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Drug ReportsVismodegib
Erivedge(vismodegib)
Erivedge (vismodegib) is a small molecule pharmaceutical. Vismodegib was first approved as Erivedge on 2012-01-30. It is used to treat skin neoplasms in the USA. It has been approved in Europe to treat basal cell neoplasms. The pharmaceutical is active against protein smoothened.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Erivedge
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vismodegib
Tradename
Company
Number
Date
Products
ERIVEDGEGenentechN-203388 RX2012-01-30
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
erivedgeNew Drug Application2023-03-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
skin neoplasmsEFO_0004198D012878C44
basal cell neoplasms—D018295—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Vismodegib, Erivedge, Genentech
92789612028-12-15U-1825
78883642028-11-11DS, DP
97901832025-09-02U-3109
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XJ: Hedgehog pathway inhibitors
— L01XJ01: Vismodegib
HCPCS
No data
Clinical
Clinical Trials
91 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0822—2536
Basal cell carcinomaD002280——419—2630
Basal cell neoplasmsD018295——217—2627
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80512——117
Pancreatic neoplasmsD010190EFO_0003860C2564———9
AdenocarcinomaD000230——45———8
RecurrenceD012008——44———7
SyndromeD013577——15——17
Basal cell nevus syndromeD001478EFO_0004136—15——17
Breast neoplasmsD001943EFO_0003869C5033———6
Prostatic neoplasmsD011471—C6142———5
Multiple myelomaD009101—C90.023———5
Skin neoplasmsD012878EFO_0004198C4413——15
Show 86 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3————3
Primary myelofibrosisD055728—D47.42————2
Acinar cell carcinomaD018267——2————2
Castration-resistant prostatic neoplasmsD064129——1————1
Myeloproliferative disordersD009196—D47.11————1
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.01————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1————1
Myelomonocytic leukemia chronicD015477—C93.11————1
AnemiaD000740HP_0001903D64.91————1
Hodgkin diseaseD006689—C811————1
Show 8 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SpasmD013035—M62.83————11
Musculoskeletal painD059352——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVismodegib
INNvismodegib
Description
Vismodegib is a benzamide obtained by formal condensation between the carboxy group of 2-chloro-4-(methylsulfonyl)benzoic acid and the anilino group of 4-chloro-3-(pyridin-2-yl)aniline. Used for the treatment metastatic basal cell carcinoma. It has a role as an antineoplastic agent, a SMO receptor antagonist, a Hedgehog signaling pathway inhibitor and a teratogenic agent. It is a sulfone, a member of benzamides, a member of pyridines and a member of monochlorobenzenes.
Classification
Small molecule
Drug classhedgehog signaling inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1
Identifiers
PDB—
CAS-ID879085-55-9
RxCUI—
ChEMBL IDCHEMBL473417
ChEBI ID66903
PubChem CID24776445
DrugBankDB08828
UNII ID25X868M3DS (ChemIDplus, GSRS)
Target
Agency Approved
SMO
SMO
Organism
Homo sapiens
Gene name
SMO
Gene synonyms
SMOH
NCBI Gene ID
Protein name
protein smoothened
Protein synonyms
frizzled family member 11, Protein Gx, seven transmembrane helix receptor, smoothened homolog, smoothened, frizzled family receptor, smoothened, seven transmembrane spanning receptor
Uniprot ID
Mouse ortholog
Smo (319757)
protein smoothened (P56726)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Erivedge – Roche
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,003 documents
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Safety
Black-box Warning
Black-box warning for: Erivedge
Adverse Events
Top Adverse Reactions
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8,052 adverse events reported
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