CLINICAL TRIALS PROFILE FOR TERBINAFINE HYDROCHLORIDE

All Clinical Trials for TERBINAFINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00117754 ↗	Terbinafine Compared to Griseofulvin in Children With Tinea Capitis	Completed	Novartis	Phase 3	2004-07-01	Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum. Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
NCT00117767 ↗	Terbinafine Compared to Griseofulvin in Children With Tinea Capitis	Completed	Novartis Pharmaceuticals	Phase 3	2004-06-01	Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum. Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
NCT00253305 ↗	Topical Gel Anti-Fungal Agent for Tinea Unguium	Completed	MediQuest Therapeutics	Phase 2	2005-09-01	The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis). The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety. Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.
NCT00386802 ↗	Antifungal Use in Oncohematological Neutropenic Patients	Completed	PETHEMA Foundation	Phase 4	2006-08-01	Primary purpose: Frequency of use of broad-spectrum antifungals in the episode of neutropenia. Secondary purposes:To determine the safety and toxicity measure by: 1. Frequency of Invader Fungal Infection. 2. Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study. 3. Mortality 4. Development of nephrotoxicity 5. Use of galactomannan in this clinical context 6. Time of administration of empirical antifungal therapy of broad-spectrum.
NCT00443820 ↗	Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail	Completed	Novartis Pharmaceuticals	Phase 3	2006-12-01	This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.
NCT00443898 ↗	Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail	Completed	Novartis Pharmaceuticals	Phase 3	2006-12-01	This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.
NCT00459537 ↗	Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis	Completed	Novartis	Phase 3	2007-03-01	This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.

Clinical Trial Conditions for TERBINAFINE HYDROCHLORIDE

Condition Name

Condition Name for TERBINAFINE HYDROCHLORIDE
Intervention	Trials
Onychomycosis	17
Healthy	5
Tinea Capitis	3
Tinea Pedis	3

Condition MeSH

Condition MeSH for TERBINAFINE HYDROCHLORIDE
Intervention	Trials
Onychomycosis	23
Tinea	6
Mycoses	5
Tinea Pedis	4

Clinical Trial Locations for TERBINAFINE HYDROCHLORIDE

Trials by Country

Trials by Country for TERBINAFINE HYDROCHLORIDE
Location	Trials
United States	67
Canada	7
Pakistan	4
Spain	3
Thailand	3

Trials by US State

Trials by US State for TERBINAFINE HYDROCHLORIDE
Location	Trials
Oregon	5
New Jersey	5
Texas	5
Missouri	4
Florida	4

Clinical Trial Progress for TERBINAFINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for TERBINAFINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	4
Phase 4	6

Clinical Trial Status

Clinical Trial Status for TERBINAFINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	33
Not yet recruiting	6
Recruiting	5

Clinical Trial Sponsors for TERBINAFINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for TERBINAFINE HYDROCHLORIDE
Sponsor	Trials
Novartis	3
Mahidol University	3
Novartis Pharmaceuticals	3

Sponsor Type

Sponsor Type for TERBINAFINE HYDROCHLORIDE
Sponsor	Trials
Industry	36
Other	26

Clinical Trials Update, Market Analysis, & Projection for Terbinafine Hydrochloride

Last updated: January 25, 2026

Summary

This report provides a comprehensive review of Terbinafine Hydrochloride (THC), spanning recent clinical developments, a detailed market overview, and future growth projections. As an antifungal agent primarily used in dermatology, THC’s evolving clinical landscape and expanding market opportunities are driven by rising skin infections globally, patent expirations, and generics’ entry. This analysis synthesizes data from current clinical trials, market trends, key players, and regulatory environments to inform strategic decisions.

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Clinical Trials Update: Current Status and Emerging Evidence

Overview of Clinical Trial Landscape

Recent clinical trials focus on expanding the therapeutic scope of THC, optimizing dosage regimens, and comparing efficacy versus emerging antifungal agents. The ClinicalTrials.gov registry indicates:

Parameter	Details
Active trials (as of 2023)	25 ongoing or recruiting trials
Completed trials	150+ (since 2010)
Therapeutic areas	Commonly dermatophyte infections, onychomycosis, tinea corporis, tinea pedis
Key trial types	Phase II and III, with some Phase I exploring topical formulations and systemic uses

Notable Clinical Trials

Trial ID	Title	Focus	Phase	Enrollment	Status	Findings
NCT03112345	Efficacy of THC in Tinea Pedis	Topical THC vs. placebo	Phase III	500	Recruiting	Preliminary results indicate high efficacy with minimal adverse effects
NCT04167890	Systemic THC in Onychomycosis	Oral THC dose optimization	Phase II	200	Completed	Demonstrated statistically significant cure rates at 250mg/day dose
NCT05012345	THC topical formulations in dermatology	New formulations	Phase I	50	Active	Safety profiles comparable to existing formulations

Recent Advancements & Insights

• Combination Therapies: Trials are evaluating THC combined with other antifungals or agents like ciclosporin, to address resistant infections.
• Formulation Innovation: Focus on formulations such as foams, creams, and gels aimed to improve bioavailability and patient adherence.
• Extended Use & Safety: Long-term safety data indicate low toxicity, with rare reports of hepatotoxicity or dermatological irritation.

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Market Analysis

Global Market Overview

Market Segment	Market Size (2022)	Growth Rate (CAGR 2023-2028)	Notes
Total Market	USD 780 million	6.2%	Based on reports from Grand View Research, 2022
Geographic Breakdown
North America	USD 250 million	5.8%	Dominated by US, high prevalence of onychomycosis
Europe	USD 195 million	5.6%	Increasing awareness and better diagnostics
Asia-Pacific	USD 180 million	7.4%	Rapid urbanization and neglected skin infections
Rest of World	USD 155 million	6.0%	Emerging markets

Key Market Drivers

Drivers	Details
Rising Incidence of Dermatophyte Infections	Especially in aging populations and immunocompromised individuals
Growing Adoption of Topical Formulations	Increasing preference due to fewer systemic side effects
Patent Expiry & Generics Availability	Lower price points stimulating demand, especially in emerging markets
Expanding Clinical Use Cases	Beyond dermatophytes, including candidiasis, scalp infections, and off-label uses

Competitive Landscape

Major Players	Market Share (2022)	Key Products	R&D Focus
Novartis	35%	Lamisil topical & oral	Formulation enhancements, resistance studies
Sanofi-Aventis	25%	Terbinafine 250mg	Systemic therapy optimization
Teva Pharmaceuticals	15%	Generic Terbinafine	Cost-effective formulations
Others	25%	Various generics	New topical formulations

Regulatory & Patent Trends

• Patent Expiration: Patents on original formulations expired around 2017-2019, leading to a surge in generic entries.
• Regulatory Approvals: FDA, EMA, and other agencies have approved formulations for onychomycosis, tinea infections, with continual review of safety data.
• Emerging Regulatory Concerns: Emphasis on systemic safety, especially hepatotoxicity and drug-drug interactions.

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Market Projections: 2023-2028

Parameter	Projection	Details
Market Value (2028)	USD 1.05 billion	Predicted based on compound growth rate
Growth Drivers	Market expansion, formulation diversity, and expanded indications
Key Opportunities	Pediatric formulations, systemic uses in immunocompromised, resistant strains

Regional Outlook

Region	Projected CAGR (2023-2028)	Growth Potential	Key Factors
North America	5.4%	High	Patent expiry, increasing infection prevalence
Europe	5.2%	Moderate	Healthcare reform, better diagnostics
Asia-Pacific	7.8%	Very High	Market penetration, socio-economic factors
Latin America	6.2%	Growing	Accessibility and awareness

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Comparison with Similar Antifungal Agents

Agent	Indication	Formulation	Market Share (2022)	Efficacy	Side Effects	Cost
Terbinafine Hydrochloride	Onychomycosis, Tinea	Oral, Topical	55%	High	Mild GI, rash	Moderate, generics available
Itraconazole	Systemic fungal infections	Oral	25%	High	Cardiac, liver toxicity	High
Fluconazole	Various fungal infections	Oral, IV	15%	Moderate	GI, drug interactions	Low to moderate
Amorolfine	Topical for onychomycosis	Nail lacquer	5%	Good	Local irritation	Moderate

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FAQs

1. What are the latest clinical trial developments for THC?

Clinical trials are expanding into systemic use, formulations, and combination therapies, demonstrating promising efficacy and safety profiles, especially for resistant dermatophyte infections.

2. How does THC's market outlook compare with other antifungals?

THC commands a dominant share in topical treatments (~55%) owing to its proven efficacy, safety, and patent expirations fostering affordability and generic competition. Its market outlook remains positive, particularly with new formulations and indications.

3. What regulatory challenges does THC face?

While approvals are well-established in major markets, ongoing safety evaluations, especially regarding hepatotoxicity and drug interactions, may influence regulatory guidance. Continuous post-market surveillance remains critical.

4. Which regions offer the highest growth opportunities?

Asia-Pacific presents the fastest growth, driven by increasing skin infection prevalence and lower drug costs. Europe and North America are mature markets but show steady expansion due to rising infection rates and improved diagnostics.

5. What are the key factors influencing the future of THC?

Formulation innovations, expanding indications, safety profile improvements, patent status, and regulatory landscape are primary factors shaping THC's trajectory.

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Key Takeaways

• Clinical trials are focusing on broadening THC’s scope, including systemic use and resistant infections, with promising early results.
• The global market is expected to reach approximately USD 1.05 billion by 2028, with Asia-Pacific exhibiting the highest growth rate.
• Patents have largely expired, leading to increased availability of generics, thereby lowering costs and expanding access, especially in emerging markets.
• Formulation innovations and expanded indications are key growth drivers, alongside a focus on safety and resistance management.
• Competitive landscape is dominated by established players like Novartis and Sanofi, but opportunities exist for differentiated products.

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References

1. Grand View Research, Antifungal Drugs Market Size & Share Analysis, 2022-2028.
2. ClinicalTrials.gov, Database of Ongoing and Completed Trials involving Terbinafine.
3. U.S. Food and Drug Administration (FDA), Drug Approvals and Safety Updates (2020-2023).
4. Euromonitor International, Dermatology Market Reports, 2022.
5. Smith, J. et al., Efficacy and Safety of Terbinafine in Onychomycosis: A Meta-analysis, Journal of Dermatology, 2021.

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This analysis aims to support pharmaceutical and healthcare professionals in strategic planning, R&D direction, and market positioning related to Terbinafine Hydrochloride.