Benzoyl peroxide
/ Benzoyl Peroxide, Acanya, Benzamycin, Benzoyl Peroxide /, Cabtreo, Duac, Epiduo, Epsolay, Onexton, Twyneo (benzoyl peroxide) is a small molecule pharmaceutical. Benzoyl peroxide was first approved as Benzamycin on 1984-10-26. It is used to treat acne vulgaris and rosacea in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Epsolay
CombinationsAdapalene benzoyl peroxide, Benzamycin, Cabtreo, Clindamycin benzoyl peroxide, Duac, Epiduo, Erythromycin benzoyl peroxide, Onexton, Twyneo (discontinued: Adapalene benzoyl peroxide, Aktipak, Benzaclin, Clindamycin benzoyl peroxide, Erythromycin benzoyl peroxide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Benzoyl peroxide
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Clindamycin phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACANYA | Bausch Health Companies | N-050819 RX | 2008-10-23 | 1 products, RLD, RS |
| ONEXTON | Bausch Health Companies | N-050819 RX | 2014-11-24 | 1 products, RLD, RS |
| DUAC | Stiefel Laboratories | N-050741 RX | 2002-08-26 | 1 products, RLD |
Show 1 discontinued
Benzoyl peroxide
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Erythromycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BENZAMYCIN | Bausch Health Companies | N-050557 RX | 1984-10-26 | 1 products, RLD, RS |
Show 1 discontinued
Adapalene
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Benzoyl peroxide
Benzoyl peroxide
Benzoyl peroxide
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Tretinoin
Adapalene
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Benzoyl peroxide
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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 |
|---|---|---|
| 10 acne med | C200263 | 2024-06-05 |
| 111 medco benzoyl peroxide | C200263 | 2023-12-12 |
| 2.5 acne med | C200263 | 2024-06-05 |
| 3 step acne system | OTC monograph final | 2018-02-22 |
| 30 day acne treatment kit | C200263 | 2024-11-04 |
| 5 acne med | C200263 | 2024-06-05 |
| 5 percent benzoyl peroxide cleanser | C200263 | 2023-11-10 |
| ab skincare acne spot treatment | OTC monograph final | 2018-09-27 |
| acanya | New Drug Application | 2020-09-30 |
| acne vanishing gel-10% | OTC monograph final | 2020-01-23 |
Show 347 more
Indications
FDA
EMA
Show 16 more
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BENZOYL PEROXIDE, EPSOLAY, GALDERMA LABS LP | |||
| 2025-04-22 | NP | ||
BENZOYL PEROXIDE / TRETINOIN, TWYNEO, GALDERMA LABS LP | |||
| 2024-07-26 | NC | ||
BENZOYL PEROXIDE / CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, ENCUBE | |||
| 2023-03-13 | CGT | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Benzoyl Peroxide, Epsolay, Galderma Labs Lp | |||
| 11628155 | 2040-12-27 | U-3356 | |
| 11426378 | 2040-08-18 | U-3356 | |
| 10933046 | 2040-02-19 | DP | U-3357 |
| 10945987 | 2040-02-19 | U-3356 | |
| 11541026 | 2040-02-19 | U-3356 | |
| 9687465 | 2032-11-27 | DP | U-3356 |
| 9868103 | 2028-08-08 | DP | U-3194, U-3356 |
| Benzoyl Peroxide / Tretinoin, Twyneo, Galderma Labs Lp | |||
| 10420743 | 2038-07-12 | U-3194 | |
| 10653899 | 2030-12-30 | DP | U-3194 |
| 11071878 | 2030-12-30 | DP | |
| 8617580 | 2028-02-03 | DP | |
| Benzoyl Peroxide / Clindamycin Phosphate, Acanya, Bausch | |||
| 8288434 | 2029-08-05 | DP | U-124, U-134, U-818, U-916, U-921, U-1033 |
| 8663699 | 2029-06-03 | U-124 | |
| 8895070 | 2029-06-03 | U-124 | |
| 9078870 | 2029-06-03 | DP | |
| 9504704 | 2029-06-03 | DP | U-124, U-134, U-818, U-916 |
| 9561208 | 2029-06-03 | DP | U-916 |
| 10137142 | 2029-06-03 | DP | U-916 |
| 10220049 | 2029-06-03 | DP | U-916 |
| 10624918 | 2029-06-03 | U-916 | |
| 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 | |
| 8445543 | 2027-07-12 | U-1078 | |
| 7820186 | 2025-11-23 | DP | |
| 7964202 | 2024-09-01 | DP | U-1078 |
| Adapalene / Benzoyl Peroxide, Epiduo Forte, Galderma Labs | |||
| 8703820 | 2023-03-12 | U-1078 | |
| 8729127 | 2023-03-12 | U-1078 | |
| 9381179 | 2023-03-12 | U-1078 | |
| 9387187 | 2023-03-12 | U-1078 | |
HCPCS
No data
Clinical
Clinical Trials
5577 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 6 | 4 | 6 | 11 | 152 | 178 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 13 | 7 | 14 | 17 | 127 | 174 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 17 | 14 | 39 | 59 | 41 | 165 |
| Syndrome | D013577 | — | — | 10 | 33 | 24 | 10 | 84 | 153 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 8 | 4 | 13 | 15 | 77 | 117 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 2 | 8 | 12 | 6 | 78 | 104 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 5 | 12 | 12 | 65 | 94 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 3 | 10 | 40 | 9 | 32 | 92 |
| Depression | D003863 | — | F33.9 | 6 | 2 | 8 | 2 | 75 | 91 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 3 | 9 | 4 | 6 | 69 | 88 |
Show 439 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exercise | D015444 | EFO_0000483 | — | — | 1 | 2 | — | 84 | 87 |
| Covid-19 | D000086382 | — | — | — | 10 | 9 | — | 46 | 64 |
| Infections | D007239 | EFO_0000544 | — | — | 11 | 9 | — | 26 | 45 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | 4 | 2 | — | 30 | 36 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 3 | 2 | 2 | — | 29 | 34 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 2 | — | 1 | — | 31 | 34 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 2 | 2 | 3 | — | 25 | 32 |
| Communicable diseases | D003141 | — | — | — | 7 | 5 | — | 18 | 30 |
| Lymphoma | D008223 | — | C85.9 | 6 | 20 | 5 | — | 3 | 30 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | 2 | 1 | — | 26 | 29 |
Show 288 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aging | D000375 | GO_0007568 | R41.81 | 3 | 3 | — | — | 38 | 44 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 2 | — | — | 32 | 36 |
| Neck pain | D019547 | HP_0030833 | M54.2 | — | 1 | — | — | 33 | 34 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 3 | 2 | — | — | 26 | 31 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 4 | 4 | — | — | 19 | 26 |
| Pediatric obesity | D063766 | — | — | — | 1 | — | — | 22 | 23 |
| Chronic disease | D002908 | — | — | — | 1 | — | — | 21 | 22 |
| Dental caries | D003731 | EFO_0003819 | K02 | — | 1 | — | — | 17 | 18 |
| Sleep wake disorders | D012893 | — | G47 | 3 | 1 | — | — | 12 | 16 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | 2 | 1 | — | — | 13 | 16 |
Show 284 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral palsy | D002547 | — | G80 | 3 | — | — | — | 25 | 28 |
| Sleep | D012890 | GO_0030431 | — | 3 | — | — | — | 18 | 21 |
| Problem behavior | D000066553 | — | — | 1 | — | — | — | 9 | 10 |
| Mental health | D008603 | EFO_0003935 | — | 1 | — | — | — | 8 | 9 |
| Oxygen inhalation therapy | D010102 | — | — | 1 | — | — | — | 8 | 9 |
| Respiration disorders | D012120 | — | J00-J99 | 1 | — | — | — | 7 | 8 |
| Laparoscopic cholecystectomy | D017081 | — | — | 1 | — | — | — | 6 | 7 |
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | 1 | — | — | — | 6 | 7 |
| Sleep deprivation | D012892 | — | F51.12 | 2 | — | — | — | 4 | 6 |
| Aortic aneurysm | D001014 | EFO_0001666 | I71.9 | 1 | — | — | — | 4 | 5 |
Show 48 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sedentary behavior | D057185 | — | — | — | — | — | — | 49 | 49 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 41 | 41 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 25 | 25 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 22 | 22 |
| Health behavior | D015438 | — | — | — | — | — | — | 20 | 20 |
| Emergencies | D004630 | — | — | — | — | — | — | 19 | 19 |
| Weight gain | D015430 | HP_0004324 | — | — | — | — | — | 15 | 15 |
| Hypercapnia | D006935 | — | — | — | — | — | — | 15 | 15 |
| Psychological stress | D013315 | — | — | — | — | — | — | 14 | 14 |
| Neurocognitive disorders | D019965 | — | F09 | — | — | — | — | 13 | 13 |
Show 917 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Benzoyl peroxide |
| INN | — |
| Description | Benzoyl peroxide is a carbonyl compound. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(OOC(=O)c1ccccc1)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 94-36-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200370 |
| ChEBI ID | 82405 |
| PubChem CID | 7187 |
| DrugBank | DB09096 |
| UNII ID | — |
Target
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Variants
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Estimated US medical usage
Benzoyl peroxide
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Adapalene
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Benzoyl peroxide
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Benzoyl peroxide
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Clindamycin
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Benzoyl peroxide
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Erythromycin
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Benzoyl peroxide
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Hydrocortisone
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Benzoyl peroxide
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Sulfur
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Trends
PubMed Central
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Safety
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Adverse Events
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3,414 adverse events reported
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