Adapalene
Adapalene, Cabtreo, Differin, Epiduo (adapalene) is a small molecule pharmaceutical. Adapalene was first approved as Differin on 1996-05-31. It is used to treat acne vulgaris in the USA. The pharmaceutical is active against retinoic acid receptor beta and retinoic acid receptor gamma. In addition, it is known to target retinoic acid receptor alpha.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Adapalene, Differin (discontinued: Differin)
CombinationsAdapalene benzoyl peroxide, Cabtreo, Epiduo (discontinued: Adapalene benzoyl peroxide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Adapalene
Adapalene
+
Benzoyl peroxide
Adapalene
+
Benzoyl peroxide
+
Clindamycin phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CABTREO | Bausch Health Companies | N-216632 RX | 2023-10-20 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adapalene | ANDA | 2024-09-25 |
| adapalene 0.1% / benzoyl peroxide 2.5% / clindamycin 1% | unapproved drug other | 2020-06-03 |
| adapalene 0.1% / benzoyl peroxide 2.5% / niacinamide 4% | unapproved drug other | 2020-06-03 |
| adapalene 0.3% / benzoyl peroxide 2.5% / clindamycin 1% | unapproved drug other | 2020-06-03 |
| adapalene 0.3% / benzoyl peroxide 2.5% / niacinamide 4% | unapproved drug other | 2020-06-03 |
| adapalene 0.3% / niacinamide 4% | unapproved drug other | 2019-05-09 |
| adapalene and benzoyl peroxide | ANDA | 2024-10-18 |
| adapalene and benzoyl peroxide 0.1%/2.5% gel pad | unapproved drug other | 2022-10-06 |
| adapalene and benzoyl peroxide gel, 0.1%/2.5% | ANDA | 2024-04-30 |
| adapalene and benzoyl peroxide swab | unapproved drug other | 2020-12-22 |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ADAPALENE / BENZOYL PEROXIDE / CLINDAMYCIN PHOSPHATE, CABTREO, BAUSCH | |||
| 2026-10-20 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Adapalene / Benzoyl Peroxide / Clindamycin Phosphate, Cabtreo, Bausch | |||
| 11389467 | 2040-12-28 | DP | U-3713 |
| 8288434 | 2029-08-05 | DP | U-3713 |
| 9561208 | 2029-06-03 | DP | U-3713 |
| 10220049 | 2029-06-03 | DP | U-3713 |
| 10624918 | 2029-06-03 | U-3713 | |
| Adapalene, Differin, Galderma Labs Lp | |||
| 7998467 | 2028-05-31 | DP | U-1078 |
| 8435502 | 2026-09-15 | DP | U-1078 |
| 8709392 | 2026-09-15 | DP | U-1078 |
| 7579377 | 2025-02-23 | U-818 | |
| 7737181 | 2024-08-29 | DP | |
| Adapalene / Benzoyl Peroxide, Epiduo, Galderma Labs Lp | |||
| 8071644 | 2027-07-18 | DP | U-1078 |
| 8080537 | 2027-07-18 | U-1078 | |
| 8129362 | 2027-07-18 | U-1078 | |
| 7820186 | 2025-11-23 | DP | |
| 7964202 | 2024-09-01 | DP | U-1078 |
HCPCS
No data
Clinical
Clinical Trials
107 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 11 | 8 | 25 | 41 | 11 | 94 |
| Atrophy | D001284 | — | — | — | 1 | — | 1 | — | 2 |
| Cicatrix | D002921 | HP_0100699 | L90.5 | — | — | — | 1 | — | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Skin aging | D015595 | EFO_0005422 | — | — | — | 2 | — | — | 2 |
| Skin diseases | D012871 | — | L00-L99 | — | — | 1 | — | — | 1 |
| Molluscum contagiosum | D008976 | EFO_0007375 | B08.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinitis pigmentosa | D012174 | HP_0000580 | H35.52 | 1 | 1 | — | — | — | 1 |
| Retinitis | D012173 | — | H30.9 | 1 | 1 | — | — | — | 1 |
| Purpura | D011693 | HP_0000979 | D69.2 | — | 1 | — | — | — | 1 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | 1 | 1 | — | — | — | 1 |
| Optic nerve diseases | D009901 | EFO_1001330 | H47.14 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Skin manifestations | D012877 | — | — | 2 | — | — | — | — | 2 |
| Warts | D014860 | — | B07 | 1 | — | — | — | — | 1 |
| Foot diseases | D005534 | — | — | 1 | — | — | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diet therapy | D004035 | — | — | — | — | — | — | 1 | 1 |
| Microspheres | D008863 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Adapalene |
| INN | adapalene |
| Description | Adapalene is a naphthoic acid that is CD437 in which the phenolic hydroxy group has been converted to its methyl ether. It has a role as a dermatologic drug, a non-steroidal anti-inflammatory drug and an EC 2.7.11.22 (cyclin-dependent kinase) inhibitor. It is a monocarboxylic acid, a member of adamantanes and a naphthoic acid. It is functionally related to a CD437. |
| Classification | Small molecule |
| Drug class | Retinoids |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2 |
Identifiers
| PDB | — |
| CAS-ID | 106685-40-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1265 |
| ChEBI ID | 31174 |
| PubChem CID | 60164 |
| DrugBank | DB00210 |
| UNII ID | 1L4806J2QF (ChemIDplus, GSRS) |
Target
Agency Approved
RARB
RARB
RARG
RARG
Organism
Homo sapiens
Gene name
RARB
Gene synonyms
HAP, NR1B2
NCBI Gene ID
Protein name
retinoic acid receptor beta
Protein synonyms
HBV-activated protein, hepatitis B virus activated protein, Nuclear receptor subfamily 1 group B member 2, RAR-beta, RAR-epsilon, retinoic acid receptor, beta polypeptide
Uniprot ID
Mouse ortholog
Rarb (218772)
retinoic acid receptor beta (P22605)
Alternate
RARA
RARA
Organism
Homo sapiens
Gene name
RARA
Gene synonyms
NR1B1
NCBI Gene ID
Protein name
retinoic acid receptor alpha
Protein synonyms
Nuclear receptor subfamily 1 group B member 1, nucleophosmin-retinoic acid receptor alpha fusion protein NPM-RAR long form, PML-DDX5-RARA fusion, PML-DDX5-RARA fusion protein, RAR-alpha, retinoic acid receptor, alpha polypeptide
Uniprot ID
Mouse ortholog
Rara (19401)
retinoic acid receptor alpha (P11416)
Variants
No data
Financial
Revenue by drug
$
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£
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Estimated US medical usage
Adapalene
Total medical expenditures per year (USD, in millions)
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Adapalene
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Benzoyl peroxide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,206 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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178,365 adverse events reported
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