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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR TERBINAFINE HYDROCHLORIDE


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All Clinical Trials for terbinafine hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for terbinafine hydrochloride

Condition Name

175320024681012141618OnychomycosisHealthyTinea PedisTinea Capitis[disabled in preview]
Condition Name for terbinafine hydrochloride
Intervention Trials
Onychomycosis 17
Healthy 5
Tinea Pedis 3
Tinea Capitis 2
[disabled in preview] 0
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Condition MeSH

236540-2024681012141618202224OnychomycosisTineaMycosesTinea Pedis[disabled in preview]
Condition MeSH for terbinafine hydrochloride
Intervention Trials
Onychomycosis 23
Tinea 6
Mycoses 5
Tinea Pedis 4
[disabled in preview] 0
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Clinical Trial Locations for terbinafine hydrochloride

Trials by Country

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Trials by Country for terbinafine hydrochloride
Location Trials
United States 65
Canada 7
Pakistan 3
Germany 3
Spain 3
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Trials by US State

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Trials by US State for terbinafine hydrochloride
Location Trials
Texas 5
Oregon 5
Missouri 4
Florida 4
Pennsylvania 4
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Clinical Trial Progress for terbinafine hydrochloride

Clinical Trial Phase

20.0%33.3%6.7%40.0%012345678910111213Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for terbinafine hydrochloride
Clinical Trial Phase Trials
Phase 4 6
Phase 3 10
Phase 2/Phase 3 2
[disabled in preview] 12
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Clinical Trial Status

70.5%13.6%9.1%6.8%051015202530CompletedNot yet recruitingUnknown status[disabled in preview]
Clinical Trial Status for terbinafine hydrochloride
Clinical Trial Phase Trials
Completed 31
Not yet recruiting 6
Unknown status 4
[disabled in preview] 3
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Clinical Trial Sponsors for terbinafine hydrochloride

Sponsor Name

trials0112233NovartisMahidol UniversityNovartis Pharmaceuticals[disabled in preview]
Sponsor Name for terbinafine hydrochloride
Sponsor Trials
Novartis 3
Mahidol University 3
Novartis Pharmaceuticals 3
[disabled in preview] 2
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Sponsor Type

63.0%37.0%005101520253035IndustryOther[disabled in preview]
Sponsor Type for terbinafine hydrochloride
Sponsor Trials
Industry 34
Other 20
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Terbinafine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Terbinafine Hydrochloride

Terbinafine hydrochloride is a widely used antifungal medication, particularly effective in treating fungal infections of the nails, such as onychomycosis. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Efficacy in Onychomycosis Treatment

Clinical trials have consistently demonstrated the efficacy of terbinafine hydrochloride in treating onychomycosis. In three US/Canadian placebo-controlled clinical trials, terbinafine tablets showed significant results. For instance, in the first toenail study, 70% of patients achieved a mycological cure at week 48, defined by negative KOH and culture tests. Additionally, 59% of patients achieved effective treatment, which includes mycological cure plus either 0% nail involvement or more than 5mm of new unaffected nail growth[1].

Topical Terbinafine Hydrochloride Trials

Recent studies have focused on the safety and efficacy of topical terbinafine hydrochloride formulations. A phase 1 maximal usage trial assessed the safety, tolerability, and pharmacokinetic characteristics of a 10% topical terbinafine hydrochloride solution (MOB015B) in patients with moderate-to-severe onychomycosis. The study found that the topical application resulted in very low systemic exposure, with a maximum plasma concentration (Cmax) approximately 2,000 times lower than that seen with oral administration. This indicates a favorable safety and tolerability profile for the topical formulation[4].

Ongoing and Pivotal Trials

Cipher Pharmaceuticals, in collaboration with Moberg Pharma AB, is currently conducting a pivotal phase 3 clinical trial in the U.S. for MOB-015, another topical terbinafine formulation. This product, branded as Terclara®, has already been launched in Sweden and has seen strong interest and sales, exceeding initial forecasts[3].

Market Analysis

Current Market Size

As of 2023, the global market for terbinafine hydrochloride was estimated to be worth approximately $614 million. This market is segmented based on type (topical and oral) and application (fingernail and toenail infections)[2].

Key Players

The market is dominated by several major pharmaceutical companies, including Novartis, GSK, TEVA, Dr. Reddy's Laboratories, CIPLA LTD, TARO, and others. These companies play a crucial role in the production, distribution, and marketing of terbinafine hydrochloride products[2].

Market Projections

Forecasted Market Size

The global terbinafine hydrochloride market is projected to grow significantly. By 2030, the market is expected to reach a value of $912.6 million, with a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period from 2024 to 2030[2].

Driving Factors

The growth in the terbinafine hydrochloride market is driven by several factors, including the increasing incidence of fungal infections and advancements in drug formulations and delivery systems. These advancements have improved the efficacy and safety profiles of terbinafine hydrochloride products, making them more appealing to both healthcare providers and patients[5].

Regional and Segmental Analysis

The market is segmented by region and by type and application. The topical and oral forms of terbinafine hydrochloride cater to different patient needs, with topical formulations gaining traction due to their lower systemic side effects. Fingernail and toenail infections are the primary applications, with toenail infections being more prevalent and thus driving a larger share of the market[2][5].

Competitive Landscape

The competitive landscape of the terbinafine hydrochloride market is highly competitive, with multiple players vying for market share. Companies are focusing on strategic partnerships, product innovation, and expanding their distribution networks to maintain and grow their market presence. For example, Cipher Pharmaceuticals is actively managing its product pipeline, including the advancement of MOB-015, which has shown promising results in clinical trials and early market adoption[3].

Future Outlook

The future outlook for the terbinafine hydrochloride market appears promising, driven by the increasing demand for effective antifungal treatments and the ongoing advancements in drug formulations. As more clinical trials conclude and new products are launched, the market is expected to continue its growth trajectory.

"Interest in the product within Sweden has exceeded Management’s forecasts of pharmacies, whereby Terclara® has occasionally sold out at several pharmacy chains. Accordingly, pharmacies are increasing their orders to maintain supply of the product on their shelves."[3]

This strong initial response to new products like Terclara® indicates a robust market demand and sets a positive tone for future market growth.

Key Takeaways

  • Clinical Efficacy: Terbinafine hydrochloride has shown high efficacy in treating onychomycosis, with significant mycological and clinical cure rates.
  • Topical Formulations: New topical formulations are being developed and tested, offering lower systemic exposure and favorable safety profiles.
  • Market Growth: The global market is projected to grow to $912.6 million by 2030, driven by increasing fungal infections and advancements in drug formulations.
  • Competitive Landscape: The market is highly competitive, with major pharmaceutical companies and new entrants focusing on innovation and strategic partnerships.
  • Future Outlook: The market is expected to continue growing, driven by demand for effective antifungal treatments and ongoing product innovations.

Frequently Asked Questions

What is the current market size of the terbinafine hydrochloride drug market?

The global market for terbinafine hydrochloride was estimated to be worth approximately $614 million in 2023[2].

What is the projected market size of the terbinafine hydrochloride drug market by 2030?

The market is expected to reach $912.6 million by 2030, with a CAGR of 6.4% during the forecast period from 2024 to 2030[2].

What are the main applications of terbinafine hydrochloride?

The primary applications are fingernail and toenail infections, with toenail infections being more prevalent[2][5].

Who are the key players in the terbinafine hydrochloride market?

Key players include Novartis, GSK, TEVA, Dr. Reddy's Laboratories, CIPLA LTD, TARO, and others[2].

What are the driving factors for the growth of the terbinafine hydrochloride market?

The growth is driven by the increasing incidence of fungal infections and advancements in drug formulations and delivery systems[5].

Sources

  1. eMPR.com: Terbinafine Tablets Prescription & Dosage Information.
  2. Valuates Reports: Terbinafine Hydrochloride Drug - Market Size.
  3. Cipher Pharmaceuticals Inc.: MANAGEMENT'S DISCUSSION AND ANALYSIS.
  4. PubMed: A phase 1 maximal usage trial in patients with moderate-to-severe onychomycosis.
  5. Business Research Insights: Terbinafine Hydrochloride Drug Market [2024-2032].

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