Rates had been higher for IBX in comparison to FLU, respectively [113]. In two phase 3 randomized, double-blind, placebo-controlled clinical trials in individuals with acute vulvovaginal candidiasis, VANISH 303 (NCT03734991) and VANISH 306 (NCT03987620), using the very same end points because the DOVE study, full resolution of all vaginal indicators and symptoms by test of remedy (day 10) date was considerably greater within the IBX groups when compared with placebo [114,115]. In VANISH 303, clinical cure, mycological eradication, clinical improvement at TOC date and complete resolution of symptoms at day 25 have been 51 vs. 29 , 50 vs. 19 , 64 vs. 37 , and 60 vs. 45 , respectively, inside the IBX group in comparison to the placebo [114]. Similarly in VANISH 306, clinical remedy, mycological eradication, clinical improvement and resolution of symptoms have been 63 vs. 44 , 59 vs. 30 , 72 vs. 55 , and 74 vs. 52 , respectively, in the IBX group when compared with the placebo [115]. A sizable (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 presently ongoing and expected to end in September 2021 [116].J. Fungi 2021, 7,7 ofTable 1. This is a table showing the specifics of mTORC1 Activator manufacturer existing clinical trials involving ibrexafungerp. Phase NCT Number Acronym Title Conditions Drugs Outcome Measures Mass balance|Routes prices of elimination of [14C]-IBX |Quantity of subjects with treatment-emergent adverse events Pharmacokinetics of PRA + SCY-078: AUC, Cmax, Tmax, Half-life |Safety PPARβ/δ Modulator web tolerability from the oral mixture PRA + SCY-078 Pharmacokinetics of DAB + SCY-078: AUC, Cmax, Tmax, Half-life |Safety tolerability of your oral mixture DAB + SCY-078 Age (yrs) # Commence Date End DatePhaseNCTADMEADME Study of [14C]-Ibrexafungerp in Healthful Male Subjects Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthful Subjects Study to Evaluate the Impact 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 final results, physical examination findings, ECG benefits, vital sign SCYmeasurements|Dose of 078|Fluconazole| SCY-078 that achieves the Micafungin target exposure (AUC)|International response| Clinical response| Microbiological response|Relapse of subjects achieving 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 Number Acronym Title An Active-Controlled, Dose-Finding Study of Oral IBX vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis Circumstances Drugs Outcome Measures Age (yrs) # Begin Date Finish DatePhaseNCTDOVECandida VulvovaginitisClinical remedy (complete resolution of indicators Fluconazole|SCY078 symptoms)|Co-occurrence of clinical mycological remedy Adverse events; discontinuation due to AE; dea.
