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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR MICAFUNGIN IN SODIUM CHLORIDE 0.9%


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505(b)(2) Clinical Trials for Micafungin In Sodium Chloride 0.9%

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 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Micafungin In Sodium Chloride 0.9%

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00047827 ↗ Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis Terminated Astellas Pharma Inc Phase 2 2002-12-01 The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.
NCT00048750 ↗ Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU Terminated Astellas Pharma Inc Phase 3 2003-01-01 The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.
NCT00105144 ↗ Study of Micafungin in Patients With Invasive Candidiasis or Candidemia Completed Astellas Pharma Inc Phase 3 2004-09-01 The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.
NCT00106288 ↗ Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia Completed Astellas Pharma Inc Phase 3 2003-01-01 The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.
NCT00189709 ↗ Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia Completed Astellas Pharma Taiwan, Inc. Phase 3 2004-08-01 To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia
NCT00189709 ↗ Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia Completed Astellas Pharma Inc Phase 3 2004-08-01 To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia
NCT00304772 ↗ Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients Withdrawn Astellas Pharma Inc Phase 4 2006-08-01 The purpose of this study is to verify the equivalence in clinical efficacy of fluconazole and micafungin for the treatment of Candida bloodstream infection in non-neutropenic patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Micafungin In Sodium Chloride 0.9%

Condition Name

Condition Name for Micafungin In Sodium Chloride 0.9%
Intervention Trials
Candidemia 8
Invasive Candidiasis 7
Candidiasis 7
Mycoses 3
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Condition MeSH

Condition MeSH for Micafungin In Sodium Chloride 0.9%
Intervention Trials
Candidiasis 21
Mycoses 20
Candidiasis, Invasive 14
Invasive Fungal Infections 11
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Clinical Trial Locations for Micafungin In Sodium Chloride 0.9%

Trials by Country

Trials by Country for Micafungin In Sodium Chloride 0.9%
Location Trials
United States 183
Canada 22
Brazil 12
France 10
Belgium 8
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Trials by US State

Trials by US State for Micafungin In Sodium Chloride 0.9%
Location Trials
Texas 13
North Carolina 12
California 11
Missouri 8
Michigan 8
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Clinical Trial Progress for Micafungin In Sodium Chloride 0.9%

Clinical Trial Phase

Clinical Trial Phase for Micafungin In Sodium Chloride 0.9%
Clinical Trial Phase Trials
Phase 4 18
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Micafungin In Sodium Chloride 0.9%
Clinical Trial Phase Trials
Completed 35
Terminated 12
Unknown status 4
[disabled in preview] 7
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Clinical Trial Sponsors for Micafungin In Sodium Chloride 0.9%

Sponsor Name

Sponsor Name for Micafungin In Sodium Chloride 0.9%
Sponsor Trials
Astellas Pharma Inc 20
Astellas Pharma China, Inc. 4
Radboud University 3
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Sponsor Type

Sponsor Type for Micafungin In Sodium Chloride 0.9%
Sponsor Trials
Industry 38
Other 35
NIH 4
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Micafungin in 0.9% Sodium Chloride Injection: Clinical Trials, Market Analysis, and Projections

Introduction

Micafungin, an echinocandin antifungal agent, is widely used for the treatment and prophylaxis of various fungal infections. Here, we will delve into the clinical trials, market analysis, and projections for Micafungin in 0.9% Sodium Chloride Injection.

Clinical Trials and Efficacy

Treatment Indications

Micafungin in Sodium Chloride Injection is indicated for the treatment of several serious fungal infections, including candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses in adult and pediatric patients 4 months of age and older. It is also used for the treatment of esophageal candidiasis and as a prophylaxis for Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT)[1].

Pediatric Studies

Clinical trials have been conducted to establish the efficacy and safety of micafungin in pediatric patients, including those younger than 4 months. Studies such as 9463-CL-6001 and 9463-CL-6002 involved infants less than 120 days old treated with micafungin at various doses. These studies, although limited by varying designs and endpoints, provided valuable data on the use of micafungin in this vulnerable population[3].

Comparative Studies

Micafungin has been compared to other antifungal agents in clinical studies. For instance, a study comparing micafungin to liposomal amphotericin B showed that micafungin demonstrated non-inferiority in treating invasive candidiasis, with a lower incidence of infusion-related reactions and a smaller mean peak decrease in estimated glomerular filtration rate[4].

Safety and Adverse Reactions

Common Adverse Reactions

The most common adverse reactions reported across adult and pediatric clinical trials include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache. In pediatric patients younger than 4 months, additional common adverse reactions include hypokalemia, acidosis, sepsis, anemia, and decreased oxygen saturation[1].

Drug Interactions

Micafungin can interact with other medications such as sirolimus, itraconazole, and nifedipine, necessitating monitoring and potential dosage adjustments to avoid toxicity[1].

Market Analysis

Market Size and Growth

The Micafungin Sodium For Injection market was valued at USD 3.49 billion in 2023 and is projected to reach USD 6.38 billion by 2031, growing at a CAGR of 8.2% during the forecast period. This growth is driven by innovations in pharmaceutical formulations, increased healthcare access, and the preference for injectable formulations in hospital settings[2].

Distribution Channels

The market is segmented by distribution channels, with hospitals being the primary channel due to the urgent need for antifungal medications in these settings. Clinics and online pharmacies also play significant roles, particularly for outpatient management of fungal infections[2].

Geographic Segmentation

The market is strategically segmented by geography, with North America, Europe, and the Asia-Pacific region being key markets. The demand in these regions is influenced by factors such as healthcare infrastructure, prevalence of fungal infections, and regulatory environments[2].

Market Projections

Regulatory Approvals and Market Expansion

New approvals and indications for micafungin can open up additional market opportunities, especially in regions with rising healthcare access. Regulatory environments, particularly in the EU, facilitate drug approval processes, further boosting market growth[2].

Increased Investment in Research and Development

Ongoing research to develop new antifungal agents and combinations can enhance the market for existing treatments like micafungin. Innovations in pharmaceutical formulations and delivery methods continue to contribute to market growth[2].

Healthcare Infrastructure Development

Improvements in healthcare infrastructure, especially in developing regions, can lead to increased accessibility to antifungal treatments, driving the demand for micafungin[2].

Key End-User Segments

Healthcare Providers

Healthcare providers, including hospitals, clinics, and specialized treatment centers, are crucial in the adoption and administration of micafungin. These providers directly influence treatment protocols and adoption rates[2].

Pharmaceutical Companies

Pharmaceutical companies play a vital role in manufacturing, distributing, and researching micafungin. Their efforts in enhancing formulations, improving efficacy, and determining new indications are essential for market penetration[2].

Pharmacokinetic Properties

Micafungin's pharmacokinetics are linear over the daily dose range, with no evidence of systemic accumulation and steady-state generally reached within 4 to 5 days. This predictable pharmacokinetic profile makes it a reliable choice for antifungal therapy[4].

Conclusion

Micafungin in 0.9% Sodium Chloride Injection is a critical antifungal agent with established efficacy in treating and preventing serious fungal infections. The drug's market is expected to grow significantly, driven by innovations, regulatory approvals, and improvements in healthcare infrastructure.

Key Takeaways

  • Efficacy: Micafungin is effective against various Candida infections and is used for prophylaxis in HSCT patients.
  • Safety: Common adverse reactions include gastrointestinal issues, thrombocytopenia, and neutropenia.
  • Market Growth: The market is projected to grow at a CAGR of 8.2% from 2023 to 2031.
  • Distribution: Hospitals are the primary distribution channel, with clinics and online pharmacies also playing significant roles.
  • Geographic Segmentation: North America, Europe, and the Asia-Pacific region are key markets.

FAQs

Q: What are the primary indications for Micafungin in Sodium Chloride Injection?

A: The primary indications include the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis, abscesses, and esophageal candidiasis, as well as prophylaxis for Candida infections in HSCT patients[1].

Q: What are the common adverse reactions associated with micafungin?

A: Common adverse reactions include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache[1].

Q: How is the Micafungin Sodium For Injection market expected to grow?

A: The market is projected to grow from USD 3.49 billion in 2023 to USD 6.38 billion by 2031, at a CAGR of 8.2%[2].

Q: What are the key distribution channels for micafungin?

A: The primary distribution channels include hospitals, clinics, and online pharmacies[2].

Q: What role do pharmaceutical companies play in the micafungin market?

A: Pharmaceutical companies are involved in manufacturing, distributing, and researching micafungin to enhance formulations, improve efficacy, and determine new indications[2].

Sources

  1. Baxter: Micafungin in 0.9% Sodium Chloride Injection.
  2. Verified Market Research: Micafungin Sodium For Injection Market Size And Forecast.
  3. FDA: NDA Multi-Disciplinary Review and Evaluation - Micafungin.
  4. European Commission: MICAFUNGIN-PSJ, INN-Micafungin Sodium.
  5. Health Canada: PRODUCT MONOGRAPH - Micafungin.

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