CLINICAL TRIALS PROFILE FOR CASPOFUNGIN ACETATE

All Clinical Trials for Caspofungin Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00008359 ↗	Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment	Completed	National Cancer Institute (NCI)	Phase 3	2000-08-01	RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or amphotericin B liposomal is more effective for treating these side effects. PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with that of amphotericin B liposomal in treating patients who have persistent fever and neutropenia after receiving anticancer therapy.
NCT00008359 ↗	Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment	Completed	Memorial Sloan Kettering Cancer Center	Phase 3	2000-08-01	RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or amphotericin B liposomal is more effective for treating these side effects. PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with that of amphotericin B liposomal in treating patients who have persistent fever and neutropenia after receiving anticancer therapy.
NCT00020527 ↗	Caspofungin Acetate in Treating Children With Fever and Neutropenia	Completed	National Cancer Institute (NCI)	N/A	2001-03-01	RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and neutropenia caused by chemotherapy or bone marrow transplantation. PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating children who have fever and neutropenia caused by a weakened immune system.
NCT00082524 ↗	Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2004-04-01	This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3 months-17 years).
NCT00082537 ↗	MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2004-04-01	This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.
NCT00083343 ↗	Caspofungin for the Treatment of Non-blood Candida Infections (0991-045)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2004-05-01	Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection.
NCT00110045 ↗	Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	2005-02-01	RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant. PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.

Clinical Trial Conditions for Caspofungin Acetate

Condition Name

Condition Name for Caspofungin Acetate
Intervention	Trials
Fungal Infection	8
Candidiasis	4
Neutropenia	3
Leukemia	2

Condition MeSH

Condition MeSH for Caspofungin Acetate
Intervention	Trials
Mycoses	11
Candidiasis	7
Neutropenia	7
Infections	5

Clinical Trial Locations for Caspofungin Acetate

Trials by Country

Trials by Country for Caspofungin Acetate
Location	Trials
United States	77
Canada	10
Spain	5
France	2
Slovakia	2

Trials by US State

Trials by US State for Caspofungin Acetate
Location	Trials
Tennessee	3
New York	3
Nebraska	2
Missouri	2
Mississippi	2

Clinical Trial Progress for Caspofungin Acetate

Clinical Trial Phase

Clinical Trial Phase for Caspofungin Acetate
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	9
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Caspofungin Acetate
Clinical Trial Phase	Trials
Completed	16
Terminated	2
Not yet recruiting	1

Clinical Trial Sponsors for Caspofungin Acetate

Sponsor Name

Sponsor Name for Caspofungin Acetate
Sponsor	Trials
Merck Sharp & Dohme Corp.	11
National Cancer Institute (NCI)	5
European Organisation for Research and Treatment of Cancer - EORTC	2

Sponsor Type

Sponsor Type for Caspofungin Acetate
Sponsor	Trials
Other	11
Industry	11
NIH	5

Caspofungin Acetate: Clinical Trials, Market Analysis, and Projections

Introduction

Caspofungin acetate, marketed as Cancidas by Merck Sharp & Dohme, is a pivotal antifungal drug that has been widely used for the treatment of invasive fungal infections, particularly those caused by Candida and Aspergillus species. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Efficacy in Invasive Candidiasis and Aspergillosis

Caspofungin has demonstrated significant efficacy in clinical trials for the treatment of invasive candidiasis (IC) and invasive aspergillosis (IA). Studies have shown that caspofungin is effective in patients who are refractory to or intolerant of conventional antifungal therapies. For instance, clinical trials have reported favorable responses in 67-93% of patients with oropharyngeal and esophageal candidiasis, and efficacy equivalent to that of amphotericin B in invasive candidiasis[4].

ProCAS Study

The ProCAS study, a prospective, multicenter, observational study, further reinforced the effectiveness and safety of caspofungin in routine clinical practice. The study included 98 patients and reported favorable clinical responses in 91.9% of proven IC cases, 84% of probable IC cases, and 81.8% of probable IA cases. No serious adverse effects were observed, highlighting the safety profile of caspofungin[3].

Comparison with Rezafungin

A recent phase 3 trial, ReSTORE, compared the efficacy and safety of rezafungin with caspofungin in patients with candidaemia and invasive candidiasis. The results showed that rezafungin was non-inferior to caspofungin for the primary endpoints of day-14 global cure and 30-day all-cause mortality, indicating that caspofungin remains a robust standard for comparison[1].

Market Analysis

Current Market Size and Growth

The global caspofungin market was valued at USD 471.57 million in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 1.9% from 2024 to 2030. This growth is driven by the rising prevalence of candidiasis, increased usage of echinocandins, and public awareness regarding preventive measures for microbial infections[2].

Regional Market Segmentation

The market is segmented into regions such as North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Developed regions like North America and Europe hold significant shares due to a large patient population and the presence of major pharmaceutical companies. The Asia Pacific region, particularly countries like India and China, is expected to expand at a high CAGR due to improving healthcare facilities and increasing investment by pharmaceutical companies[5].

Distribution Channels and Indications

The market is also segmented by distribution channels and indications. The candidiasis segment, including invasive candidiasis, esophageal candidiasis, intra-abdominal abscesses, peritonitis, and pleural space infections, accounts for a major share of the global market. Caspofungin's approval as a first-line treatment for patients resistant to other antifungal agents further propels its market growth[5].

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the caspofungin market:

• Rising Prevalence of Candidiasis: The increasing incidence of candidiasis, including antibiotic-resistant strains like Candida auris, will continue to drive demand for effective antifungal therapies[2].
• Geriatric Population: The growing geriatric population, which is highly susceptible to severe fungal infections, will also contribute to market growth[2].
• Public Awareness: Increased public awareness about preventive measures for microbial infections will further boost the market[5].

Market Forecast

By 2030, the global caspofungin market is anticipated to reach a value slightly above its current level, driven by a steady CAGR. The Asia Pacific region is expected to show significant growth, while North America and Europe will continue to be major contributors to the global market[5].

Safety and Adverse Events

Clinical Trials Data

Clinical trials have consistently shown that caspofungin is well-tolerated and safe. The ProCAS study and other clinical trials have reported no serious adverse effects, with common treatment-emergent adverse events including pyrexia, hypokalaemia, pneumonia, septic shock, and anaemia[1][3].

Key Takeaways

• Efficacy: Caspofungin has proven efficacy in treating invasive candidiasis and aspergillosis, especially in patients refractory to or intolerant of conventional therapies.
• Market Growth: The global caspofungin market is expected to grow at a CAGR of 1.9% from 2024 to 2030, driven by rising candidiasis prevalence and public awareness.
• Regional Segmentation: North America and Europe are current market leaders, while the Asia Pacific region is expected to show significant growth.
• Safety Profile: Caspofungin has a favorable safety profile with no serious adverse effects reported in clinical trials.

FAQs

Q: What is caspofungin acetate used for?

A: Caspofungin acetate is used for the treatment of invasive fungal infections, including invasive candidiasis and invasive aspergillosis.

Q: How effective is caspofungin in clinical trials?

A: Caspofungin has shown high efficacy in clinical trials, with favorable responses in 67-93% of patients with oropharyngeal and esophageal candidiasis, and efficacy equivalent to that of amphotericin B in invasive candidiasis[4].

Q: What are the common adverse events associated with caspofungin?

A: Common treatment-emergent adverse events include pyrexia, hypokalaemia, pneumonia, septic shock, and anaemia[1][3].

Q: What is the current market size of caspofungin and its projected growth?

A: The global caspofungin market was valued at USD 471.57 million in 2023 and is expected to grow at a CAGR of 1.9% from 2024 to 2030[2].

Q: Which regions are expected to drive the growth of the caspofungin market?

A: The Asia Pacific region, particularly countries like India and China, is expected to show significant growth, while North America and Europe will continue to be major contributors to the global market[5].

Sources

1. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis: a randomised, double-blind, double-dummy, phase 3 trial. PubMed.
2. Caspofungin Market Size, Share And Growth Report, 2030. Grand View Research.
3. Efficacy and safety of caspofungin in critically ill patients. ProCAS study. PubMed.
4. Caspofungin: the first representative of a new antifungal class. Journal of Antimicrobial Chemotherapy.
5. Caspofungin Market | Global Analysis Report 2027. Transparency Market Research.