Eskata

(Hydrogen Peroxide)

Small molecule

AAclaris Therapeutics, Inc.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q3 2028

Phase 2Active, not recruiting

Breast Cancer

NCT03946202

Clinical

Trials by Indication[1]

Breast Cancer2 trials

KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response

Completed·IInstitute of Cancer Research, United Kingdom·Phase 1/2·NCT02757651·12 enrolled

Randomised Phase II Trial Testing Efficacy of Intra-tumoural Hydrogen Peroxide as a Radiation Sensitiser in Patients With Locally Advanced/Recurrent Breast Cancer

Active, not recruiting·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT03946202·184 enrolled

Antibiotics1 trial

Effect of Antibiotics on Penile Microbiome and HIV Susceptibility Study in Ugandan Men

Unknown status·UUniversity of Toronto·N/A·NCT03412071·125 enrolled

Post-operative Endodontic Pain1 trial

Comparison of Post-Operative Endodontic Pain Using Sodium Hypochlorite, Hydrogen Peroxide, and Normal Saline as Root Canal Irrigants

Completed·—·N/A·NCT07486245·90 enrolled

Efficacy and Safety1 trial

Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE

Completed·JJDC Tech·Phase 3·NCT00978861·70 enrolled

Whitening1 trial

Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening

Completed·UUniversity of Campinas, Brazil·Phase 4·NCT03019224·4 enrolled

5 more indications

Acne Vulgaris1 trial

DMT310-001 Topical in the Treatment of Acne Vulgaris

Completed·DDermata Therapeutics·Phase 2·NCT03536637·121 enrolled

Infection1 trial

Clinical Investigation of Chemomechanical Parameters for an Efficient Disinfection of the Root Canal

Active, not recruiting·NNational and Kapodistrian University of Athens·N/A·NCT06949176·44 enrolled

Peri-Implantitis1 trial

Antiseptic Effects on the Dental Implant Internal Surface Microbiome

Completed·MMadigan Army Medical Center·Phase 1·NCT05024760·97 enrolled

Tonsillitis1 trial

Efficacy of Hydrogen Peroxide Versus Adrenaline for Intraoperative Hemostasis During Tonsillectomy. A Quasi-Experimental Study

Completed·RRawalpindi Medical College·Preclinical·NCT07675278·64 enrolled

Unspecified2 trials

Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model

Completed·UUniversity of Pennsylvania·Phase 1·NCT03678012·16 enrolled

Evaluation of Aerosol in a Dental Clinic

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT04659928·41 enrolled

Regulatory

FDA Approval Timeline[3]

Dec 14, 2017

ESKATA

NDA NDA209305

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Hydrogen Peroxide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Hydrogen Peroxide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA209305). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Eskata. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Aclaris Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: AAclaris Therapeutics, Inc.

Patent Landscape[4]

Patent Cliff

Apr 21, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10098910Apr 21, 2035

9980983Apr 21, 2035

10493103Apr 21, 2035

10729720Apr 21, 2035

9675639Jul 4, 2035