Rates have been larger for IBX in comparison with FLU, respectively [113]. In two phase three randomized, double-blind, placebo-controlled clinical trials in patients with acute vulvovaginal candidiasis, VANISH 303 (NCT03734991) and VANISH 306 (NCT03987620), using the very same finish points because the DOVE study, complete resolution of all vaginal indicators and symptoms by test of remedy (day ten) date was significantly greater inside the IBX groups when compared with placebo [114,115]. In VANISH 303, clinical remedy, mycological eradication, clinical improvement at TOC date and total resolution of symptoms at day 25 had been 51 vs. 29 , 50 vs. 19 , 64 vs. 37 , and 60 vs. 45 , respectively, within the IBX group in comparison to the placebo [114]. Similarly in VANISH 306, clinical remedy, mycological eradication, clinical improvement and resolution of symptoms were 63 vs. 44 , 59 vs. 30 , 72 vs. 55 , and 74 vs. 52 , respectively, in the IBX group compared to the placebo [115]. A big (320 participants) multicentre, randomized, double-blind phase 3 study (CANDLE: NCT04029116) to investigate the efficacy of IBX compared placebo in participants with recurrent vulvovaginal candidiasis is currently ongoing and expected to end in September 2021 [116].J. Fungi 2021, 7,7 ofTable 1. This is a table showing the facts of current clinical trials involving ibrexafungerp. Phase NCT Quantity Acronym Title Circumstances Drugs Outcome Measures Mass balance|Routes rates of elimination of [14C]-IBX |Quantity of subjects with treatment-emergent adverse events Pharmacokinetics of PRA + SCY-078: AUC, Cmax, Tmax, Half-life |Security tolerability from the oral combination PRA + SCY-078 Pharmacokinetics of DAB + SCY-078: AUC, Cmax, Tmax, Half-life |Security tolerability of your oral combination DAB + SCY-078 Age (yrs) # Start off Date End DatePhaseNCTADMEADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects Study to Evaluate the Impact of SCY-078 (Ibrexafungerp) PARP7 Inhibitor custom synthesis around the PK of Pravastatin in Healthier Subjects Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Wholesome SubjectsFungal Infection[14C]Ibrexafungerp (IBX)305 December30 JunePhaseNCTPharmacokineticsPRA| SCY-078 plus PRA1822 November20 DecemberPhaseNCTPharmacokineticsDAB|SCY-078 plus DAB189 September3 JanuaryPhaseNCTOral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive CandidiasisMycoses, Candidiasis, Invasive, CandidemiaSafety tolerability, assessed by adverse events, clinical laboratory benefits, physical examination findings, ECG outcomes, essential sign SCYmeasurements|Dose of 078|Fluconazole| SCY-078 that achieves the Micafungin target exposure (AUC)|International response| Clinical response| Microbiological response|Relapse of subjects attaining therapeutic remedy at TOC visit SCY(Day 24 +/-3)| of subjects 078|Fluconazole with recurrence of VVC in the course of the observation period181 SeptemberAugustPhaseNCTSafety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal CandidiasisVulvovaginal Candidiasis181 November5 AugustJ. Fungi 2021, 7,eight ofTable 1. Cont. Phase NCT Quantity Acronym Title An Active-Controlled, Dose-Finding Study of Oral IBX vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis Situations Drugs Outcome Measures Age (yrs) # Get started Date End DatePhaseNCTDOVECandida VulvovaginitisClinical remedy (complete resolution of indicators Fluconazole|SCY078 symptoms)|Co-occurrence of clinical mycological remedy Adverse events; discontinuation as a SGLT2 Inhibitor Storage & Stability result of AE; dea.
