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
CombinationsAcanya, Benzamycin, Duac, Epiduo, Onexton, Twyneo (generic drugs available since 2009-08-11, discontinued: Aktipak, Benzaclin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Adapalene
+
Benzoyl peroxide
Benzoyl peroxide
Benzoyl peroxide
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Clindamycin phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ONEXTON | Bausch Health Companies | N-050819 RX | 2014-11-24 | 1 products, RLD, RS |
| ACANYA | Bausch Health Companies | N-050819 RX | 2008-10-23 | 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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 10 acne med | C200263 | 2023-10-26 |
| 111 medco benzoyl peroxide | C200263 | 2023-12-12 |
| 2.5 acne med | C200263 | 2023-10-26 |
| 24 hour acne serum | OTC monograph final | 2019-06-07 |
| 3 step acne system | OTC monograph final | 2018-02-22 |
| 30 day acne treatment kit | OTC monograph final | 2023-08-23 |
| 5 acne med | C200263 | 2023-10-26 |
| 5 percent benzoyl peroxide cleanser | C200263 | 2023-11-10 |
| acanya | New Drug Application | 2020-09-30 |
| acne | OTC monograph final | 2023-01-12 |
Show 307 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| acne vulgaris | EFO_0003894 | D000152 | L70 |
| rosacea | — | D012393 | L71 |
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
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Clinical
Clinical Trials
5147 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 | 16 | 13 | 37 | 56 | 33 | 151 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 4 | 3 | 5 | 8 | 122 | 141 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 7 | 4 | 13 | 11 | 49 | 84 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | 1 | 6 | 5 | 2 | 51 | 65 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 6 | 7 | 2 | 46 | 59 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 2 | 8 | 8 | 40 | 58 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 7 | 4 | 1 | 39 | 52 |
| Anemia | D000740 | HP_0001903 | D64.9 | 1 | 12 | 34 | 3 | 2 | 52 |
| Anesthesia | D000758 | — | — | — | 1 | 2 | 11 | 37 | 51 |
| Heart failure | D006333 | HP_0001635 | I50 | 4 | 2 | 5 | 5 | 33 | 49 |
Show 272 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 | — | 65 | 68 |
| Covid-19 | D000086382 | — | U07.1 | — | 5 | 7 | — | 28 | 40 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 2 | 1 | 1 | — | 25 | 28 |
| Weight loss | D015431 | HP_0001824 | — | 1 | 1 | 2 | — | 20 | 23 |
| Myelodysplastic syndromes | D009190 | — | D46 | 5 | 13 | 3 | — | 2 | 22 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 1 | 3 | — | 16 | 19 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 3 | 11 | — | 5 | 18 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 1 | 2 | 3 | — | 12 | 18 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 2 | 3 | 7 | — | 3 | 15 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 10 | 3 | — | — | 15 |
Show 196 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 | 2 | 2 | — | — | 28 | 32 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 2 | — | — | 25 | 28 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 3 | 1 | — | — | 19 | 22 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | 1 | — | — | 21 | 22 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 2 | 2 | — | — | 13 | 17 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 4 | 3 | — | — | 9 | 15 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 3 | — | — | 9 | 12 |
| Graft vs host disease | D006086 | — | D89.81 | 3 | 7 | — | — | — | 9 |
| Dyspnea | D004417 | HP_0002094 | R06.0 | — | 1 | — | — | 8 | 9 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 3 | — | — | 5 | 8 |
Show 205 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep | D012890 | GO_0030431 | — | 2 | — | — | — | 17 | 19 |
| Cerebral palsy | D002547 | — | G80 | 3 | — | — | — | 15 | 18 |
| Frailty | D000073496 | — | R53.1 | 1 | — | — | — | 12 | 13 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 2 | — | — | — | 7 | 9 |
| Laparoscopic cholecystectomy | D017081 | — | — | 1 | — | — | — | 6 | 7 |
| Cocaine-related disorders | D019970 | — | F14 | 3 | — | — | — | 2 | 5 |
| Pain management | D059408 | — | — | 1 | — | — | — | 3 | 4 |
| Sleep wake disorders | D012893 | — | G47 | 1 | — | — | — | 2 | 3 |
| Hyperinsulinism | D006946 | HP_0000842 | E16.1 | 1 | — | — | — | 2 | 3 |
| Spinal stenosis | D013130 | EFO_0007490 | M48.0 | 1 | — | — | — | 2 | 3 |
Show 33 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 29 | 29 |
| Sedentary behavior | D057185 | — | — | — | — | — | — | 27 | 27 |
| Neck pain | D019547 | HP_0030833 | M54.2 | — | — | — | — | 20 | 20 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 18 | 18 |
| Health behavior | D015438 | — | — | — | — | — | — | 16 | 16 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 16 | 16 |
| Psychotic disorders | D011618 | — | F20.81 | — | — | — | — | 15 | 15 |
| Pediatric obesity | D063766 | — | — | — | — | — | — | 11 | 11 |
| Feeding behavior | D005247 | — | — | — | — | — | — | 9 | 9 |
| Disease progression | D018450 | — | — | — | — | — | — | 8 | 8 |
Show 665 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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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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PubMed Central
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Safety
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2,852 adverse events reported
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