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Levulan, Gliolan(aminolevulinic acid)
Ameluz, Gleolan, Gliolan, Levulan (aminolevulinic acid) is a small molecule pharmaceutical. Aminolevulinic acid was first approved as Levulan on 1999-12-03. It is used to treat actinic keratosis in the USA. It has been approved in Europe to treat actinic keratosis, basal cell neoplasms, and glioma.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Ameluz, Gleolan, Levulan
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aminolevulinic acid hydrochloride
Tradename
Company
Number
Date
Products
AMELUZBiofronteraN-208081 RX2016-05-10
1 products, RLD, RS
LEVULANDUSA PharmaceuticalsN-020965 RX1999-12-03
1 products, RLD, RS
GLEOLANNX DevelopmentN-208630 RX2017-06-06
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ameluzNew Drug Application2020-08-06
gleolanNew Drug Application2022-04-27
levulan kerastickNew Drug Application2020-02-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
actinic keratosis—D055623L57.0
Agency Specific
FDA
EMA
Expiration
Code
AMINOLEVULINIC ACID HYDROCHLORIDE, GLEOLAN, NXDC
2024-06-06ODE-146
Patent Expiration
Patent
Expires
Flag
FDA Information
Aminolevulinic Acid Hydrochloride, Ameluz, Biofrontera
112351692040-10-15U-3303
115409812028-02-07DP
Aminolevulinic Acid Hydrochloride, Levulan, Dusa
103575672038-01-12U-3163
110771922038-01-12U-3163
111352932038-01-12U-3163
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XD: Sensitizers used in photodynamic/radiation therapy
— L01XD04: Aminolevulinic acid
HCPCS
Code
Description
J7308
Aminolevulinic acid hcl for topical administration, 20%, single unit dosage form (354 mg)
J7345
Aminolevulinic acid hcl for topical administration, 10% gel, 10 mg
Level 3: J7308-J7309
Aminolevulinic Acid HCL
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAMINOLEVULINIC ACID
INN—
Description
5-aminolevulinic acid is the simplest delta-amino acid in which the hydrogens at the gamma position are replaced by an oxo group. It is metabolised to protoporphyrin IX, a photoactive compound which accumulates in the skin. Used (in the form of the hydrochloride salt)in combination with blue light illumination for the treatment of minimally to moderately thick actinic keratosis of the face or scalp. It has a role as a photosensitizing agent, an antineoplastic agent, a dermatologic drug, a prodrug, a plant metabolite, a human metabolite, a Saccharomyces cerevisiae metabolite, an Escherichia coli metabolite and a mouse metabolite. It is a delta-amino acid and a 4-oxo monocarboxylic acid. It is functionally related to a 4-oxopentanoic acid. It is a conjugate base of a 5-ammoniolevulinic acid. It is a conjugate acid of a 5-aminolevulinate. It is a tautomer of a 5-ammoniolevulinate.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
NCC(=O)CCC(=O)O
Identifiers
PDB—
CAS-ID106-60-5
RxCUI683
ChEMBL IDCHEMBL601
ChEBI ID17549
PubChem CID137
DrugBankDB00855
UNII ID—
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Ameluz - Biofrontera
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,437 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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92 adverse events reported
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