Aspergillosis

6
Pipeline Programs
5
Companies
21
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
1
4
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
4100%
+ 2 programs with unclassified modality

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Astellas
AstellasChina - Shenyang
3 programs
1
2
IsavuconazolePhase 3Small Molecule5 trials
isavuconazolePhase 3Small Molecule1 trial
FK463Phase 22 trials
Active Trials
NCT00036179Completed75Est. Jan 2002
NCT00036166Completed326Est. Jan 2002
NCT04707703Terminated8Est. Oct 2021
+5 more trials
BP
Basilea PharmaceuticaSwitzerland - Allschwil
2 programs
2
IsavuconazolePhase 3Small Molecule
isavuconazolePhase 3Small Molecule
GS
Gilead SciencesFOSTER CITY, CA
1 program
1
nebulised liposomal amphotericin BPhase 2/31 trial
Active Trials
NCT00263315Completed320Est. May 2006

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AstellasIsavuconazole
Astellasisavuconazole
AstellasIsavuconazole
AstellasIsavuconazole
Gilead Sciencesnebulised liposomal amphotericin B
AstellasIsavuconazole
AstellasFK463
AstellasFK463
AstellasIsavuconazole
AstellasIsavuconazole
AstellasIsavuconazole
AstellasIsavuconazole
AstellasIsavuconazole
AstellasIsavuconazole
AstellasIsavuconazole

Showing 15 of 21 trials with date data

Clinical Trials (21)

Total enrollment: 2,299 patients across 21 trials

NCT04707703AstellasIsavuconazole

Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis

Start: Mar 2021Est. completion: Oct 20218 patients
Phase 3Terminated
NCT00634049Astellasisavuconazole

Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

Start: Apr 2008Est. completion: May 2016149 patients
Phase 3Completed
NCT00413218AstellasIsavuconazole

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

Start: Mar 2007Est. completion: Mar 2015450 patients
Phase 3Completed
NCT00412893AstellasIsavuconazole

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Start: Mar 2007Est. completion: Mar 2013527 patients
Phase 3Completed
NCT00263315Gilead Sciencesnebulised liposomal amphotericin B

Inhalation of Liposomal Amphotericin B to Prevent Invasive Aspergillosis

Start: Jan 2000Est. completion: May 2006320 patients
Phase 2/3Completed
NCT03149055AstellasIsavuconazole

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

Start: May 2017Est. completion: Nov 202199 patients
Phase 2Completed
NCT00036179AstellasFK463

Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

Start: Feb 1999Est. completion: Jan 200275 patients
Phase 2Completed
NCT00036166AstellasFK463

Study of FK463 for the Treatment of Invasive Aspergillosis

Start: Jan 1999Est. completion: Jan 2002326 patients
Phase 2Completed
NCT04096157AstellasIsavuconazole

A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants

Start: Sep 2019Est. completion: Jan 202017 patients
Phase 1Completed
NCT02128321AstellasIsavuconazole

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

Start: Jan 2014Est. completion: Feb 201424 patients
Phase 1Completed
NCT01884636AstellasIsavuconazole

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

Start: Feb 2013Est. completion: Mar 201324 patients
Phase 1Completed
NCT01884558AstellasIsavuconazole

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

Start: Feb 2013Est. completion: Feb 201324 patients
Phase 1Completed
NCT01813461AstellasIsavuconazole

Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects

Start: Oct 2012Est. completion: Nov 20128 patients
Phase 1Completed
NCT01635946AstellasIsavuconazole

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

Start: Aug 2012Est. completion: Aug 201224 patients
Phase 1Completed
NCT01555918AstellasIsavuconazole

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

Start: Aug 2012Est. completion: Nov 201236 patients
Phase 1Completed
NCT01635972AstellasIsavuconazole

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

Start: Jun 2012Est. completion: Jul 201224 patients
Phase 1Completed
NCT01660477AstellasIsavuconazole

Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole

Start: Jun 2012Est. completion: Oct 201268 patients
Phase 1Completed
NCT01657838AstellasIsavuconazole

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

Start: May 2012Est. completion: May 201224 patients
Phase 1Completed
NCT01651325AstellasIsavuconazole

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

Start: May 2012Est. completion: May 201224 patients
Phase 1Completed
NCT01582425AstellasIsavuconazole

Drug Interaction Study of Isavuconazole and Methadone

Start: Apr 2012Est. completion: Jun 201224 patients
Phase 1Completed
NCT01582412AstellasIsavuconazole

Drug Interaction Study of Isavuconazole and Digoxin

Start: Mar 2012Est. completion: May 201224 patients
Phase 1Completed

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
Small Molecule is the dominant modality (100% of programs)
5 companies competing in this space