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.
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).

Clinical Trial Conditions for griseofulvin

Condition Name

Condition Name for griseofulvin
Intervention	Trials
Healthy	3
Tinea Capitis	3
Diabetes	1
Dyslipidemias	1

Condition MeSH

Condition MeSH for griseofulvin
Intervention	Trials
Tinea	4
Tinea Capitis	3
Lichen Planus	2
Lupus Erythematosus, Systemic	1

Clinical Trial Locations for griseofulvin

Trials by Country

Trials by Country for griseofulvin
Location	Trials
United States	5
Canada	2
Mexico	1
Germany	1
Brazil	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
Williams, Judith V., M.D.	1

Sponsor Type

Sponsor Type for griseofulvin
Sponsor	Trials
Other	12
Industry	9

Griseofulvin clinical trials update, market analysis and projection (2024-2035)

Last updated: July 28, 2026

Griseofulvin remains an established oral antifungal used primarily for dermatophyte infections. No new late-stage, registration-enabling clinical development program with clearly disclosed timelines or endpoints is apparent in publicly indexed sources. Market growth is limited by generic availability and low pricing, with demand tied to dermatophyte incidence, drug access, and safety-driven prescribing shifts. A practical forecast window is therefore demand-led rather than innovation-led: modest low single-digit growth with periodic inventory swings around supply stability and local procurement cycles.

What is the current clinical trials landscape for griseofulvin?

Are there new phase 3 trials for griseofulvin?

Public trial registries show an overall pattern consistent with an off-patent product: studies are more likely to be pharmacokinetic (PK), bioequivalence (BE), formulation work, or small investigator-led or regional trials rather than large multinational phase 3 efficacy programs. No widely reported, clearly registration-driven phase 3 program with near-term readouts is visible in major public sources as of the latest accessible data.

What trial types dominate griseofulvin studies?

Typical griseofulvin trial activity falls into:

• Bioequivalence and bridging studies for generics and reformulated oral products
• PK studies addressing food effect, dose-response, and population covariates
• Safety and tolerability studies in special populations (pediatrics, hepatic risk stratification)
• Comparisons against topical therapies in limited settings for tinea infections, often at regional scope

Where are trials being run geographically?

Reported locations tend to skew toward countries with active generic manufacturing and routine dermatophyte disease burden. Trial scale is usually small to medium relative to modern global phase 3 programs.

How does griseofulvin’s clinical pipeline compare with newer oral antifungals?

Is griseofulvin replacing terbinafine or itraconazole?

Clinical practice patterns generally favor newer oral agents like terbinafine for many tinea indications due to broader efficacy windows and shorter courses in typical protocols. Griseofulvin persists where:

• Dermatophyte susceptibility and clinical history favor it
• Treatment duration is acceptable
• Specific patient or product-access constraints exist

What is the competitive clinical edge for griseofulvin?

Griseofulvin’s advantage is mostly practical:

• Established safety profile with known monitoring needs
• Long-standing clinician familiarity
• Availability across many generic SKUs, supporting continuity of supply in some regions

What is the competitive disadvantage?

Main disadvantages are operational:

• Longer treatment courses in many regimens
• Drug interaction profile consistent with CYP-mediated metabolism
• Need for adherence and monitoring, which can reduce real-world uptake

What is the market size for griseofulvin, and what drives demand?

Where is griseofulvin used commercially?

Commercial use concentrates in dermatology and primary care for:

• Tinea capitis
• Tinea corporis
• Tinea pedis (in selected settings)
• Mycological infections where oral therapy is selected over topical treatment

Key demand drivers

• Dermatophyte incidence and reinfection cycles
• Pediatric case load (tinea capitis is a meaningful segment)
• Treatment-access constraints that support oral low-cost options
• Supply continuity from generic manufacturers
• Prescriber and guideline patterns that maintain an oral role for older agents

Key headwinds

• Generic price compression and SKU fragmentation
• Substitution toward terbinafine and azoles where clinically preferred
• Limited innovation-led differentiation
• Regulatory and pharmacovigilance burden associated with older substances, typically handled via routine variation packages rather than new approvals

How will the griseofulvin market evolve through 2030?

Base-case projection (demand-led, low growth)

Griseofulvin is structurally positioned as an off-patent antifungal. In such products, market growth usually tracks:

• Underlying dermatophyte disease burden
• Population growth and treatment penetration
• Periodic procurement and availability shocks
• Real-world adherence to oral regimens

A reasonable base-case for 2024-2030 is low single-digit CAGR, driven by volume rather than value. Pricing trends are likely flat-to-down due to generic competition.

Upside scenario (inventory and access improvements)

• Supply stabilization across manufacturing sites
• Increased oral treatment adoption in regions where topical access is inconsistent
• Public health efforts that improve diagnosis and treatment initiation

This scenario lifts volume growth and partially offsets price pressure.

Downside scenario (substitution and guideline drift)

• Increased global preference for terbinafine-centric pathways
• Greater reliance on topical strategies when feasible
• Continued physician shift away from long-course regimens

This compresses volumes further and accelerates price erosion.

What patent and exclusivity issues matter for griseofulvin commercialization?

Is griseofulvin still under patent protection?

Griseofulvin is long off-patent in major markets, and current competition is dominated by generics. Patent estate relevance typically appears only as:

• Formulation-specific patents for particular particle size, co-crystal-like solid forms, or dosing technologies
• Method-of-use patents tied to dosing schedules or combinations (less common for this class)
• Local rights for branded versions or legacy manufacturing processes

How does this affect clinical development?

Because core active substance protection is largely expired, investment shifts to:

• BE and formulation changes
• Local regulatory packages and label harmonization
• Rarely, new combination studies or pediatric-focused dosing analyses

What is the regulatory status of griseofulvin and how does it affect uptake?

FDA approval and labeling expectations

Griseofulvin is an established drug with a mature regulatory history. Regulatory pathways for new entrants are generally generic-based. Labeling and safety language influence switching behavior, especially for long courses and hepatic risk counseling.

How do safety and drug interactions affect commercial adoption?

Griseofulvin requires adherence to safety guidance around:

• Liver function considerations in at-risk patients
• Drug-drug interaction management due to metabolic induction properties common to older antifungals
• Monitoring practices that vary by country and clinician habits

These factors can reduce real-world switching compared with simpler regimens.

What are the main formulation and dosing variants that shape the market?

Oral dosing forms and patient adherence

Market structure often depends on:

• Tablet strength and dosing convenience
• Formulation changes that improve tolerability or bioavailability
• Pediatric dosing practicality

Are there meaningful differentiation opportunities?

Differentiation is limited. Most competitive differentiation is:

• Price and availability
• BE equivalence and local supply reliability
• Margin structure across wholesalers and public tenders

How strong is the patent estate for griseofulvin generics, and what does it mean for litigation risk?

What patent litigation risk exists?

For off-patent drugs, litigation is less common and usually localized to:

• Product-specific formulation patents
• Brand versus generic disputes where residual rights exist
• Legacy jurisdiction-specific rights

Any litigation that exists tends to be narrow and tied to specific versions rather than the active ingredient.

How does this influence new generic entry?

New entrants can typically rely on:

• Generic regulatory filing pathways
• BE packages rather than full clinical data
• Product manufacturing compliance rather than complex clinical endpoints

Clinical trial update: what is likely to be studied next?

Near-term likely study categories

• Additional BE studies as generics expand or switch manufacturing sites
• PK studies in subpopulations
• Safety follow-up observational studies tied to real-world prescribing patterns
• Limited head-to-head trials in regions where older oral agents remain common

Registration-enabling innovation outlook

Given the established role, any registration-enabling innovation would need clear clinical value in outcomes, tolerability, or duration of therapy. The public trial landscape is more consistent with incremental and compliance-driven studies.

Market projection by geography: where growth is most likely

Drivers by region

• Emerging markets: growth potential from unmet dermatophyte treatment access and expanding healthcare coverage
• Mature markets: mostly stable volume due to substitution by newer antifungals, with growth constrained by generics maturity

What can change projections materially

• National reimbursement policy shifts for dermatophytosis treatment
• Supply constraints or manufacturing changes affecting local availability
• Public health initiatives targeting tinea capitis and outbreaks

Key risks to forecast accuracy for griseofulvin

• Rapid substitution toward preferred oral antifungals in guideline updates
• Sudden supply disruptions in one or more major generic manufacturing regions
• Pricing compression accelerating faster than volume growth
• Regulatory labeling changes that tighten safety counseling and reduce switching

Key Takeaways

• Griseofulvin clinical development is predominantly generic-supporting: BE/PK/safety work rather than large phase 3 efficacy programs.
• Market growth is demand-led and low single-digit, with value constrained by generic price compression.
• Forecast outcomes hinge on dermatophyte disease burden management, supply stability, and substitution dynamics versus terbinafine and other modern oral agents.
• Patent and exclusivity barriers are limited in major markets, shifting commercial differentiation to formulation practicality, availability, and tender economics.

FAQs

1) Is griseofulvin still used for tinea capitis in children?
Yes in many settings, especially where oral therapy is indicated and where local prescribing and access favor older antifungals.

2) What adverse effects are most monitored with griseofulvin?
Hepatic considerations and tolerability over longer courses are primary monitoring themes.

3) Does food affect griseofulvin absorption and dosing guidance?
Food effects are commonly assessed in PK work; dosing guidance in product labels reflects these data.

4) How do generics of griseofulvin typically enter the market?
Primarily via generic regulatory pathways supported by bioequivalence and quality system compliance.

5) What factors most affect real-world prescribing of griseofulvin?
Adherence to longer regimens, safety counseling for drug interactions, and substitution toward newer oral antifungals.

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References

1. ClinicalTrials.gov. Search results for griseofulvin (accessed 2026-07-28).
2. U.S. Food and Drug Administration. Drugs@FDA records for griseofulvin (accessed 2026-07-28).