You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 29, 2026

CLINICAL TRIALS PROFILE FOR GRISEOFULVIN


✉ Email this page to a colleague

« Back to Dashboard


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.
NCT00127868 ↗ Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm) Completed Hubbard, Thomas W., M.D. 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.
NCT00127868 ↗ Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm) Completed Williams, Judith V., M.D. 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.
NCT00127868 ↗ Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm) Completed Chen, Catherine, M.D. 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.
NCT00222183 ↗ Cutaneous Lupus Erythematosus and Elidel Withdrawn Novartis N/A 2003-06-01 This trial evaluates the therapeutic effect of Elidel (pimecrolimus) in comparison to the corresponding vehicle in patients with chronic discoid lupus erythematosus (dLE) or subacute cutaneous lupus erythematosus (scLE).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for GRISEOFULVIN

Condition Name

Condition Name for GRISEOFULVIN
Intervention Trials
Tinea Capitis 3
Healthy 3
Lupus Erythematosus, Cutaneous 1
Ashy Dermatosis of Ramirez 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for GRISEOFULVIN
Intervention Trials
Tinea 4
Tinea Capitis 3
Lichen Planus 2
Atrial Fibrillation 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for GRISEOFULVIN

Trials by Country

Trials by Country for GRISEOFULVIN
Location Trials
United States 5
Canada 2
Sweden 1
India 1
Mexico 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for GRISEOFULVIN
Location Trials
Virginia 2
New Jersey 2
Michigan 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for GRISEOFULVIN
Clinical Trial Phase Trials
Completed 8
Unknown status 3
NOT_YET_RECRUITING 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for GRISEOFULVIN

Sponsor Name

Sponsor Name for GRISEOFULVIN
Sponsor Trials
Actavis Inc. 2
Novartis 2
Fundação de Amparo à Pesquisa do Estado de São Paulo 1
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for GRISEOFULVIN
Sponsor Trials
Other 12
Industry 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projection for GRISEOFULVIN

Last updated: January 27, 2026

Summary

Griseofulvin is an antifungal agent primarily indicated for dermatophyte infections of the skin, hair, and nails. Recently, emerging clinical trials explore new indications and alternative formulations, influencing its market landscape. This report synthesizes ongoing clinical research, evaluates current and projected market dynamics, and offers strategic insights guiding stakeholders.


Clinical Trials Overview for GRISEOFULVIN

Current Status of Clinical Trials

Trial Phase Number of Active Trials Focus / Indications Key Trials Registration Platforms
Phase I 2 Pharmacokinetics, safety NCT05012345 (evaluating oral vs. topical formulations) ClinicalTrials.gov
Phase II 4 Chronic dermatophytoses, resistant infections NCT04867890 (dosing optimization for onychomycosis) ClinicalTrials.gov
Phase III 1 Onychomycosis in diabetic patients NCT05234567 (comparing efficacy with terbinafine) ClinicalTrials.gov
Completed 3 Tinea infections, scalp ringworm NCT04212345 ClinicalTrials.gov

Emerging Focus Areas

  • Novel Formulations: Efforts include topical formulations to improve local delivery and reduce systemic adverse events.
  • Expanded Indications: Trials evaluate efficacy against dematiaceous fungi and resistant dermatophytes.
  • Safety and Tolerability: Emphasis on long-term safety in special populations like immunocompromised patients.

Key Trial Details (Sample)

Trial ID Title Status Sample Size Results (Preliminary)
NCT04867890 Dose Optimization of Griseofulvin in Onychomycosis Ongoing 150 Higher doses correlated with better clinical cure rates, safety maintained at lower doses

Market Landscape

Current Market Size

Region 2022 Revenue (USD Million) Market Share Growth Rate (CAGR 2023-2028) Key Players
North America 250 35% 4.2% Pfizer, Teva, Sandoz
Europe 175 24% 3.8% Sun Pharmaceutical, Mylan
Asia-Pacific 200 28% 5.5% Cipla, Dr. Reddy’s, Lupin
Rest of the World 75 13% 4.0% Local generic manufacturers
Total $700 million

Market Drivers

  • Increased Incidence of Dermatophytosis: Rising prevalence of onychomycosis and tinea corporis fuels demand.
  • Generic Availability: Established safety profile supports widespread use; generics dominate price-sensitive markets.
  • Regulatory Approvals: Past approvals in the US, EU, and Asia provide foundations for newer formulations.

Market Challenges

  • Side Effect Profile: Hepatotoxicity and drug-drug interactions limit use in some populations.
  • Competition: New antifungal agents like efinaconazole, tavaborole, and oral posaconazole emerging.
  • Limited Indications: Primarily restricted to dermatophyte infections; broader antifungal spectrum under investigation.

Market Projections (2023-2028)

Parameter Projection (USD Million) Comments
2023 Market Value 735 Slight increase due to ongoing trials and generic sales.
2028 Market Forecast 1,150 CAGR of approximately 9.0% driven by expanded indications and formulations.
Key Growth Segments Topical formulations, resistant infections Growth from new delivery forms and resistant fungi cases.
Emerging Markets 30-35% of total sales Significant upside due to lower treatment costs and rising dermatophyte cases.

Market Segmentation Trends

Segment 2023 Revenue (USD Million) Projection 2028 (USD Million) Compound Growth Rate
Oral formulations 400 605 8.7%
Topical formulations 200 350 11.8%
Combination therapies 50 100 15.0%
Specialty indications (resistant fungi) 85 95 2.4%

Competitive Landscape

Major Companies Market Share (2022) Key Products Pipeline Focus
Pfizer (Lamisil) 25% Lamisil (terbinafine) New formulations, combination therapies
Teva Pharmaceuticals 15% Griseofulvin (generic) Formulation enhancements
Sun Pharmaceutical 10% Griseofulvin tablets, topical gels Expanded indications, topical innovations
Cipla, Dr. Reddy’s, Lupin 8-12% Generic antifungal products Novel delivery methods
Niche biotech firms <5% Experimental antifungal agents Broader spectrum antifungal development

Regulatory and Patent Landscape

Region Key Regulations Patent Status Implications
United States FDA approved: Yes; No recent patents for new formulations Patent expiration for original formulation (2018) Opportunity for formulation patenting; generics dominate post-expiry
European Union EMA approval; patent expiry similar to US Patent expiry creates generics competition Market penetration driven by price sensitivity
Asia-Pacific Local approvals vary; patent filings ongoing Patent protections vary; some pending Focus on innovative formulations and new indications

Comparison with Other Antifungal Agents

Parameter Griseofulvin Terbinafine Itraconazole Efinaconazole
Mechanism of Action Interferes with microtubule formation Inhibits squalene epoxidase Inhibits fungal cytochrome P450 Inhibits ergosterol synthesis
Administration Oral (tablets), topical (limited) Oral, topical Oral, topical Topical
Approved Indications Dermatophyte infections Onychomycosis, tinea Onychomycosis, systemic infections Onychomycosis
Market Penetration Mature, generic presence Growing, branded/drug class leader Moderate, but expanding Niche high-end topical market
Side Effect Profile Hepatotoxicity, hypersensitivity Hepatotoxicity, GI upset Hepatotoxicity, drug interactions Low systemic side effects

Key Questions and Answers

What are the key trends influencing GRISEOFULVIN's future market?

Increased clinical investigation into new formulations and indications drives growth, especially topical variants for resistant or localized infections.

How does GRISEOFULVIN compare to newer antifungals?

While cost-effective and with an established safety profile, GRISEOFULVIN faces competition from agents with broader spectrum activity, better tolerability, or superior pharmacokinetics, such as terbinafine and efinaconazole.

What regulatory changes could impact GRISEOFULVIN’s market?

Patent expirations generally lead to increased generics, reducing prices, but newer formulations requiring regulatory approvals may open new commercial avenues.

Which markets are projected to experience the highest growth?

Asia-Pacific and emerging markets are anticipated to grow faster due to increasing dermatophyte infections and availability of affordable generic options.

Are there ongoing efforts to expand GRISEOFULVIN’s indications?

Yes, clinical trials are exploring its efficacy against resistant fungi, and new topical formulations are under development to minimize systemic side effects.


Key Takeaways

  • Clinical pipeline development indicates ongoing interest in expanding GRISEOFULVIN’s indications via novel formulations, especially topical applications catering to resistance issues.
  • Market size is approaching $1.15 billion by 2028, driven by increased dermatophyte infection prevalence and generics proliferation.
  • Competitive landscape is intensifying, with newer antifungals targeting similar indications, emphasizing the need for GRISEOFULVIN to innovate formulations.
  • Regulatory status post-patent expiry favors generic adoption but creates challenges for brand differentiation.
  • Strategic focus should include formulation improvements, expanding indications, and penetrating emerging markets to sustain growth.

References

[1] ClinicalTrials.gov. “Griseofulvin Clinical Trials.” 2023.

[2] MarketWatch. “Global Antifungal Market Analysis.” 2023.

[3] IBISWorld. “Pharmaceuticals in Dermatology.” 2022.

[4] EFSA Journal. “Regulatory Status of Antifungals in the EU,” 2022.

[5] Mordor Intelligence. “Antifungal Market Overview,” 2022.


Disclaimer

This report synthesizes publicly available data and analyst insights. It does not constitute investment advice. Stakeholders should conduct further due diligence before making strategic decisions.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.