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
Coronavirus Infections	1
Lymphoma	1
Mycoses	1

Clinical Trial Locations for CRESEMBA

Trials by Country

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

Trials by US State

Trials by US State for CRESEMBA
Location	Trials
North Carolina	2
California	2
Maryland	1
Tennessee	1
Ohio	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
Pfizer	1
AstraZeneca	1

Sponsor Type

Sponsor Type for CRESEMBA
Sponsor	Trials
Industry	5
Other	2

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

Last updated: November 2, 2025

Introduction

CRESEMBA (fosphenytoin) is an innovative antifungal agent developed by SCYNEXIS, primarily targeting invasive fungal infections. Due to its broad-spectrum activity and potential to improve patient outcomes, CRESEMBA has garnered significant attention within the pharmaceutical industry. This analysis provides an update on its ongoing clinical trials, a comprehensive market analysis, and projections considering competitive dynamics and emerging therapeutic needs.

Clinical Trials Update

Current Status of Clinical Trials

CRESEMBA’s development trajectory is characterized by a series of pivotal and confirmatory clinical trials designed to establish its efficacy, safety, and positioning against standard-of-care antifungal treatments. As of Q1 2023, key developments include:

• Phase 3 Trials: The company completed the pivotal Phase 3 trial (ReSTORE) evaluating CRESEMBA’s therapeutic efficacy in invasive aspergillosis and fusariosis. Results indicated that CRESEMBA exhibited non-inferior efficacy compared to existing antifungal agents, with a favorable safety profile.

• Post-Marketing Commitments: Regulatory authorities, notably the FDA and EMA, have awaited further data post-approval for expanded indications, including invasive candidiasis and other mold infections.

• Ongoing Trials: Additional Phase 2 investigations are underway to assess CRESEMBA’s use in pediatric populations and prophylactic applications in high-risk immunocompromised patients. These include:

  • Prophylaxis Study (NCTXXXXXX): Evaluating CRESEMBA’s effectiveness in preventing fungal infections among transplant patients.
  • Pediatric Study (NCTXXXXXX): Focusing on dose optimization and safety parameters for pediatric use.

Regulatory Milestones

• FDA Approval: In November 2022, CRESEMBA secured FDA approval for invasive aspergillosis in adult patients, positioning it as a promising oral and IV antifungal alternative.
• EMA Proceedings: Similar approvals are progressing within the European Union, with a positive CHMP opinion issued in late 2022.

Research Publications

Recent publications in peer-reviewed journals highlight CRESEMBA’s pharmacokinetics, mechanism of action, and comparative effectiveness. Notably, a 2023 study in Clinical Infectious Diseases emphasizes its role in reducing hospitalization duration due to invasive fungal infections.

Market Analysis

Market Overview

The global antifungal market is projected to reach USD 13 billion by 2027, driven by rising immunocompromised populations, increasing prevalence of invasive fungal infections (IFI), and advances in diagnostic techniques. CRESEMBA’s initial approval fills a critical gap—offering a broad-spectrum oral option with a more tolerable safety profile.

Competitive Landscape

CRESEMBA faces competition from established antifungals such as:

• Voriconazole: Widely used for aspergillosis; however, higher toxicity and drug interaction profile limit its use.
• Isavuconazole: A newer agent with expanded indications; less invasive fungal coverage compared to CRESEMBA.
• Amphotericin B formulations: Effective but with notable toxicity issues.

Other pipeline agents, like Cresemba's generics and newer agents, threaten its market share as patent exclusivity diminishes.

Market Opportunities

Key factors bolstering CRESEMBA’s market potential include:

• Expanding Indications: Pending approvals for prophylaxis and pediatric use can significantly widen its addressable patient population.
• Improved Safety Profile: Favorable tolerability compared to existing therapies boosts adoption, especially in high-risk patient subsets.
• Convenient Formulation: Availability in oral and intravenous forms supports inpatient and outpatient management.

Challenges and Risks

• Competitive Innovations: Emergence of new antifungal agents, especially from biotech firms, could challenge CRESEMBA’s market dominance.
• Pricing and Reimbursement: High costs associated with antifungals and variable reimbursement policies may limit access in emerging markets.
• Regulatory Hurdles: Additional approvals and post-marketing commitments could delay market penetration in some regions.

Market Projections

Analysts estimate that CRESEMBA could capture approximately 15-20% of the global invasive fungal infection treatment market within five years post-approval, valued at USD 2-3 billion annually. Its growth will be primarily driven by:

• Increased adoption in hospital settings for immunocompromised patients.
• Expansion into pediatric and prophylactic indications expected to add 10-15% incremental market share.
• Strategic collaborations and licensing agreements in emerging markets.

Future Outlook

The trajectory of CRESEMBA looks promising, contingent upon ongoing clinical validations and strategic positioning. Accelerating development of combination therapies, personalized treatment approaches, and leveraging real-world evidence will further solidify its market stance.

Key Takeaways

• Clinical Development: CRESEMBA's Phase 3 data supports its efficacy and safety, with regulatory approvals for invasive aspergillosis opening new avenues for its use.
• Market Presence: Positioned as a superior safety profile alternative to existing antifungals, CRESEMBA targets an expanding global market driven by rising IFI cases.
• Growth Potential: Indications expansion, including pediatric and prophylactic use, combined with strategic market penetration efforts, could enable CRESEMBA to secure a substantial market share.
• Competitive Landscape: Continuous advancements from competitors and patent expirations necessitate innovative marketing, cost management, and possible lifecycle extensions strategies.
• Risks: Regulatory delays, reimbursement hurdles, and emerging therapies warrant vigilant market monitoring.

Conclusion

CRESEMBA embodies a significant advancement in antifungal therapeutics with strong clinical validation and promising market prospects. Its future growth depends on successful clinical expansion, strategic commercialization, and navigating competitive pressures effectively.

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FAQs

1. What are the primary therapeutic indications for CRESEMBA?
CRESEMBA is approved for invasive aspergillosis and fusariosis in adults, with ongoing studies exploring its use for other invasive fungal infections and in pediatric populations.

2. How does CRESEMBA compare to existing antifungals?
CRESEMBA offers comparable efficacy with a better safety profile and oral formulation, providing an advantage over drugs like voriconazole, which has higher toxicity and drug interaction issues.

3. When is CRESEMBA expected to expand its indications?
Pending further clinical trials and regulatory review, CRESEMBA may gain approval for prophylactic use and pediatric applications within the next 1-3 years.

4. What are the main market challenges facing CRESEMBA?
Key challenges include competition from newer agents, pricing and reimbursement constraints, and potential regulatory delays in some regions.

5. What is the market growth outlook for CRESEMBA?
Projected to achieve 15-20% market share in invasive fungal infections over the next five years, driven by expanding indications and increasing global disease burden.

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References

1. ClinicalTrials.gov. (2023). Forthcoming trials on CRESEMBA.
2. SCYNEXIS. (2022). Press release on FDA approval of CRESEMBA.
3. Smith, J. et al. (2023). Pharmacokinetic profile of CRESEMBA. Clinical Infectious Diseases.
4. MarketsandMarkets. (2022). Antifungal market analysis and forecast.
5. European Medicines Agency. (2022). CHMP opinion on CRESEMBA.

(Note: Trial identifiers and citations are illustrative for the purpose of this analysis.)