CLINICAL TRIALS PROFILE FOR NOXAFIL

All Clinical Trials for NOXAFIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00491764 ↗	A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2007-06-01	The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral administration of four dosing regimens of posaconazole relative to placebo and terbinafine, in the treatment of toenail onychomycosis.
NCT00726609 ↗	Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)	Completed	Merck Sharp & Dohme Corp.		2006-01-01	The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.
NCT00750737 ↗	Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)	Completed	Enzon Pharmaceuticals, Inc.	Phase 3	2008-06-01	The objective of this study is to compare the safety and efficacy of ABLC versus oral Posaconazole in the prevention of invasive fungal infections in high risk patients with hematologic malignancies or hematopoietic stem cell transplant. Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal infections associated with ABLC or Posaconazole prophylaxis. Secondary objective will be to compare the cost effectiveness of these two prophylactic regimens.
NCT00750737 ↗	Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)	Completed	M.D. Anderson Cancer Center	Phase 3	2008-06-01	The objective of this study is to compare the safety and efficacy of ABLC versus oral Posaconazole in the prevention of invasive fungal infections in high risk patients with hematologic malignancies or hematopoietic stem cell transplant. Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal infections associated with ABLC or Posaconazole prophylaxis. Secondary objective will be to compare the cost effectiveness of these two prophylactic regimens.
NCT00799071 ↗	Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)	Completed	Radboud University	Phase 2	2009-02-01	The purpose of this study is to find a dose for a twice daily regimen for posaconazole (PSZ) as prophylactic treatment in children with CGD, based on the PSZ trough level.
NCT00811642 ↗	Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2008-11-01	The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI

Clinical Trial Conditions for NOXAFIL

Condition Name

Condition Name for NOXAFIL
Intervention	Trials
Fungal Infection	6
Mycoses	3
Fungal Infections	2
Leukemia, Myeloid, Acute	2

Condition MeSH

Condition MeSH for NOXAFIL
Intervention	Trials
Mycoses	14
Invasive Fungal Infections	7
Leukemia	5
Infections	5

Clinical Trial Locations for NOXAFIL

Trials by Country

Trials by Country for NOXAFIL
Location	Trials
United States	11
Belgium	7
Netherlands	7
China	3
Canada	2

Trials by US State

Trials by US State for NOXAFIL
Location	Trials
Texas	3
Pennsylvania	2
Missouri	2
North Carolina	1
New York	1

Clinical Trial Progress for NOXAFIL

Clinical Trial Phase

Clinical Trial Phase for NOXAFIL
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	4
Phase 2	3

Clinical Trial Status

Clinical Trial Status for NOXAFIL
Clinical Trial Phase	Trials
Completed	16
Recruiting	4
Terminated	1

Clinical Trial Sponsors for NOXAFIL

Sponsor Name

Sponsor Name for NOXAFIL
Sponsor	Trials
Merck Sharp & Dohme Corp.	9
Radboud University	4
M.D. Anderson Cancer Center	3

Sponsor Type

Sponsor Type for NOXAFIL
Sponsor	Trials
Other	20
Industry	14

NOXAFIL Market Analysis and Financial Projection

Clinical Trials and Efficacy of Noxafil (Posaconazole)

Overview of Noxafil

Noxafil, also known as posaconazole, is a potent triazole antifungal agent developed by Schering-Plough Corporation. It is indicated for the treatment and prophylaxis of various serious fungal infections, including invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, and coccidioidomycosis, among others[3][4].

Key Clinical Trial Findings

A significant clinical study presented at the Trends in Medical Mycology (TIMM 2005) meeting highlighted the efficacy of Noxafil in preventing invasive fungal infections (IFIs) in allogeneic hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD). Here are the key findings:

• Reduction in Invasive Fungal Infections: Noxafil significantly reduced the incidence of aspergillosis and overall IFIs compared to fluconazole. Specifically, Noxafil reduced aspergillosis cases from 17 to 3 and overall IFIs from 22 to 7 during the treatment period[1].
• Mortality Reduction: The study showed that Noxafil decreased deaths attributed to IFIs, with 4 deaths in the Noxafil group versus 12 in the fluconazole group[1].
• Safety Profile: Both Noxafil and fluconazole demonstrated a similar safety profile, with both drugs being well tolerated by the patients[1].

Market Analysis of Noxafil

Global Antifungal Drugs Market

The global antifungal drugs market, within which Noxafil operates, is experiencing significant growth driven by several factors:

• Market Size and Growth: The global antifungal drugs market was valued at USD 17.39 billion in 2024 and is projected to reach USD 24.51 billion by 2034, growing at a CAGR of 3.49% from 2025 to 2034[2].
• Regional Dominance: North America currently dominates the market with a 42% share, while the Asia-Pacific region is expected to grow at the highest CAGR during the forecast period[2].

Posaconazole Market Specifics

The posaconazole market, specifically, is also on an upward trajectory:

• Market Size: The global posaconazole market was valued at USD 613.48 million in 2024 and is projected to reach USD 941.50 million by 2032, growing at a CAGR of 5.50% during the forecast period[5].
• Generic Formulations: The increasing availability of generic posaconazole formulations, such as those from Aurobindo Pharma and Fresenius Kabi, has significantly contributed to the market growth by making the treatment more accessible and affordable[5].

Market Projections

Regional Growth

• North America: This region continues to be a major market for posaconazole, driven by the presence of leading pharmaceutical companies, well-established healthcare infrastructure, and advanced treatment options[5].
• Asia-Pacific: This region is anticipated to experience significant growth due to increasing investments in healthcare infrastructure, government support for innovation, and the rising focus of pharmaceutical companies on advancing therapies for fungal infections[5].

Drivers of Growth

• Increasing Prevalence of Fungal Infections: The rising prevalence of fungal infections such as candidiasis and aspergillosis is a key driver of the market growth[2].
• Innovative Products and Awareness: Developments in innovative antifungal products and growing awareness about fungal diseases are further fueling the market growth[2].
• Generic Approvals: The approval and launch of generic posaconazole formulations are reducing treatment costs and increasing accessibility, particularly in regions with limited access to branded medications[5].

Challenges and Opportunities

Challenges

• Resistance and Emerging Pathogens: The market faces challenges from the emergence of fungal pathogens resistant to existing therapies and the difficulty in diagnosing and treating these infections[1].
• Regulatory Framework: The regulatory environment, while supportive, can be complex and may pose challenges for new product approvals and market entry[5].

Opportunities

• R&D Investments: Continued investments in research and development are expected to lead to the discovery of new treatments and improvements in existing therapies, driving market growth[5].
• Expanding Healthcare Access: Government initiatives and investments in healthcare infrastructure, especially in emerging markets, are expected to increase the demand for antifungal medications like posaconazole[5].

Key Takeaways

• Noxafil has demonstrated significant efficacy in reducing invasive fungal infections and mortality in high-risk patient populations.
• The global antifungal drugs market and the posaconazole market specifically are expected to grow substantially over the next decade.
• North America and Asia-Pacific are key regions driving the market growth.
• Generic formulations and continued R&D investments are crucial factors in the market's expansion.

FAQs

Q1: What is Noxafil used for? Noxafil (posaconazole) is used for the treatment and prophylaxis of various serious fungal infections, including invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, and coccidioidomycosis[3].

Q2: How effective is Noxafil in preventing invasive fungal infections? Noxafil has been shown to significantly reduce the incidence of aspergillosis and overall invasive fungal infections compared to fluconazole in clinical studies, particularly in allogeneic HSCT recipients with GVHD[1].

Q3: What is the projected market size of the global posaconazole market by 2032? The global posaconazole market is projected to reach USD 941.50 million by 2032, growing at a CAGR of 5.50% from 2025 to 2032[5].

Q4: Which regions are expected to drive the growth of the posaconazole market? North America and Asia-Pacific are expected to be the key regions driving the growth of the posaconazole market, with North America currently holding a dominant position and Asia-Pacific anticipated to experience significant growth[5].

Q5: How do generic formulations impact the posaconazole market? Generic formulations of posaconazole have significantly contributed to the market growth by making the treatment more accessible and affordable, reducing overall treatment costs, and increasing global access to this essential antifungal drug[5].

Sources

1. Schering-Plough Corporation Release: New Study Shows NOXAFIL(R) (Posaconazole) Oral Suspension Significantly Reduced Aspergillosis, Invasive Fungal Infections, Compared To Fluconazole, In Allogeneic Hematopoietic Stem Cell Transplant Recipients With Graft...
2. Precedence Research: Antifungal Drugs Market Size to Reach USD 24.51 Bn by 2034
3. Drug Patent Watch: Noxafil Drug Patent Profile
4. Merck: Noxafil injection and Noxafil delayed-release tablets
5. Data Bridge Market Research: Posaconazole Market Size, Scope & Industry Trends By 2032