CLINICAL TRIALS PROFILE FOR ISAVUCONAZONIUM SULFATE

All Clinical Trials for Isavuconazonium Sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01813461 ↗	Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects	Completed	Basilea Pharmaceutica International Ltd	Phase 1	2012-10-01	The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.
NCT01813461 ↗	Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects	Completed	Astellas Pharma Global Development, Inc.	Phase 1	2012-10-01	The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.
NCT02059590 ↗	A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects	Completed	Basilea Pharmaceutica International Ltd	Phase 1	2013-04-01	The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of BAL8728 in human plasma, urine and/or feces after a single intravenous dose of pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815. Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled isavuconazonium sulfate will also be evaluated.
NCT02059590 ↗	A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects	Completed	Astellas Pharma Global Development, Inc.	Phase 1	2013-04-01	The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of BAL8728 in human plasma, urine and/or feces after a single intravenous dose of pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815. Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled isavuconazonium sulfate will also be evaluated.
NCT03149055 ↗	Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)	Active, not recruiting	Astellas Pharma US, Inc.	Phase 2	2017-05-04	The purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (HCT).

Clinical Trial Conditions for Isavuconazonium Sulfate

Condition Name

Condition Name for Isavuconazonium Sulfate
Intervention	Trials
Healthy Subjects	3
Invasive Aspergillosis	1
Invasive Mucormycosis	1
Myeloproliferative Disorder	1

Condition MeSH

Condition MeSH for Isavuconazonium Sulfate
Intervention	Trials
Hematologic Neoplasms	2
Aspergillosis	2
COVID-19	1
Myeloproliferative Disorders	1

Clinical Trial Locations for Isavuconazonium Sulfate

Trials by Country

Trials by Country for Isavuconazonium Sulfate
Location	Trials
United States	29
Japan	19
Germany	2
United Kingdom	2
Spain	1

Trials by US State

Trials by US State for Isavuconazonium Sulfate
Location	Trials
California	3
North Carolina	2
Missouri	2
Kentucky	2
Illinois	2

Clinical Trial Progress for Isavuconazonium Sulfate

Clinical Trial Phase

Clinical Trial Phase for Isavuconazonium Sulfate
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	2
Phase 1	4

Clinical Trial Status

Clinical Trial Status for Isavuconazonium Sulfate
Clinical Trial Phase	Trials
Completed	5
Recruiting	2
Active, not recruiting	1

Clinical Trial Sponsors for Isavuconazonium Sulfate

Sponsor Name

Sponsor Name for Isavuconazonium Sulfate
Sponsor	Trials
Astellas Pharma Global Development, Inc.	6
Basilea Pharmaceutica International Ltd	3
Astellas Pharma US, Inc.	1

Sponsor Type

Sponsor Type for Isavuconazonium Sulfate
Sponsor	Trials
Industry	11
Other	2

Isavuconazonium Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction

Isavuconazonium sulfate, the prodrug of isavuconazole, is a potent azole antifungal agent used in the treatment of invasive fungal diseases, including invasive aspergillosis and mucormycosis. This article provides an update on the clinical trials, market analysis, and future projections for this drug.

Clinical Pharmacology and Mechanism of Action

Isavuconazole, the active metabolite of isavuconazonium sulfate, works by inhibiting the cytochrome P450-dependent enzyme lanosterol 14-alpha-demethylase. This inhibition blocks the synthesis of ergosterol, a crucial component of the fungal cell membrane, leading to the accumulation of methylated sterol precursors and depletion of ergosterol, thereby weakening the fungal cell membrane and exerting a fungicidal effect[3].

Clinical Trials and Efficacy

Invasive Aspergillosis and Mucormycosis

The clinical efficacy of isavuconazonium sulfate (Cresemba) has been established through two pivotal Phase III studies. These studies involved patients with invasive aspergillosis and mucormycosis, many of whom were immunocompromised due to conditions such as hematological malignancy, neutropenia, graft-versus-host disease, and hematopoietic stem cell transplant. The trials demonstrated that isavuconazonium sulfate is effective in treating these invasive fungal diseases, with response rates comparable to those of voriconazole[4].

Pediatric Patients

Research on the pharmacokinetics of isavuconazonium sulfate in pediatric patients is ongoing. A recent case series reported the use of therapeutic drug monitoring to guide dosing in pediatric patients receiving isavuconazonium sulfate for invasive fungal diseases. The study highlighted the importance of monitoring serum isavuconazole concentrations to achieve and maintain therapeutic levels, typically between 2 mcg/mL and 4 mcg/mL[1].

Market Analysis

Current Market Size and Growth

The global market for isavuconazonium sulfate is experiencing significant growth. As of 2023, the market size was valued at approximately USD 1.2 billion and is projected to reach USD 2.5 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 9.8%[2].

Market Segmentation

The market is segmented based on type, application, and geography. Key applications include pharmaceutical and scientific research. The market is also segmented geographically into North America, Europe, Asia Pacific, and the rest of the world. Major players in the market include FCDA, Tecoland, Pharmaffiliates, and several others[2].

Competitive Landscape

The competitive landscape of the isavuconazonium sulfate market is characterized by several key players. These companies are evaluated based on their product offerings, financial statements, strategic approaches, and geographical penetration. The report also includes a SWOT analysis for the top players, highlighting their strengths, weaknesses, opportunities, and threats[2].

Market Projections

Forecasted Market Size

By 2030, the global market for isavuconazole, the active ingredient of isavuconazonium sulfate, is forecasted to reach USD 93 million, growing at a CAGR of 5.6% from 2024 to 2030[5].

Regional Growth

The market growth is expected to be driven by increasing demand across various regions, particularly in North America, Europe, and the Asia Pacific. The report provides detailed insights into the market dynamics, including country-level data and the impact of economic, social, and political factors[2].

Challenges and Considerations

Hepatic Impairment

Pharmacokinetic studies have shown that hepatic impairment significantly affects the systemic exposure of isavuconazole. Patients with mild to moderate liver impairment exhibit increased exposure to the drug, and its use in patients with severe hepatic impairment is not recommended unless the potential benefits outweigh the risks[3].

Drug Interactions

Isavuconazole is an inhibitor of CYP3A4 and CYP3A5 and acts as a CYP2B6 inducer, which can lead to interactions with other medicinal products. Therefore, careful monitoring and adjustment of dosages are necessary when isavuconazonium sulfate is used concomitantly with other drugs[3].

Key Takeaways

• Clinical Efficacy: Isavuconazonium sulfate has demonstrated efficacy in treating invasive aspergillosis and mucormycosis in clinical trials.
• Market Growth: The global market for isavuconazonium sulfate is projected to grow significantly, reaching USD 2.5 billion by 2030.
• Therapeutic Drug Monitoring: Monitoring serum isavuconazole concentrations is crucial for achieving and maintaining therapeutic levels, especially in pediatric patients.
• Hepatic Impairment and Drug Interactions: Careful consideration is needed for patients with hepatic impairment and when using isavuconazonium sulfate with other drugs due to potential interactions.

FAQs

What is the mechanism of action of isavuconazonium sulfate?

Isavuconazonium sulfate works by inhibiting the cytochrome P450-dependent enzyme lanosterol 14-alpha-demethylase, blocking the synthesis of ergosterol and weakening the fungal cell membrane[3].

What are the key clinical trials that established the efficacy of isavuconazonium sulfate?

The efficacy of isavuconazonium sulfate was established through two pivotal Phase III studies (Study 9766-CL-0104 and Study 9766-CL-0103) involving patients with invasive aspergillosis and mucormycosis[4].

How does hepatic impairment affect the use of isavuconazonium sulfate?

Hepatic impairment increases the systemic exposure of isavuconazole, and its use in patients with severe hepatic impairment is not recommended unless the potential benefits outweigh the risks[3].

What is the projected market size for isavuconazonium sulfate by 2030?

The global market for isavuconazonium sulfate is projected to reach USD 2.5 billion by 2030, growing at a CAGR of 9.8% from 2023 to 2030[2].

Who are the major players in the isavuconazonium sulfate market?

Major players include FCDA, Tecoland, Pharmaffiliates, Jigs chemical, Hangzhou Keying Chem, and several others[2].

Sources

1. Isavuconazonium Sulfate Dosing in Pediatric Patients Using Serum Therapeutic Drug Monitoring at a Single Center: A Case Series. Journal of Hematology and Oncology Pharmacy, October 2022.
2. Isavuconazonium Sulfate API Market Size, Share. Verified Market Reports.
3. Summary Basis of Decision for Cresemba. Health Canada.
4. Drug Trials Snapshots: CRESEMBA (aspergillosis). FDA.
5. Isavuconazole - Market Size. Valuates Reports.