Clinical Trials

Numerous clinical trials, spanning Phase 1 pharmacokinetic studies through Phase 4 post-marketing evaluations, evaluate isavuconazole for invasive fungal infections—including invasive aspergillosis, mucormycosis, and candidiasis—and therapeutic drug monitoring in high-risk transplant recipients and intensive care patients. Sponsored by pharmaceutical companies such as Pfizer, Astellas Pharma, and Basilea Pharmaceutica alongside academic and government institutes, these studies encompass completed, recruiting, and active, non-recruiting protocols. Across these patient cohorts, the research primarily evaluates treatment safety, efficacy, and pharmacokinetic profiles.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07780565 NOT_YET_RECRUITING
Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome
M.D. Anderson Cancer Center
 2027-01-01 PHASE1
NCT03964090 ACTIVE_NOT_RECRUITING
Central Nervous System Lymphoma; Secondary Central Nervous System Lymphoma
National Cancer Institute (NCI)
 2019-06-27 PHASE2
NCT02203526 ACTIVE_NOT_RECRUITING
Primary Central Nervous System Lymphoma
National Cancer Institute (NCI)
 2014-08-14 PHASE1
NCT06440915 RECRUITING
Aspergillosis Invasive; Mucormycosis
Shanghai Children's Medical Center
 2024-06-06
NCT06756191 NOT_YET_RECRUITING
Pulmonary Mucormycosis
Bin Cao
 2025-01-10 PHASE4
NCT05630976 COMPLETED
Invasive Fungal Disease
Pfizer
 2023-02-07 PHASE4
NCT05630976 Recruiting
Invasive Fungal Disease
Pfizer
 2023-02-07 Phase 4
NCT04707703 TERMINATED
Severe Acute Respiratory Syndrome Coronavirus 2; Aspergillosis Invasive
Jeffrey Jenks, MD, MPH
 2021-03-16 PHASE3
NCT04486885 Unknown status
Cerebral Aspergillosis|Invasive Aspergillosis
Imagine Institute
 2021-08-01 --
NCT04777058 Completed
Invasive Fungal Infections|Pharmacokinetics|Intensive Care Unit
Radboud University Medical Center
 2021-03-01 --
NCT04550936 Completed
Invasive Aspergillosis|Mucormycosis
Pfizer
 2021-03-10 --
NCT03019939 COMPLETED
Acute Myeloid Leukemia; Myelodysplastic Syndrome; Neutropenia
M.D. Anderson Cancer Center
 2017-03-28 PHASE2
NCT05140096 COMPLETED
Healthy Volunteers
Acerta Pharma BV
 2020-01-03 PHASE1
NCT04096157 COMPLETED
Healthy Subjects
Astellas Pharma Global Development, Inc.
 2019-09-24 PHASE1
NCT03149055 COMPLETED
Hematologic Malignancy; Myeloproliferative Disorder
Memorial Sloan Kettering Cancer Center
 2017-05-04 PHASE2
NCT03327727 TERMINATED
Invasive Aspergillosis; Invasive Pulmonary Aspergillosis
Vical
 2018-02-20 PHASE2
NCT00413218 COMPLETED
Candidiasis, Invasive; Candidemia; Mycoses
Astellas Pharma Inc
 2007-03-08 PHASE3
NCT02128893 COMPLETED
Pharmacokinetics of Isavuconazole; Healthy Subjects
Astellas Pharma Global Development, Inc.
 2014-01 PHASE1
NCT02128321 COMPLETED
Pharmacokinetics of Repaglinide; Pharmacokinetics of Caffeine; Healthy Subjects
Astellas Pharma Global Development, Inc.
 2014-01 PHASE1
NCT00634049 COMPLETED
Aspergillosis; Invasive Fungal Infections
Astellas Pharma Inc
 2008-04-22 PHASE3
NCT01555866 COMPLETED
Pharmacokinetics of Isavuconazole; Healthy Volunteers; Renal Impaired
Astellas Pharma Global Development, Inc.
 2012-03 PHASE1
NCT00412893 COMPLETED
Aspergillosis; Invasive Fungal Infection
Astellas Pharma Inc
 2007-03-07 PHASE3
NCT01884636 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Methotrexate; Pharmacokinetics of 7-hydroxymethotrexate; Healthy Subjects
Astellas Pharma Global Development, Inc.
 2013-02 PHASE1
NCT01884558 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Metformin; Healthy Subjects
Astellas Pharma Global Development, Inc.
 2013-02 PHASE1
NCT01657890 COMPLETED
Pharmacokinetics of Isavuconazole; Healthy Volunteers; Safety and Tolerability in Elderly
Astellas Pharma Global Development, Inc.
 2012-06 PHASE1
NCT01555918 COMPLETED
Pharmacokinetics of BAL4815; Pharmacokinetics of BAL8728; Healthy Volunteers
Astellas Pharma Inc
 2012-08 PHASE1
NCT01813461 COMPLETED
Pharmacokinetics of 14C-labeled Isavuconazole; Healthy Subjects
Astellas Pharma Global Development, Inc.
 2012-10 PHASE1
NCT01660477 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Lopinavir/Ritonavir; Healthy Volunteers
Astellas Pharma Global Development, Inc.
 2012-06 PHASE1
NCT01635946 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Atorvastatin; Healthy Volunteers
Astellas Pharma Global Development, Inc.
 2012-08 PHASE1
NCT01657825 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of S- and R-warfarin; Pharmacodynamics of Warfarin; Healthy Volunteers
Astellas Pharma Global Development, Inc.
 2012-06 PHASE1
NCT01635972 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Bupropion; Healthy Volunteers
Astellas Pharma Global Development, Inc.
 2012-06 PHASE1
NCT01565720 COMPLETED
Pharmacokinetics of Isavuconazole; Healthy Volunteers
Astellas Pharma Global Development, Inc.
 2012-03 PHASE1
NCT01597986 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ethinyl Estradiol and Norethindrone; Healthy Volunteers
Astellas Pharma Global Development, Inc.
 2012-04 PHASE1
NCT01582425 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Methadone; Healthy Volunteers
Astellas Pharma Global Development, Inc.
 2012-04 PHASE1
NCT01582412 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Digoxin; Healthy Volunteers
Astellas Pharma Global Development, Inc.
 2012-03 PHASE1
NCT01657838 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ketoconazole; Healthy Adult Volunteers
Astellas Pharma Global Development, Inc.
 2012-05 PHASE1
NCT01651325 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Dextromethorphan; Healthy Adult Volunteers
Astellas Pharma Global Development, Inc.
 2012-05 PHASE1
NCT01711489 COMPLETED
Healthy Subjects; Pharmacokinetics of Isavuconazole; Pharmacokinetics of Plasma Mycophenolic Acid (MPA); Pharmacokinetics of Plasma Phenolic Glucuronide of MPA (MPAG)
Astellas Pharma Global Development, Inc.
 2012-03 PHASE1
NCT01711827 COMPLETED
Healthy Subjects; Pharmacokinetics of Isavuconazole; Pharmacokinetics of Prednisolone
Astellas Pharma Global Development, Inc.
 2012-02 PHASE1
NCT01535547 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Tacrolimus; Healthy Volunteers
Astellas Pharma Inc
 2011-12 PHASE1
NCT01809860 COMPLETED
Healthy Subjects; Pharmacokinetics of Isavuconazole; Pharmacokinetics of Sirolimus
Astellas Pharma Global Development, Inc.
 2011-11 PHASE1
NCT01494597 COMPLETED
Healthy
Astellas Pharma Inc
 2011-11 PHASE1
NCT01406171 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Midazolam; Healthy Volunteers
Astellas Pharma Inc
 2011-05 PHASE1
NCT00413439 COMPLETED
Acute Myeloid Leukemia
Basilea Pharmaceutica
 2006-05 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-21)

Check the Isavuconazole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isavuconazole selectively binds to and inhibits fungal cytochrome P450-dependent 14α-lanosterol demethylase, thereby suppressing ergosterol biosynthesis and compromising fungal cell membrane integrity. This structural disruption arrests fungal cell proliferation and induces cell lysis, establishing its therapeutic efficacy against life-threatening invasive fungal infections such as invasive aspergillosis and mucormycosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.