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 |
|---|---|
| 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 | 2025-04-15 |
| gleolan | New Drug Application | 2025-02-12 |
| 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
270 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Actinic keratosis | D055623 | — | L57.0 | 6 | 18 | 19 | 14 | 28 | 82 |
| Keratosis | D007642 | — | — | 6 | 18 | 19 | 14 | 28 | 82 |
| Glioma | D005910 | EFO_0000520 | — | 9 | 6 | 5 | 1 | 11 | 31 |
| Carcinoma | D002277 | — | C80.0 | 5 | 10 | 8 | 1 | 3 | 24 |
| Basal cell carcinoma | D002280 | — | — | 4 | 7 | 8 | 1 | 3 | 20 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 3 | 5 | 1 | 1 | 4 | 13 |
| Bowen's disease | D001913 | — | D00-D09 | 2 | — | 1 | 1 | 2 | 6 |
| Cheilitis | D002613 | HP_0100825 | K13.0 | 1 | 1 | — | 1 | — | 3 |
| Rosacea | D012393 | — | L71 | — | — | — | 1 | 1 | 2 |
| Hutchinson's melanotic freckle | D018327 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 8 | 11 | 1 | — | 7 | 25 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 9 | 11 | 1 | — | 6 | 24 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 3 | 5 | 1 | — | 6 | 14 |
| Basal cell neoplasms | D018295 | — | — | 3 | 6 | 6 | — | 2 | 14 |
| Carcinoma in situ | D002278 | — | D09.9 | 1 | 4 | 1 | — | 1 | 7 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | 5 | — | 2 | 7 |
| Squamous cell carcinoma | D002294 | — | — | 1 | 3 | 1 | — | 1 | 6 |
| Recurrence | D012008 | — | — | 4 | 4 | 1 | — | — | 6 |
| Precancerous conditions | D011230 | — | — | 2 | 2 | 1 | — | 1 | 5 |
| Warts | D014860 | — | B07 | — | — | 1 | — | 3 | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 4 | — | — | 3 | 8 |
| Photochemotherapy | D010778 | — | — | 1 | 2 | — | — | 3 | 5 |
| Astrocytoma | D001254 | EFO_0000271 | — | 3 | 1 | — | — | 1 | 5 |
| Leukoplakia | D007971 | — | — | 2 | 3 | — | — | — | 4 |
| Nervous system neoplasms | D009423 | — | — | 1 | 2 | — | — | 2 | 4 |
| Basal cell nevus syndrome | D001478 | EFO_0004136 | — | 1 | 1 | — | — | 1 | 3 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | — | — | 1 | 3 |
| Syndrome | D013577 | — | — | — | 1 | — | — | 1 | 2 |
| Neurofibromatosis 1 | D009456 | — | Q85.01 | 1 | 1 | — | — | — | 2 |
| Neurofibromatoses | D017253 | — | Q85.00 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 1 | — | — | — | 5 | 6 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | 3 | 4 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | 1 | 3 |
| Wound infection | D014946 | — | — | 1 | — | — | — | 1 | 2 |
| Surgical wound infection | D013530 | — | — | 1 | — | — | — | 1 | 2 |
| Prostheses and implants | D019736 | — | — | 1 | — | — | — | 1 | 2 |
| Prosthesis-related infections | D016459 | EFO_1001406 | — | 1 | — | — | — | 1 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | 1 | 2 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | 1 | 2 |
| Oligodendroglioma | D009837 | EFO_0000631 | — | 2 | — | — | — | — | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | — | 3 | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 2 | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 2 | 2 |
| Sars-cov-2 | D000086402 | — | — | — | — | — | — | 2 | 2 |
| Erythropoietic porphyria | D017092 | — | — | — | — | — | — | 2 | 2 |
| Porphyrias | D011164 | EFO_0000665 | — | — | — | — | — | 2 | 2 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 1 | 1 |
| Psychological adaptation | D000223 | — | — | — | — | — | — | 1 | 1 |
| Irritable mood | D007508 | — | — | — | — | — | — | 1 | 1 |
| Rectal fistula | D012003 | — | K60.3 | — | — | — | — | 1 | 1 |
Show 34 more
Epidemiology
Epidemiological information for investigational and approved indications
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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 |
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Ameluz – Biofrontera
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Safety
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1,734 adverse events reported
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