Rates have been larger for IBX in comparison to 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), with the exact same end points because the DOVE study, complete resolution of all vaginal indicators and symptoms by test of remedy (day 10) date was substantially larger in the IBX groups in comparison with placebo [114,115]. In VANISH 303, clinical cure, mycological eradication, clinical improvement at TOC date and full resolution of symptoms at day 25 were 51 vs. 29 , 50 vs. 19 , 64 vs. 37 , and 60 vs. 45 , respectively, inside the IBX group in comparison with 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, within the IBX group in comparison with the placebo [115]. A big (320 participants) multicentre, randomized, double-blind phase three 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 displaying the facts of current clinical trials involving ibrexafungerp. Phase NCT Number Acronym Title Situations Drugs Outcome Measures Mass balance|Routes rates of elimination of [14C]-IBX |Number of subjects with treatment-emergent adverse events Pharmacokinetics of PRA + SCY-078: AUC, Cmax, Tmax, Half-life |Safety tolerability in the oral combination PRA + SCY-078 Pharmacokinetics of DAB + SCY-078: AUC, Cmax, Tmax, Half-life |Safety tolerability with the oral combination DAB + SCY-078 Age (yrs) # Get started Date Finish DatePhaseNCTADMEADME Study of [14C]-Ibrexafungerp in Wholesome Male Subjects Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) around the PK of Pravastatin in Wholesome Subjects Study to Evaluate the Effect of SCY-078 around the PK of Dabigatran in Healthful 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 Therapy of Invasive CandidiasisMycoses, Candidiasis, Invasive, CandidemiaSafety tolerability, assessed by adverse events, clinical laboratory benefits, physical examination findings, ECG results, essential sign SCYmeasurements|Dose of 078|Fluconazole| SCY-078 that achieves the Micafungin target exposure (AUC)|Worldwide response| Clinical response| Microbiological response|TrkB Agonist drug Relapse of subjects attaining NMDA Receptor Agonist custom synthesis therapeutic cure at TOC stop by 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 Situations Drugs Outcome Measures Age (yrs) # Begin Date End DatePhaseNCTDOVECandida VulvovaginitisClinical cure (full resolution of signs Fluconazole|SCY078 symptoms)|Co-occurrence of clinical mycological remedy Adverse events; discontinuation on account of AE; dea.
