Ibrexafungerp: A First-in-Class Oral Triterpenoid Glucan Synthase Inhibitor
Open accessAbstract
Ibrexafungerp (formerly SCY-078 or MK-3118) is a first-in-class triterpenoid antifungal or “fungerp” that inhibits biosynthesis of β-(1,3)-D-glucan in the fungal cell wall, a mechanism of action similar to that of echinocandins. Distinguishing characteristics of ibrexafungerp include oral bioavailability, a favourable safety profile, few drug–drug interactions, good tissue penetration, increased activity at low pH and activity against multi-drug resistant isolates including C. auris and C. glabrata. In vitro data has demonstrated broad and potent activity against Candida and Aspergillus species. Importantly, ibrexafungerp also has potent activity against azole-resistant isolates, including biofilm-forming Candida spp., and echinocandin-resistant isolates. It also has activity against the asci form of Pneumocystis spp., and other pathogenic fungi including some non-Candida yeasts and non-Aspergillus moulds. In vivo data have shown IBX to be effective for treatment of candidiasis and aspergillosis. Ibrexafungerp is effective for the treatment of acute vulvovaginal candidiasis in completed phase 3 clinical trials.
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Ibrexafungerp 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 [159]
Section 8, “Indications and Usage,” says the FDA had accepted a new drug application for oral ibrexafungerp to treat vulvovaginal candidiasis; it does not say the drug was approved. Section 9, “Conclusions,” says an FDA action date was still pending and a US commercial launch was planned, contrary to the claim that approval had already been granted. (LLM, conf=0.87)
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Experimental — accuracy not yet measuredIbrexafungerp 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 [159]
Section 7 (Pharmacokinetics/Pharmacodynamics) reports oral bioavailability of 35%, 45%, and greater than 51% in dogs, rats, and mice, respectively. It also reports extensive tissue distribution and limited to no CNS distribution in rats. The claim omits that these findings come from animal studies and overlooks limited distribution to adipose tissue and parts of the eye. (LLM, conf=0.85)
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References 110 · Cited by 129
Research works printed but not linked: 11
- [10]PubChem [Internet] Bethesda (MD): National Library of Medicine (US), National Center for Biotechnology Information; 2004-.PubChem Compound Summary Available online: https://pubchem.ncbi.nlm.nih.gov/compound/ (accessed on 30 December 2020)
- [14]Azie N. A Phase 2b, Dose Finding Study Evaluating Oral Ibrexafungerp in Moderate to Severe Acute Vulvovaginal Candidiasis (DOVE) Proceedings of the 3rd ISIDOG Congress Porto, Portugal 31 Octorber–3 November 2019 Available online: https://www.scynexis.com/science/publications-and-presentations/posters-and-presentations?page=2 (accessed on 29 December 2020)
- [16]Scynexis The World Health Organization Recognizes New Antifungal Class by Granting “ibrexafungerp” to SCYNEXIS as the International Non-Proprietary Name for SCY-078. SCYNEXIS, Inc. Press Release Online 2018 Available online: https://ir.scynexis.com/press-releases/detail/156/the-world-health-organization-recognizes-new-antifungal (accessed on 29 December 2020)
- [81]Cushion M. Ashbaugh A. Borroto-Esoda K. Barat S.A. Angulo D. SCY-078 demonstrates antifungal activity against pneumocystis in a prophylactic murine model of pneumocystis pneumonia ASM Microbe Online 2018 10.1128/AAC.00244-18 · DOI · Paper page
- [91]Zhu Y.C. Barat S.A. Borroto-Esoda K. Angulo D. Chaturvedi S. Chaturvedi V. In vitro Efficacy of Novel Glucan Synthase Inhibitor, Ibrexafungerp (SCY-078), Against Multidrug- and Pan-resistant Candida auris Isolates from the Outbreak in New York BioRxiv 2020 10.1101/811182 32092395 · DOI
- [94]Ghannoum M. Long L. Sherif R. Abidi F.Z. Borroto-Esoda K. Barat S. Angulo D. Wiederhold N. Determination of Antifungal Activity of SCY-078, a Novel Glucan Synthase Inhibitor, Against a broad panel of Rare Pathogenic Fungi ASM Microbe Online 2020 10.1128/AAC.02429-19 · DOI
- [112]Juneja D. Singh O. Tarai B. Angulo D. Successful Treatment of Two Patients with Candida auris Candidemia with the Investigational Agent, Oral Ibrexafungerp (formerly SCY-078) from the CARES Study Proceedings of the 29th ECCMID Congress Amsterdam, The Netherlands 13–16 April 2019
- [115]Scynexis SCYNEXIS Announces Positive Top-Line Results from Its Second Pivotal Phase 3 Study (VANISH-306) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (Vaginal Yeast Infection). SCYNEXIS, Inc. Press Release Online 2020 Available online: https://www.globenewswire.com/news-release/2020/04/21/2019183/0/en/SCYNEXIS-Announces-Positive-Top-Line-Results-from-its-Second-Pivotal-Phase-3-Study-VANISH-306-of-Oral-Ibrexafungerp-for-the-Treatment-of-Vulvovaginal-Candidiasis-Vaginal-Yeast-Infe.html (accessed on 29 December 2020)
- [116]Scynexis SCYNEXIS Completes Patient Enrollment Ahead of Schedule in the Second Pivotal Phase 3 Study (VANISH-306) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (Vaginal Yeast Infection). SCYNEXIS, Inc. Press Release Online 2020 Available online: https://www.scynexis.com/news-media/press-releases/detail/201/scynexis-completes-patient-enrollment-ahead-of-schedule-in (accessed on 29 December 2020)
- [121]Scynexis SCYNEXIS Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections. SCYNEXIS, Inc. Press Release Online 2020 Available online: https://ir.scynexis.com/press-releases/detail/225/scynexis-announces-fda-acceptance-and-priority-review-of (accessed on 29 December 2020)
- [122]Scynexis SCYNEXIS Announces Interim Results from Phase 2 Study of Oral SCY-078 in Patients with Invasive Candidiasis scyNEXIS, Inc. Press Release Online 2016 Available online: https://www.scynexis.com/news-media/press-releases/detail/79/scynexis-announces-interim-results-from-phase-2-study-of (accessed on 29 December 2020)
- Authors
- Jallow, S., & Govender, N. P.
- Affiliations
- National Health Laboratory Service (ZA)
- Corresponding author
- Jallow, Sabelle
- Venue
- Journal of Fungi
- Publisher
- MDPI AG
- Published
- 2021-02-25
- Volume
- 7
- Issue
- 3
- Pages
- 163
- ISSN
- 2309-608X (ISSN-L)
- PMC
- PMC7996284
- OpenAlex
- W3133395095
- Cited by
- 129
- References
- 110
- Citations by year
- 2026: 24 · 2025: 28 · 2024: 31 · 2023: 17 · 2022: 23 · 2021: 6
- FWCI
- 2.25
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal of Fungi (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- 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 › Epidemiology › Fungal Infections and Studies
- Keywords
- ibrexafungerp, oral antifungal agents, Candida auris, Candida glabrata, Candida, Aspergillus, azole resistance, echinocandin resistance, Pneumocystis, candidiasis, aspergillosis, vaginal candidiasis, multidrug resistance
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