Ibrexafungerp
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| Clinical data | |
|---|---|
| Pronunciation | /aɪˌbrɛksəˈfʌndʒɜːrp/ eye-BREKS-ə-FUN-jurp |
| Trade names | Brexafemme |
| Other names | SCY-078 |
| License data | |
| Pregnancy category |
|
intravenous | |
| Drug class | Antifungal |
| ATC code | |
| Legal status | |
| Legal status | |
| Elimination half-life | 20 hours[1] |
| Identifiers | |
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Ibrexafungerp, sold under the brand name Brexafemme, is an
intravenous (IV) formulation. An estimated 75% of women will have at least one episode of VVC and 40 to 45% will have two or more episodes in their lifetime.[3]
Ibrexafungerp acts via
Ibrexafungerp was approved for medical use in the United States in June 2021.[1][4] It is the first non-azole oral antifungal drug to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of vaginal yeast infections.[4] The FDA considers it to be a first-in-class medication.[5]
Medical uses
Ibrexafungerp is
Ibrexafungerp is currently undergoing late-stage clinical trials for an
Pharmacology
Pharmacodynamics
Ibrexafungerp is a triterpenoid antifungal agent.
Pharmacokinetics
Ibrexafungerp has a
elimination half-life of approximately 20 hours.[1]
Synthesis
References
- ^ a b c d e f g h i j k l m n o p "Brexafemme- ibrexafungerp tablet, film coated". DailyMed. U.S. National Library of Medicine. Retrieved 12 September 2021.
- FDA. Retrieved 22 October 2023.
- ^ "Vulvovaginal Candidiasis - STI Treatment Guidelines". U.S. Centers for Disease Control and Prevention. 22 July 2021. Retrieved 6 April 2022.
- ^ a b c "Scynexis Announces FDA Approval of Brexafemme (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections". Scynexis, Inc. (Press release). 2 June 2021. Archived from the original on 31 December 2021. Retrieved 2 June 2021.
- ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023.
This article incorporates text from this source, which is in the public domain.
- ^ "SCYNEXIS Announces Successful Completion of Phase 1 Trial Evaluating Intravenous (IV) Formulation of Ibrexafungerp". www.scynexis.com. Scynexis inc. 9 November 2021. Archived from the original on 20 October 2022. Retrieved 20 October 2022.
- S2CID 260377572.
Further reading
- Azie N, Angulo D, Dehn B, Sobel JD (September 2020). "Oral Ibrexafungerp: an investigational agent for the treatment of vulvovaginal candidiasis". Expert Opinion on Investigational Drugs. 29 (9): 893–900. PMID 32746636.
- Davis MR, Donnelley MA, Thompson GR (July 2020). "Ibrexafungerp: A novel oral glucan synthase inhibitor". Medical Mycology. 58 (5): 579–592. PMID 31342066.
- Petraitis V, Petraitiene R, Katragkou A, Maung BB, Naing E, Kavaliauskas P, et al. (May 2020). "Combination Therapy with Ibrexafungerp (Formerly SCY-078), a First-in-Class Triterpenoid Inhibitor of (1→3)-β-d-Glucan Synthesis, and Isavuconazole for Treatment of Experimental Invasive Pulmonary Aspergillosis". Antimicrobial Agents and Chemotherapy. 64 (6). PMID 32179521.
External links
- "Ibrexafungerp". Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT03734991 for "Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)" at ClinicalTrials.gov
- Clinical trial number NCT03987620 for "Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (Vanish 306)" at ClinicalTrials.gov
