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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
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 |
|---|---|---|---|---|
| AMELUZ | Biofrontera | N-208081 RX | 2016-05-10 | 1 products, RLD, RS |
| GLEOLAN | NX Development | N-208630 RX | 2017-06-06 | 1 products, RLD, RS |
| LEVULAN | Sun Pharmaceutical Industries | N-020965 RX | 1999-12-03 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ameluz | New Drug Application | 2024-10-04 |
| gleolan | New Drug Application | 2024-05-03 |
| levulan kerastick | New Drug Application | 2024-09-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| actinic keratosis | — | D055623 | L57.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMINOLEVULINIC ACID HYDROCHLORIDE, GLEOLAN, NXDC | |||
| 2024-06-06 | ODE-146 | ||
Patent Expiration
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
Clinical Trials
264 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningioma | D008579 | EFO_0003098 | D32.9 | — | — | 1 | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | 1 | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | — | 1 |
| Skull base neoplasms | D019292 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pituitary neoplasms | D010911 | — | — | — | — | — | — | 1 | 1 |
| Adenoma | D000236 | — | — | — | — | — | — | 1 | 1 |
| Pituitary diseases | D010900 | — | E23.7 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Aminolevulinic 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 |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Ameluz – Biofrontera
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 15,939 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
1,497 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use