CLINICAL TRIALS PROFILE FOR ERAXIS

All Clinical Trials for Eraxis

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00496197 ↗	Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis	Completed	Pfizer	Phase 4	2007-07-01	The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.
NCT00531479 ↗	Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis	Completed	Pfizer	Phase 3	2008-07-01	This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.
NCT00548262 ↗	This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis	Completed	Pfizer	Phase 4	2008-02-01	The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.
NCT00620074 ↗	Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)	Terminated	Pfizer	Phase 4	2008-08-01	This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.
NCT00672841 ↗	β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients	Completed	Pfizer	N/A	2008-06-01	This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.
NCT00672841 ↗	β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients	Completed	Duke University	N/A	2008-06-01	This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.

Clinical Trial Conditions for Eraxis

Condition Name

Condition Name for Eraxis
Intervention	Trials
Candidiasis	3
Fungemia	3
Aspergillosis	2
Candidemia	2

Condition MeSH

Condition MeSH for Eraxis
Intervention	Trials
Candidiasis	6
Candidiasis, Invasive	4
Candidemia	3
Fungemia	3

Clinical Trial Locations for Eraxis

Trials by Country

Trials by Country for Eraxis
Location	Trials
United States	55
Brazil	12
Canada	6
Italy	5
Russian Federation	5

Trials by US State

Trials by US State for Eraxis
Location	Trials
Texas	5
North Carolina	5
Michigan	5
Pennsylvania	4
Florida	4

Clinical Trial Progress for Eraxis

Clinical Trial Phase

Clinical Trial Phase for Eraxis
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Eraxis
Clinical Trial Phase	Trials
Completed	8
Terminated	3

Clinical Trial Sponsors for Eraxis

Sponsor Name

Sponsor Name for Eraxis
Sponsor	Trials
Pfizer	8
Duke University	1
Michael Cohen-Wolkowiez	1

Sponsor Type

Sponsor Type for Eraxis
Sponsor	Trials
Industry	8
Other	5
NIH	1

ERAXIS (Anidulafungin): Clinical Trials, Market Analysis, and Projections

Introduction

ERAXIS, also known as anidulafungin, is an echinocandin antifungal agent used to treat various fungal infections, including candidemia and other forms of invasive candidiasis. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Phase 3 Trials for Candidemia and Invasive Candidiasis

ERAXIS has been evaluated in several Phase 3 clinical trials. One notable study was a randomized, double-blind trial comparing the efficacy and safety of ERAXIS to fluconazole in patients with candidemia and other forms of invasive candidiasis. Patients received either IV ERAXIS (200 mg loading dose followed by 100 mg maintenance dose) or IV fluconazole (800 mg loading dose followed by 400 mg maintenance dose) for at least 14 and not more than 42 days. The results showed that ERAXIS was as effective as fluconazole, with similar safety profiles. The study also noted that the number of patients discontinuing the study due to adverse reactions was lower in the ERAXIS arm (11.5%) compared to the fluconazole arm (21.6%)[2][4].

Pediatric Trials

A prospective, open-label, non-comparative trial assessed the safety and efficacy of ERAXIS in 68 pediatric patients with candidemia/invasive candidiasis. Patients received once daily IV ERAXIS (3 mg/kg loading dose on Day 1, and 1.5 mg/kg daily maintenance dose thereafter) followed by an optional switch to oral fluconazole. The trial indicated that ERAXIS was safe and effective in this pediatric population[4].

Combination Therapy Trials

Another significant trial compared the combination of VFEND (voriconazole) and ERAXIS to VFEND monotherapy for the treatment of invasive aspergillosis. Although the combination therapy resulted in a lower all-cause mortality rate at six weeks, this difference did not achieve statistical superiority. The safety and tolerability of the combination were similar to those of VFEND monotherapy[1].

Safety and Efficacy

Adverse Reactions

Clinical trials have shown that ERAXIS has a favorable safety profile. Common adverse reactions include gastrointestinal disorders such as nausea, diarrhea, and vomiting, as well as general disorders like pyrexia and peripheral edema. The rate of discontinuation due to adverse events was lower in ERAXIS-treated patients compared to those receiving fluconazole[2][4].

Efficacy in Different Indications

ERAXIS has demonstrated high efficacy in treating candidemia and other forms of invasive candidiasis. In a trial comparing ERAXIS to fluconazole for esophageal candidiasis, ERAXIS showed an endoscopic success rate of 97.4%, although it had a higher relapse rate two weeks after completing therapy[4].

Market Analysis

Global Echinocandins Market

The global echinocandins market, which includes ERAXIS, is projected to grow rapidly. This growth is driven by the broad spectrum of activity of echinocandins, including their effectiveness against fungal strains resistant to other antifungal agents, and their lower side effect profile compared to other classes of antifungals[5].

Regional Market Share

North America is expected to account for the largest share of the global echinocandins market due to high research and development activities, ongoing clinical trials, and an increase in the incidence of fungal infections. Europe is anticipated to be the second largest market, driven by high awareness of treatment options and the rise in prevalence of chronic diseases. The Asia Pacific region is also expected to witness strong growth due to government initiatives to improve healthcare, an increase in the geriatric population, and high investment by key players[5].

Competitive Landscape

The global echinocandins market is highly fragmented, with several major players including Alkem Laboratories Ltd., Glenmark Pharmaceuticals Ltd., Teva Pharmaceutical Industries Ltd., and Merck & Co., Inc. This competition is expected to drive innovation and further growth in the market[5].

Market Projections

Growth Drivers

The market for ERAXIS and other echinocandins is expected to be driven by several factors:

• Expanding Indications: Echinocandins are being studied for secondary fungal infections, which is expected to expand their market.
• Increasing Incidence of Fungal Infections: The rise in healthcare-associated infections, such as invasive candidiasis, will drive the demand for effective antifungal agents.
• Advantages Over Other Antifungals: The broad spectrum of activity and lower side effect profile of echinocandins compared to other classes of antifungals will continue to make them a preferred choice[5].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as the emergence of resistance and the need for continuous innovation to stay ahead of fungal pathogens. However, these challenges also present opportunities for research and development, which can further solidify the position of ERAXIS and other echinocandins in the market.

Key Takeaways

• Clinical Efficacy: ERAXIS has shown strong efficacy in treating candidemia and other forms of invasive candidiasis, with a favorable safety profile.
• Market Growth: The global echinocandins market is projected to grow rapidly, driven by expanding indications, increasing incidence of fungal infections, and the advantages of echinocandins over other antifungals.
• Regional Dynamics: North America, Europe, and the Asia Pacific region are key markets, each driven by different factors such as research activities, awareness, and government initiatives.
• Competitive Landscape: The market is highly fragmented, with several major players driving innovation and growth.

FAQs

What are the common indications for ERAXIS?

ERAXIS is indicated for the treatment of candidemia and other forms of invasive candidiasis, as well as esophageal candidiasis[2].

How does ERAXIS compare to fluconazole in clinical trials?

ERAXIS has been shown to be as effective as fluconazole in treating candidemia and other forms of invasive candidiasis, with a lower rate of discontinuation due to adverse reactions[2][4].

What are the most common adverse reactions associated with ERAXIS?

Common adverse reactions include gastrointestinal disorders such as nausea, diarrhea, and vomiting, as well as general disorders like pyrexia and peripheral edema[2][4].

What is the projected growth of the global echinocandins market?

The global echinocandins market is projected to grow rapidly, driven by expanding indications, increasing incidence of fungal infections, and the advantages of echinocandins over other antifungals[5].

Which regions are expected to dominate the global echinocandins market?

North America is expected to account for the largest share, followed by Europe and the Asia Pacific region[5].

Sources

1. Pfizer Reports Top-Line Results Of A Phase 3 Clinical Trial Comparing The Efficacy And Safety Of VFEND® (voriconazole) And ERAXISTM (anidulafungin) Combination Therapy To VFEND Alone In Invasive Aspergillosis. Pfizer.
2. ERAXIS® (anidulafungin) | Pfizer Medical Information - US. Pfizer Medical Information.
3. COST-EFFECTIVENESS ANALYSIS OF ANIDULAFUNGIN FOR .... Value in Health Journal.
4. ERAXIS® (anidulafungin) Clinical Studies - Pfizer Medical Information. Pfizer Medical Information.
5. Echinocandins Market Key Trends and Opportunity Analysis up to 2027. BioSpace.

Last updated: 2024-12-31