CLINICAL TRIALS PROFILE FOR TERBINAFINE

All Clinical Trials for terbinafine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.

Clinical Trial Conditions for terbinafine

Condition Name

Condition Name for terbinafine
Intervention	Trials
Onychomycosis	17
Healthy	5
Tinea Pedis	3
Fungal Infection	2

Condition MeSH

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

Clinical Trial Locations for terbinafine

Trials by Country

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−

Trials by Country for terbinafine
Location	Trials
United States	65
Canada	7
Spain	3
Thailand	3
Pakistan	3

Trials by US State

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−

Trials by US State for terbinafine
Location	Trials
Texas	5
Oregon	5
Missouri	4
Florida	4
Pennsylvania	4

Clinical Trial Progress for terbinafine

Clinical Trial Phase

Clinical Trial Phase for terbinafine
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	10
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for terbinafine
Clinical Trial Phase	Trials
Completed	31
Not yet recruiting	6
Unknown status	4

Clinical Trial Sponsors for terbinafine

Sponsor Name

Sponsor Name for terbinafine
Sponsor	Trials
Novartis	3
Mahidol University	3
Novartis Pharmaceuticals	3

Sponsor Type

Sponsor Type for terbinafine
Sponsor	Trials
Industry	34
Other	20

Terbinafine: Clinical Trials, Market Analysis, and Projections

Introduction to Terbinafine

Terbinafine is a widely used antifungal medication, effective against a variety of fungal infections, including onychomycosis (fungal infections of the nails), tinea infections (ringworm), and athlete’s foot. Here, we will delve into the recent clinical trials, market analysis, and future projections for terbinafine.

Recent Clinical Trials

Topical Terbinafine Formulations

Recent clinical trials have focused on developing effective topical formulations of terbinafine, particularly for onychomycosis.

• MOB-015 Trial: A phase 3 trial conducted by Moberg Pharma AB demonstrated the efficacy and safety of MOB-015, a topical terbinafine 10% solution. This formulation showed a favorable benefit-to-risk ratio and is considered a promising option for managing toenail onychomycosis. Historically, developing a topical terbinafine formulation has been challenging due to the difficulty in achieving adequate drug delivery to the subungual tissue, but MOB-015 has overcome this hurdle[1].

• BB2603 Trial: Blueberry Therapeutics Limited conducted a Phase 2b trial for BB2603, another novel topical terbinafine product. The trial showed that BB2603 met its primary endpoint with an 83.3% response rate, demonstrating superiority over placebo. This treatment requires only a 3-month treatment duration, significantly shorter than other topical agents used for onychomycosis, which often require around 11 months of treatment[4].

Market Analysis

Global Market Size and Growth

The global terbinafine hydrochloride market is experiencing significant growth driven by several factors.

• Current Market Size: As of 2023, the global terbinafine hydrochloride market was valued at several million dollars, with projections indicating it will reach higher figures by 2030, exhibiting a notable compound annual growth rate (CAGR)[2][3].

• Growth Drivers: The increasing incidence of fungal infections, particularly among immunocompromised individuals, is a major driver of the market. Advancements in drug formulations and delivery systems are also propelling market demand. The rising awareness and accessibility of antifungal treatments further contribute to the market's expansion[2][3].

Market Segmentation

The terbinafine market is segmented based on several criteria:

• Product Types: The market is divided into topical and oral formulations. Topical formulations, such as those developed by Moberg Pharma AB and Blueberry Therapeutics, are gaining traction due to their efficacy and convenience[3][5].

• Applications: The primary applications include fungal infections of the fingernails and toenails, as well as tinea infections of the groin, body, and feet (athlete’s foot)[5].

Key Players

Several pharmaceutical companies are active in the terbinafine market, including:

• Novartis Pharma AG
• Hanmi Pharm. Co.
• Aurobindo Pharma
• Taro Pharmaceuticals USA
• Dr. Reddy’s Laboratories
• Moberg Pharma AB
• Blueberry Therapeutics Limited

These companies are focusing on strengthening their product portfolios and expanding their market presence through strategic initiatives[5].

Market Projections

Future Growth

The terbinafine market is expected to continue its growth trajectory over the next several years.

• CAGR: The market is projected to exhibit a CAGR of around 6.4% from 2024 to 2032, indicating a robust growth rate[3].

• Market Size by 2032: By 2032, the global terbinafine hydrochloride drug market is expected to reach approximately USD 1.09 billion[3].

Emerging Trends

• Advancements in Formulations: The development of novel topical formulations with improved delivery systems is a significant trend. These formulations offer better efficacy and patient compliance compared to traditional oral treatments[1][4].

• Increased Awareness and Accessibility: Growing awareness about fungal infections and the availability of effective treatments are driving market growth. This trend is expected to continue as more individuals seek solutions for these conditions[2].

Key Takeaways

• Effective Topical Formulations: Recent clinical trials have successfully developed topical terbinafine formulations that are effective and safe for treating onychomycosis.
• Market Growth: The global terbinafine market is expected to grow significantly, driven by the increasing incidence of fungal infections and advancements in drug formulations.
• Segmentation: The market is segmented into topical and oral formulations, with topical formulations gaining prominence.
• Key Players: Several pharmaceutical companies are actively involved in the market, focusing on product development and market expansion.

FAQs

What are the recent advancements in topical terbinafine formulations?

Recent clinical trials have shown significant advancements in topical terbinafine formulations, such as MOB-015 and BB2603, which have demonstrated high efficacy and safety in treating onychomycosis with shorter treatment durations compared to traditional topical agents[1][4].

What drives the demand for terbinafine?

The demand for terbinafine is driven by the increasing incidence of fungal infections, particularly among immunocompromised individuals, and advancements in drug formulations and delivery systems[2][3].

What is the projected market size of the terbinafine hydrochloride drug market by 2032?

The global terbinafine hydrochloride drug market is expected to reach approximately USD 1.09 billion by 2032[3].

Which companies are key players in the terbinafine market?

Key players include Novartis Pharma AG, Hanmi Pharm. Co., Aurobindo Pharma, Taro Pharmaceuticals USA, Dr. Reddy’s Laboratories, Moberg Pharma AB, and Blueberry Therapeutics Limited[5].

What is the expected CAGR of the terbinafine hydrochloride drug market from 2024 to 2032?

The market is expected to exhibit a CAGR of around 6.4% from 2024 to 2032[3].

Sources

1. The Derm Digest: "Novel topical terbinafine demonstrates efficacy and safety in pivotal trial" - December 30, 2021
2. OpenPR: "Terbinafine Hydrochloride Market: Size, Share, Growth, Analysis, Key Players, Revenue" - January 2, 2025
3. Business Research Insights: "Terbinafine Hydrochloride Drug Market [2024-2032]" - December 2, 2024
4. BioSpace: "Blueberry Therapeutics Meets Primary and Secondary Endpoints in Phase 2b Trial in Onychomycosis" - November 13, 2023
5. Cognitive Market Research: "Terbinafine Market Report 2024 (Global Edition)" - February 2, 2023