Adapalene - PharmaKB

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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FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Completion date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Adapalene, Differin (discontinued: Differin)

Combinations

Adapalene benzoyl peroxide, Cabtreo, Epiduo (discontinued: Adapalene benzoyl peroxide)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Adapalene

Tradename	Company	Number	Date	Products
DIFFERIN	Galderma	N-020380 OTC	2016-07-08	1 products, RLD, RS
DIFFERIN	Galderma	N-020748 RX	2000-05-26	1 products, RLD, RS
DIFFERIN	Galderma	N-021753 RX	2007-06-19	1 products, RLD, RS

Show 2 discontinued

Adapalene

Benzoyl peroxide

Tradename	Company	Number	Date	Products
EPIDUO FORTE	Galderma	N-207917 RX	2015-07-15	1 products, RLD, RS
EPIDUO	Galderma	N-022320 RX	2008-12-08	1 products, RLD, RS

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	2025-09-09
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	2025-07-03
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	2025-09-30
adapalene and benzoyl peroxide swab	unapproved drug other	2020-12-22

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
acne vulgaris	EFO_0003894	D000152	L70
rosacea	—	D012393	L71
toxoplasmosis	EFO_0007517	D014123	B58
bacterial infections	—	D001424	A49
streptococcal infections	EFO_1001476	D013290	—
bacterial vaginosis	EFO_0003932	D016585	—
pneumocystis pneumonia	EFO_0007448	D011020	B59
staphylococcal infections	—	D013203	A49.01
actinomycetales infections	EFO_1001122	D000193	—
bacteroides infections	EFO_1000832	D001442	—

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

ATC Codes

D: Dermatologicals

— D10: Anti-acne preparations

— D10A: Anti-acne preparations for topical use

— D10AD: Retinoids for topical use in acne

— D10AD03: Adapalene

— D10AD53: Adapalene, combinations

HCPCS

No data

Clinical

Clinical Trials

111 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	12	9	26	42	12	98
Warts	D014860	—	B07	1	—	—	1	—	2
Atrophy	D001284	—	—	—	1	—	1	—	2
Cicatrix	D002921	—	L90.5	—	—	—	1	—	1
Hypersensitivity	D006967	EFO_0003785	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
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	—	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	—	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
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

No data

Alternate

RARA

Organism

Homo sapiens

Gene name

RARA

Gene synonyms

NR1B1

NCBI Gene ID

5914

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

Q9NQS0

Mouse ortholog

Rara (19401)

retinoic acid receptor alpha (P11416)

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Adapalene

Total medical expenditures per year (USD, in millions)

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Adapalene

Benzoyl peroxide

Total medical expenditures per year (USD, in millions)

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Trends

PubMed Central

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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182,525 adverse events reported

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