Drug · Small Molecule

Vismodegib

CI-DRUG-00000640Explore in graph →NCIt C74038 CHEMBL473417 CIViC Approved

Regulatory

Approvals (4)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2019-01-18 (see label)	approved	Jan 18, 2019	openfda
US FDA	Basal Cell Carcinoma	ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ERIVEDGE ® (vismodegib) is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ( 1 )	approved	Jan 30, 2012	openfda

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 11 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	14	9	71	4	CA, EU, US	Jan 30, 2012	2007-04
Multiple Myeloma	Phase2	Phase 2	3	1	5	0	—	—	2010-12
Non-Hodgkin Lymphoma	Phase2	Phase 2	3	1	6	0	—	—	2010-12
Malignant Pancreatic Neoplasm	Phase2	Phase 2	2	0	8	0	—

Curated evidence

Clinical evidence (35)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–35 of 35 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PTCH1 Loss-of-function1
Vismodegib	Basal Cell Carcinoma

Clinical trials

Trials with this intervention (75)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–75 of 75 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02694224	Addition of Vismodegib to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients(SHH-CM)	unknown	Phase 2	40	Clinica Universidad de Navarra, Universidad de NavarraOTHER	1	Oct 24, 2017	clinicaltrials
NCT01815840	A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Molecule

Record

Kind: Small Molecule
Mechanism: Smoothened homolog inhibitor
Targets: 1 gene
UNII: 25X868M3DS
Aliases: 2-chloro-N-[4-chloro-3-(pyridin-2-yl)phenyl]-4-(methylsulfonyl)benzamide, Erivedge, GDC 0449, GDC-0449, GDC0449, Hedgehog Antagonist GDC-0449, NSC-747691, NSC-755986, Vismodegib

Data updated 14 hours agoSource updated unknown

Identifiers

Codes (5)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XJ01	VISMODEGIB
ATC (WHO)	L01XX43	Antineoplastic agents
DIN (Health Canada)

SMO D473H3
Vismodegib	Basal Cell Carcinoma	Predictive	D	Supports Resistance	3	accepted	EID755 D473 mutations were identified in 5/30 resistant basal cell carcinomas. Crystal structure indicated this mutation interacts with a water molecule in the ligand binding pocket, putatively altering its … (full text at CIViC) PMID 25759020 · Atwood et al., 2015 · Open in CIViC	civic
〃	MedulloblastomaCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID745 In this case report, the D473H mutation was reported as an acquired mechanism of resistance to the hedgehog pathway inhibitor GDC-0449 (vismodegib). PMID 19726788 · Yauch et al., 2009 · Open in CIViC	civic
〃	MedulloblastomaCURATED_BROADER	Predictive	D	Supports Resistance	—	submitted	EID4427 In an in vitro study, a C3H10T1/2 cell line expressing SMO D473H mutation, demonstrated resistance to vismodegib treatment (IC50: 3,000,000 nmol/L vs. 20 nmol/L) compared to C3H10T1/2 cells expressing… (full text at CIViC) PMID 21123452 · Dijkgraaf et al., 2011 · Open in CIViC	civic

SMO L412F3
Vismodegib	Basal Cell Carcinoma	Predictive	C	Supports Resistance	—	accepted	EID4654 An Arab basal cell carcinoma patient harboring SMO L412F mutation was associated with response to vismodegib monotherapy. Prior to the identification of the mutation, the patient was treated with acit… (full text at CIViC) PMID 26822128 · Khamaysi et al., 2016 · Open in CIViC	civic
〃	Basal Cell Carcinoma	Predictive	D	Supports Resistance	—	submitted	EID4652 In an in vitro study, a C3H10T1/2 cell line expressing a SMO L412F mutation, demonstrated resistance to vismodegib treatment, compared to C3H10T1/2 cells expressing wild-type SMO. Resistance was deter… (full text at CIViC) PMID 25759019 · Sharpe et al., 2015 · Open in CIViC	civic
〃	Basal Cell Carcinoma	Predictive	D	Supports Resistance	—	accepted	EID4653 In an in vitro study, mouse embryonic fibroblasts (MEFs), null for the Smo mouse gene expressing SMO L412F mutation, demonstrated resistance to vismodegib treatment (IC50: >320 nmol/L vs. 8.23 nmol/L)… (full text at CIViC) PMID 25759020 · Atwood et al., 2015 · Open in CIViC	civic

SMO Mutation3
Vismodegib	Basal Cell Carcinoma	Predictive	B	Supports Resistance	4	accepted	EID746 In basal cell carcinoma, H231R, D473G, W281C and Q477E mutations conferred resistance to SMO-inhibitor vismodegib. SMO mutations were identified in 22 of 44 resistant basal cell carcinomas in 15 patie… (full text at CIViC) PMID 25759020 · Atwood et al., 2015 · Open in CIViC	civic
Sonidegib + VismodegibSequential	Basal Cell Carcinoma	Predictive	B	Supports Resistance	2	accepted	EID1477 Study explored the response to the SMO inhibitor sonidegib (LDE225) in a cohort of 9 patients with advanced basal cell carcinoma that exhibited treatment resistance with vismodegib (GDC0449). Sequenc… (full text at CIViC) PMID 26546616 · Danial et al., 2016 · Open in CIViC	civic
Vismodegib	Malignant NeoplasmALIAS	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID5979 The phase 2a MyPathway study assigned patients with HER2, EGFR, BRAF or SHH alterations to treatment with pertuzumab plus trastuzumab, erlotinib, vemurafenib, or vismodegib, respectively. Twenty-one p… (full text at CIViC) PMID 29320312 · Hainsworth et al., 2018 · Open in CIViC	civic

SMO V321M3
Vismodegib	Basal Cell Carcinoma	Predictive	C	Supports Resistance	—	submitted	EID4660 In a basal cell carcinoma (BCC) patient harboring PTCH1 inactivating alterations (known to be sensitizing to vismodegib treatment) and a SMO V321M mutation, SMO V321M was associated with acquired resi… (full text at CIViC) PMID 25199678 · Brinkhuizen et al., 2014 · Open in CIViC	civic
〃	Basal Cell Carcinoma	Predictive	D	Supports Resistance	—	submitted	EID4661 In an in vitro study, mouse embryonic fibroblasts (MEFs), null for the Smo mouse gene expressing SMO V321M mutation, demonstrated resistance to vismodegib treatment (IC50: >320 nmol/L vs. 8.23 nmol/L)… (full text at CIViC) PMID 25759020 · Atwood et al., 2015 · Open in CIViC	civic
〃	Basal Cell Carcinoma	Predictive	D	Supports Resistance	—	submitted	EID4662 In an in vitro study, a C3H10T1/2 cell line expressing a SMO V321M mutation, demonstrated resistance to vismodegib treatment, compared to C3H10T1/2 cells expressing wild-type SMO. Resistance was deter… (full text at CIViC) PMID 25759019 · Sharpe et al., 2015 · Open in CIViC	civic

SMO W281C2
Vismodegib	Basal Cell Carcinoma	Predictive	D	Supports Resistance	—	submitted	EID4637 In an in vitro study, mouse embryonic fibroblasts (MEFs) null for the Smo mouse gene, expressing SMO W281C mutation, demonstrated resistance to vismodegib treatment (IC50: >320 nmol/L vs. 8.23 nmol/L)… (full text at CIViC) PMID 25759020 · Atwood et al., 2015 · Open in CIViC	civic
〃	Basal Cell Carcinoma	Predictive	D	Supports Resistance	—	submitted	EID4638 In an in vitro study, a C3H10T1/2 cell line expressing a SMO W281C mutation, demonstrated resistance to vismodegib treatment, compared to C3H10T1/2 cells expressing wild-type SMO. Resistance was deter… (full text at CIViC) PMID 25759019 · Sharpe et al., 2015 · Open in CIViC	civic