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A fungal infection by any of the Candida species in a sterile body compartment.
Biomarker and diagnostic research for candidiasis, invasive has been reported in the published literature.
No approved treatments are currently available for candidiasis, invasive. An additional 5 compounds hold orphan drug designation.
While no drugs are FDA-approved specifically for candidiasis, invasive, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for candidiasis, invasive. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
Estimated prevalence: Unknown (Unknown prevalence).
8 clinical trials registered, 5 recruiting. Interventions under study include drug therapy and other interventions. Pipeline includes 2 PHASE4, 1 PHASE3, 1 PHASE2. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT05763251](https://clinicaltrials.gov/study/NCT05763251) |
Data assembled from 5 of 12 sources · Last updated Sep 20, 2026, 1:11 PM UTC
European rare disease database
Designated
Exclusivity End |
|---|
Designation Status |
|---|
fosmanogepix | fosmanogepix | Basilea Pharmaceutica Ltd, Allschwil | 2016 | — | Designated |
Rezzayo | rezafungin | Mundipharma GmbH | 2016 | 2030 | Designated (drug approved for other indication) |
isavuconazonium sulfate | isavuconazonium sulfate | Astellas Pharma Global Development, Inc. | 2014 | — | Designated |
recombinant human monoclonal antibody to hsp90 | recombinant human monoclonal antibody to hsp90 | Novartis Pharmaceuticals Corp. | 2002 | — | Withdrawn |
Amphotericin B lipid complex | Amphotericin B lipid complex | The Liposome Company, Inc. | 1996 | — | Withdrawn |
fosmanogepix is referenced in active clinical trials for candidiasis, invasive (designated 2016).
Gene therapy approaches for candidiasis, invasive have been reported in the published literature.
8 trials found
Comparison of Uncomplicated Candidemia Therapy Duration in Children
NA |
Arkansas Children's Hospital Research Institute |
RECRUITING |
[NCT03717623](https://clinicaltrials.gov/study/NCT03717623) | Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants | PHASE4 | Melbourne Health | RECRUITING |
[NCT03450005](https://clinicaltrials.gov/study/NCT03450005) | ECMM Candida Registry - CandiReg | — | University of Cologne | RECRUITING |
[NCT05421858](https://clinicaltrials.gov/study/NCT05421858) | A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis. | PHASE3 | Basilea Pharmaceutica | RECRUITING |
[NCT03538912](https://clinicaltrials.gov/study/NCT03538912) | Early Discontinuation of Empirical Antifungal Therapy and Biomarkers | NA | University Hospital, Lille | UNKNOWN |
275 publications have been identified in PubMed for candidiasis, invasive. Kisho has analyzed 145 by research type. Research spans Epidemiology / Natural History (29%), Review / Meta-Analysis (28%), and Clinical Trial Publication (12%).
Research Type | Count | % of Total |
|---|---|---|
Disease patterns and progression | 42 | 29% |
Research summaries | 41 | 28% |
Clinical study results | 17 | 12% |
Laboratory research | 16 | 11% |
Testing and diagnosis research | 12 | 8% |
Patient case studies | 8 | 6% |
New treatment approaches | 7 | 5% |
Other research | 2 | 1% |
Tan C (2026). [PMID: 41165332](https://pubmed.ncbi.nlm.nih.gov/41165332/). *Infect Control Hosp Epidemiol*. [Basic Science / Preclinical]
Parnandi VA (2026). [PMID: 41308648](https://pubmed.ncbi.nlm.nih.gov/41308648/). *Curr Biol*. [Case Report / Case Series]
Liu J (2026). [PMID: 41604463](https://pubmed.ncbi.nlm.nih.gov/41604463/). *Sci Transl Med*. [Clinical Trial Publication]
Standl L (2026). [PMID: 42023876](https://pubmed.ncbi.nlm.nih.gov/42023876/). *J Clin Microbiol*. [Clinical Trial Publication]
Zheng G (2026). [PMID: 41781919](https://pubmed.ncbi.nlm.nih.gov/41781919/). *BMC Pediatr*. [Clinical Trial Publication]
Quindós G (2026). [PMID: 41933578](https://pubmed.ncbi.nlm.nih.gov/41933578/). *Rev Iberoam Micol*. [Review / Meta-Analysis]
Jabrodini A (2026). [PMID: 41418970](https://pubmed.ncbi.nlm.nih.gov/41418970/). *Int J Biol Macromol*. [Case Report / Case Series]
Portugal Gonzales J (2026). [PMID: 41626302](https://pubmed.ncbi.nlm.nih.gov/41626302/). *Open Forum Infect Dis*. [Clinical Trial Publication]
Della Mina E (2026). [PMID: 42018653](https://pubmed.ncbi.nlm.nih.gov/42018653/). *JCI Insight*. [Gene Therapy / Novel Therapeutics]
Yi Q-L (2026). [PMID: 42037397](https://pubmed.ncbi.nlm.nih.gov/42037397/). *Antimicrob Agents Chemother*. [Epidemiology / Natural History]