Drugs / Ibrexafungerp
Ibrexafungerp
also known as
SCY-078 · Brexafemme · IBREXAFUNGERP CITRATE · MK 3118 · MK-3118 FREE BASE · SCY-078 citrate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | BREXAFEMME | — | 2022-11-30 | fda.gov ↗ |
| Approved | US (FDA) | BREXAFEMME | — | 2021-06-01 | fda.gov ↗ |
Trials 16 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06954493 | Jul → Nov 2023 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05668429 | Dec 2022 → Jan 2023 | fungal infectious disease | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04307082 | Dec 2019 → May 2020 | fungal infectious disease | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04092751 | Nov → Dec 2019 | — | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04092725 | Sep 2019 → Jan 2020 | — | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03672292 | Jan 2019 → Mar 2023 | invasive aspergillosis | Scynexis, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03253094 | Aug 2017 → May 2018 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02679456 | Nov 2015 → Aug 2016 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02244606 | Sep 2014 → Jun 2016 | candidemia | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT05178862 | Aug 2022 → Nov 2025 | candidemia | Scynexis, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT05399641 | May 2022 → May 2023 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04029116 | Oct 2019 → Sep 2021 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03987620 | Jun 2019 → Mar 2020 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03734991 | Jan → Aug 2019 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03363841 | Nov 2017 → Apr 2023 | candidemia | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03059992 | Apr 2017 → Aug 2023 | allergic bronchopulmonary aspergillosis, blastomycosis, candidiasis, invasive, chronic mucocutaneous candidiasis +4 | Scynexis, Inc. | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ibrexafungerp | “Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor, has demonstrated broad fungicidal Candida activity and a favorable tolerability profile.” PMID 34555149 ↗ Jul 202213“repeated oral doses of SCY-078 (Ibrexafungerp) on the pharmacokinetics of dabigatran administered orally to healthy subjects.” NCT04092725 ↗ “Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis” NCT02244606 ↗ “Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects” NCT04092751 ↗ “Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole” NCT02679456 ↗ “Ibrexafungerp” NCT05178862 ↗ |
| Known as | Brexafemme | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Known as | IBREXAFUNGERP CITRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Known as | MK 3118 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Known as | MK-3118 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Known as | SCY-078 | “Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis” NCT03253094 ↗7“Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis” NCT02244606 ↗ “Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole” NCT02679456 ↗ |
| Known as | SCY-078 citrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Action | Inhibit | “oral triterpenoid glucan synthase inhibitor” PMID 34555149 ↗ Jul 2022 |
| Modality | Small molecule | “Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor” PMID 34555149 ↗ Jul 2022 |
| Route | Oral | “750mg/day orally administered” NCT03059992 ↗ |