Pharmacokinetics and Pharmacodynamics of Ibrexafungerp
Open accessAbstract
On 2 June, 2021, the US Food and Drug Administration approved ibrexafungerp (formerly MK-3118 and SCY-078) for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection. Ibrexafungerp is the first drug approved in a novel antifungal class in more than two decades, and the Food and Drug Administration's decision was based on positive results from two pivotal phase III studies in which oral ibrexafungerp proved both safe and effective in patients with vulvovaginal candidiasis. The decision was also based on substantial preclinical and clinical work in both the pharmacokinetics and pharmacodynamics of ibrexafungerp. This paper reviews that research and looks ahead to explore how this novel antifungal agent may be used in the future to address the expanding problem of drug-resistant mycotic infections.
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Ibrexafungerp has oral bioavailability of 35-50% and good systemic distribution except for the CNS.
“It has oral bioavailability of 35–50% and good systemic distribution except for the CNS.”
From Epidemiology of Invasive Candidiasis (2024) · cites this paper as [157]
The Preclinical Studies section (page unavailable) reports oral bioavailability of 35% in dogs and 45% in rats, but greater than 51% in mice; it does not establish 35–50% as a general range. It reports high kidney exposure in mice, not good systemic distribution across tissues, and gives no CNS-distribution finding. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIbrexafungerp retains solubility and activity in acidic environments, making it suitable for use in abscesses.
“Importantly, it retains solubility and activity in acidic environments, making it suitable for use in abscesses.149,157”
From Epidemiology of Invasive Candidiasis (2024) · cites this paper as [157]
The Future Directions section (page unavailable) says ibrexafungerp is soluble at lower pH, facilitating penetration into acidic environments. Its references also identify a study of activity at the lower pH of vulvovaginitis. Our copy does not say this makes ibrexafungerp suitable for use in abscesses. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIbrexafungerp is currently only FDA approved as oral therapy for vulvovaginal candidiasis.
“Ibrexafungerp is currently only FDA approved as oral therapy for vulvovaginal candidiasis, although clinical trials for invasive candidiasis step-down therapy, refractory candidiasis, and C. auris are ongoing.149,156–159”
From Epidemiology of Invasive Candidiasis (2024) · cites this paper as [157]
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- Authors
- McCarthy, M. W.
- Affiliations
- Weill Cornell Medicine (US)
- Corresponding author
- McCarthy, Matthew William
- Venue
- Drugs in R&D
- Published
- 2021-12-27
- Volume
- 22
- Issue
- 1
- Pages
- 9-13
- ISSN
- 1174-5886 (ISSN-L)
- 1179-6901
- PMC
- PMC8885872
- OpenAlex
- W4200371261
- Cited by
- 28
- References
- 46
- Citations by year
- 2026: 5 · 2025: 2 · 2024: 7 · 2023: 7 · 2022: 7
- FWCI
- 0.61
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Drugs in R&D (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Life Sciences › Agricultural and Biological Sciences › Ecology, Evolution, Behavior and Systematics › Fungal Plant Pathogen Control
- Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
- Keywords
- ibrexafungerp, pharmacokinetics, pharmacodynamics, vaginal candidiasis, antifungal agents, FDA approval
- MeSH terms
- Antifungal Agents, Candidiasis, Vulvovaginal, Female, Glycosides, Humans, Triterpenes, United States
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