CLINICAL TRIALS PROFILE FOR LAMISIL AT

All Clinical Trials for Lamisil At

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002394 ↗	Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment	Completed	Novartis	N/A	1969-12-31	The purpose of this study is to see if it is safe and effective to give Lamisil to HIV-positive patients with thrush (a fungal infection) that has not responded to fluconazole.
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.
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.

Clinical Trial Conditions for Lamisil At

Condition Name

Condition Name for Lamisil At
Intervention	Trials
Onychomycosis	6
Healthy	5
Ankylosing Spondylitis	1
Onychomycosis/Onycholysis and Tinea Pedis	1

Condition MeSH

Condition MeSH for Lamisil At
Intervention	Trials
Onychomycosis	7
Colitis, Ulcerative	1
Inflammatory Bowel Diseases	1
Tinea Capitis	1

Clinical Trial Locations for Lamisil At

Trials by Country

Trials by Country for Lamisil At
Location	Trials
United States	48
Canada	3
Iceland	1
Pakistan	1
Germany	1

Trials by US State

Trials by US State for Lamisil At
Location	Trials
Pennsylvania	3
Oregon	3
Missouri	3
Virginia	3
Texas	3

Clinical Trial Progress for Lamisil At

Clinical Trial Phase

Clinical Trial Phase for Lamisil At
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	2
Phase 1	8

Clinical Trial Status

Clinical Trial Status for Lamisil At
Clinical Trial Phase	Trials
Completed	17
Recruiting	2

Clinical Trial Sponsors for Lamisil At

Sponsor Name

Sponsor Name for Lamisil At
Sponsor	Trials
Novartis Pharmaceuticals	3
Mylan Pharmaceuticals	2
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for Lamisil At
Sponsor	Trials
Industry	17
Other	5

Lamisil (Terbinafine): Clinical Trials, Market Analysis, and Projections

Introduction to Lamisil (Terbinafine)

Lamisil, commonly known by its generic name terbinafine, is an antifungal medication that belongs to the class of allylamines. It is widely used to treat various fungal infections, including dermatophyte infections such as ringworm, athlete's foot, and jock itch, as well as onychomycosis (fungal nail infections) and cutaneous candidiasis.

Clinical Efficacy and Trials

Mechanism of Action

Terbinafine exerts its fungicidal action by inhibiting squalene epoxidation during sterol synthesis in fungal membranes, effectively eliminating the infection[1].

Clinical Trials Outcomes

Clinical trials have demonstrated the high efficacy of terbinafine in treating various fungal infections. For instance, in the treatment of tinea corporis, tinea cruris, and tinea pedis, topical application of 1% terbinafine cream has shown complete or mycological cure rates of 70-90% in over 1200 patients. Systemic treatment with 125 mg of terbinafine twice daily has achieved cure rates of 75-90% for tinea corporis and chronic tinea pedis, 60-70% for cutaneous candidiasis, and 90-100% for onychomycosis[1].

A notable study, the Lamisil vs Itraconazole in Onychomycosis (LION) study, compared the long-term effectiveness of terbinafine with itraconazole. The study found that terbinafine achieved significantly higher long-term mycological and clinical cure rates than itraconazole, with follow-up data showing sustained cure rates up to 5 years[4].

Safety and Tolerability

Terbinafine has been found to be well-tolerated with minimal side effects. Gastrointestinal symptoms, allergic reactions, and miscellaneous mild non-specific symptoms are reported in a small percentage of patients. No significant hematological, hepatic, or renal effects have been observed[1].

Market Analysis

Market Size and Growth

The terbinafine (Lamisil) market is experiencing robust growth, driven by several key factors. The increasing prevalence of fungal infections, particularly in developing regions, and rising awareness about the effectiveness of antifungal medications are significant drivers. The market is expected to grow at a compound annual growth rate (CAGR) of around 9.6% during the forecast period from 2024 to 2031[2][3].

Market Segmentation

The terbinafine market is segmented based on type (oral and external use) and application (fungal infections of the skin and mucous membrane, onychomycosis, and others). Geographically, the market is divided into regions such as North America, Europe, Asia-Pacific, and the Middle East & Africa. The Asia-Pacific region is expected to be the fastest-growing market, while North America remains the largest market[2][3].

Key Drivers

• Increasing Prevalence of Fungal Infections: The rising incidence of fungal infections, especially in developing regions, is a major driver of the market.
• Growing Awareness and Personal Hygiene: Increased awareness about personal hygiene and the availability of effective antifungal treatments are driving more people to seek treatment.
• Rising Disposable Income: The growth in disposable income in various regions is enabling more people to afford antifungal medications.
• Innovative Product Developments: Continuous innovation in product formulations and delivery methods is enhancing the market's growth potential[2][3].

Regional Outlook

The North American market is driven by increasing occurrences of nail fungal infections and rising awareness about personal grooming. The Asia-Pacific and European regions are witnessing a surge in demand due to the growing prevalence of dermatophytosis and rising disposable incomes. The USA and China are projected to dominate the market, holding significant market shares[2].

Market Projections

Forecast Period

The terbinafine market is anticipated to continue its upward trajectory from 2024 to 2031. The market size is expected to expand significantly, driven by the factors mentioned above. By 2031, the market is projected to reach substantial growth, presenting lucrative opportunities for key market players to expand their market presence and revenue[2][3].

Global Antifungal Drugs Market Context

Within the broader context of the global antifungal drugs market, terbinafine is a significant player. The global antifungal drugs market is expected to grow at a CAGR of 3.49% from 2025 to 2034, reaching USD 24.51 billion by 2034. The Asia-Pacific region is expected to be the fastest-growing market in this segment as well[5].

Conclusion

Terbinafine, under the brand name Lamisil, is a highly effective antifungal medication with a strong clinical efficacy profile and favorable safety and tolerability data. The market for terbinafine is poised for significant growth, driven by increasing demand for antifungal treatments, rising awareness, and innovative product developments.

Key Takeaways

• High Clinical Efficacy: Terbinafine has shown high cure rates in various fungal infections.
• Good Safety Profile: Minimal side effects and no significant hematological, hepatic, or renal effects.
• Market Growth: Expected to grow at a CAGR of around 9.6% from 2024 to 2031.
• Key Drivers: Increasing prevalence of fungal infections, growing awareness, and rising disposable income.
• Regional Dominance: North America, Asia-Pacific, and Europe are key regions driving market growth.

FAQs

What is the mechanism of action of terbinafine?

Terbinafine inhibits squalene epoxidation during sterol synthesis in fungal membranes, exerting a fungicidal action[1].

What are the common side effects of terbinafine?

Common side effects include gastrointestinal symptoms, allergic reactions, and miscellaneous mild non-specific symptoms, all occurring in a small percentage of patients[1].

How effective is terbinafine in treating onychomycosis?

Terbinafine achieves cure rates of 90-100% in onychomycosis, with sustained cure rates observed up to 5 years in clinical trials[1][4].

What are the key drivers of the terbinafine market?

Key drivers include the increasing prevalence of fungal infections, growing awareness about personal hygiene, rising disposable income, and innovative product developments[2][3].

Which regions are expected to dominate the terbinafine market?

The USA and China are projected to dominate the market, with significant contributions from the North American, Asia-Pacific, and European regions[2].

Sources

1. Clinical efficacy and tolerability of terbinafine (Lamisil) - PubMed
2. Terbinafine (Lamisil) Market Analysis and Latest Trends - GitHub
3. Global Terbinafine (Lamisil) Market Size, Trends and Projections - Market Research Intellect
4. Long-term Effectiveness of Treatment With Terbinafine vs Itraconazole in Onychomycosis - JAMA Network
5. Antifungal Drugs Market Size to Reach USD 24.51 Bn by 2034 - Precedence Research