Drugs / Benzoyl Peroxide
Benzoyl Peroxide
also known as
BPO · E-BPO · Benzoylperoxid · Acetoxyl 2.5 · Acetoxyl 5 · Acnecide · Acnecide 10 · Acnegel · +62 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BENZAMYCIN | — | 1984-10-26 | fda.gov ↗ |
Trials 77 · started per year
today
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT06673641 | May → Sep 2024 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05675501 | Jun 2020 → Jul 2021 | rosacea | Sol-Gel Technologies, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02709902 | Sep 2015 → Feb 2016 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02578043 | Apr → Aug 2015 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01769235 | Nov 2012 → Sep 2013 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01742637 | Oct 2012 → Feb 2014 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01769664 | Sep 2012 → Jun 2013 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01132443 | May → Jun 2010 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03076320 | Mar 2017 → Jan 2019 | acne | University of Guadalajara | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07032649 | Jan 2026 → Jan 2027 expected | — | Greg Bew | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04892706 | Jun 2021 → Sep 2022 | acne | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03257202 | Sep 2017 → Jan 2018 | — | University of Southern California | Completed | No outcome recorded |
| Phase 2 | NCT03122457 | Jan 2017 → Jul 2018 | actinic keratosis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 2 | NCT00713609 | Jun 2008 → Mar 2009 | acne | Stiefel, a GSK Company | Completed | Mixed |
| Phase 324 trials · 4 met primary | ||||||
| Phase 3 | NCT05536882 | May 2022 → Oct 2023 | molluscum contagiosum | University of Oklahoma | Withdrawn | No outcome recorded |
| Phase 3 | NCT04028401 | Jun 2020 → Jun 2029 expected | skin infection | Nantes University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT03761784 | Dec 2018 → Dec 2019 | acne | Sol-Gel Technologies, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03564145 | Sep 2018 → Nov 2019 | rosacea | Sol-Gel Technologies, Ltd. | Terminated | No outcome recorded |
| Phase 3 | NCT03448939 | Jun 2018 → May 2019 | rosacea | Sol-Gel Technologies, Ltd. | Completed | Met primary |
| Phase 3 | NCT02932267 | Feb 2017 → Jan 2018 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT02651220 | Nov 2015 → Apr 2016 | acne | Actavis Inc. | Completed | Met primary |
| Phase 3 | NCT02515305 | Jul 2015 → Apr 2016 | acne | Padagis LLC | Completed | No outcome recorded |
| Phase 3 | NCT02465632 | Apr → Nov 2015 | acne | Glenmark Pharmaceuticals Ltd. India | Completed | No outcome recorded |
| Phase 3 | NCT02005666 | Nov 2013 → Sep 2016 | acne | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Phase 3 | NCT01910064 | May 2013 → Aug 2014 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT01788384 | Jul → Dec 2012 | acne | Watson Laboratories, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01796665 | Feb 2012 → Feb 2013 | acne | Padagis LLC | Completed | No outcome recorded |
| Phase 3 | NCT01474590 | Nov 2011 → Jul 2013 | acne | Galderma R&D | Completed | Met primary |
| Phase 3 | NCT01445301 | Sep 2011 → Aug 2012 | acne | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00891982 | Apr → Jun 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 3 | NCT00687908 | Nov 2008 → Jul 2009 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00776919 | Oct 2008 → Sep 2009 | acne | Stiefel, a GSK Company | Completed | Mixed |
| Phase 3 | NCT00688064 | Aug 2008 → Feb 2009 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00869492 | Aug 2008 → Jun 2009 | acne | Marmara University | Unknown | No outcome recorded |
| Phase 3 | NCT00441415 | Feb → Oct 2007 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00422240 | Jun 2006 → Jul 2007 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00151541 | Feb → Jul 2005 | acne | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT00446043 | Feb 2004 → May 2005 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 432 trials · 5 met primary · 2 missed | ||||||
| Phase 4 | NCT05676411 | Jun 2024 → Jul 2025 | periprosthetic joint infection | University of Missouri-Columbia | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT06336629 | Nov 2023 → Jul 2024 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT05446402 | Jun 2022 → May 2023 | acne | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT04548349 | Apr 2021 → Aug 2022 | acne | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03849885 | Feb 2019 → Dec 2023 | osteoarthritis | Colorado Joint Replacement | Unknown | No outcome recorded |
| Phase 4 | NCT04021524 | Sep 2018 → May 2019 | acne | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT03563365 | Jun 2018 → Mar 2021 | acne | Yardley Dermatology Associates | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02899000 | Jul 2016 → Mar 2017 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT02735421 | May 2016 → Jun 2017 | acne | Galderma R&D | Completed | Met primary |
| Phase 4 | NCT02557399 | Oct → Dec 2015 | acne | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT02589405 | Aug 2015 → Jan 2016 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT02058628 | Feb → Sep 2014 | acne | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT02052752 | Feb → May 2014 | skin disorder | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT01951417 | Oct 2013 → Mar 2014 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT01504204 | Dec 2011 → Nov 2012 | acne | Wake Forest University | Completed | No outcome recorded |
| Phase 4 | NCT01448733 | Jul → Oct 2011 | acne | Zeichner, Joshua, M.D. | Unknown | No outcome recorded |
| Phase 4 | NCT01260571 | Jan → Mar 2011 | — | Zurita Laboratorio Farmaceutico Ltda. | Unknown | No outcome recorded |
| Phase 4 | NCT01209949 | Oct 2010 → Jan 2011 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT01206348 | Sep 2010 → Jul 2011 | acne | Medicis Global Service Corporation | Completed | No outcome recorded |
| Phase 4 | NCT01149330 | Jul 2010 → Mar 2011 | acne | Galderma Brasil Ltda. | Completed | No outcome recorded |
| Phase 4 | NCT01706263 | Aug → Nov 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00964366 | Jul → Aug 2009 | acne | Stiefel, a GSK Company | Completed | Missed primary |
| Phase 4 | NCT00952523 | Jul → Oct 2009 | acne | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00907101 | Jun → Jul 2009 | — | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00919191 | Apr → May 2009 | acne | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00907257 | Feb → Sep 2009 | acne | Bausch Health Americas, Inc. | Completed | Met primary |
| Phase 4 | NCT00671749 | Dec 2007 → Aug 2008 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00841776 | Aug 2007 → Nov 2008 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00807014 | Nov 2006 → Aug 2008 | acne | Stiefel, a GSK Company | Completed | Met primary |
| Phase 4 | NCT00658112 | Jul 2006 → May 2008 | acne | Wake Forest University | Completed | No outcome recorded |
| Phase 4 | NCT00377000 | Nov 2005 → Mar 2006 | acne | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00160394 | Dec 2004 → Aug 2005 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT05355844 | May 2022 → May 2023 | rotator cuff syndrome, spondylosis | Hospital del Mar | Unknown | No outcome recorded |
| — | NCT05855629 | Feb 2022 → Jun 2023 | acne | Treatment and Diagnostic Center of Private Enterprise "Asklepiy" | Unknown | No outcome recorded |
| — | NCT03949751 | Nov 2018 → Apr 2020 | — | Balgrist University Hospital | Completed | No outcome recorded |
| — | NCT03573115 | Jan → Jul 2018 | acne | Merete Haedersdal | Completed | No outcome recorded |
| — | NCT02219776 | Sep 2015 → Jun 2021 | infectious disease | McLaren Health Care | Completed | No outcome recorded |
| — | NCT02510144 | Aug 2015 → Jul 2018 | — | University of Maryland, Baltimore | Completed | Mixed |
| — | NCT00787943 | May 2008 → Jan 2009 | acne | Northwestern University | Completed | No outcome recorded |
| Comparator or background therapy40 trials | ||||||
| Phase 1 | NCT04206631 Comparator | Apr → Sep 2015 | acne | Indonesia University | Completed | No outcome recorded |
| Phase 1 | NCT02595034 Comparator | Jan → Oct 2015 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01428466 Comparator | Nov 2010 → Feb 2011 | acne | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01106807 Comparator | Apr → Sep 2010 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT01880320 Comparator | Jul 2013 → Mar 2014 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT01915732 Comparator | Apr 2013 → Apr 2014 | acne | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01138514 Comparator | Oct 2009 → Oct 2010 | acne | Padagis LLC | Completed | No outcome recorded |
| Phase 3 | NCT01014689 Comparator | Aug 2009 → Apr 2010 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00883233 Comparator | Apr → Sep 2009 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00877409 Comparator | Apr → Jul 2009 | acne | Zurita Laboratorio Farmaceutico Ltda. | Unknown | No outcome recorded |
| Phase 3 | NCT00664248 Comparator | Oct 2006 → Aug 2007 | acne | Dow Pharmaceutical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00663286 Comparator | Oct 2006 → Aug 2007 | acne | Dow Pharmaceutical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00421993 Comparator | Oct 2006 → Oct 2007 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT02716090 Background | ? → Nov 2015 | acne | Ache Laboratorios Farmaceuticos S.A. | Withdrawn | No outcome recorded |
| Phase 4 | NCT04300010 Comparator | Oct 2020 → Jan 2021 | acne | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 4 | NCT04000347 Comparator | Jun 2019 → Apr 2022 | — | Mahidol University | Withdrawn | No outcome recorded |
| Phase 4 | NCT03832647 Background | Feb 2019 → Feb 2020 | acne | Vichy Laboratoires | Completed | No outcome recorded |
| Phase 4 | NCT05096312 Comparator | Dec 2018 → Jul 2019 | acne | East Avenue Medical Center, Philippines | Completed | No outcome recorded |
| Phase 4 | NCT02731105 Comparator | Feb 2015 → Feb 2017 | acne | GWT-TUD GmbH | Completed | No outcome recorded |
| Phase 4 | NCT01522456 Comparator | Apr → May 2012 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT01422785 Comparator | Jul → Dec 2011 | acne | Zeichner, Joshua, M.D. | Unknown | No outcome recorded |
| Phase 4 | NCT01231334 Comparator | Aug 2010 → Jun 2011 | acne | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01138735 Comparator | Jun 2010 → Aug 2011 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT01188538 Comparator | Mar → Aug 2010 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT01015638 Comparator | Aug → Sep 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00964223 Background | Jul → Nov 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00926367 Comparator | May → Jun 2009 | acne | Stiefel, a GSK Company | Completed | Missed primary |
| Phase 4 | NCT00887484 Background | Feb → Jun 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00837213 Comparator | Aug 2007 → Aug 2008 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| — | NCT07805655 Comparator | Sep → Dec 2026 expected | acne | Jeisys Medical Inc | Recruiting | No outcome recorded |
| — | NCT03650881 Comparator | Aug 2018 → Feb 2020 | acne | NYU Langone Health | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT02698436 Comparator | Mar → Aug 2016 | acne | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| — | NCT01818167 Comparator | Jan 2013 → Dec 2014 | hidradenitis suppurativa | Henry Ford Health System | Completed | No outcome recorded |
| — | NCT01472900 Comparator | Oct 2010 → Apr 2012 | acne | Chulalongkorn University | Completed | No outcome recorded |
| — | NCT01237821 Comparator | Oct 2010 → Aug 2011 | acne | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| — | NCT01176955 Background | May 2009 → Aug 2010 | acne | Wake Forest University | Completed | No outcome recorded |
| — | NCT01052246 Comparator | Oct 2008 → Jun 2009 | acne | Laserklinik Karlsruhe | Completed | No outcome recorded |
| — | NCT01044264 Comparator | Dec 2007 → Sep 2008 | acne | Padagis LLC | Completed | No outcome recorded |
| — | NCT00558831 Comparator | Oct 2007 → Jan 2008 | acne | Northwestern University | Completed | No outcome recorded |
| — | NCT00624676 Comparator | Jan → Aug 2006 | acne | Cosmetique Active International | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-05-22 | Galderma R&D | Regulatory Galderma receives U.S. FDA approval for Differin® Epiduo® Acne Gel Prescription-to-OTC switch galderma.com ↗
Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter |
| 2024-03-06 | AbbVie | Results AbbVie and Allergan Aesthetics to Present New Data at 2024 Annual AAD Meeting Showcasing Depth and Strength Across Dermatology and Aesthetics Portfolios abbvie.com ↗
Comparable Efficacy and Less Dryness With a Novel Cosmetic Regimen When Compared to a Topical Drug Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% in Subjects With Mild to Moderate Facial Acne |
| 2024-02-28 | Galderma R&D | Results AAD 2024: scientific presentations supported by Galderma galderma.com ↗
Treatment with encapsulated benzoyl peroxide leads to a durable shift in the microbiome in rosacea |
| 2023-03-17 | Galderma R&D | Results AAD 2023: Extensive updates from Galderma’s broad and innovative portfolio through posters and presentation sessions galderma.com ↗
Micrencapsulated benzoyl peroxide 5% is well accepted by patients with rosacea: patient-reported outcomes and results from two phase 3 randomized vehicle-controlled trials |
| 2022-08-01 | Alembic Pharmaceuticals Ltd. | Regulatory 81h August, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals announces its wholly owned subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. |
| 2022-06-07 | Zydus Lifesciences Limited | Regulatory Zydus Lifesciences receives final approval from USFDA for Adapalene and Benzoyl Peroxide Topical Gel zyduslife.com ↗ |
| 2022-04-25 | Galderma R&D | Regulatory Sol-Gel Technologies and Galderma Announce FDA Approval of EPSOLAY® galderma.com ↗
Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, announced today the Food and Drug Administration (FDA) approval of its drug product, EPSOLAY®, a proprietary cream formulation of benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults. |
| 2021-10-08 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives tentative approval from USFDA for Adapalene and Benzoyl Peroxide Gel zyduslife.com ↗
Zydus Cadila has received tentative approval from the USFDA to market Adapalene and Benzoyl Peroxide Gel 0.3%/2.5%. |
| 2021-07-27 | Galderma R&D | Regulatory Sol-Gel Technologies Announces FDA Approval of TWYNEO® galderma.com ↗
TWYNEO®, a once-daily cream treatment for acne vulgaris, is the first FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide |
| 2019-11-11 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Adapalene and Benzoyl Peroxide Gel, 0.1%|2.5% glenmarkpharma.com ↗ |
| 2019-03-15 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Clindamycin and Benzoyl Peroxide Gel, 1%|5% glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin and Benzoyl Peroxide Gel, 1%|5%, a generic version of BenzaClin®1 Gel, 1%|5%, of Valeant Bermuda. |
| 2018-12-29 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Clindamycin Phosphate and Benzoyl Peroxide Gel zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Clindamycin Phosphate and Benzoyl Peroxide Gel, (US RLD – DUAC® Gel), 1.2%/ 5%. |
| 2018-05-07 | Galderma R&D | Results Galderma Announces Results of ALAMO: A Real-World, Phase 4 Study Demonstrating Efficacy and Safety of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% Plus Oral Doxycycline 200 mg in Treating Severe Inflammatory Acne galderma.com ↗
In this study, the primary efficacy endpoint of reduction in number of inflammatory lesions at the end of the 12-week treatment period was met. |
| 2018-04-30 | Galderma R&D | Results New Phase 4 OSCAR Trial Data Showed that Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% Decreased Acne Lesions Therefore Reducing the Risk of Scars in Moderate-to-Severe Acne Patients galderma.com ↗
Results demonstrated Epiduo Forte Gel significantly decreased acne lesions, as measured over a period of 24 weeks vs. vehicle (P < .0001), with acne lesion reduction as early as week one. |
| 2018-01-24 | Perrigo Company | Regulatory Perrigo Announces Final FDA Approval And Launch Of An AB Rated Generic Version Of Epiduo® Gel perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration and has launched an AB rated generic version of Epiduo ® (adapalene and benzoyl peroxide) Gel, 0.1%/2.5%. |
| 2017-07-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Launch of Generic Epiduo® in the United States tevapharm.com ↗ |
| 2016-09-27 | Galderma R&D | Regulatory Galderma receives Positive Opinion through European Decentralised Procedure for Approval of EPIDUO® 0.3% / 2.5% gel for Acne Patient galderma.com ↗
it has received a Positive Opinion from 16 concerned European regulatory agencies for the market approval of EPIDUO 0.3% / 2.5% gel |
| 2016-09-01 | Perrigo Company | Regulatory Perrigo Announces Tentative FDA Approval For Generic Version Of Epiduo® Gel perrigo.com ↗
Perrigo Company plc (NYSE: PRGO; TASE) today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Epiduo® Gel (adapalene and benzoyl peroxide 0.1%/2.5%). |
| 2016-07-05 | Galderma R&D | Regulatory Galderma’s Epiduo Gel approved for the treatment of acne in Japan galderma.com ↗
Galderma, Nestlé Skin Health’s medical solutions business, today announced that Japan’s Ministry of Health, Labor and Welfare has approved Epiduo, a novel topical treatment for acne vulgaris in Japan. |
| 2015-03-26 | GlaxoSmithKline | Regulatory GSK receives approval for Encruse® Ellipta® in Japan for the treatment of COPD gsk.com ↗
The MHLW also today announced the approval of Duac® Combination Gel in Japan, for use in the treatment of acne vulgaris. |
All press releases naming this drug 28 releases
Evidence & citations 74 cited values
Every value below carries the sentence it was read from. 126 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Benzoyl Peroxide | “METHODS: This 16-week, two-center, investigator-blinded, randomized, parallel-group study evaluated the antimicrobial efficacy of clindamycin phosphate 1%/benzoyl peroxide 5%...” PMID 20214175 ↗ Feb 2010115“Participants with moderate and severe acne will be treated once a day (at night) on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area...” NCT03076320 ↗ “OBJECTIVE: The aim of this study was to compare the efficacy and safety of clindamycin (1%) and benzoyl peroxide (5%) (CDP/BPO) gel once daily vs. clindamycin (1%) (CDP)...” PMID 27075705 ↗ Apr 2016 “Objective: Evaluate subject-reported outcomes after treatment with adapalene 0.3%/ benzoyl peroxide 2.5% gel (0.3% A/BPO) in subjects with SOC and moderate to severe acne vulgaris.” PMID 31251543 ↗ Jun 2019 “Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2.” NCT02735421 ↗ “Clindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) is the only triple-combination topical approved for acne.” PMID 40377868 ↗ May 2025 “Benzoyl peroxide has antimicrobial and anti inflammatory properties and is often considered an important component of acne treatment.” NCT01706263 ↗ “gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily” NCT00160394 ↗ “Evaluation of Efficacy and Safety of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris” NCT01149330 ↗ “A new formulation of benzoyl peroxide (E-BPO cream, 5%) entraps benzoyl peroxide (BPO) in silica microcapsules.” PMID 37636253 ↗ Aug 2023 “Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets” NCT00688064 ↗ |
| Known as | Acetoxyl 2.5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Acetoxyl 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Acnecide | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Acnecide 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Acnegel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Acnegel fte | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Acnidazil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Anhydrous benzoyl peroxide | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benoxyl 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benoxyl 20 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benoxyl 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzagel 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzagel 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzamycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of acanya | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of aktipak | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of benzaclin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of benzamycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of cabtreo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of duac | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of epiduo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of idp-126 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of onexton | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoyl peroxide component of twyneo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | benzoyl peroxide gel 4% | “Dapsone Topical Gel + benzoyl peroxide gel 4%” NCT00151541 ↗ |
| Known as | Benzoyl superoxide | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoylis peroxidum cum aqua | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Benzoylperoxid | “The study specific intervention product is a combination of Benzoylperoxid and Miconazolnitrat (Widmer Acne Crème Plus, 47033 Swissmedic) to apply daily in the evening on the skin” NCT03949751 ↗1“Adapalen 0,1% and Benzoylperoxid 2,5%” NCT02731105 ↗ |
| Known as | BPO | “The purpose of this study was to compare the efficacy of blue light therapy (BLT) and 5% topical benzoyl peroxide (BPO) gel in combination with standard chlorhexidine (CHX)...” PMID 34478863 ↗ Aug 202115“OBJECTIVE: The aim of this study was to compare the efficacy and safety of clindamycin (1%) and benzoyl peroxide (5%) (CDP/BPO) gel once daily vs. clindamycin (1%) (CDP)...” PMID 27075705 ↗ Apr 2016 “Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2.” NCT02735421 ↗ “BACKGROUND: Skin care products (cleansers and moisturizers) to complement benzoyl peroxide (BPO) in the treatment of acne may improve treatment tolerability and adherence.” PMID 28678647 ↗ Jul 2017 “The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.” NCT01706263 ↗ “Clindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) is the only triple-combination topical approved for acne.” PMID 40377868 ↗ May 2025 “A fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% recently has been developed for the treatment of acne vulgaris.” PMID 19746769 ↗ Aug 2009 “Topical tretinoin and benzoyl peroxide (BPO) are often prescribed in combination for the treatment of acne vulgaris” PMID 20677537 ↗ Jul 2010 “Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets” NCT00688064 ↗ “Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules” NCT01014689 ↗ “GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO” NCT01910064 ↗ |
| Known as | Brevoxyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Brevoxyl-4 | “A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)” NCT02510144 ↗ |
| Known as | Brevoxyl-8 | “A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)” NCT02510144 ↗ |
| Known as | Clearasil max 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Dermoxyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Dry clear | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | E-928 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | E-BPO | “A new formulation of benzoyl peroxide (E-BPO cream, 5%) entraps benzoyl peroxide (BPO) in silica microcapsules.” PMID 37636253 ↗ Aug 20232“Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)” NCT03761784 ↗ “once-daily topical microencapsulated benzoyl peroxide (E-BPO) compared to vehicle cream” PMID 39148964 ↗ Aug 2024 |
| Known as | Encapsulated benzoyl peroxide (E-BPO) cream | “Encapsulated benzoyl peroxide (E-BPO) cream” NCT03448939 ↗ |
| Known as | Epsolay | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Gppe lotio gel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Hydrous benzoyl peroxide | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Ins no.928 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Ins-928 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Mediclear | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Mediclear acne 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Mediclear acne 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Nericur | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | NSC-671 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | NSC-675 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Oxy-10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Oxy-10 cover-up | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Oxy-5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Panoxyl 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Panoxyl 10 acnegel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Panoxyl 10 aquagel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Panoxyl 2.5 aquagel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Panoxyl 5 acnegel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Panoxyl 5 aquagel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Panoxyl crm 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Panoxyl lot 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Panoxyl lot 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Quinoderm 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Quinoped | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Theraderm 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Theraderm 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Topex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Ultra clearasil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Valderma | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Known as | Vanair | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200370 ↗ |
| Action | Inhibit | “the fixed-dose combination gel containing adapalene 0.1% and benzoyl peroxide 2.5% effectively inhibited both antibiotic-susceptible and antibiotic-resistant Propionibacterium acnes.” PMID 21607190 ↗ May 2011 |
| Modality | Other / unclassified | “and an antimicrobial (benzoyl peroxide 2.5%)” PMID 21607190 ↗ May 2011 |
| Route | Topical | “Dapsone Topical Gel + benzoyl peroxide gel 4%” NCT00151541 ↗ |