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Drug

Isavuconazole

Approved · EMA
Emerging researchLate-stage development

Also known as isavuconazol, isavuconazolum.

RxNorm1720882ChEMBLCHEMBL409153ATCJ02AC05UNII60UTO373KE
1
Research papers
3
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, Rituximab (TEDDI-R) in Primary CNS Lymphoma

Clinical trial2026-07-10Results expected Q3 2026 · ClinicalTrials.gov

Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A SINGLE ARM, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF ISAVUCONAZOLE FOR PRIMARY TREATMENT OF CHINESE PATIENTS WITH INVASIVE FUNGAL DISEASE (IFD) CAUSED BY ASPERGILLUS SPECIES OR OTHER FILAMENTOUS FUNGI

Clinical trial2026-05-27Results posted · ClinicalTrials.gov

A Study of Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)

Clinical trial2026-04-30Results expected Q3 2027 · ClinicalTrials.gov

A Single Center, Open-label Trial of Isavuconazole Prophylaxis Against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)

Clinical trial2025-05-16Results posted · ClinicalTrials.gov

Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

Clinical trial2024-12-11Results posted · ClinicalTrials.gov

A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.

Clinical trial2024-12-10Results posted · ClinicalTrials.gov

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

Clinical trial2024-12-10Results posted · ClinicalTrials.gov

A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia

Clinical trial2021-10-26Results posted · ClinicalTrials.gov

Defining and managing COVID-19-associated pulmonary aspergillosis: the 2020 ECMM/ISHAM consensus criteria for research and clinical guidance.

Research2020-12-14The Lancet. Infectious diseases

An Open-Label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of Acalabrutinib and Its Active Metabolite, ACP-5862, When Administered Alone and in Combination With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole

Clinical trial2020-04-15Completed · ClinicalTrials.gov

Approval: Cresemba (EMA)

Regulatory2015-10-15EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Isavuconazole
Aliases & brands
isavuconazolisavuconazolum
RxNorm CUI
1720882
ChEMBL ID
CHEMBL409153
ATC codes
J02AC05
UNII
60UTO373KE
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2015-10-15
Latest approval
2015-10-15
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2015-10-15Approval
Approval: Cresemba (EMA)
Indication: Powder for concentrate for solution for infusion: Cresemba is indicated in patients from 1 year of age and older for the treatment of invasive aspergillosis mucormycosis in… Show full indication

Powder for concentrate for solution for infusion: Cresemba is indicated in patients from 1 year of age and older for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Hard capsules: Cresemba hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Cresemba 40 mg hard capsules are intended to be used for paediatric patients.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

34 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
34
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
1
Recruiting
6
Late-stage (III+)
31
Completed
PHASE DISTRIBUTIONn = 34
Phase 125Phase 23Phase 2 / 31Phase 33Phase 41Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A SINGLE ARM, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF ISAVUCONAZOLE FOR PRIMARY TREATMENT OF CHINESE PATIENTS WITH INVASIVE FUNGAL DISEASE (IFD) CAUSED BY ASPERGILLUS SPECIES OR OTHER FILAMENTOUS FUNGI

CompletedPH IVPfizern=702025

Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

CompletedPH IIIAstellas Pharma Incn=1492016

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

CompletedPH IIIAstellas Pharma Incn=4502015

A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.

CompletedPH IIIAstellas Pharma Incn=5272013

Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia

CompletedPH II/IIIBasilea Pharmaceutican=182007

Recent completions

Trials that read out recently, adding to the completed evidence base.

A SINGLE ARM, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF ISAVUCONAZOLE FOR PRIMARY TREATMENT OF CHINESE PATIENTS WITH INVASIVE FUNGAL DISEASE (IFD) CAUSED BY ASPERGILLUS SPECIES OR OTHER FILAMENTOUS FUNGI

CompletedPH IVPfizern=702025

A Single Center, Open-label Trial of Isavuconazole Prophylaxis Against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)

CompletedPH IIMemorial Sloan Kettering Cancer Centern=992021

A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia

CompletedPH IIM.D. Anderson Cancer Centern=652020

An Open-Label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of Acalabrutinib and Its Active Metabolite, ACP-5862, When Administered Alone and in Combination With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole

CompletedPH IAcerta Pharma BVn=302020

Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

CompletedPH IIIAstellas Pharma Incn=1492016

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

CompletedPH IIIAstellas Pharma Incn=4502015

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • The Lancet. Infectious diseases1
Leading researchers
  • Bassetti M1
  • Böll B1
  • Brüggemann R1
  • Chakrabarti A1
  • Chen SCA1
  • Colombo AL1
  • Cornely OA1
  • Gangneux JP1
Leading institutions
free-text, unnormalised
  • Center of Expertise in Mycology Radboudumc/CWZ1
  • Centre for Infectious Diseases and Microbiology Laboratory Services1
  • Clinical and Translational Fungal-Working Group and Division of Infectious Diseases and Global Public Health1
  • College of Medicine1
  • Department of Clinical Mycology1
  • Duke University Medical Center1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Amphotericin B

Studied across 3 of the same disease areas as Isavuconazole in the shared literature.

3 shared diseases1 shared paper
liposomal amphotericin B

Studied across 3 of the same disease areas as Isavuconazole in the shared literature.

3 shared diseases1 shared paper
Voriconazole

Studied across 3 of the same disease areas as Isavuconazole in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.