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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
EMA
No data
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
80 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—L57.0541291644
KeratosisD007642——541291644
Basal cell carcinomaD002280——3371315
CarcinomaD002277—C80.03271214
Bowen's diseaseD001913—D00-D092—1126
CheilitisD002613HP_0100825K13.01——1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Basal cell neoplasmsD018295——236—211
Skin diseasesD012871—L00-L992—1—14
Skin neoplasmsD012878EFO_0004198C441—1—24
Squamous cell carcinomaD002294——111——3
Skin agingD015595EFO_0005422——11—13
Precancerous conditionsD011230————1——1
RecurrenceD012008————1——1
Squamous cell neoplasmsD018307————1——1
WartsD014860—B07——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acne vulgarisD000152EFO_0003894L70—3——14
PhotochemotherapyD010778——12———2
Phototoxic dermatitisD017484——11———1
Uterine cervical dysplasiaD002578EFO_1000910N8711———1
FaciesD019066———1———1
Cutaneous leishmaniasisD016773—B55.1—1———1
LeishmaniasisD007896EFO_0005044B55—1———1
NeoplasmsD009369—C80—1———1
Carcinoma in situD002278—D09.9—1———1
Vulvar neoplasmsD014846—C51—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—1———12
Communicable diseasesD003141——1———12
Wound infectionD014946——1———12
Surgical wound infectionD013530——1———12
Prostheses and implantsD019736——1———12
Prosthesis-related infectionsD016459EFO_1001406—1———12
Healthy volunteers/patients———2————2
PainD010146EFO_0003843R521————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Leg ulcerD007871——————11
RosaceaD012393—L71————11
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
No data
Trends
PubMed Central
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Safety
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No Black-box warning
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92 adverse events reported
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