Isavuconazole

Phase 3Small molecule

Astellas

Isavuconazole is one of 180 small molecule programs targeting Mucormycosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

179

Competitors

Pipeline

Status by Indication[3][1]

Indication

MucormycosisActive, not recruiting

Disseminated CandidiasisActive, not recruiting

Candidiasis, InvasiveActive, not recruiting

AspergillosisUnknown

LymphomaActive, not recruiting

Kidney DiseaseActive, not recruiting

Fungal Infectious DiseaseActive, not recruiting

CandidemiaActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

MucormycosisPreclinical

Active, not recruiting

Disseminated CandidiasisPhase 3

Active, not recruiting

Candidiasis, InvasivePhase 3

Active, not recruiting

AspergillosisPreclinical

Unknown

LymphomaPhase 2

Active, not recruiting

Kidney DiseasePhase 1

Active, not recruiting

Fungal Infectious DiseasePhase 3

Active, not recruiting

CandidemiaPhase 3

Active, not recruiting

Myelodysplastic SyndromePhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Isavuconazole

Astellas

Phase 3

1 2

Oncaspar

SServier

Preclinical

15 3

Velban

EEastern Cooperative Oncology Group

Preclinical

15 4

Zofran

Novartis

Preclinical

2 5

Norvir

AbbVie

Preclinical

1 6

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

PEG-Intron

Merck & Co.

Preclinical

1 9

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 1Active, not recruiting

Primary Central Nervous System Lymphoma

NCT02203526

Q3 2028

Phase 2Active, not recruiting

Lymphoma

NCT03964090

Clinical

Trials by Indication[1]

Interaction9 trials

Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01657825·20 enrolled

Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion

Completed· Astellas logo

Astellas·Phase 1·NCT01635972·24 enrolled

Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole

Completed· Astellas logo

Astellas·Phase 1·NCT01660477·68 enrolled

Show 6 more trials

Drug Interaction Study of Isavuconazole and Methadone

Completed· Astellas logo

Astellas·Phase 1·NCT01582425·24 enrolled

Drug Interaction Study of Isavuconazole and Tacrolimus

Completed· Astellas logo

Astellas·Phase 1·NCT01535547·24 enrolled

Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

Completed· Astellas logo

Astellas·Phase 1·NCT01597986·24 enrolled

Drug Interaction Study of Isavuconazole and Midazolam

Completed· Astellas logo

Astellas·Phase 1·NCT01406171·24 enrolled

Drug Interaction Study of Isavuconazole and Digoxin

Completed· Astellas logo

Astellas·Phase 1·NCT01582412·24 enrolled

Drug Interaction Study of Isavuconazole and Cyclosporine

Completed· Astellas logo

Astellas·Phase 1·NCT01494597·24 enrolled

Adult Subject4 trials

A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01711489·24 enrolled

Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01657838·24 enrolled

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01711827·21 enrolled

Show 1 more trial

Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01651325·24 enrolled

Tics2 trials

A Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese Volunteers

Completed· Astellas logo

Astellas·Phase 1·NCT01555918·36 enrolled

A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole

Completed· Astellas logo

Astellas·Phase 1·NCT02128893·24 enrolled

Aspergillosis2 trials

Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

Completed· Astellas logo

Astellas·Phase 3·NCT00634049·149 enrolled

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Completed· Astellas logo

Astellas·Phase 3·NCT00412893·527 enrolled

Atorvastatin1 trial

Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Atorvastatin

Completed· Astellas logo

Astellas·Phase 1·NCT01635946·24 enrolled

18 more indications

Mucormycosis1 trial

Amphotericin B Versus Isavuconazole for Mucormycosis: A Comparative Efficacy and Safety Study

Active, not recruiting·QQiu Ye··NCT07191756·150 enrolled

Hematopoietic Stem Cell Transplant1 trial

Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03149055·99 enrolled

Lymphoma1 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03964090·48 enrolled

CAR1 trial

A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions.

Completed· Pfizer logo

Pfizer··NCT04550936·307 enrolled

Adult1 trial

A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants

Completed·AAcerta Pharma BV·Phase 1·NCT05140096·30 enrolled

Chemotherapy1 trial

Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy

Completed· Basilea Pharmaceutica logo

Basilea Pharmaceutica·Phase 2/3·NCT00413439·18 enrolled

Caffeine1 trial

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine

Completed· Astellas logo

Astellas·Phase 1·NCT02128321·24 enrolled

Methotrexate1 trial

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate

Completed· Astellas logo

Astellas·Phase 1·NCT01884636·24 enrolled

Metformin1 trial

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin

Completed· Astellas logo

Astellas·Phase 1·NCT01884558·24 enrolled

Myelodysplastic Syndrome1 trial

Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03019939·65 enrolled

Single Dose1 trial

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Sirolimus in Healthy Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01809860·22 enrolled

Elderly1 trial

Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01657890·28 enrolled

Renal Impairment1 trial

Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.

Completed· Astellas logo

Astellas·Phase 1·NCT01555866·49 enrolled

Candidemia1 trial

Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

Completed· Astellas logo

Astellas·Phase 3·NCT00413218·450 enrolled

Cardiac Repolarization1 trial

Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization

Completed· Astellas logo

Astellas·Phase 1·NCT01565720·161 enrolled

Drug Monitoring1 trial

Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Recruiting·SShanghai Children's Medical Center·N/A·NCT06440915·200 enrolled

LAM1 trial

Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi

Completed· Pfizer logo

Pfizer·Phase 4·NCT05630976·70 enrolled

Primary Central Nervous System Lymphoma1 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02203526·68 enrolled

Sources

References

[1]
ClinicalTrials.gov — 36 trial records for Isavuconazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Isavuconazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Isavuconazole. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Astellas

Isavuconazole

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q3 2028

Trials by Indication[1]

Interaction9 trials

Adult Subject4 trials

Tics2 trials

Aspergillosis2 trials

Atorvastatin1 trial

Mucormycosis1 trial

Hematopoietic Stem Cell Transplant1 trial

Lymphoma1 trial

CAR1 trial

Adult1 trial

Chemotherapy1 trial

Caffeine1 trial

Methotrexate1 trial

Metformin1 trial

Myelodysplastic Syndrome1 trial

Single Dose1 trial

Elderly1 trial

Renal Impairment1 trial

Candidemia1 trial

Cardiac Repolarization1 trial

Drug Monitoring1 trial

LAM1 trial

Primary Central Nervous System Lymphoma1 trial

References

Drug Info

Quick Facts

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