Acne-Clear

(Benzoyl Peroxide)

ApprovedSmall molecule

This medication is applied to the skin to treat mild to moderate acne. It works by reducing the bacteria and irritation that cause acne breakouts.[2] Acne-Clear is currently approved and in use across 2 indications[4].[1]

Acne-Clear is one of 56 small molecule programs targeting Surgery. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

SurgeryUnknown status

Total Hip ArthroplastyUnknown status

SurgeryPreclinical

Unknown status

Total Hip ArthroplastyApproved

Unknown status

Competition

Competitive Landscape

36 competitors in Surgery

#DrugCompanyPhaseTrials

Alfenta

Jazz Pharmaceuticals

Approved

1 2

Journavx

Vertex Pharmaceuticals

Approved

1 3

Neo-Synephrine

EExela Pharma Sciences, LLC.

Approved

3 4

Nubain

AAultman Health Foundation

Approved

2 5

Desferal

Jazz Pharmaceuticals

Phase 3

1 6

Marinol

Jazz Pharmaceuticals

Phase 3

1 7

Levophed

GGeneral Hospital of Ningxia Medical University

Phase 3

2 8

Acne-Clear

MMayne Pharma International Pty Ltd

Approved

1 9

Cardene

Sun Pharmaceutical Industries, Inc.

Phase 2

2 10

Tukysa

Pfizer

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Safety and Efficacy3 trials

A Clinical Trial Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

Completed·DDow Pharmaceutical Sciences·Phase 3·NCT00663286·1,399 enrolled

Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

Completed· GSK logo

GSK·Phase 2·NCT00713609·591 enrolled

A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

Completed·DDow Pharmaceutical Sciences·Phase 3·NCT00664248·1,414 enrolled

Acne Vulgaris3 trials

Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne

Completed·WWake Forest University·Phase 4·NCT00658112·20 enrolled

Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris

Completed·GGalderma R&D·Phase 4·NCT02589405·50 enrolled

Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris

Completed·NNorthwestern University·N/A·NCT00558831·11 enrolled

Treatment2 trials

2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne

Completed·—·N/A·NCT01472900·25 enrolled

Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne

Unknown status·MMarmara University·Phase 3·NCT00869492·90 enrolled

Efficacy and Safety2 trials

A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Completed·GGalderma R&D·Phase 3·NCT00421993·1,670 enrolled

Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Completed·GGalderma R&D·Phase 3·NCT00422240·1,668 enrolled

Acne1 trial

Benzoyl Peroxide and Electrocautery Skin Incision to Eradicate Cutibacterium Acnes

Withdrawn·UUniversity of Missouri-Columbia·Phase 4·NCT05676411

4 more indications

Total Hip Arthroplasty1 trial

Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

Unknown status·CColorado Joint Replacement·Phase 4·NCT03849885·496 enrolled

Skin Microbiome1 trial

Profiling the Skin Microbiome in Response to Altreno in Acne Patients

Completed·—·Phase 4·NCT04548349·25 enrolled

RCT1 trial

MC RCT - BPO vs Adapalene

Withdrawn·UUniversity of Oklahoma·Phase 3·NCT05536882

Surgery1 trial

Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery

Unknown status·—·N/A·NCT05355844·200 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 22, 2022

EPSOLAY

NDA NDA214510

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Benzoyl Peroxide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Acne-Clear drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Benzoyl Peroxide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Benzoyl Peroxide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214510). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Acne-Clear. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Mayne Pharma International Pty Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMayne Pharma International Pty Ltd

Patent Landscape[6]

Patent Cliff

Feb 3, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12350382Feb 3, 2028

12156946Feb 3, 2028

9868103Aug 8, 2028

9687465Nov 27, 2032

11877997Feb 19, 2040

8 more patents

10933046Feb 19, 2040

11865100Feb 19, 2040

11541026Feb 19, 2040

11986456Feb 19, 2040

10945987Feb 19, 2040

11426378Aug 18, 2040

12295935Dec 27, 2040

11628155Dec 27, 2040

Acne-Clear

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Safety and Efficacy3 trials

Acne Vulgaris3 trials

Treatment2 trials

Efficacy and Safety2 trials

Acne1 trial

Total Hip Arthroplasty1 trial

Skin Microbiome1 trial

RCT1 trial

Surgery1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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