastatic or Unresectable Basal Cell Skin Cancer |
| NCT01163084 results posted | NCI-2010-01737 NCI-2010-01737, CDR0000670590 | Ph 1, Ph 2 | terminated | Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer |
| NCT01154452 results posted | NCI-2011-01412 NCI-2011-01412, CDR0000680558 | Ph 1, Ph 2 | completed | Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma |
| NCT02639117 PDT-Vismo | 1511201549 | Ph 1 | completed | Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas |
| NCT02593760 | WO29806 2015-001620-33 | Ph 1 | completed | A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination With Ruxolitinib for the Treatment of Intermediate- or High-Risk Myelofibrosis (MF) |
| NCT02648048 ISLAND2 | GB29764 2015-003481-81 | Ph 1 | completed | A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis |
| NCT01815840 results posted | MO28295 2012-003305-10 | Ph 2 | completed | A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas |
| NCT00980343 results posted | NCI-2012-02922 NCI-2012-02922, CDR0000654829 | Ph 2 | completed | GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery |
| NCT01195415 results posted | NCI-2011-03746 NCI-2011-03746, UMCC 2010-003 | Ph 2 | completed | Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer |
| NCT01174264 results posted | NCI-2012-03099 NCI-2012-03099, NCI 8395 | Ph 1, Ph 2 | completed | Evaluation of Food Effect on Pharmacokinetics of Vismodegib |
| NCT01898598 results posted | ML28726 | Ph 2 | terminated | A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma |
| NCT01944943 VISMOLY | VISMOLY | Ph 2 | terminated | Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia |
| NCT02168530 | GB29298 2014-000963-42 | Ph 2 | withdrawn | A Study of Oral Vismodegib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) |
| NCT01772290 | GP28465 | Ph 1 | completed | A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib |
Showing 50 of 61 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ERIVEDGE FDA Label Details
Indications & Usage
FDA Label (PDF)ERIVEDGE is indicated for the treatment of Metastatic Basal Cell Carcinoma; Basal Cell Carcinoma.
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 malformation...
Pro Intelligence Preview
Deep insights for ERIVEDGE
Revenue Insights
- • FY-2022: $283M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 2 active patents
Trial Analysis
- • 61 total trials
- • Stage: Stable
Competitive Landscape
- • 6 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment