CLINICAL TRIALS PROFILE FOR POSACONAZOLE

505(b)(2) Clinical Trials for Posaconazole

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01075984 ↗	Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520)	Completed	Merck Sharp & Dohme Corp.	Phase 1	2010-02-23	The purpose of this study is to collect pharmacokinetic (PK) information related to how well intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety and tolerability of this new formulation. In addition, the PK, safety, and tolerability of switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be evaluated. The data collected in this study will be compared to data collected in previous studies. Individuals who have been diagnosed by their physicians with a blood disease or cancer that can affect their infection-fighting white blood cells will be asked to participate in the trial. Since these blood diseases and their treatments can weaken the immune system, they may put these individuals at a high risk for getting a serious fungal infection of their internal organs or blood (invasive fungal infection). As these fungal infections can be hard to detect early and can be life-threatening, many physicians believe that individuals diagnosed with these diseases should receive antifungal therapy to try to lower their risk of getting this type of infection. Enrollment into this study will take place in several stages (cohorts). The determination of which cohort an individual will be asked to participate in is based on which cohort is open at the site at the time the individual is approached to consider study participation.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni Bucharest	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Universitaire Ziekenhuizen Leuven	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.

All Clinical Trials for Posaconazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002399 ↗	A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients	Completed	Schering-Plough	Phase 2	1969-12-31	The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.
NCT00002446 ↗	Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients	Completed	Schering-Plough	Phase 3	1998-08-01	The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.
NCT00033982 ↗	Posaconazole to Treat Invasive Fungal Infections	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2002-04-11	This study will evaluate the safety and effectiveness of posaconazole for treating invasive fungal infections. New therapies for these infections are needed for patients who do not respond, to or cannot tolerate, standard treatment. These patients include those with immune defects who have significant side effects from treatment with amphotericin or other antifungals. Patients 13 years of age or older who are on other primary NIH protocols with an invasive fungal infection 1) that does not respond to standard antifungal therapies; 2) for which there is no effective therapy; 3) who develop serious side effects from their current treatment; or 4) who have organ dysfunction that does not permit use of standard antifungal treatments may be eligible for this study. Candidates will be screened with a medical history, including a review of current and previous antifungal treatments, pregnancy test for women of childbearing potential, electrocardiogram (EKG), and detailed neurologic examination. Participants will take either 200 mg (1 teaspoonful) of liquid posaconazole by mouth four times a day or 400 mg (two teaspoonfuls) twice a day for a period of 28 days to 24 months. (The physician will determine the duration of treatment.) Patients will have monthly follow-up visits during the treatment period and 1 month after treatment is completed for the following procedures: - Detailed neurologic exam every 3 months - Blood tests every month - EKG every month - Imaging studies, including chest x-ray, computed tomography (CT), magnetic resonance imaging (MRI) radionuclide scanning or ultrasound, every month until the infection has been stable for three determinations. Thereafter, imaging studies will be done every 3 months as long as the infection remains stable or improves. On the last day of the study treatment period, participants will have a detailed neurologic exam and review of medications and medical complaints since their last visit.
NCT00034632 ↗	Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2001-04-01	This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A. which are refractory or resistant to standard antifungal therapies; B. for which there are currently no effective therapies; C. with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.

Clinical Trial Conditions for Posaconazole

Condition Name

Condition Name for Posaconazole
Intervention	Trials
Fungal Infection	14
Mycoses	10
Acute Myeloid Leukemia	7
Myelodysplastic Syndromes	5

Condition MeSH

Condition MeSH for Posaconazole
Intervention	Trials
Mycoses	37
Invasive Fungal Infections	21
Infections	17
Infection	17

Clinical Trial Locations for Posaconazole

Trials by Country

Trials by Country for Posaconazole
Location	Trials
United States	74
Belgium	14
France	11
Netherlands	10
Spain	9

Trials by US State

Trials by US State for Posaconazole
Location	Trials
Texas	12
California	7
Pennsylvania	6
Illinois	6
New York	5

Clinical Trial Progress for Posaconazole

Clinical Trial Phase

Clinical Trial Phase for Posaconazole
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	14
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Posaconazole
Clinical Trial Phase	Trials
Completed	50
Recruiting	15
Terminated	5

Clinical Trial Sponsors for Posaconazole

Sponsor Name

Sponsor Name for Posaconazole
Sponsor	Trials
Merck Sharp & Dohme Corp.	32
Radboud University	5
M.D. Anderson Cancer Center	4

Sponsor Type

Sponsor Type for Posaconazole
Sponsor	Trials
Other	72
Industry	57
NIH	2

Posaconazole: Clinical Trials, Market Analysis, and Projections

Introduction to Posaconazole

Posaconazole is a triazole antifungal medication widely used for the prevention and treatment of invasive fungal infections, particularly in immunocompromised patients such as those with hematologic malignancies or undergoing hematopoietic stem cell transplantation (HCT)[1].

Clinical Trials and Efficacy

Recent Clinical Studies

A recent retrospective, single-center cohort study at a national comprehensive cancer center evaluated the factors associated with subtherapeutic concentrations of the newer delayed-release tablet formulation of posaconazole. The study included 98 oncology patients receiving posaconazole at a standard dose of 300 mg orally per day. It found that albumin levels ≤3 g/dL and ideal body weight ≥60 kg were associated with subtherapeutic drug levels. The median concentration of posaconazole was 1.29 µg/mL, with 50% of patients receiving the drug for treatment failing to achieve concentrations ≥1.25 µg/mL[1].

Another prospective, non-randomized, single-arm study conducted at the Transplantation Center of Blood Diseases Hospital in China involved 143 patients who received posaconazole enteric-coated tablets for the prevention of pulmonary invasive fungal disease after HCT. The study showed a significantly lower breakthrough rate of 2.80% compared to the historical control group, indicating the efficacy of posaconazole in preventing invasive fungal infections. The blood drug concentration of posaconazole stabilized after 15 days of treatment, and there was no significant correlation between the UGT1A4*3 gene polymorphism and posaconazole blood drug concentration[4].

Safety and Adverse Events

The clinical trials have also highlighted the safety profile of posaconazole. The study in China reported a low incidence of liver adverse events, with only a slight increase in ALT levels after 14 days of medication. Overall, posaconazole enteric-coated tablets were found to be highly safe for prophylactic use in transplant patients[4].

Market Analysis

Current Market Size and Growth

The global posaconazole market was valued at USD 613.48 million in 2024 and is projected to reach USD 941.50 million by 2032, with a compound annual growth rate (CAGR) of 5.50% during the forecast period of 2025 to 2032. This growth is driven by the increasing demand for effective antifungal treatments, particularly for invasive fungal infections such as aspergillosis and candidiasis[2].

Market Segmentation

The posaconazole market is segmented by type (injection, delayed-release tablets, oral suspension, and others), applications (prophylaxis of invasive Aspergillus and Candida infections, oropharyngeal candidiasis, invasive infections by Candida, Mucor, and Aspergillus species), end-users (clinics, hospitals, diagnostic centers), and distribution channels (hospital pharmacy, retail pharmacy, online pharmacy). The oral suspension segment accounted for a noticeable share of the global market and is expected to experience significant growth in the near future[5].

Regional Analysis

North America holds a dominant position in the posaconazole market due to the presence of leading pharmaceutical companies and well-established healthcare infrastructure. The Asia-Pacific region is anticipated to experience significant growth, driven by government initiatives, expanding healthcare infrastructure, and increasing investment in research and development activities. Emerging regions such as India, China, and Brazil are also investing heavily in healthcare, presenting significant market opportunities for posaconazole[2].

Key Market Players

The market includes key players such as Fresenius Kabi and Aurobindo Pharma, which have launched generic versions and are expanding their portfolios to include posaconazole-based therapies. Other companies like Patheon and BrightGene Bio Medical Technology are focusing on strategy building to strengthen their product portfolios and expand their business in the global market[2][5].

Market Trends and Drivers

Growing Demand for Antifungal Treatments

The increasing prevalence of fungal infections, particularly in immunocompromised patients, is a major driver of the posaconazole market. The growing number of patients undergoing organ transplants and cancer therapies, who are at high risk of invasive fungal infections, further fuels the demand for effective antifungal medications like posaconazole[2].

Advancements in Drug Formulations

Recent innovations in drug formulations, such as the introduction of delayed-release tablets and enteric-coated tablets, have improved the bioavailability and patient compliance of posaconazole. These advancements have enhanced the accessibility and efficacy of the drug, contributing to market growth[1][4].

Government Support and R&D

Government support for antifungal drug development and the increasing investment in research and development activities are expected to further propel the market. Initiatives such as India's National Health Mission, which aims to enhance hospital infrastructure and improve access to critical medications, are driving the growth of the antifungal market[2].

Projections and Future Outlook

Market Growth Projections

The posaconazole market is poised for sustained growth over the forecast period, driven by the factors mentioned above. The projected CAGR of 5.50% indicates a steady increase in market size, with the market expected to reach USD 941.50 million by 2032[2].

Emerging Markets

Emerging regions such as Asia-Pacific and Latin America are expected to contribute significantly to the market growth. The expanding healthcare infrastructure and increasing focus on advancing therapies for various diseases, including fungal infections, in these regions will drive the demand for posaconazole[2].

Competitive Landscape

The market is expected to remain competitive with key players continuing to innovate and expand their product portfolios. The growing shift towards generic formulations and the entry of new players will further intensify competition, driving innovation and reducing costs[2][5].

Key Takeaways

• Clinical Efficacy: Posaconazole has shown high efficacy in preventing and treating invasive fungal infections, particularly in immunocompromised patients.
• Market Growth: The global posaconazole market is projected to grow from USD 613.48 million in 2024 to USD 941.50 million by 2032, with a CAGR of 5.50%.
• Regional Dominance: North America currently dominates the market, but the Asia-Pacific region is expected to experience significant growth.
• Advancements in Formulations: New drug formulations have improved bioavailability and patient compliance.
• Government Support: Government initiatives and increasing investment in R&D are driving market growth.

FAQs

What is the current market size of the global posaconazole market?

The global posaconazole market was valued at USD 613.48 million in 2024[2].

What is the projected growth rate of the posaconazole market?

The posaconazole market is projected to grow at a CAGR of 5.50% from 2025 to 2032[2].

Which regions are expected to drive the growth of the posaconazole market?

North America and the Asia-Pacific region are expected to be key drivers of market growth, with emerging regions such as India, China, and Brazil also contributing significantly[2].

What are the main factors driving the demand for posaconazole?

The increasing prevalence of fungal infections, advancements in drug formulations, and government support for antifungal drug development are major drivers of the posaconazole market[2].

What are the common formulations of posaconazole available in the market?

Posaconazole is available in various formulations including delayed-release tablets, oral suspension, injection, and others[2].

Sources

1. Real-world Experience of Posaconazole Therapeutic Drug Monitoring with the Newer Delayed-Release Tablet Formulation. Oxford Academic, 2024.
2. Global Posaconazole Market Size, Scope & Industry Trends By 2032. Data Bridge Market Research, 2024.
3. Indicative Budget Impact Of Posaconazole Versus Fluconazole In Preventing Invasive Fungal Infections. Value in Health, 2017.
4. The Therapeutic Efficacy and Blood Drug Concentration of Posaconazole Enteric-Coated Tablets in Preventing Pulmonary Invasive Fungal Disease After Hematopoietic Stem Cell Transplantation. Blood, 2023.
5. Posaconazole Market Report 2024 (Global Edition). Cognitive Market Research, 2023.