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Disease
Aspergillosis
Late-stage therapeutic developmentEmerging researchRising momentum
3
Publications
18
Clinical trials
2024
Latest publication
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this disease.
BTK drives neutrophil activation for sterilizing antifungal immunity.
Research2024-05-02The Journal of clinical investigation
Research2016-06-29Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Regulatory2015-10-15EMA
Approval: Voriconazole Hikma (previously Voriconazole Hospira) (EMA)
Regulatory2015-05-27EMA
Approval: Voriconazole Accord (EMA)
Regulatory2013-05-16EMA
Research2008-02-01Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Regulatory2005-10-25EMA
Regulatory2002-03-19EMA
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: Low
Key developments
- 4 clinical trials with recent milestones.
Major developments
Major clinical milestoneImportant
Primary completion2026-06-03
Major clinical milestoneImportant
Primary completion2026-06-01
Clinical MilestonesViewHide
Recently completed
- 2026-06-30Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in ChildrenPrimary completion
- 2026-06-03A Randomized Controlled Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Increasing Time to Relapse in Patients With Chronic Pulmonary Aspergillosis Treated With 12 Months of Oral ItraconazolePrimary completion
- 2026-06-01A Randomized Trial Comparing the Role of Prednisolone, Itraconazole, or Their Combination in Patients with Acute Stage of Allergic Bronchopulmonary AspergillosisPrimary completion
- 2025-11-18Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus SpeciesPrimary completion
Activity timeline4
- 2026-06-30ClinicalStudy on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in ChildrenPrimary completion
- 2026-06-03ClinicalA Randomized Controlled Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Increasing Time to Relapse in Patients With Chronic Pulmonary Aspergillosis Treated With 12 Months of Oral ItraconazolePrimary completion
- 2026-06-01ClinicalA Randomized Trial Comparing the Role of Prednisolone, Itraconazole, or Their Combination in Patients with Acute Stage of Allergic Bronchopulmonary AspergillosisPrimary completion
- 2025-11-18ClinicalPhase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus SpeciesPrimary completion
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approved & established therapies
Posaconazoleapproved
Approval — Posaconazole Accord is indicated for use in the treatment of the following fungal infecti… (2019)
Isavuconazoleapproved
Approval — Powder for concentrate for solution for infusion: Cresemba is indicated in patients from… (2015)
Voriconazoleapproved
Approval — Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults an… (2015)
Clinical trials
The current development programme across all trial phases.
Clinical programme
18
6
16
5
Late-stage studies
Recruiting
Recently completed
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
First approvals
2019emaApproval — Posaconazole· Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults: Invasive aspergillosis; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. source ↗
2019emaApproval — Posaconazole· Posaconazole AHCL oral suspension is indicated for use in the treatment of the following fungal infections in adults: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. source ↗
2015emaApproval — Isavuconazole· Powder for concentrate for solution for infusion: Cresemba is indicated in patients from 1 year of age and older for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Hard capsules: Cresemba hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Cresemba 40 mg hard capsules are intended to be used for paediatric patients. source ↗
2015emaApproval — Voriconazole· Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)recipients. source ↗
2013emaApproval — Voriconazole· Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections. source ↗
2005emaApproval — Posaconazole· Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following invasive fungal infections in adult and paediatric patients from 2 years of age: Invasive aspergillosis Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in adults and paediatric patients from 2 years of age: Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in adults with oropharyngeal candidiasis. Noxafil gastro-resistant tablets are indicated for use in the treatment of the following invasive fungal infections in adults and paediatric patients from 2 years of age weighing more than 40 kg: Invasive aspergillosis Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in adults and paediatric patients from 2 years of age weighing more than 40 kg: Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products; Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following invasive fungal infections in paediatric patients from 2 years of age: Invasive aspergillosis Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age: Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. source ↗
2002emaApproval — Voriconazole· Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of in candidaemianon-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Vfend should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients. source ↗
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Publications over time
20082024
Most influential
Recent publications
Major themes4
- Agammaglobulinaemia Tyrosine Kinase1
- Aspergillosis1
- Neutrophil Activation1
- Neutrophils1
Leading journals2
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America2
- The Journal of clinical investigation1
Leading researchers8
- Denning DW2
- Herbrecht R2
- Kontoyiannis DP2
- Marr KA2
- Morrison VA2
- Patterson TF2
- Segal BH2
- Steinbach WJ2
Affiliations (unnormalised)6
- National Cancer Institute2
- California Institute for Medical Research1
- Centre de Recherche sur l'Inflammation1
- Department of Clinical Microbiology and Microbial Pathogenesis1
- Duke University Medical Center1
- Geisel School of Medicine at Dartmouth1
Reference
Authoritative identity, definition & identifiers.
Defined in MeSH
Infections with fungi of the genus ASPERGILLUS.
Identifiers
References & data sources
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.