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Last Updated: January 15, 2025

CLINICAL TRIALS PROFILE FOR GRIFULVIN V


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All Clinical Trials for GRIFULVIN V

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00863863 ↗ A Relative Bioavailability Study of Griseofulvin 125 mg/5 mL Suspension Under Non-fasting Conditions Completed Actavis Inc. Phase 1 2006-01-01 To compare the rate and extent of absorption of griseofulvin from a test formulation of Griseofulvin 125 mg/5 mL Suspension versus the reference Grifulvin V® 125 mg/5 mL Suspension under fed conditions.
NCT00864071 ↗ A Relative Bioavailability Study of Griseofulvin 125 mg/5 mL Suspension Under Fasting Conditions Completed Actavis Inc. Phase 1 2005-11-01 To compare the rate and extent of absorption of griseofulvin from a test formulation of Griseofulvin 125 mg/5 mL Suspension versus the reference Grifulvin V® 125 mg/5 mL Suspension under fasting conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for GRIFULVIN V

Condition Name

Condition Name for GRIFULVIN V
Intervention Trials
Healthy 2
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Condition MeSH

Condition MeSH for GRIFULVIN V
Intervention Trials
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Clinical Trial Locations for GRIFULVIN V

Trials by Country

Trials by Country for GRIFULVIN V
Location Trials
Canada 2
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Clinical Trial Progress for GRIFULVIN V

Clinical Trial Phase

Clinical Trial Phase for GRIFULVIN V
Clinical Trial Phase Trials
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for GRIFULVIN V
Clinical Trial Phase Trials
Completed 2
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Clinical Trial Sponsors for GRIFULVIN V

Sponsor Name

Sponsor Name for GRIFULVIN V
Sponsor Trials
Actavis Inc. 2
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Sponsor Type

Sponsor Type for GRIFULVIN V
Sponsor Trials
Industry 2
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Grifulvin V: Clinical Trials, Market Analysis, and Projections

Introduction

Grifulvin V, also known as griseofulvin microsize, is an antifungal medication widely used to treat various fungal infections of the skin, hair, and nails. This article delves into the clinical trials, market analysis, and future projections for Grifulvin V, providing a comprehensive overview of its use, efficacy, and market dynamics.

Clinical Uses of Grifulvin V

Grifulvin V is indicated for the treatment of several types of fungal infections, including:

  • Tinea Capitis (Ringworm of the Scalp)
  • Tinea Corporis (Ringworm of the Body)
  • Tinea Pedis (Athlete's Foot)
  • Tinea Unguium (Onychomycosis; Ringworm of the Nails)
  • Tinea Cruris (Ringworm of the Thigh)
  • Tinea Barbae (Barber's Itch)[1].

Mechanism of Action

Grifulvin V acts systemically to inhibit the growth of fungi by binding to keratin in human cells and then interfering with the function of spindle and cytoplasmic microtubules in fungal cells. This process alters the fungal cell mitosis and nuclear acid synthesis, making it a fungistatic agent rather than a fungicidal one[5].

Clinical Trials and Efficacy

Several clinical trials have compared the efficacy of Grifulvin V with other antifungal agents, particularly terbinafine.

  • Griseofulvin vs. Terbinafine in Tinea Capitis: A meta-analysis of randomized clinical trials showed that while griseofulvin is the current treatment of choice for tinea capitis, terbinafine is variably effective and can be as effective as griseofulvin in some cases. For Trichophyton species infections, a 2- to 4-week course of terbinafine was found to be at least as effective as a 6- to 8-week course of griseofulvin. However, griseofulvin may be superior for infections caused by Microsporum species[4].

Side Effects and Warnings

Grifulvin V can cause several side effects, including:

  • Hypersensitivity Reactions: Skin rashes, urticaria, and rarely angioneurotic edema or erythema multiforme-like drug reactions.
  • Other Side Effects: Oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion, and impairment of performance of routine activities.
  • Serious Warnings: Proteinuria, leukopenia, and granulocytopenia have been reported rarely. It is also contraindicated in pregnant women and those planning to become pregnant within a month after treatment due to potential teratogenic effects[1].

Market Analysis

The griseofulvin market is expected to experience significant growth driven by several key factors:

  • Increase in Fungal Infections: The rise in cases of dermatophytosis, particularly post-COVID-19, is a major driver. Weakened immunity in patients recovered from COVID-19 has led to an increase in fungal infections[2].
  • Geriatric Population: The globally rising geriatric population contributes to the high prevalence of dermatophytosis, as the immune system weakens with age[2].
  • Lifestyle Factors: Sedentary lifestyles and the increase in hospital-acquired diseases have also contributed to the higher rate of dermatophytosis[2].

Market Trends

  • Post-COVID-19 Impact: The pandemic has accelerated the growth of the griseofulvin market due to the increased incidence of fungal infections among patients with weakened immunity[2].
  • Competitive Landscape: Griseofulvin faces competition from newer antifungal agents like terbinafine and itraconazole, which have broader spectra of activity and higher efficacy rates. However, griseofulvin remains a potent molecule for treating tinea capitis and other dermatophyte-related infections[2].

Key Market Players

The griseofulvin market includes several key players such as:

  • BAL Pharma Ltd
  • Inga Pharmaceuticals
  • Chifeng Pharmaceutical Co. Ltd
  • Sun Pharmaceuticals
  • Pfizer
  • Dr. Reddy’s Laboratories
  • GlaxoSmithKline Plc.
  • Comed Chemicals Limited
  • CFL Pharmaceuticals Limited
  • Nippon Kayaku[2].

Future Projections

The griseofulvin market is anticipated to grow significantly over the next few years due to the increasing demand for antifungal treatments. Here are some key projections:

  • Market Growth: The market is expected to grow due to the rise in fungal infection cases and the need for effective treatments, especially in regions with high prevalence rates[2].
  • Research and Development: Investment in R&D is crucial for discovering new potential activities of griseofulvin and improving its efficacy. This could lead to new treatment options and market expansion[2].

Challenges and Limitations

Despite the growth potential, the griseofulvin market faces several challenges:

  • Lack of Awareness: Limited awareness about dermatophytosis and its treatment options hampers market growth.
  • Patient Reluctance: Reluctance among patients to seek treatment for fungal infections also limits market expansion[2].
  • Competition from Newer Drugs: Griseofulvin's relatively low efficacy compared to newer antifungal agents like terbinafine and itraconazole poses a significant challenge[2].

Key Takeaways

  • Grifulvin V is an effective antifungal medication for treating various fungal infections.
  • Clinical trials have shown variable efficacy compared to other antifungal agents like terbinafine.
  • The market is driven by increasing cases of fungal infections, particularly post-COVID-19.
  • Key players are investing in R&D to improve efficacy and expand market share.
  • Challenges include lack of awareness, patient reluctance, and competition from newer drugs.

FAQs

What are the primary uses of Grifulvin V?

Grifulvin V is used to treat fungal infections such as tinea capitis, tinea corporis, tinea pedis, tinea unguium, tinea cruris, and tinea barbae[1].

How does Grifulvin V work?

Grifulvin V inhibits fungal cell mitosis and nuclear acid synthesis by binding to and interfering with the function of spindle and cytoplasmic microtubules in fungal cells[5].

What are the common side effects of Grifulvin V?

Common side effects include hypersensitivity reactions, oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, and mental confusion[1].

Why is the griseofulvin market expected to grow?

The market is expected to grow due to the increase in fungal infection cases post-COVID-19, the rising geriatric population, and sedentary lifestyles[2].

What are the challenges facing the griseofulvin market?

Challenges include lack of awareness about dermatophytosis, patient reluctance to seek treatment, and competition from newer antifungal agents[2].

Which companies are key players in the griseofulvin market?

Key players include BAL Pharma Ltd, Inga Pharmaceuticals, Chifeng Pharmaceutical Co. Ltd, Sun Pharmaceuticals, Pfizer, and others[2].

Sources

  1. RxList: Grifulvin V (Griseofulvin Microsize): Side Effects, Uses, Dosage, Overdose, Pregnancy, Alcohol.
  2. Allied Market Research: Griseofulvin Market Size & Growth | Analysis & Forecast 2030.
  3. Fortune Business Insights: Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032].
  4. PubMed: Griseofulvin versus terbinafine in the treatment of tinea capitis.
  5. DrugBank: Griseofulvin: Uses, Interactions, Mechanism of Action.

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