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Drug ReportsMethyl aminolevulinate
Methyl aminolevulinate
Metvixia (methyl aminolevulinate) is a small molecule pharmaceutical. Methyl aminolevulinate was first approved as Metvixia on 2004-07-27.
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Methyl aminolevulinate hydrochloride
Tradename
Company
Number
Date
Products
METVIXIAGaldermaN-021415 DISCN2004-07-27
1 products
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FDA
EMA
Brand Name
Status
Last Update
metvixia2007-09-26
Indications
FDA
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Agency Specific
FDA
EMA
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Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XD: Sensitizers used in photodynamic/radiation therapy
— L01XD03: Methyl aminolevulinate
HCPCS
Code
Description
J7309
Methyl aminolevulinate (mal) for topical administration, 16.8%, 1 gram
Clinical
Clinical Trials
79 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Actinic keratosisD055623—L57.0—182314
KeratosisD007642———182314
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
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CarcinomaD002277—C80.0——5—16
Basal cell carcinomaD002280————5—16
Basal cell neoplasmsD018295————4—15
Skin agingD015595EFO_0005422——11——2
Bowen's diseaseD001913—D00-D09——1—12
RecurrenceD012008————1——1
Skin neoplasmsD012878EFO_0004198C44——1——1
Squamous cell neoplasmsD018307————1——1
WartsD014860—B07——1——1
Indications Phases 2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
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Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
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Extramammary paget diseaseD010145——————11
Mammary paget's diseaseD010144—C50————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMethyl aminolevulinate
INN—
Description
Methyl 5-aminolevulinate is the methyl ester of 5-aminolevulinic acid. A prodrug, it is metabolised to protoporphyrin IX, a photosensitizer, and is used in the photodynamic treatment of non-melanoma skin cancer (including basal cell carcinoma). Topical application (often as the hydrochloride salt) results in an accumulation of protoporphyrin IX in the skin lesions to which the cream has been applied. Subsequent illumination with red light results in the generation of toxic singlet oxygen that destroys cell membranes and thereby kills the tumour cells. It has a role as an antineoplastic agent, a photosensitizing agent, a prodrug and a dermatologic drug. It is functionally related to a 5-aminolevulinic acid.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
COC(=O)CCC(=O)CN
Identifiers
PDB—
CAS-ID33320-16-0
RxCUI—
ChEMBL IDCHEMBL1096562
ChEBI ID724125
PubChem CID157922
DrugBankDB00992
UNII ID—
Target
No data
Variants
No data
Financial
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Trends
PubMed Central
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Additional graphs summarizing 952 documents
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Safety
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92 adverse events reported
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