Invasive Aspergillosis

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule

2100%

+ 32 programs with unclassified modality

On Market (2)

Approved therapies currently available

VFENDApproved

voriconazole

Pfizer

Azole Antifungal [EPC]intravenous2002

10K Part D

VORICONAZOLEApproved

voriconazole

Pfizer

Azole Antifungal [EPC]oral2016

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

PfizerNEW YORK, NY

4 programs

VoriconazolePhase 3Small Molecule1 trial

Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker TestingN/A1 trial

Diagnostic Study of Biomarkers in BAL of ICU Patients With Lung InfiltratesN/A

IsavuconazoleN/ASmall Molecule1 trial

Active Trials

NCT02104479Unknown200Est. Dec 2020

NCT04550936Completed307Est. Dec 2023

NCT00836875Terminated31Est. May 2013

AstellasChina - Shenyang

2 programs

MicafunginPhase 41 trial

MicafunginPhase 21 trial

Active Trials

NCT00376337Terminated17Est. Sep 2008

NCT02646774Terminated43Est. Jun 2015

Kite PharmaCA - El Segundo

2 programs

AmbisomePhase 41 trial

AmBisomePhase 31 trial

Active Trials

NCT00158730Completed800Est. Jan 2005

NCT00334412Completed30Est. May 2006

F2GUK - Manchester

12 programs

OlorofimPhase 3

F901318Phase 11 trial

+7 more programs

Active Trials

NCT03076905Withdrawn0Est. Aug 2017

NCT02730442Completed20Est. Jun 2016

NCT03340597Completed45Est. Apr 2018

+8 more trials

ShionogiJapan - Osaka

1 program

OlorofimPhase 31 trial

Active Trials

NCT05101187Active Not Recruiting225Est. Nov 2026

Sharp TherapeuticsPA - Pittsburgh

1 program

Posaconazole IVPhase 2

MSDIreland - Ballydine

1 program

Posaconazole IVPhase 2

Quotient TherapeuticsMA - Cambridge

3 programs

F901318Phase 1

F901318 SDDPhase 1

IV F901318Phase 1

OrionUK - Cambridge

1 program

F901318 safetyPhase 1

Orion PharmaUK - Reading

1 program

F901318 safetyPhase 1

BiocorpFrance - Issoire

1 program

cyclosporine APhase 1

Gilead SciencesFOSTER CITY, CA

3 programs

AmBisomePHASE_3

AmbisomePHASE_4

Heidelberg PharmaGermany - Ladenburg

1 program

Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker TestingN/A

IQVIADURHAM, NC

1 program

OlorofimPHASE_3

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

AstellasMicafungin

Kite PharmaAmbisome

ShionogiOlorofim

PfizerVoriconazole

Kite PharmaAmBisome

AstellasMicafungin

F2GIV F901318

F2GF901318

F2Gcyclosporine A

F2GF901318 SDD

F2GF901318 Dose level A oral

F2GF901318

F2GMidazolam with F901318

F2GF901318 safety

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 1,956 patients across 19 trials

NCT02646774 AstellasMicafungin

Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis

Start: Mar 2014Est. completion: Jun 201543 patients

Phase 4Terminated

NCT00334412 Kite PharmaAmbisome

COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis

Start: Mar 2004Est. completion: May 200630 patients

Phase 4Completed

NCT05101187 ShionogiOlorofim

Olorofim Aspergillus Infection Study

Start: Mar 2022Est. completion: Nov 2026225 patients

Phase 3Active Not Recruiting

NCT00836875 PfizerVoriconazole

A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

Start: May 2009Est. completion: May 201331 patients

Phase 3Terminated

NCT00158730 Kite PharmaAmBisome

Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment

Start: Apr 2003Est. completion: Jan 2005800 patients

Phase 3Completed

NCT00376337 AstellasMicafungin

Micafungin Salvage Mono-therapy in Invasive Aspergillosis

Start: Jun 2006Est. completion: Sep 200817 patients

Phase 2Terminated

NCT02912026 F2GIV F901318

Radiolabelled IV and Oral Metabolism Study of F901318

Start: May 2019Est. completion: Jul 20190

Phase 1Withdrawn

NCT03340597 F2GF901318

Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects

Start: Dec 2017Est. completion: Apr 201845 patients

Phase 1Completed

NCT03076905 F2GF901318

Pharmacokinetics of IV Formulation

Start: May 2017Est. completion: Aug 20170

Phase 1Withdrawn

NCT03095547 F2Gcyclosporine A

Drug/Drug Interactions With F901318

Start: May 2017Est. completion: Oct 20170

Phase 1Withdrawn

NCT02808741 F2GF901318 SDD

Evaluation of Immediate Release Tablet

Start: Jul 2016Est. completion: Nov 201620 patients

Phase 1Completed

NCT02737371 F2GF901318 Dose level A oral

Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects

Start: May 2016Est. completion: May 201740 patients

Phase 1Completed

NCT02730442 F2GF901318

Study of Potential for Interaction of Fluconazole With F901318

Start: Feb 2016Est. completion: Jun 201620 patients

Phase 1Completed

NCT02680808 F2GMidazolam with F901318

Evaluation of the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe

Start: Jan 2016Est. completion: Jun 201620 patients

Phase 1Completed

NCT02394483 F2GF901318 safety

Single Ascending Oral Dose Study of F901318

Start: Oct 2015Est. completion: Sep 201646 patients

Phase 1Completed

NCT02342574 F2GF901318

F901318 Multiple Ascending Dose Study

Start: Feb 2015Est. completion: Sep 201672 patients

Phase 1Completed

NCT02142153 F2GF901318

F901318 Single Ascending Dose Study in Healthy Male Volunteers

Start: Aug 2014Est. completion: Oct 201440 patients

Phase 1Completed

NCT04550936 PfizerIsavuconazole

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

Start: Mar 2021Est. completion: Dec 2023307 patients

N/ACompleted

NCT02104479 PfizerDiagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

Start: Mar 2014Est. completion: Dec 2020200 patients

N/AUnknown

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals

14 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.