Back to discover
Disease
Candidiasis
Late-stage therapeutic developmentEmerging researchRising momentum
8
Publications
18
Clinical trials
3
Related conditions
2024
Latest publication
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this disease.
Research2024-06-04Microbiology and molecular biology reviews : MMBR
Research2024-04-27International journal of molecular sciences
Regulatory2023-12-22EMA
Research2021-05-01FEMS microbiology reviews
Candida auris: Epidemiology, biology, antifungal resistance, and virulence.
Research2020-10-22PLoS pathogens
Candida auris: The recent emergence of a multidrug-resistant fungal pathogen.
Research2019-01-01Medical mycology
Research2015-09-15Circulation
Candida albicans Biofilms and Human Disease.
Research2015-01-01Annual review of microbiology
Regulatory2008-04-25EMA
Regulatory2007-09-20EMA
Regulatory2005-10-25EMA
Research2004-07-15Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: Moderate
Key developments
- 4 clinical trials expected to report results, the earliest in Q2 2027.
Upcoming Milestones
- Q2 2027Candi5V01 A FTIH Phase I/II Randomized and Controlled Study to Test Safety, Immunogenicity and Preliminary Efficacy of a Pentavalent Bioconjugate Vaccine (Candi5V) Against Candida in Women With Recurrent Vulvovaginal Candidiasis.
- Q4 2027A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
- Q1 2028An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis
- Q1 2031A Phase 2 Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis
Major developments
Upcoming trial readoutHigh impact
Results expected Q1 20282026-06-15
Upcoming trial readoutHigh impact
Results expected Q4 20272026-06-22
Clinical MilestonesViewHide
Results expected
- 2026-06-22A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia AreataResults expected Q4 2027
- 2026-06-15An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive CandidiasisResults expected Q1 2028
- 2026-03-04Candi5V01 A FTIH Phase I/II Randomized and Controlled Study to Test Safety, Immunogenicity and Preliminary Efficacy of a Pentavalent Bioconjugate Vaccine (Candi5V) Against Candida in Women With Recurrent Vulvovaginal Candidiasis.Results expected Q2 2027
- 2025-12-11A Phase 2 Randomized Stepped Wedge Study of Emapalumab in APECED EnteritisResults expected Q1 2031
Recently completed
- 2026-07-01Safety and Efficacy Study to Assess 600 mg Boric Acid Vaginal Inserts With 7- or 14-Days Treatment of Vulvovaginal Candidiasis (VVC)Primary completion
- 2026-04-22A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal CandidiasisPrimary completion
Activity timeline7
- 2026-07-01ClinicalSafety and Efficacy Study to Assess 600 mg Boric Acid Vaginal Inserts With 7- or 14-Days Treatment of Vulvovaginal Candidiasis (VVC)Primary completion
- 2026-06-22ClinicalA Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia AreataResults expected Q4 2027
- 2026-06-15ClinicalAn Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive CandidiasisResults expected Q1 2028
- 2026-04-22ClinicalA Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal CandidiasisPrimary completion
- 2026-03-04ClinicalCandi5V01 A FTIH Phase I/II Randomized and Controlled Study to Test Safety, Immunogenicity and Preliminary Efficacy of a Pentavalent Bioconjugate Vaccine (Candi5V) Against Candida in Women With Recurrent Vulvovaginal Candidiasis.Results expected Q2 2027
- 2025-12-16ClinicalA Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)Terminated
- 2025-12-11ClinicalA Phase 2 Randomized Stepped Wedge Study of Emapalumab in APECED EnteritisResults expected Q1 2031
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
Rezafunginapproved
Approval — Rezzayo is indicated for the treatment of invasive candidiasis in adults. Consideration s… (2023)
Posaconazoleapproved
Approval — Posaconazole AHCL oral suspension is indicated for use in the treatment of the following… (2019)
Micafunginapproved
Approval — Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly treatment o… (2008)
Anidulafunginapproved
Approval — Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to <… (2007)
Clinical trials
The current development programme across all trial phases.
Clinical programme
18
6
15
6
Late-stage studies
Recruiting
Recently completed
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
First approvals
2023emaApproval — Rezafungin· Rezzayo is indicated for the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents. 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 ↗
2008emaApproval — Micafungin· Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly treatment of invasive candidiasis; treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. Children (including neonates) and adolescents < 16 years of age treatment of invasive candidiasis. prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate. source ↗
2007emaApproval — Anidulafungin· Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years. 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 ↗
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
20042024
Most influential
Recent publications
Major themes8
- Candidiasis2
- Antifungal Agents1
- Aspartic Acid Proteases1
- Biofilms1
- Candida albicans1
- Candida glabrata1
- Disease Outbreaks1
- Drug Resistance, Fungal1
Leading journals6
- Annual review of microbiology1
- Circulation1
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America1
- FEMS microbiology reviews1
- International journal of molecular sciences1
- Medical mycology1
Leading researchers8
- Hube B2
- Nobile CJ2
- Alaban LR1
- Baddour LM1
- Baltimore RS1
- Barsic B1
- Bayer AS1
- Bednarek A1
Affiliations (unnormalised)6
- Institute of Microbiology2
- MRC Centre for Medical Mycology2
- University of California2
- BIOASTER Microbiology Technology Institute1
- Center for Microbial Ecology and Technology (CMET)1
- Centers for Disease Control and Prevention1
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Overview
Candidiasis is an infection caused by fungi of the genus Candida. It is usually a superficial infection of moist body areas and is generally caused by Candida albicans, although Candida species can also cause mucosal and invasive disease.
Causes
The immediate cause is infection or overgrowth by Candida species, most commonly Candida albicans. The literature also notes that Candida auris is an emerging multidrug-resistant Candida species that can cause serious invasive infections.
Pathophysiology
Candida albicans commonly colonizes the oral cavity, gut, and genital tract as a commensal organism, and disease can arise when host immunity, epithelial barriers, resident microbiota, or other local defenses are perturbed. The transition from commensalism to pathogenicity is associated with fungal overgrowth, host-pathogen interactions, and the ability to form biofilms, including on implanted medical devices.
Risk factors
Alterations in host immunity are a major risk factor for progression from colonization to infection. Perturbation of the resident microbiota, stress, and compromised immunity are also associated with overgrowth and more severe mucosal or systemic disease, and healthcare-associated factors can predispose to invasive infection.
Current standard of care
Treatment is generally described at the antifungal class level. The grounding supports use of antifungal therapy for Candida infections, with management complicated in some settings by multidrug resistance and biofilm-associated persistence, particularly for Candida auris and device-associated infection.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
Defined in MeSH
Infection with a fungus of the genus CANDIDA. It is usually a superficial infection of the moist areas of the body and is generally caused by CANDIDA ALBICANS. (Dorland, 27th ed)
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.