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).
NCT03149055 ↗	Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)	Active, not recruiting	Memorial Sloan Kettering Cancer Center	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).
NCT03241550 ↗	A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients	Completed	Basilea Pharmaceutica International Ltd	Phase 1	2017-10-02	The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.

Clinical Trial Conditions for isavuconazonium sulfate

Condition Name

Condition Name for isavuconazonium sulfate
Intervention	Trials
Healthy Subjects	3
Myeloproliferative Disorder	1
Pharmacokinetics of 14C-labeled Isavuconazole	1
Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate	1

Condition MeSH

Condition MeSH for isavuconazonium sulfate
Intervention	Trials
Hematologic Neoplasms	2
Aspergillosis	2
Mycoses	1
Pulmonary Aspergillosis	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
Tennessee	2
Ohio	2
North Carolina	2
Missouri	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 Update, Market Analysis, and 2025-2030 Projection

Last updated: April 28, 2026

What is isavuconazonium sulfate, and what is the commercial reality today?

Isavuconazonium sulfate is the prodrug of isavuconazole, an oral and IV azole antifungal approved for invasive fungal infections. Commercially, it competes in a narrow, high-acuity segment (invasive aspergillosis and mucormycosis) where prescribing depends on guideline fit, formulary adoption, and clinician familiarity.

Current branded footprint (global):

• Brand: CRESEMBA (isavuconazonium sulfate)
• Originator approvals: US/EU/JP across the major invasive mold indications
• Key competitor set (same therapeutic purpose):
  • Amphotericin B (including liposomal formulations)
  • Voriconazole (aspergillosis comparator)
  • Posaconazole (prophylaxis in selected settings; systemic use in some mold contexts)
  • Lipid amphotericin B for mucormycosis in practice

Commercial implication: Invasive fungal disease has structural demand (acute care, ICU exposure, neutropenia, transplant, hematology-oncology pipelines). But brand share is shaped by hospital pathways, safety profile preference (renal tolerance vs amphotericin; visual/auditory tolerability vs voriconazole), and stewardship decisions.

What clinical trials are active, and what do they target?

A precise “active trials” inventory must be anchored to a current, verifiable registry snapshot (ClinicalTrials.gov / EU CTR). With no registry feed or dated trial list in the prompt, a complete and accurate update cannot be produced.

No clinical-trial-specific claims (status, enrollment, endpoints, readouts, or phase changes) are included below.

What is the market for isavuconazonium sulfate, by use-case?

Demand drivers by clinical category

Isavuconazonium sulfate sales track invasive mold care pathways:

1. Invasive Aspergillosis (IA)

   • ICU and oncology-related disease burden
   • Therapy choices influenced by voriconazole toxicity and alternative-agent preference

2. Mucormycosis (including rhino-orbital-cerebral and pulmonary forms)

   • Often driven by high-risk immunosuppression
   • Therapy choices influenced by amphotericin tolerance, administration logistics, and institutional protocols

Purchase dynamics (where brands win or lose)

• Formulary inclusion in tertiary centers
• Step-in pathways (first-line vs salvage) in local guidelines
• IV-to-oral conversion and outpatient transition capability
• Pharmacovigilance history and drug-drug interaction management burden

How big is the addressable market, and what share can CRESEMBA sustain?

A numeric market size and share forecast requires at minimum:

• current unit sales and regional breakdown
• therapy incidence rates (aspergillosis, mucormycosis)
• competitive substitution rates (voriconazole vs amphotericin vs posaconazole)
• payer coverage and tender dynamics

The prompt does not provide these inputs, and a full, accurate projection cannot be generated without a verifiable dataset.

No numerical market sizing is provided.

What are the 2025-2030 market projection scenarios that fit the evidence base?

A credible 2025-2030 projection for isavuconazonium sulfate must incorporate:

• patent/market exclusivity timing and any generic entry risk
• competitor launches (new antifungals or formulation changes)
• guideline evolution and safety-profile reinforcement
• market access changes (hospital contracting, reimbursement)
• conversion to oral therapy and length-of-therapy trends

Those elements require current sources and timelines. The prompt includes no patent timeline, sales base year, or trial readout schedule. A complete, accurate forecast is not produced.

What is the key valuation and risk framework for R&D or investment decisions?

Even without numerical forecasts, business-relevant levers for isavuconazonium sulfate include:

• Label breadth and guideline positioning

  • Locked-in indications support baseline demand, but growth depends on expansions, rule-of-use changes, and clinician preference shifts

• Safety and tolerability economics

  • Reduced renal burden vs amphotericin can drive uptake in renally vulnerable cohorts
  • Clinician selection is influenced by monitoring burden compared with voriconazole

• Access and contracting

  • Hospital formularies can move slowly; the same brand can show steady growth or plateau depending on tender cycles

• Competitive substitution

  • Shelf competition is less about blockbuster rivalry and more about institutional therapy algorithms in IA and mucormycosis

Where could incremental growth come from (without relying on trial readouts)?

Growth levers that do not require an external trial registry update:

• Earlier intervention protocols that increase use in appropriate patients
• IV-to-oral transition optimization in hospitals that support outpatient follow-up pathways
• Transplant and hematology service line intensification (more early diagnosis and antifungal stewardship)
• Renal-safety preference in amphotericin-averse cohorts

These are pathway-driven rather than trial-outcome-driven.

Key regulatory and IP realities that shape the forecast

A forward-looking projection is tightly coupled to:

• patent term and exclusivity end dates
• key jurisdictional status (US vs EU vs Japan)
• enforcement posture and generic entry timelines

No IP dates were provided, so no legally grounded projection is included.

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Key Takeaways

• Isavuconazonium sulfate (CRESEMBA) remains concentrated in invasive aspergillosis and mucormycosis pathways where prescribing depends on formulary access and safety-driven substitution choices.
• A complete clinical trials update and a numeric 2025-2030 market projection cannot be produced from the information provided in the prompt.
• The highest-impact commercial levers are guideline fit, hospital contracting, IV-to-oral pathway adoption, and substitution dynamics versus voriconazole and amphotericin products.

FAQs

1. What infections does isavuconazonium sulfate treat?
   It treats invasive fungal infections including invasive aspergillosis and mucormycosis under its approved labeling.

2. What are the main competitor therapies for CRESEMBA?
   Amphotericin B (especially liposomal formulations) and voriconazole are primary comparators; posaconazole plays a role in prophylaxis and certain mold-related contexts.

3. What determines whether a hospital uses CRESEMBA?
   Formulary status, local treatment algorithms, safety considerations (renal tolerance vs amphotericin; monitoring burden vs voriconazole), and IV-to-oral workflow fit.

4. How should investors think about market growth for antifungals like CRESEMBA?
   Growth is typically pathway-driven (earlier diagnosis, stewardship algorithms, conversion to oral therapy) rather than broad population expansion.

5. Why can’t this response provide trial-by-trial updates and numeric projections?
   A complete and accurate update requires a current, dated registry and sales/IP dataset, which is not included in the prompt.

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References

[1] FDA. CRESEMBA (isavuconazonium sulfate) Prescribing Information.
[2] EMA. CRESEMBA (isavuconazole) Product Information.