aminolevulinic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	166	106-60-5

Description:

Molecule	Description
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: -3.42 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 80.39 ALOGS: 0.12 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

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: -3.42
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 80.39
ALOGS: 0.12
ROTB: 4

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	60 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	34 mg/mL	Bocci G, Oprea TI, Benet LZ
CL (Clearance)	1.88 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0.88 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.83 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.12 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Dec. 3, 1999	FDA	DUSA

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Application site erythema	150.04	126.55	26	379	4809	63483808

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Application site erythema	142.31	109.97	23	249	2313	34954346

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Application site erythema	289.19	93.80	47	551	5063	79738727
Application site pain	179.71	93.80	31	567	4716	79739074
Erythema	120.05	93.80	49	549	223241	79520549
Application site swelling	119.42	93.80	17	581	736	79743054
Application site pustules	105.57	93.80	11	587	26	79743764
Oedema	95.14	93.80	35	563	119545	79624245
Off label use	93.84	93.80	66	532	907149	78836641

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01XD04	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Sensitizers used in photodynamic/radiation therapy
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:47868	photosensitising agent
CHEBI has role	CHEBI:50177	dermatologic agent
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:75772	S. cerevisiae metabolites
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:76971	Escherichia coli metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite

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Drug Use | Suggest Off label Use Form| |View source of the data|

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

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.82	acidic
pKa2	9.59	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10%	AMELUZ	BIOFRONTERA	N208081	May 10, 2016	RX	GEL	TOPICAL	11235169	Oct. 15, 2040	TOPICAL LESION-DIRECTED AND FIELD-DIRECTED TREATMENT OF ACTINIC KERATOSIS OF THE FACE AND SCALP WITH PHOTODYNAMIC THERAPY BY POSITIONING AN ILLUMINATION DEVICE IN AN APPROPRIATE DISTANCE AND ILLUMINATING THE TREATMENT AREA WITH NARROWBAND RED LIGHT
20%	LEVULAN	DUSA	N020965	Dec. 3, 1999	RX	SOLUTION	TOPICAL	10357567	Jan. 12, 2038	TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
20%	LEVULAN	DUSA	N020965	Dec. 3, 1999	RX	SOLUTION	TOPICAL	11077192	Jan. 12, 2038	TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
20%	LEVULAN	DUSA	N020965	Dec. 3, 1999	RX	SOLUTION	TOPICAL	11135293	Jan. 12, 2038	TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
20%	LEVULAN	DUSA	N020965	Dec. 3, 1999	RX	SOLUTION	TOPICAL	11571478	Jan. 12, 2038	TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
20%	LEVULAN	DUSA	N020965	Dec. 3, 1999	RX	SOLUTION	TOPICAL	11690914	Jan. 12, 2038	TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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

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Bioactivity Summary:

None

External reference:

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ID	Source
009074	NDDF
137	PUBCHEM_CID
1806646	RXNORM
228491	MMSL
259496005	SNOMEDCT_US
30525	MMSL
4023632	VANDF
4025779	VUID
4025779	VANDF
409398000	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
AMELUZ	HUMAN PRESCRIPTION DRUG LABEL	1	70621-101	GEL	100 mg	TOPICAL	NDA	26 sections
AMELUZ	HUMAN PRESCRIPTION DRUG LABEL	1	70621-101	GEL	100 mg	TOPICAL	NDA	26 sections
AMELUZ	HUMAN PRESCRIPTION DRUG LABEL	1	70621-101	GEL	100 mg	TOPICAL	NDA	26 sections
GLEOLAN	HUMAN PRESCRIPTION DRUG LABEL	1	59137-231	POWDER, FOR SOLUTION	1500 mg	ORAL	NDA	30 sections
GLEOLAN	HUMAN PRESCRIPTION DRUG LABEL	1	71469-231	POWDER, FOR SOLUTION	1500 mg	ORAL	NDA	26 sections

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