Vismodegib

Treats metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma. Sold as Erivedge. Every FDA application for this active ingredient.

As of Nov 13, 2026, FDA lists 1 application for Vismodegib (sold as Erivedge), first approved Jan 30, 2012, with 1 new use approved and 0 published complete response letters.

First approved: Jan 30, 2012
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $160M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Erivedge	Part D	$160M	+37%	2,421

Clinical Trials

17 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Molecularly Tailored Therapy in Advanced Pancreatic CancerPancreatic Cancer · Herlev Hospital	Phase 2	Not yet recruiting	Sep 3, 2026
Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)Advanced Lymphoma, Advanced Malignant Solid Neoplasm · National Cancer Institute (NCI)	Phase 2	Active, not recruiting	Apr 10, 2024
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell CarcinomaBasal Cell Carcinoma · Stamford Pharmaceuticals, Inc.	Phase 2	Recruiting	Apr 3, 2024
Adaptive Therapy of Vismodegib in Advanced Basal Cell CarcinomaAdvanced Basal Cell Carcinoma · H. Lee Moffitt Cancer Center and Research Institute	Early phase 1	Recruiting	Dec 15, 2022
Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell CarcinomaBasal Cell Carcinoma, Radiotherapy; Complications · University Hospital, Lille	Phase 2	Recruiting	Sep 30, 2022
Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal CancerPlatinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma · Ronald Buckanovich	Phase 2	Recruiting	Sep 13, 2022
Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration StudyBasal Cell Carcinoma, Locally Advanced Basal Cell Carcinoma · Maastricht University Medical Center	—	Recruiting	Jul 19, 2022
The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer DrugsAdvanced Cancer, Solid Tumor · Helsinki University Central Hospital	Phase 2	Recruiting	Dec 16, 2021

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jan 30, 2012	ErivedgeNDA 203388 · New molecular entity	Genentech	14	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA