benzoyl peroxide
Trade name: clearasil
Approved
Jun 1, 1930
Benzoyl peroxide (BPO) is an organic compound in the peroxide family. It consists of two benzoyl groups bridged by a peroxide link. It is one of the most important organic peroxides in terms of applications and the scale of its production. Benzoyl peroxide is used as an acne treatment, for bleaching hair and teeth. Adverse reactions are: dryness and urticarial reaction, contact dermatitis, application site burning, application site irritation and skin irritation. — NCATS
Clinical trial activity
134 trials · 99 clinical orgs · 25 marketing orgs
Earliest trial started Feb 1, 2004 (NCT00446043)
Timeline
1930s
- Jun 1, 1930
Evidence of US Marketing
- Jun 1, 1930
Earliest FDA Approval
1950s
- Jun 1, 1950
Richardson Vicks Inc — First NDA Organization
- Jun 1, 1950
Richardson Vicks Inc — NDA Organization
2000s
- Nov 27, 2000
Biofrontera Bioscience GmbH — NDA Secondary Org
- Dec 21, 2000
Bausch Health Companies — NDA Secondary Org
- Aug 26, 2002
Stiefel Laboratories — NDA Secondary Org
- Jan 1, 2004
- Mar 29, 2004
Tolmar Inc. — Marketing Organization
- Jan 1, 2008
Stiefel Laboratories — Earliest Phase 2 Sponsor(trial)
- Aug 11, 2009
Mylan — Marketing Organization
2010s
- Jan 1, 2010
Stiefel Laboratories — Earliest Phase 1 Sponsor(trial)
- Jun 26, 2012
Perrigo — Marketing Organization
- Jun 26, 2012
Padagis Us — Marketing Organization
- Jun 19, 2015
Actavis — Marketing Organization
- Jun 19, 2015
Allergan PLC (2015) — Marketing Organization
- Jul 15, 2015
Galderma — NDA Secondary Org
- Jul 15, 2015
Nestle — NDA Secondary Org
- Sep 18, 2015
Lyne Laboratories — Marketing Organization
- Sep 18, 2015
Rising Pharmaceuticals — Marketing Organization
- Aug 25, 2016
Chartwell Pharmaceuticals — Marketing Organization
- Dec 15, 2017
Sun Pharmaceuticals — Marketing Organization
- Jan 24, 2018
Taro Pharmaceuticals — Marketing Organization
- Dec 28, 2018
Zydus Discovery DMCC — Marketing Organization
- Aug 19, 2019
ANDA Repository — Marketing Organization
- Nov 8, 2019
Glenmark Pharmaceuticals — Marketing Organization
2020s
- Apr 12, 2021
AbbVie — Marketing Organization
- Apr 28, 2021
Encube Ethicals Pvt. Ltd. — Marketing Organization
- Jul 26, 2021
Sol-Gel Technologies, Ltd. — NDA Secondary Org
- Jul 26, 2021
Mayne Pharma — NDA Secondary Org
- Aug 4, 2022
Alembic — Marketing Organization
Indications
Approved for
Studied for
- Benzoyl Peroxide · Phase 4
- Foot Dermatoses · Phase 4
- General Surgery · Phase 3
- Healthy Volunteers · Phase 4
- Herpes Simplex · Phase 2
- Infections · Phase 4
- Keratosis, Actinic · Phase 2
- Molluscum Contagiosum · Phase 3
- Propionibacterium acnes · Phase 4
- Rosacea · Phase 3
- Skin Diseases · Phase 4
- Surgical Wound Infection · Phase 2
Mechanism of action
- Unspecified targetOTHER
Releases active oxygen
- UnclearUnclear
Unclear unclear
Combination products
benzaclin
with clindamycin
Also known as acanya, duac, onexton
benzamycin
with erythromycin
Also known as aktipak
cabtreo
with adapalene, clindamycin
epiduo
with adapalene
Also known as epiduo forte, epiduo® forte gel
twyneo
with tretinoin
Approval history
- approvedJun 1, 1930
- approvedJun 1, 1930
Chemistry & pharmacology
SMILES
O=C(OOC(=O)C1=CC=CC=C1)C2=CC=CC=C2- Mol. weight
- 242.2268 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- WikipediaBenzoyl peroxide ↗
- NCATSW9WZN9A0GM ↗
- ChEMBLCHEMBL1200688 ↗
- ChEMBLCHEMBL1200370 ↗
Also known as
- acetoxyl
- acetoxyl 2.5
- acetoxyl 5
- acne-aid cream
- acne-aid cream
- acnecide
- acnecide 10
- acnegel
- acnegel
- acnegel fte
- acnidazil
- adapalene mixture with benzoyl peroxide
- adapalene mixture with benzoyl peroxide
- arpimycin
- arpimycin
- arpimycin
- benoxyl
- benoxyl
- benoxyl
- benoxyl 10
- benoxyl 20
- benoxyl 5
- benzac
- benzac
- benzaclin
- benzaclin
- benzaclin
- benzac w
- benzac w
- benzagel 10
- benzagel 10
- benzagel 5
- benzamycin
- benzamycin
- benzamycin
- benzamycin
- benzoperoxide
- benzoyl benzenecarboperoxoate
- benzoyl benzenecarboperoxoate
- benzoyl peroxide
- benzoyl peroxide
- benzoyl peroxide
- benzoyl peroxide
- benzoyl peroxide
- benzoyl peroxide
- benzoyl peroxide
- benzoyl peroxide
- benzoyl peroxide
- benzoyl peroxide
- benzoyl peroxide, clindamycin drug combination
- benzoyl peroxide clindamycin phosphate combination
- benzoyl peroxide - erythromycin
- benzoyl peroxide, erythromycin drug combination
- benzoyl peroxide-erythromyxin mixt.
- benzoyl superoxide
- bepio
- bepio
- brevoxyl
- brevoxyl
- clearasil
- clearasil
- clearasil max 10
- clear by design
- clear by design
- clindamycin phosphate benzoyl peroxide combination
- clindoxyl
- clindoxyl gel
- dermoxyl
- dermoxyl
- diphenylglyoxal peroxide
- dorzolamide hydrochloride-timolol maleate combination
- dorzolamide-timolol combination
- dry and clear
- dry and clear
- dry clear
- duac gel
- e928
- e928
- epi-clear
- epi-clear
- fostex bpo bar, gel, and wash
- gi148512
- gppe lotio gel
- idp 120
- idp-120
- loroxide
- loroxide
- mediclear
- mediclear acne 10
- mediclear acne 5
- nericur
- nericur
- oxy-10
- oxy-10
- oxy-10 cover-up
- oxy-5
- oxy-5
- panoxyl
- panoxyl
- panoxyl 10
- panoxyl 10 acnegel
- panoxyl 10 aquagel
- panoxyl 2.5 aquagel
- panoxyl 5 acnegel
- panoxyl 5 aquagel
- panoxyl crm 5
- panoxyl lot 10
- panoxyl lot 5
- persa-gel
- persa-gel
- quinoderm 5
- quinoped
- s6g5t
- theraderm 10
- theraderm 5
- topex
- topex
- ultra clearasil
- valderma
- vanair
- vanoxide
- vanoxide
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07032649 | Phase 2 | Jan 1, 2026 | Erroll McCoy |
| NCT05676411 | Phase 4 | Jun 1, 2024 | University of Missouri |
| NCT05536882 | Phase 3 | Feb 28, 2023 | University of Oklahoma |
| NCT05582434 | Early Phase 1 (Phase 1) | Jan 31, 2023 | Bausch Health Companies, Wake Forest University |
| NCT05355844 | N/A | May 31, 2022 | Universidad Autonoma de Barcelona |
| NCT05629468 | Phase 3 | Oct 15, 2021 | Government of Pakistan, Riphah International University |
| NCT04892706 | Phase 2 | Jun 11, 2021 | Bausch Health Companies |
| NCT04548349 | Phase 4 | Oct 1, 2020 | Harvard University |
| NCT04300010 | Phase 4 | Jul 31, 2020 | University of Wisconsin |
| NCT05675501 | Phase 1 | Jun 10, 2020 | Sol-Gel Technologies, Ltd. |
| NCT04112407 | N/A | Oct 1, 2019 | Albany Medical College |
| NCT03949751 | N/A | Oct 1, 2019 | Balgrist Universitaets |
| NCT04028401 | Phase 3 | Sep 30, 2019 | University of Nantes |
| NCT04059523 | Phase 1 | Jun 27, 2019 | Sol-Gel Technologies, Ltd. |
| NCT04000347 | Phase 4 | Jun 26, 2019 | Mahidol University |
| NCT03832647 | Phase 4 | Feb 18, 2019 | Vichy Laboratoires |
| NCT03761784 | Phase 3 | Dec 31, 2018 | Sol-Gel Technologies, Ltd. |
| NCT03650881 | N/A | Dec 31, 2018 | New York University |
| NCT03761810 | Phase 3 | Dec 31, 2018 | Sol-Gel Technologies, Ltd. |
| NCT05096312 | Phase 4 | Dec 21, 2018 | East Avenue Medical Center, Philippines |
Organizations
Research & Development (99)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 24 | 9 | 4 | 2004 |
| Galderma | For profit | 23 | 22 | 3 | 2004 |
| Stiefel Laboratories | For profit | 15 | 15 | 4 | 2004 |
| Bausch Health Companies | For profit | 12 | 10 | 4 | 2009 |
| Sol-Gel Technologies, Ltd. | For profit | 9 | 9 | 3 | 2012 |
| Perrigo | For profit | 6 | 6 | 2 | 2007 |
| Taro Pharmaceuticals | For profit | 6 | 6 | 1 | 2012 |
| Wake Forest University | Academic/Hospital | 5 | 4 | 3 | 2006 |
| Catawba Clinical Research | For profit | 4 | 0 | 1 | 2012 |
| Actavis | For profit | 3 | 3 | 2 | 2011 |
| Henry Ford Health System | Academic/Hospital | 3 | 1 | 3 | 2008 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 3 | 3 | 2 | 2011 |
| Johnson and Johnson | For profit | 3 | 1 | 2 | 2009 |
| Pennsylvania State University | Academic/Hospital | 3 | 1 | 3 | 2008 |
| Allergan | For profit | 2 | 2 | 2 | 2005 |
| Cosmetique Active International | For profit | 2 | 2 | 1 | 2006 |
| Dow Pharmaceutical Sciences | For profit | 2 | 2 | 1 | 2006 |
| Northwestern University | Academic/Hospital | 2 | 2 | 1 | 2007 |
| Zurita Laboratorio Farmaceutico Ltda. | For profit | 2 | 2 | 2 | 2009 |
| Accelovance | For profit | 1 | 0 | 1 | 2016 |
Marketing (34)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Aug 19, 2019 |
| AbbVie | For profit | MKTG | Apr 12, 2021 |
| Actavis | For profit | MKTG | Jun 19, 2015 |
| Actavis | For profit | SYN | Sep 30, 2015 |
| Alembic | For profit | MKTG | Aug 4, 2022 |
| Alembic | For profit | SYN | Aug 4, 2022 |
| Allergan PLC (2015) | For profit | MKTG | Jun 19, 2015 |
| Bausch Health Companies | For profit | NDA2 | Dec 21, 2000 |
| Bausch Health Companies | For profit | SYN | Oct 26, 1984 |
| Biofrontera Bioscience GmbH | For profit | NDA2 | Nov 27, 2000 |
| Chartwell Pharmaceuticals | For profit | MKTG | Aug 25, 2016 |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | Apr 28, 2021 |
| Galderma | For profit | NDA2 | Jul 15, 2015 |
| Galderma | For profit | SYN | Dec 8, 2008 |
| Glenmark Pharmaceuticals | For profit | MKTG | Nov 8, 2019 |
| Glenmark Pharmaceuticals | For profit | SYN | Mar 14, 2019 |
| Glenmark Pharmaceuticals | For profit | SYN | Mar 14, 2019 |
| Lyne Laboratories | For profit | MKTG | Sep 18, 2015 |
| Mayne Pharma | For profit | NDA2 | Jul 26, 2021 |
| Mylan | For profit | MKTG | Aug 11, 2009 |
| Nestle | For profit | NDA2 | Jul 15, 2015 |
| Padagis Us | For profit | MKTG | Jun 26, 2012 |
| Perrigo | For profit | MKTG | Jun 26, 2012 |
| Perrigo | For profit | SYN | Sep 21, 2015 |
| Perrigo | For profit | SYN | Nov 25, 2019 |
| Richardson Vicks Inc | For profit | NDA | Jun 1, 1950 |
| Rising Pharmaceuticals | For profit | MKTG | Sep 18, 2015 |
| Sol-Gel Technologies, Ltd. | For profit | NDA2 | Jul 26, 2021 |
| Stiefel Laboratories | For profit | NDA2 | Aug 26, 2002 |
| Sun Pharmaceuticals | For profit | MKTG | Dec 15, 2017 |
| Taro Pharmaceuticals | For profit | MKTG | Jan 24, 2018 |
| Taro Pharmaceuticals | For profit | SYN | Dec 15, 2017 |
| Tolmar Inc. | For profit | MKTG | Mar 29, 2004 |
| Zydus Discovery DMCC | For profit | MKTG | Dec 28, 2018 |