CLINICAL TRIALS PROFILE FOR ECONAZOLE NITRATE

All Clinical Trials for ECONAZOLE NITRATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00768599 ↗	A Study of Econazole Foam 1% in Athlete's Foot	Completed	AmDerma	Phase 2	2008-03-01	This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.
NCT01353976 ↗	Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis	Completed	AmDerma Pharmaceuticals, LLC	Phase 3	2011-05-01	This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.
NCT01353976 ↗	Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis	Completed	AmDerma	Phase 3	2011-05-01	This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.
NCT01358240 ↗	Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis	Completed	AmDerma Pharmaceuticals, LLC	Phase 3	2011-06-01	This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.
NCT01358240 ↗	Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis	Completed	AmDerma	Phase 3	2011-06-01	This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.
NCT01696799 ↗	Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years	Completed	AmDerma Pharmaceuticals, LLC	Phase 2	2011-09-01	To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in subjects with interdigital tinea pedis aged 12 years to less than 18 years.
NCT01696799 ↗	Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years	Completed	AmDerma	Phase 2	2011-09-01	To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in subjects with interdigital tinea pedis aged 12 years to less than 18 years.

Clinical Trial Conditions for ECONAZOLE NITRATE

Condition Name

Condition Name for ECONAZOLE NITRATE
Intervention	Trials
Tinea Pedis	4
Athlete's Foot	3
Healthy	1
Healthy Women	1

Condition MeSH

Condition MeSH for ECONAZOLE NITRATE
Intervention	Trials
Tinea Pedis	5
Tinea	5

Clinical Trial Locations for ECONAZOLE NITRATE

Trials by Country

Trials by Country for ECONAZOLE NITRATE
Location	Trials
United States	24
Switzerland	2

Trials by US State

Trials by US State for ECONAZOLE NITRATE
Location	Trials
Texas	3
Tennessee	3
California	3
Florida	2
Minnesota	2

Clinical Trial Progress for ECONAZOLE NITRATE

Clinical Trial Phase

Clinical Trial Phase for ECONAZOLE NITRATE
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for ECONAZOLE NITRATE
Clinical Trial Phase	Trials
Completed	7

Clinical Trial Sponsors for ECONAZOLE NITRATE

Sponsor Name

Sponsor Name for ECONAZOLE NITRATE
Sponsor	Trials
AmDerma	4
AmDerma Pharmaceuticals, LLC	3
Cross Research S.A.	2

Sponsor Type

Sponsor Type for ECONAZOLE NITRATE
Sponsor	Trials
Industry	13

Econazole Nitrate: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is the current clinical trial landscape for econazole nitrate?

Econazole nitrate is an established imidazole antifungal used in topical dermatology and mucocutaneous indications. For clinical-trials monitoring and investment screening, the key practical point is that econazole nitrate is largely in a legacy, marketed state rather than a late-stage pipeline product.

Trial activity pattern (high-level):

• Active recruitment / late-stage global trials: No consistently reported, material late-stage (Phase 3 or pivotal) econazole nitrate programs appear in public trial registries in a way that supports a near-term “pipeline rerating” thesis.
• Earlier-phase or investigator-initiated studies: Small trials and formulation studies can occur, but they do not typically change the competitive position of an already established generic/local-therapy antifungal.

Implication for R&D planning:

• Near-term clinical value creation is more likely to come from new formulations, fixed-dose combinations, and expanded local indications than from a traditional Phase 3 path, because econazole nitrate’s therapeutic class is mature and regulatory expectations focus on formulation equivalence rather than new molecular evidence.

What is econazole nitrate’s market position?

Econazole nitrate sits in the topical azole antifungal market, competing against broad therapy peers:

• Imidazoles: clotrimazole, miconazole
• Other azoles: ketoconazole (topical), oxiconazole (regional)
• Allied antifungals (depending on territory): terbinafine (allylamine), nystatin (polyene)

Market structure:

• Primary demand drivers: prevalence of dermatomycoses (tinea corporis/cruris/pedis), vulvovaginal candidiasis (where applicable), interdigital fungal conditions, and chronic relapsing fungal skin conditions.
• Purchase behavior: OTC or low-friction prescription refill patterns in many geographies, with strong price competition and high generic penetration.
• Regulatory economics: line extensions via formulation changes often face lower barriers than novel systemic antifungals, but they compete in a low-margin category.

What pricing and access dynamics shape the competitive environment?

Key commercial constraints in topical antifungals:

• Generic-led pricing: econazole nitrate products are exposed to pricing pressure once multiple generics exist.
• Switching is easy: prescriber preference typically matters less than demonstrated local tolerability and availability.
• Promotion is limited: the segment often relies on channel availability and bundled dermatology routines, not brand-driven spend.

Commercial consequence:

• The market is unlikely to support large revenue upside from incremental clinical proof unless econazole nitrate enters:
  • a new route or delivery system with differentiated outcomes, or
  • an expanded label that redefines usage frequency or target populations.

How should investors and planners project the near-term demand for econazole nitrate?

For projection, the highest-confidence approach in this class is market-size scaling off topical antifungal demand combined with unit elasticity driven by local incidence and treatment frequency. Without a robust evidence trail of new Phase 3 programs, the most defensible forecast uses the category’s baseline growth and assumes econazole nitrate tracks it with minor share drift.

Base-case projection framework (category-tracking)

Because econazole nitrate is mature, projection should follow:

• Incidence-driven volume stability (dermatophyte and candidal burden)
• Share drift versus competing azoles and allylamines depending on:
  • formulary access
  • product availability (packaging and supply reliability)
  • relative tolerability perceptions and clinician habits

Base-case stance (directional):

• Demand for topical antifungal agents is expected to grow at low to mid single digits in mature markets, driven by population aging, chronicity, and geographic prevalence.
• Econazole nitrate is likely to show moderate volume maintenance with pricing decline unless a differentiated product format is introduced.

What growth levers can still move econazole nitrate revenue?

Within topical antifungals, revenue upside comes from limited levers:

1. Differentiated formulation

   • Enhanced penetration vehicles
   • Better spreadability and reduced irritation
   • Combination products when supported by clinical rationale

2. Label and indication expansion (targeted)

   • Higher-frequency or longer-use indications can raise treatment days
   • New demographic targeting can widen the addressable population

3. Channel execution

   • Stronger pharmacy distribution and e-commerce presence
   • Strategic pack sizes aligned to treatment durations

4. Local compliance and manufacturing scale

   • Supply continuity reduces lost sales in pharmacy-led categories

What are the main regulatory and patent considerations?

Econazole nitrate is an active ingredient with legacy discovery and widespread generic availability. In practice, the competitive landscape depends on:

• formulation and manufacturing process IP (where still protected in specific jurisdictions),
• product-specific regulatory exclusivities (if any) at the product level,
• brand vs generic differentiation by country and marketing authorizations.

For patent analytics, the business-relevant framing is:

• A new econazole nitrate “molecule patent” thesis is generally weak.
• Real protection usually concentrates in formulations, combination regimens, device-like delivery systems, or specific use claims.

How does econazole nitrate compare to key competitive antifungals?

Competitor differentiation typically falls into four dimensions:

Competitor	Class	Typical Differentiator in market	Econazole nitrate competitive risk
Clotrimazole	Imidazole	Extensive generic penetration	High price pressure
Terbinafine	Allylamine	Faster terbinafine-associated cure perceptions in some indications	Share shift in dermatophytes
Ketoconazole (topical)	Azole	Broad antifungal utility (region dependent)	Similar class substitution
Miconazole	Imidazole	Strong topical presence	Similar switching behavior

What matters commercially: in topical antifungals, outcomes are often comparable at the class level, so price, availability, and tolerability dominate.

What investment-grade takeaways follow from the clinical and market setup?

1. Econazole nitrate’s value proposition is mature and largely category-driven, not pipeline-driven.
2. Near-term growth is most likely to be volume stable with pricing downside unless a differentiated product format captures preference.
3. Clinical-trials monitoring should prioritize signals of:
   • new formulations with demonstrable tolerability/acceptance improvements
   • combination products with clear clinical utility
   • jurisdiction-specific label expansions

Key Takeaways

• Econazole nitrate is a mature topical azole antifungal with limited evidence of a near-term late-stage clinical pipeline that would materially change its market trajectory.
• The market is highly generic and price pressured, with easy switching among azole peers and substitution from allylamines in certain dermatophyte segments.
• Revenue projections should follow category tracking (low to mid single digit demand growth in mature markets) with pricing decline risk, offset only by differentiation via formulation, label refinement, or channel execution.

FAQs

1. Is econazole nitrate in a late-stage development cycle globally?
   Publicly observable late-stage pivotal activity is not a consistent feature for econazole nitrate; most activity is typically legacy or formulation-level.

2. What determines econazole nitrate sales in practice?
   Availability, pack format, local pricing, and physician/pharmacist familiarity dominate in topical antifungals.

3. What competitors most threaten econazole nitrate share?
   Generic imidazoles (clotrimazole, miconazole) and terbinafine in dermatophyte use where cure-speed perception drives switching.

4. Where can econazole nitrate still win?
   Differentiated formulations and combinations that improve user adherence or tolerability, plus targeted label expansions that increase treatment days.

5. How should forecasts be structured for econazole nitrate?
   Use a category-tracking model with share drift assumptions and pricing decline sensitivity, then layer only differentiation scenarios for specific jurisdictions or product formats.

References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. Econazole nitrate search results. https://clinicaltrials.gov/
[2] European Medicines Agency. Public information on topical antifungal medicines and class-level therapeutic background. https://www.ema.europa.eu/
[3] World Health Organization. Antifungal treatment and dermatophyte/candidiasis public health background. https://www.who.int/