CLINICAL TRIALS PROFILE FOR LAMISIL

All Clinical Trials for Lamisil

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.
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.
NCT00602251 ↗	Bioequivalency Study of Terbinafine Tablets Under Fed Conditions	Completed	Roxane Laboratories	N/A	2004-03-01	The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
NCT00602342 ↗	Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions	Completed	Roxane Laboratories	N/A	2004-03-01	The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Clinical Trial Conditions for Lamisil

Condition Name

Condition Name for Lamisil
Intervention	Trials
Onychomycosis	6
Healthy	5
Mycoses	1
Ankylosing Spondylitis	1

Condition MeSH

Condition MeSH for Lamisil
Intervention	Trials
Onychomycosis	7
Colitis	1
Infections	1
Tinea	1

Clinical Trial Locations for Lamisil

Trials by Country

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

Trials by US State

Trials by US State for Lamisil
Location	Trials
Oregon	3
Missouri	3
Virginia	3
Texas	3
New York	3

Clinical Trial Progress for Lamisil

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Lamisil

Sponsor Name

Sponsor Name for Lamisil
Sponsor	Trials
Novartis Pharmaceuticals	3
Teva Pharmaceuticals USA	2
Dr. Reddy's Laboratories Limited	2

Sponsor Type

Sponsor Type for Lamisil
Sponsor	Trials
Industry	17
Other	5

Clinical Trials and Efficacy of Lamisil (Terbinafine)

Introduction to Lamisil (Terbinafine)

Lamisil, known generically as terbinafine, is a potent antifungal medication belonging to the allylamine class. It is widely used for treating various fungal infections, including onychomycosis, tinea corporis, tinea pedis, and tinea cruris.

Clinical Trials: Efficacy and Long-Term Outcomes

Comparative Studies

A significant clinical trial, the Lamisil vs Itraconazole in Onychomycosis (LION) study, compared the efficacy of terbinafine with itraconazole in treating onychomycosis. This double-blind, double-dummy study randomized patients to receive either terbinafine (250 mg/day for 12 or 16 weeks) or itraconazole (400 mg/day for 1 week every 4 weeks for 12 or 16 weeks)[1].

• Mycological and Clinical Cure Rates: The study found that terbinafine achieved significantly higher long-term mycological and clinical cure rates compared to itraconazole. At month 18, the cure rates were higher for terbinafine-treated patients, with lower relapse rates over a 5-year follow-up period[1].

Treatment Duration and Dosage

Terbinafine is typically administered at a dosage of 250 mg once daily for adults. The duration of treatment varies depending on the indication and severity of the infection. For onychomycosis, treatment can last from 12 to 16 weeks, while skin infections may require shorter treatment durations[3].

Safety and Adverse Effects

Hepatotoxicity

One of the critical safety concerns with terbinafine is its potential for hepatotoxicity. Patients with chronic or active hepatic disease should avoid this medication, and liver function tests are recommended before and during treatment. Rare but serious cases of liver failure have been reported, some of which were fatal or required liver transplantation[3].

Other Adverse Effects

Other adverse effects include gastrointestinal symptoms, allergic reactions, and rare cases of blood dyscrasias such as agranulocytosis, thrombocytopenia, and pancytopenia. Patients should be monitored for these conditions and the medication discontinued if any of these adverse effects occur[3].

Market Analysis for Lamisil (Terbinafine)

Current Market Trends

The global terbinafine market is experiencing a sluggish growth rate, influenced by various factors including the impact of COVID-19 on healthcare systems and market dynamics. Market research reports indicate that the growth is expected to be moderate, with key regions such as Europe, North America, and Asia-Pacific driving the demand[2].

Market Size and Projections

• Global Market Size: The terbinafine market is part of the broader antifungal drugs market, which was valued at USD 17.39 billion in 2024 and is expected to grow to USD 24.51 billion by 2034, with a CAGR of 3.49% from 2025 to 2034[5].
• Regional Market Share: North America holds the largest market share, while the Asia-Pacific region is expected to be the fastest-growing market due to increasing healthcare infrastructure and rising prevalence of dermatological diseases[5].

Competitive Landscape

The market is analyzed using tools like PORTER and PESTEL analysis, which help in understanding the competitive dynamics and the impact of micro-economic factors. Key players in the market include major pharmaceutical companies, and the report provides a detailed analysis of their market strategies, financial positions, and product portfolios[2].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Dermatological Diseases: The rising incidence of fungal infections such as onychomycosis, tinea corporis, and tinea pedis drives the demand for effective antifungal medications like terbinafine[5].
• Advancements in Healthcare Infrastructure: Investments in healthcare infrastructure, particularly in emerging markets, are expected to boost the growth of the antifungal drugs market[5].

Challenges

• Drug Resistance: The increasing resistance of fungal species to antifungal medications, particularly azoles, poses a significant challenge to the market growth[5].
• Side Effects and Safety Concerns: The potential for hepatotoxicity and other adverse effects associated with terbinafine can impact its market growth and patient compliance[3].

Future Outlook

Market Growth Momentum

Despite the challenges, the terbinafine market is expected to grow steadily, driven by the increasing demand for effective antifungal treatments. The synthetic fungicidal compounds like allylamines, which include terbinafine, are projected to grow at a CAGR of over 2.2% during the forecast period[5].

Strategic Recommendations

For businesses operating in this market, it is crucial to stay updated with the latest trends and customer demands. Market research reports provide valuable insights into the competitive landscape, regional market dynamics, and future growth opportunities, enabling informed decision-making and strategic planning[2].

Key Takeaways

• Efficacy: Terbinafine has shown superior long-term mycological and clinical cure rates compared to other antifungals like itraconazole.
• Safety: Hepatotoxicity and other adverse effects are significant concerns that require careful monitoring.
• Market Size: The global terbinafine market is part of a larger antifungal drugs market expected to reach USD 24.51 billion by 2034.
• Growth Drivers: Increasing prevalence of dermatological diseases and advancements in healthcare infrastructure are key drivers.
• Challenges: Drug resistance and safety concerns are major challenges to market growth.

FAQs

Q: What is the primary indication for Lamisil (terbinafine)? A: The primary indication for Lamisil is the treatment of onychomycosis (fungal infection of the nail) and other dermatophyte and yeast infections such as tinea corporis, tinea pedis, and tinea cruris[3].

Q: How does terbinafine compare to itraconazole in treating onychomycosis? A: Terbinafine has been shown to achieve higher long-term mycological and clinical cure rates compared to itraconazole in the treatment of onychomycosis[1].

Q: What are the common side effects of terbinafine? A: Common side effects include gastrointestinal symptoms, allergic reactions, and rare but serious cases of hepatotoxicity and blood dyscrasias[3].

Q: What is the projected growth rate of the global terbinafine market? A: The global terbinafine market is expected to grow at a moderate rate, with the broader antifungal drugs market projected to have a CAGR of 3.49% from 2025 to 2034[5].

Q: Which region is expected to drive the growth of the terbinafine market? A: The Asia-Pacific region is expected to be the fastest-growing market for terbinafine due to increasing healthcare infrastructure and rising prevalence of dermatological diseases[5].

Cited Sources

1. JAMA Network: Long-term Effectiveness of Treatment With Terbinafine vs Itraconazole in Onychomycosis.
2. OpenPR: Terbinafine (Lamisil) Market Sluggish Growth Rate Foreseen by 2023-2029.
3. Novartis: Lamisil - Novartis.
4. PubMed: Clinical efficacy and tolerability of terbinafine (Lamisil).
5. Precedence Research: Antifungal Drugs Market Size to Reach USD 24.51 Bn by 2034.