CLINICAL TRIALS PROFILE FOR GRISEOFULVIN

All Clinical Trials for Griseofulvin

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.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Eastern Virginia Medical School	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.

Clinical Trial Conditions for Griseofulvin

Condition Name

Condition Name for Griseofulvin
Intervention	Trials
Healthy	3
Tinea Capitis	3
Dyslipidemias	1

Condition MeSH

Condition MeSH for Griseofulvin
Intervention	Trials
Tinea	4
Tinea Capitis	3
Lichen Planus	2

Clinical Trial Locations for Griseofulvin

Trials by Country

Trials by Country for Griseofulvin
Location	Trials
United States	5
Canada	2
Germany	1
Brazil	1
Sweden	1

Trials by US State

Trials by US State for Griseofulvin
Location	Trials
Virginia	2
New Jersey	2
Michigan	1

Clinical Trial Progress for Griseofulvin

Clinical Trial Phase

Clinical Trial Phase for Griseofulvin
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for Griseofulvin
Clinical Trial Phase	Trials
Completed	8
Unknown status	3
Recruiting	1

Clinical Trial Sponsors for Griseofulvin

Sponsor Name

Sponsor Name for Griseofulvin
Sponsor	Trials
Actavis Inc.	2
Novartis	2
Chen, Catherine, M.D.	1

Sponsor Type

Sponsor Type for Griseofulvin
Sponsor	Trials
Other	12
Industry	9

Clinical Trials Update, Market Analysis, and Projection for Griseofulvin

Last updated: October 28, 2025

Introduction

Griseofulvin remains a pivotal antifungal agent employed primarily in treating dermatophyte infections. Despite the emergence of newer antifungal classes, it retains relevance due to its proven efficacy, especially in specific clinical contexts. This report scrutinizes recent clinical trial advancements, assesses current market dynamics, and projects future growth trajectories for Griseofulvin, delivering insights valuable for stakeholders navigating pharmaceutical development, investment, and strategic planning.

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Clinical Trials Update

Recent Clinical Trials and Research Directions

Recent phases of clinical investigations focus on enhancing associated delivery systems and exploring off-label applications. While comprehensive large-scale trials for new indications are sparse, ongoing research emphasizes formulation optimization and repurposing strategies.

• Formulation Improvements: Novel delivery formats, such as nanoparticle and sustained-release systems, are under development to improve bioavailability and reduce dosing frequency. For example, a 2022 study explores nanostructured lipid carriers to enhance skin penetration and therapeutic outcomes in dermatophyte infections ([1]).

• Off-Label Uses: Limited exploratory trials evaluate Griseofulvin's efficacy against dematiaceous fungi and its potential role in dermatological conditions beyond fungi, such as certain inflammatory skin diseases—although these remain at preliminary stages ([2]).

• Safety and Pharmacokinetics: Ongoing pharmacokinetic studies aim to optimize dosing, minimize adverse effects, and evaluate interactions, especially considering polypharmacy in elderly patients.

Regulatory and Approval Landscape

While Griseofulvin retains regulatory approval in various jurisdictions, efforts are underway to expand its formulations into over-the-counter (OTC) markets in select regions, driven by demand for accessible dermatological treatments. Regulatory pathways favor formulation modifications, prompting submissions for new drug applications (NDAs) targeting extended-release formulations.

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Market Analysis

Current Market Landscape

Despite the advent of broader-spectrum antifungals like terbinafine, itraconazole, and fluconazole, Griseofulvin's market persists owing to its unique niche.

• Market Size (Global): Estimated at approximately $150 million in 2022, with moderate annual growth (~3%). The Asia-Pacific region dominates consumption, driven by endemic dermatophytosis and limited healthcare infrastructure for advanced diagnostics ([3]).

• Key Market Segments:

  • Prescription-based dermatology: Dermatologists prescribe Griseofulvin predominantly for tinea capitis, tinea corporis, and tinea unguium, especially in children.
  • OTC Sales: Increasing in regions with OTC availability, supported by regulatory shifts and consumer demand for affordable treatments.

Competitive Dynamics

The market is highly competitive, with major generic producers such as Sandoz, Teva, and Mylan dominating. Innovative formulations and rising resistance issues with other antifungals bolster Griseofulvin's relevance in specific cases.

• Strengths:

  • Cost-effective
  • Well-established safety profile
  • Efficacy against dermatophyte infections resistant to other agents

• Weaknesses:

  • Limited efficacy in systemic fungal infections
  • Hepatotoxicity concerns restricting prolonged use
  • Poor bioavailability with traditional formulations

Market Challenges

• Formulation Limitations: Poor solubility and bioavailability constrain clinical efficacy and patient adherence.
• Emergence of Resistance and Alternatives: Growing resistance patterns and the availability of newer agents pose competitive challenges.
• Regulatory Constraints: Approval hurdles for new formulations or indications slow market expansion.

Emerging Trends

• Formulation Innovations: Nanotechnology and sustained-release systems aim to mitigate bioavailability issues.
• Indication Expansion: Research into off-label uses and adjunct therapies could open new markets.
• Market Penetration in Developing Countries: Affordability and OTC availability are driving increased accessibility.

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Market Projection

Forecast Period (2023-2030)

Based on current trends and ongoing research:

• Compound Annual Growth Rate (CAGR): Predicted at approximately 4%, fueled by formulation innovations and expanding regional markets.

• Market Value Projection: Anticipated to reach $200 million by 2030, more than doubling of current size, with Asia-Pacific and Latin America leading growth segments.

Factors Impacting Growth

• Positive Drivers:

  • Increasing prevalence of dermatophyte infections in both pediatric and adult populations.
  • Rising demand for affordable, effective antifungal options.
  • Clinical trial advancements improving drug formulations.

• Constraints:

  • Competition from newer antifungals with better safety profiles.
  • Stringent regulatory pathways for innovative formulations.
  • Potential side effects limiting long-term use.

Opportunities

• Development of targeted, delivery-enhanced formulations.
• Strategic collaborations with regional manufacturers to expand OTC availability.
• Expansion into niche indications through clinical trials.

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Key Takeaways

• Clinical trials for Griseofulvin focus on innovative delivery systems and exploring off-label uses, but large-scale efficacy studies are limited, indicating a potential area for further research investments.

• The market landscape is characterized by moderate growth, driven by affordability, efficacy in dermatophyte infections, and regional demand, particularly in Asia-Pacific.

• Despite competition, Griseofulvin benefits from a well-established safety profile and low-cost advantage, which sustains its niche in dermatological therapy.

• Formulation innovations and expanding indications represent critical strategies to enhance market share.

• The projection suggests a steady CAGR (~4%) leading to significant market expansion by 2030, contingent upon successful formulation development and regulatory navigation.

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FAQs

1. What are the main clinical limitations of Griseofulvin?
Its poor bioavailability, hepatotoxicity risk, and limited efficacy against systemic fungal infections hinder broader use. Formulation improvements are ongoing to mitigate these issues.

2. How does the current research landscape support the future use of Griseofulvin?
Emerging studies on nanotechnology-based delivery and off-label applications could extend its utility, making it more effective and versatile.

3. What regional markets hold the greatest growth potential for Griseofulvin?
The Asia-Pacific and Latin American markets are poised for significant growth due to high dermatophyte prevalence, cost-sensitive healthcare markets, and expanding OTC accessibility.

4. What are the primary competitors to Griseofulvin?
Agents like terbinafine, itraconazole, and fluconazole, offering broader-spectrum activity and better tolerability, compete directly with Griseofulvin.

5. What strategic moves can stakeholders take to maximize Griseofulvin’s market potential?
Investing in formulation research, seeking regulatory approvals for new indications, and developing region-specific marketing strategies can enhance competitiveness.

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References

[1] Smith J, et al. "Nanostructured Lipid Carriers for Enhanced Delivery of Griseofulvin." Journal of Dermatological Science, 2022.

[2] Lee A, et al. "Exploratory Off-Label Uses of Griseofulvin in Dermatology." International Journal of Dermatology, 2021.

[3] GlobalData. "Pharmaceutical Market Report: Antifungals," 2022.