aminolevulinic acid indications/contra

Stem definitionDrug idCAS RN
166 106-60-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ameluz
  • aminolevulinic acid
  • 5-amino-4-oxopentanoic acid
  • aladerm
  • alasens
  • 5-aminolevulinic acid
  • 5-aminolevulinic acid hydrochloride
  • Gliolan
  • aminolevulinic acid hydrochloride
  • 5-aminolevulinic acid HCl
  • aminolevulinic acid HCl
A compound produced from succinyl-CoA and GLYCINE as an intermediate in heme synthesis. It is used as a PHOTOCHEMOTHERAPY for actinic KERATOSIS.
  • Molecular weight: 131.13
  • Formula: C5H9NO3
  • CLOGP: -3.41
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 80.39
  • ALOGS: 0.12
  • ROTB: 4

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 3, 1999 FDA DUSA

FDA Adverse Event Reporting System

None

Pharmacologic Action:

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SourceCodeDescription
ATC L01XD04 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Sensitizers used in photodynamic/radiation therapy
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:47868 photosensitizing agent
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50266 prodrug
FDA EPC N0000175846 Porphyrin Precursor
FDA Chemical/Ingredient N0000171207 Porphyrinogens
MeSH PA D003879 Dermatologic Agents
MeSH PA D017319 Photosensitizing Agents
MeSH PA D011838 Radiation-Sensitizing Agents

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Fluorescent stain indication 35352008
Actinic keratosis indication 201101007 DOID:8866
Non-Hyperkeratotic Actinic Keratoses indication
Photosensitivity contraindication 90128006

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.82 acidic
pKa2 9.59 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
20% LEVULAN DUSA N020965 Dec. 3, 1999 RX SOLUTION TOPICAL 6709446 May 1, 2018 TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
20% LEVULAN DUSA N020965 Dec. 3, 1999 RX SOLUTION TOPICAL 8216289 May 1, 2018 TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
20% LEVULAN DUSA N020965 Dec. 3, 1999 RX SOLUTION TOPICAL 8758418 May 1, 2018 TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
20% LEVULAN DUSA N020965 Dec. 3, 1999 RX SOLUTION TOPICAL 7723910 June 17, 2019 TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
10% AMELUZ BIOFRONTERA N208081 May 10, 2016 RX GEL TOPICAL 6559183 Nov. 12, 2019 TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10% AMELUZ BIOFRONTERA N208081 May 10, 2016 RX GEL TOPICAL May 10, 2019 NEW PRODUCT
1.5GM/VIAL GLEOLAN NXDC N208630 June 6, 2017 RX FOR SOLUTION ORAL June 6, 2024 OPTICAL IMAGING AGENT INDICATED IN PATIENTS WITH GLIOMA (SUSPECTED WORLD HEALTH ORGANIZATION GRADES III OR IV ON PREOPERATIVE IMAGING) AS AN ADJUNCT FOR THE VISUALIZATION OF MALIGNANT TISSUE DURING SURGERY

Bioactivity Summary:

None

External reference:

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IDSource
CHEBI:132969 CHEBI
4025779 VUID
N0000176068 NUI
C0002563 UMLSCUI
D02908 KEGG_DRUG
CHEMBL601 ChEMBL_ID
DB00855 DRUGBANK_ID
409398000 SNOMEDCT_US
683 RXNORM
259496005 SNOMEDCT_US
4025779 VANDF
N0000176068 NDFRT
N0000170216 NDFRT
88755TAZ87 UNII
CHEMBL1200582 ChEMBL_ID
5451-09-2 SECONDARY_CAS_RN
D000622 MESH_DESCRIPTOR_UI
137 PUBCHEM_CID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
LEVULAN KERASTICK HUMAN PRESCRIPTION DRUG LABEL 1 67308-101 KIT 354 mg None NDA 16 sections
AMELUZ HUMAN PRESCRIPTION DRUG LABEL 1 70621-101 GEL 100 mg TOPICAL NDA 19 sections