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 (1)

Approved therapies currently available

VFENDApproved

voriconazole

Pfizer

Azole Antifungal [EPC]intravenous2002

10K Part D

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 4

AmBisomePhase 3

F2GUK - Manchester

12 programs

OlorofimPhase 3

F901318Phase 11 trial

+7 more programs

Active Trials

NCT02142153Completed40Est. Oct 2014

NCT03076905Withdrawn0Est. Aug 2017

NCT03340597Completed45Est. Apr 2018

+8 more trials

ShionogiJapan - Osaka

1 program

OlorofimPhase 3

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

Orion PharmaUK - Reading

1 program

F901318 safetyPhase 1

OrionUK - Cambridge

1 program

F901318 safetyPhase 1

BiocorpFrance - Issoire

1 program

cyclosporine APhase 1

Gilead SciencesFOSTER CITY, CA

3 programs

AmBisomePHASE_31 trial

AmbisomePHASE_41 trial

AmbisomePHASE_4

Active Trials

NCT00158730Completed800Est. Jan 2005

NCT00334412Completed30Est. May 2006

Heidelberg PharmaGermany - Ladenburg

1 program

Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker TestingN/A

IQVIADURHAM, NC

1 program

OlorofimPHASE_31 trial

Active Trials

NCT05101187Active Not Recruiting225Est. Nov 2026

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

AstellasMicafungin

Gilead SciencesAmbisome

IQVIAOlorofim

PfizerVoriconazole

Gilead SciencesAmBisome

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 Gilead SciencesAmbisome

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

Start: Mar 2004Est. completion: May 200630 patients

Phase 4Completed

NCT05101187 IQVIAOlorofim

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 Gilead SciencesAmBisome

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.