CLINICAL TRIALS PROFILE FOR HYDROGEN PEROXIDE

505(b)(2) Clinical Trials for hydrogen peroxide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT07356271 ↗	Effects of Mouthwashes on the Oral Microbiome and Systemic Health	NOT_YET_RECRUITING	University of Plymouth	EARLY_PHASE1	2026-02-01	OVERVIEW While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies (Bescos et al 2025, Gallard et al 2025) suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis). Most findings on the oral microbiome and mouthwashes involve chlorhexidine use, demonstrating that it may induce dysbiosis and compromise the host oral microenvironment (Bescos et al 2020). A recent study completed in 2025 (Gallardo et al 2025) has shown that CPC mouthwash can also inhibit nitrate synthesis in the mouth. However there remains a need for further research on other agents used in mouthrinses, such as hydrogen peroxide, essential oils, or saline mouthwashes, to determine whether their clinical effectiveness in managing oral disease is accompanied by changes to the oral microbiome. In dentistry, despite this being the place where most people are treated, there are very few research studies that have been performed in primary care settings. Hence this study will be designed for delivery in primary care, to produce 'real-life' data on a patient cohort more typical of general dental practice. This PhD project will select several of the most commonly used over the counter (OTC) mouthwash constituents, used by the general public, that have a limited evidence base, regarding their effects on the oral microbiome in vivo. The first agent to be studied is physiological saline (sodium chloride), as this is the mouthwash advised by dental guidelines for use after tooth extractions, yet there is little evidence to support this approach. No previous studies have previously quantified its effects on clinical outcomes and the oral microbiome. All mouthwashes will be tested in people with, or without, gum disease (gingivitis and periodontitis) to determine which interventions are best used in either health or disease.

All Clinical Trials for hydrogen peroxide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00154635 ↗	Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease	Unknown status	Development Center for Biotechnology, Taiwan	Phase 2	2005-09-01	A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimer's Disease. Because of the limitation of the sample size we could expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We also should be able to obtain valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti.
NCT00154635 ↗	Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease	Unknown status	Program Office, National Science & Technology, Biotechnology & Pharmaceuticals	Phase 2	2005-09-01	A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimer's Disease. Because of the limitation of the sample size we could expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We also should be able to obtain valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti.
NCT00154635 ↗	Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease	Unknown status	Taipei Veterans General Hospital, Taiwan	Phase 2	2005-09-01	A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimer's Disease. Because of the limitation of the sample size we could expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We also should be able to obtain valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti.
NCT00154635 ↗	Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease	Unknown status	National Taiwan University Hospital	Phase 2	2005-09-01	A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimer's Disease. Because of the limitation of the sample size we could expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We also should be able to obtain valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti.
NCT00193908 ↗	Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream	Completed	3M	Phase 3	2004-03-01	This study has patients using two different moisturising creams during radiation therapy after mastectomy. These are Cavilon and sorbolene. It is hypothesised that skin reactions may be reduced by the Cavilon cream compared to sorbolene.

Clinical Trial Conditions for hydrogen peroxide

Condition Name

Condition Name for hydrogen peroxide
Intervention	Trials
Covid-19	6
Tooth Discoloration	6
Covid19	4
Tooth Sensitivity	4

Condition MeSH

Condition MeSH for hydrogen peroxide
Intervention	Trials
COVID-19	10
Dentin Sensitivity	10
Tooth Discoloration	8
Hypersensitivity	7

Clinical Trial Locations for hydrogen peroxide

Trials by Country

Trials by Country for hydrogen peroxide
Location	Trials
United States	50
Brazil	11
Egypt	10
United Kingdom	6
Australia	5

Trials by US State

Trials by US State for hydrogen peroxide
Location	Trials
California	8
Texas	5
Tennessee	4
New York	4
Maryland	3

Clinical Trial Progress for hydrogen peroxide

Clinical Trial Phase

Clinical Trial Phase for hydrogen peroxide
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	3
PHASE2	1

Clinical Trial Status

Clinical Trial Status for hydrogen peroxide
Clinical Trial Phase	Trials
Completed	54
Not yet recruiting	19
Recruiting	17

Clinical Trial Sponsors for hydrogen peroxide

Sponsor Name

Sponsor Name for hydrogen peroxide
Sponsor	Trials
Colgate Palmolive	4
Ain Shams University	3
Emphycorp	3

Sponsor Type

Sponsor Type for hydrogen peroxide
Sponsor	Trials
Other	136
Industry	24
U.S. Fed	2

Hydrogen Peroxide drug patent, clinical trials update, FDA status and market projections (2025-2035)

Last updated: July 28, 2026

Hydrogen peroxide is not a single, FDA-approved “drug” with a unified commercial pipeline. In the U.S., marketed products are primarily topical solutions and otologic (ear) products using hydrogen peroxide (H2O2) at defined strengths, with labeling tied to indications such as wound care, cleansing, and select ENT uses. Pipeline activity is fragmented across fixed formulations, controlled-release delivery, and combination regimens rather than a single systemic “hydrogen peroxide” drug development program. As a result, a defensible clinical trials update and market projection requires an unambiguous product anchor (strength, dosage form, and sponsor) and a defined regulatory status (FDA NDA/ANDA/BLA and Orange Book/Biosimilar listing), which is not provided here.

What clinical trials are ongoing for hydrogen peroxide (H2O2) and what endpoints matter?
No complete, product-specific trial registry update can be produced from the information provided. Hydrogen peroxide has multiple development lanes that are not comparable at trial level without the specific formulation and indication, including:

Which indications drive hydrogen peroxide trials?

Common research categories in hydrogen-peroxide delivery include:

• Chronic wound cleansing and infection control (topical)
• ENT debridement or antisepsis (otologic)
• Dental/periodontal antisepsis (local)
• Adjunct therapies for tissue repair (topical or local)
• Controlled-release antimicrobial or oxidative-stress modulation platforms

What trial endpoints are typically used?

Endpoints vary by indication but usually include:

• Time to wound healing or proportion healed at a fixed day
• Bacterial load reduction or culture conversion
• Debridement success and need for repeat procedures
• Pain scores, tolerability, and local irritation/irritancy grading
• Safety endpoints: hypersensitivity, mucosal injury, and systemic oxidative markers (when relevant)

Why trials are hard to aggregate across “hydrogen peroxide”

Clinical outcomes depend on:

• Concentration (e.g., 3% vs higher-strength aqueous solutions)
• Vehicle and pH
• Contact time and frequency
• Delivery format (solution vs gel/cream vs foam)
• Combination with other antiseptics/agents
• Indication definition and standard-of-care comparator

What is the FDA regulatory status of hydrogen peroxide products and what is the Orange Book status?
No product-specific Orange Book status can be determined without the exact dosage form and sponsor-labeled product. Hydrogen peroxide products may appear as:

• Listed drugs with specific strengths/labeling (topical/otologic)
• OTC products (not in the Orange Book)
• Compounded-market use (not captured as single “drug” IP/regulatory units)

Is hydrogen peroxide regulated as an NDA, ANDA, or OTC?

Hydrogen peroxide’s regulatory treatment depends on:

• Whether the product is approved under an application (NDA/ANDA) versus marketed OTC
• Whether there is a New Drug Application tied to the exact marketed strength and dosage form

What does “Orange Book status” mean in this context?

Orange Book coverage applies to FDA-approved active ingredients with application-based listings (NDA/ANDA). For a generic-entry analysis, the key is the exact listed drug name, dosage form, and strength. That anchor is not provided.

Which patents protect hydrogen peroxide formulations, delivery methods, and use cases?
A patent landscape cannot be mapped to a defensible set of listed patents without a specific marketed product or a named development program. “Hydrogen peroxide” as an active ingredient appears in many compositions, but patent protection usually tracks:

• Specific formulations (concentration ranges, stabilizers, gelling agents, pH control)
• Delivery technologies (controlled release, encapsulation, foams, applicators)
• Method-of-use claims tied to clinical protocols
• Manufacturing processes controlling decomposition products and shelf stability

How does patent scope differ by dosage form?

• Topical solutions: formulation stability, stabilizers, container/packaging, shelf-life claims
• Gels/creams/foams: polymer matrix and release kinetics
• Otologic products: vehicle plus administration protocol
• Combination products: composition claims tied to co-actives and dosing schedules

What patent artifacts typically determine enforcement risk?

• Composition claims for concentration and excipients
• Method-of-use claims for wound/ENT protocols
• Manufacturing process patents for peroxide stability and impurity controls

When does hydrogen peroxide lose exclusivity and what generic entry risks exist?
No exclusivity timeline can be produced without knowing:

• Whether the relevant hydrogen peroxide product is listed in FDA’s exclusivity database
• The application type and approval date for the listed drug
• The patent list that would trigger Paragraph IV theories

Hydrogen peroxide products, particularly well-established topical/otologic products, can be subject to long periods of market use with limited enforceable exclusivity, but that varies by product-specific application and patent listing.

What patent litigation affects hydrogen peroxide in the U.S. and elsewhere?
A litigation map requires court docket identifiers tied to:

• Specific Orange Book patents (or settlement patents)
• Specific brand/generic pairs
• Specific formulation sponsors

No such anchor is provided, so a credible, citation-backed litigation update cannot be generated.

How does hydrogen peroxide compare with competing antiseptics and wound therapies on efficacy and adoption?
Without an anchor product and indication, comparisons cannot be made responsibly. Hydrogen peroxide competes along multiple therapeutic and procedural lines, typically against:

• Other antiseptics (povidone-iodine, chlorhexidine, hypochlorous acid)
• Topical antibiotics and combination wound products
• Debridement systems and advanced wound care modalities
• ENT antisepsis standards (varies by practice)

Competitive differentiation depends on formulation and demonstrated outcomes in a specific indication.

Market analysis and projection: hydrogen peroxide (H2O2) (2025-2035)
A quantitative market forecast cannot be produced from the information provided because hydrogen peroxide spans:

• OTC and prescription channels
• Multiple dosage forms and strengths
• Multiple end-markets (wound care, ENT, dental)
• Multiple geographies with different channel structures

A defensible projection requires at least one of:

• A named FDA-listed product with annual U.S. sales (or equivalent)
• A defined global segment (e.g., topical wound cleansing, otologic antisepsis)
• A named development pipeline asset with trial endpoints and probability-of-success

Key Takeaways

• Hydrogen peroxide is not a single standardized drug asset for clinical, regulatory, IP, or market forecasting without a product anchor (strength, dosage form, indication, sponsor).
• A credible clinical trials update, Orange Book/exclusivity view, patent landscape, and market projection must be tied to the exact FDA-listed product or a specific investigational formulation.

FAQs

1. What FDA-listed hydrogen peroxide products exist for wound cleansing by strength and dosage form?
2. How do hydrogen peroxide vs hypochlorous acid products differ in wound care trial outcomes?
3. What formulation patents commonly cover hydrogen peroxide stability and delivery systems?
4. Can hydrogen peroxide be challenged via Paragraph IV if it is sold OTC or unlisted in the Orange Book?
5. What data sources are best for tracking hydrogen peroxide trials across different sponsors and delivery formats?

References

1. (No sources provided.)