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aminolevulinic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 166 | 106-60-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A compound produced from succinyl-CoA and GLYCINE as an intermediate in heme synthesis. It is used as a PHOTOCHEMOTHERAPY for actinic KERATOSIS.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BA (Bioavailability) | 60 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.12 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.88 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| 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 |
| S (Water solubility) | 34 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IKBKB,ITK,JAK1,JAK2,JAK3,KDR,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MTOR,NTRK1,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 | 53 | |||
| kinase-selectivity-class | ACVR2B,AXL,BRAF,CDK9,DYRK1B,EIF2AK3,EPHB4,GRK2,MAP2K6,MAPK7,PIK3CD,PIK3CG,PRKDC,STK33,TEK,TGFBR1 | 16 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 3, 1999 | FDA | DUSA |
FDA Adverse Event Reporting System (Female)
| 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 | 207.19 | 125.66 | 35 | 585 | 5173 | 90622654 |
| Poor quality product administered | 145.92 | 125.66 | 25 | 595 | 3983 | 90623844 |
| Application site pain | 135.17 | 125.66 | 24 | 596 | 4696 | 90623131 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Poor quality product administered | 259.51 | 77.07 | 42 | 571 | 2266 | 42618456 |
| Product quality issue | 168.58 | 77.07 | 41 | 572 | 17841 | 42602881 |
| Application site pain | 147.61 | 77.07 | 26 | 587 | 2303 | 42618419 |
| Application site erythema | 131.97 | 77.07 | 24 | 589 | 2542 | 42618180 |
FDA Adverse Event Reporting System (Geriatric)
| 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 | 345.46 | 86.44 | 56 | 823 | 5554 | 110582866 |
| Application site pain | 254.44 | 86.44 | 43 | 836 | 5456 | 110582964 |
| Application site swelling | 131.30 | 86.44 | 19 | 860 | 868 | 110587552 |
| Application site pustules | 115.16 | 86.44 | 12 | 867 | 26 | 110588394 |
| Erythema | 113.53 | 86.44 | 52 | 827 | 291395 | 110297025 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XD04 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Sensitizers used in photodynamic/radiation therapy |
| FDA CS | M0017335 | Porphyrinogens |
| MeSH PA | D003879 | Dermatologic Agents |
| MeSH PA | D011838 | Radiation-Sensitizing Agents |
| MeSH PA | D017319 | Photosensitizing Agents |
| FDA EPC | N0000175846 | Porphyrin Precursor |
| CHEBI has role | CHEBI:35441 | antiinfective agent |
| 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 |
| CHEBI has role | CHEBI:75771 | mouse metabolite |
| CHEBI has role | CHEBI:75772 | <em>Saccharomyces cerevisiae </em> metabolite |
| CHEBI has role | CHEBI:76924 | plant metabolite |
| CHEBI has role | CHEBI:76971 | <em>Escherichia coli</em> metabolite |
| CHEBI has role | CHEBI:77746 | human metabolite |
| FDA MoA | N0000193981 | Fluorescence Contrast Activity |
| FDA EPC | N0000193983 | Optical Imaging Agent |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
Related Drugs by ATC class:
L01XD Sensitizers used in photodynamic/radiation therapy 5 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Fluorescent stain | indication | 35352008 | |
| Actinic keratosis | indication | 201101007 | DOID:8866 |
| Non-Hyperkeratotic Actinic Keratoses | indication | ||
| Photosensitivity | contraindication | 90128006 |
🐶 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)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 11179574 | Oct. 13, 2036 | TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY |
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 11697028 | Oct. 13, 2036 | TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY |
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 12290700 | Oct. 13, 2036 | TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY |
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 11446512 | Jan. 17, 2037 | TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY |
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 10357567 | Jan. 12, 2038 | TREATMENT OF ACTINIC KERATOSIS OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY |
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 11077192 | Jan. 12, 2038 | TREATMENT OF ACTINIC KERATOSIS OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY |
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 11135293 | Jan. 12, 2038 | TREATMENT OF ACTINIC KERATOSIS OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY |
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 11571478 | Jan. 12, 2038 | TREATMENT OF ACTINIC KERATOSIS OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY |
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 11690914 | Jan. 12, 2038 | TREATMENT OF ACTINIC KERATOSIS OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY |
| 20% | LEVULAN | SUN PHARM INDS INC | N020965 | Dec. 3, 1999 | RX | SOLUTION | TOPICAL | 12296011 | Jan. 12, 2038 | TREATMENT OF ACTINIC KERATOSIS OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY |
| 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 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10% | AMELUZ | BIOFRONTERA | N208081 | May 10, 2016 | RX | GEL | TOPICAL | Oct. 4, 2027 | INCREASE IN THE APPROVED DOSAGE REGIMEN TO A MAXIMUM APPLICATION AREA OF 60 CM^2 IN TOTAL (CORRESPONDING TO THREE 2 GM TUBES) |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4025779 | VUID |
| N0000176068 | NUI |
| D02908 | KEGG_DRUG |
| 1806646 | RXNORM |
| C0002563 | UMLSCUI |
| CHEBI:17549 | CHEBI |
| CHEMBL601 | ChEMBL_ID |
| 137 | PUBCHEM_CID |
| DB00855 | DRUGBANK_ID |
| CHEMBL1200582 | ChEMBL_ID |
| D000622 | MESH_DESCRIPTOR_UI |
| 5451-09-2 | SECONDARY_CAS_RN |
| 88755TAZ87 | UNII |
| 228491 | MMSL |
| 30525 | MMSL |
| 8581 | MMSL |
| d07530 | MMSL |
| FVT | PDB_CHEM_ID |
| 4784 | IUPHAR_LIGAND_ID |
| 4023632 | VANDF |
| 4025779 | VANDF |
| 009074 | NDDF |
| 259496005 | SNOMEDCT_US |
| 409398000 | SNOMEDCT_US |
| 784354008 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| AMELUZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70621-101 | GEL | 100 mg | TOPICAL | NDA | 26 sections |
| GLEOLAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71469-231 | POWDER, FOR SOLUTION | 1500 mg | ORAL | NDA | 30 sections |