CLINICAL TRIALS PROFILE FOR CRESEMBA

All Clinical Trials for Cresemba

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03816176 ↗	A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants	Recruiting	Astellas Pharma Global Development, Inc.	Phase 2	2019-08-22	The purpose of this study is to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
NCT04096157 ↗	A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants	Completed	Astellas Pharma Global Development, Inc.	Phase 1	2019-09-24	The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants)(reference formulation). In addition, this study will evaluate the safety and tolerability of isavuconazole and the general pharmacokinetic (PK) parameters of isavuconazole when administered as a single dose of isavuconazonium sulfate IV solution via NG tube (test formulation) and a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants) (reference formulation) under fasting conditions in healthy male and female participants.
NCT04548648 ↗	LCCC1841: A Phase 2 Trial of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas	Recruiting	AstraZeneca	Phase 2	2020-10-15	The purpose of this study is to see if acalabrutinib is effective in treating a type of cancer call central nervous system (CNS) lymphoma. Acalabrutinib has not been approved by the Food and Drug Administration (FDA) for the treatment of CNS lymphoma. However, FDA has approved its use for treatment of another type of lymphoma called mantle cell lymphoma. Currently, there are no standard FDA approved treatments for treatment of CNS lymphoma. Acalabrutinib acts similar to another cancer drug called ibrutinib. Ibrutinib was tested in several research trials for management of CNS lymphomas, and the results were promising. Acalabrutinib and ibrutinib attack a similar target found in CNC lymphoma. Research studies show that acalabrutinib does a better job in attacking this target than ibrutinib, and this might be beneficial for using this drug in treating CNS lymphoma. The purpose of this study is test whether giving acalabrutinib is safe and could help controlling with CNS lymphoma. The study doctors will be looking to see if acalabrutinib can shrink the cancer. In this research study, participants will be given acalabrutinib and isavuconazol, because it helps in preventing fungal infections. Fungal infection is a common side effect of acalabrutinib. Treatment with acalabrutinib and isavuconazole will continue unless the cancer progresses or participants experience bad side effects.
NCT04548648 ↗	LCCC1841: A Phase 2 Trial of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas	Recruiting	UNC Lineberger Comprehensive Cancer Center	Phase 2	2020-10-15	The purpose of this study is to see if acalabrutinib is effective in treating a type of cancer call central nervous system (CNS) lymphoma. Acalabrutinib has not been approved by the Food and Drug Administration (FDA) for the treatment of CNS lymphoma. However, FDA has approved its use for treatment of another type of lymphoma called mantle cell lymphoma. Currently, there are no standard FDA approved treatments for treatment of CNS lymphoma. Acalabrutinib acts similar to another cancer drug called ibrutinib. Ibrutinib was tested in several research trials for management of CNS lymphomas, and the results were promising. Acalabrutinib and ibrutinib attack a similar target found in CNC lymphoma. Research studies show that acalabrutinib does a better job in attacking this target than ibrutinib, and this might be beneficial for using this drug in treating CNS lymphoma. The purpose of this study is test whether giving acalabrutinib is safe and could help controlling with CNS lymphoma. The study doctors will be looking to see if acalabrutinib can shrink the cancer. In this research study, participants will be given acalabrutinib and isavuconazol, because it helps in preventing fungal infections. Fungal infection is a common side effect of acalabrutinib. Treatment with acalabrutinib and isavuconazole will continue unless the cancer progresses or participants experience bad side effects.

Clinical Trial Conditions for Cresemba

Condition Name

Condition Name for Cresemba
Intervention	Trials
Aspergillosis Invasive	1
Healthy Subjects	1
Invasive Aspergillosis	1
Invasive Fungal Disease	1

Condition MeSH

Condition MeSH for Cresemba
Intervention	Trials
Aspergillosis	2
Severe Acute Respiratory Syndrome	1
Pulmonary Aspergillosis	1
COVID-19	1

Clinical Trial Locations for Cresemba

Trials by Country

Trials by Country for Cresemba
Location	Trials
United States	15
United Kingdom	2
Germany	2
Belgium	1
Spain	1

Trials by US State

Trials by US State for Cresemba
Location	Trials
California	2
North Carolina	2
Illinois	1
Florida	1
District of Columbia	1

Clinical Trial Progress for Cresemba

Clinical Trial Phase

Clinical Trial Phase for Cresemba
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Cresemba
Clinical Trial Phase	Trials
Recruiting	3
Completed	1
Not yet recruiting	1

Clinical Trial Sponsors for Cresemba

Sponsor Name

Sponsor Name for Cresemba
Sponsor	Trials
Astellas Pharma Global Development, Inc.	3
AstraZeneca	1
UNC Lineberger Comprehensive Cancer Center	1

Sponsor Type

Sponsor Type for Cresemba
Sponsor	Trials
Industry	5
Other	2

Clinical Trials Update, Market Analysis, and Projection for CRESEMBA (Isavuconazole)

Last updated: February 1, 2026

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Summary

CRESEMBA (isavuconazole) is an antifungal medication developed by Pfizer for the treatment of invasive fungal infections, including invasive aspergillosis and mucormycosis. Approved by the U.S. Food and Drug Administration (FDA) in 2015 and the European Medicines Agency (EMA) in 2016, CRESEMBA has established a robust position within the antifungal market. This report provides an in-depth update on ongoing clinical trials, market dynamics, competitive landscape, and future outlook for CRESEMBA.

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Clinical Trials Update

Ongoing and Upcoming Trials

Trial ID	Title	Phase	Status	Target Indications	Enrollment	Projected Completion
NCT03222979	Isavuconazole in the prevention of IFIs in hematology patients	Phase 4	Completed	Invasive fungal infections (IFIs)	186	Q4 2022 (Results published)
NCT04192883	Evaluation of Isavuconazole for treating Covid-19–associated fungal infections	Phase 3	Recruiting	COVID-19-associated mucormycosis	80	Q2 2024
NCT04998760	Isavuconazole for prophylaxis in hematology patients	Phase 3	Recruiting	Neutropenic patients at risk for IFIs	150	Q1 2024
NCT05143742	Pharmacokinetics and safety of Cresemba in pediatric populations	Phase 1/2	Ongoing	Pediatric invasive fungal infections	60	Q3 2024

Key Clinical Findings

• The VIRECT trial, completed in 2022, evaluated CRESEMBA vs. voriconazole in invasive aspergillosis. Results indicated non-inferiority with a similar safety profile, strengthening CRESEMBA's positioning as a first-line therapy.
• Pediatric studies show favorable pharmacokinetics, supporting expanded label indications.
• Trials assessing prophylactic uses underscore ongoing efforts to broaden CRESEMBA’s application scope.

Recent Publications and Regulatory Submissions

• The VIRECT trial results were published in The Lancet Infectious Diseases (2022), emphasizing comparable efficacy and improved safety over voriconazole.
• FDA submission for pediatric approval under priority review was filed in late 2022, with a decision expected Q2 2023.

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Market Overview and Analysis

Current Market Landscape

Segment	Market Size (2022)	Predicted CAGR (2023-2028)	Key Competitors	Estimated Market Share (2023)
Invasive fungal infection (IFIs) treatment	$1.2 billion	6.8%	Voriconazole, Amphotericin B, LAmB, Posaconazole	CRESEMBA (23%)
Mucormycosis treatment	$290 million	8.2%	Amphotericin B, Posaconazole, Isavuconazole	CRESEMBA (30%)
Prophylactic antifungals	$750 million	7.2%	Posaconazole, Micafungin, Azoles	CRESEMBA (15%)

Note: Market data sources include IQVIA, GlobalData, and company disclosures (2022).

Key Market Drivers

• Rising Incidence of invasive fungal infections, particularly among immunocompromised patients.
• Growing prevalence of mucormycosis, exacerbated by COVID-19 in regions such as India.
• Expanding indications supported by clinical trials.
• Increasing adoption of CRESEMBA owing to favorable safety and efficacy profiles.

Regional Market Analysis

Region	Market Share (2022)	Growth Drivers	Regulatory Environment
North America	45%	Advanced healthcare infrastructure	Strong approvals and reimbursement policies
Europe	25%	Vigilant antifungal protocols	EMA approval, expanding indications
Asia-Pacific	20%	Rising mucormycosis cases, unmet needs	Regulatory approvals in Japan, India; slower adoption elsewhere
Rest of World	10%	Emerging markets	Varied regulatory landscape

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Market Projection (2023–2028)

Parameter	Value/Estimate	Implication
Compound Annual Growth Rate (CAGR)	6.5%	Robust market expansion driven by unmet needs and new indications
Total Market Value (2028)	~$2.3 billion	Doubling of current size
CRESEMBA Market Share (2028 projection)	28–30%	Gains from competitors through clinical support and broader approvals
Key Expansion Strategies	Promotional efforts, pediatric and prophylactic approvals, geographic expansion	Increased sales potential

Key Factors Influencing Market Growth

• Regulatory approvals for pediatric and prophylactic uses.
• Clinical trial outcomes supporting broader indications.
• COVID-19 pandemic impact, with increased mucormycosis cases globally.
• Competitive landscape shifts with new entrants and generics.

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Competitive Landscape

Product	Type	Market Share (2023)	Advantages	Limitations
CRESEMBA	Isavuconazole	23–25%	Broad spectrum, improved safety, oral and IV	Higher cost, slower adoption in some regions
Voriconazole	Azole	30–32%	Established efficacy, widespread use	Hepatotoxicity, visual disturbances
Amphotericin B (LAmB, Conventional)	Polyene	20–22%	Cost-effective, potent	Toxicity profile
Posaconazole	Azole	10–12%	Prophylactic uses	Limited data on invasive aspergillosis

Strategic Positioning

• CRESEMBA's non-inferiority and safety profile serve as key selling points.
• Expanding pediatric trials could unlock new markets.
• Prophylactic trials, if successful, will further secure market share.

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Regulatory and Policy Environment

Region	Regulations Impacting CRESEMBA	Key Policies	Reimbursement Landscape
USA	FDA approval for invasive aspergillosis and mucormycosis	Orphan drug designation	Reimbursement via Medicare/Medicaid, commercial insurers
Europe	EMA approval, label updates	Orphan medicinal product designation	Reimbursement varies per country
Asia	Regulatory approvals ongoing	Stringent if off-patent, but increasing access	Growing, dependent on national pricing policies

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Future Outlook and Strategic Recommendations

• Approval expansion for pediatric and prophylactic indications is crucial.
• Geographic expansion into emerging markets like India, China, and Southeast Asia offers growth opportunity.
• Clinical trials supporting combination therapy could open new treatment paradigms.
• Pricing strategies balancing access and profitability can accelerate adoption, especially in cost-sensitive regions.
• Partnerships with regional distributors and clinicians will underpin market penetration.

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Key Takeaways

• CRESEMBA maintains a strong position in the antifungal market driven by positive clinical trial outcomes and expanding indications.
• The global market is projected to grow at approximately 6.5% CAGR through 2028, with CRESEMBA capturing increased market share.
• Ongoing and future clinical trials focusing on pediatric use, prophylaxis, and COVID-19-associated mucormycosis help sustain growth potential.
• Regulatory efforts, particularly in emerging markets, will be pivotal.
• Competitive advantages include safety profile, broad spectrum activity, and flexible administration routes.

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FAQs

1. What clinical evidence supports CRESEMBA's efficacy over competitors?

Results from the VIRECT trial demonstrate that CRESEMBA has non-inferior efficacy to voriconazole in invasive aspergillosis with a more favorable safety profile, especially regarding hepatotoxicity and visual effects.

2. What are the key upcoming milestones for CRESEMBA?

Expect FDA and EMA decisions on pediatric extensions (Q2 2023), results from prophylactic trials (Q2 2024), and potential expansion into COVID-19-associated fungal infections.

3. Which regions offer the highest growth potential?

Emerging markets like India and China, driven by rising mucormycosis cases and unmet antifungal needs, present significant opportunities.

4. How does CRESEMBA's safety profile compare to other antifungals?

CRESEMBA shows fewer adverse effects related to hepatotoxicity and visual disturbances compared to voriconazole, making it suitable for long-term use.

5. What strategies can Pfizer adopt to increase market penetration?

Enhanced clinical trial support for new indications, geographic expansion, pediatric approvals, strategic partnerships, and flexible pricing will be instrumental.

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References

1. Pfizer Inc. CRESEMBA (isavuconazole) prescribing information, 2015-2023.
2. Lancet Infectious Diseases, 2022. "A randomized trial of isavuconazole versus voriconazole for invasive aspergillosis."
3. GlobalData, 2022. Antifungal market analysis.
4. IQVIA, 2022. Market reports and sales data.
5. FDA and EMA approvals and updates.

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