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Glucan Synthase Inhibitor

Ibrexafungerp for Vaginal Yeast Infection

Phase 3
Waitlist Available
Research Sponsored by Scynexis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject should also have:
A recurrent vulvovaginal candidiasis (RVVC) episode with breakthrough symptoms while receiving maintenance antifungal therapy. OR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days post baseline through 60 days post end of treatment
Awards & highlights

Study Summary

This trial will treat people with a tough form of yeast infection who haven't gotten better from other drugs. Ibrexafungerp will be given for 1, 3, or 7 days.

Who is the study for?
This trial is for post-menarchal women aged 18 or older with a severe yeast infection that didn't improve after fluconazole treatment, or those allergic to azoles. Participants must not be pregnant, breastfeeding, or planning pregnancy and agree to use two forms of birth control. They should have no other vaginal infections and be willing to follow the study procedures.Check my eligibility
What is being tested?
The trial tests Ibrexafungerp's effectiveness in treating complicated vulvovaginal candidiasis (VVC) over 1, 3, or 7 days in women who haven't responded well to standard fluconazole therapy. It aims to see if this new treatment can better manage symptoms of persistent or resistant VVC.See study design
What are the potential side effects?
Potential side effects of Ibrexafungerp may include digestive issues like nausea and diarrhea, headaches, dizziness, menstrual changes, and possible liver enzyme elevations. Allergic reactions are also a concern for those with known hypersensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I apologize, but it seems like you didn't provide any specific criteria in your previous statement. Could you please provide more information or specify the criteria you would like me to summarize?
Select...
You have a recurring yeast infection in the vagina that keeps coming back even with ongoing treatment.
Select...
You have had a bad reaction or cannot tolerate azole medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days post baseline through 60 days post end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days post baseline through 60 days post end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Cure
Secondary outcome measures
Clinical Improvement
Clinical Success

Side effects data

From 2019 Phase 3 trial • 376 Patients • NCT03734991
26%
Diarrhoea
16%
Nausea
9%
Headache
7%
Abdominal pain
6%
Abdominal discomfort
5%
Bacterial vaginosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Ibrexafungerp (SCY-078)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group b (7 Day dosing)Experimental Treatment1 Intervention
Seven day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day
Group II: Group B (3 Day dosing)Experimental Treatment1 Intervention
Three day dosing, 300 mg Ibrexafungerp BID for a total of 600mg a day.
Group III: Group AExperimental Treatment1 Intervention
Single day dosing, 300mg Ibrexafungerp BID for a total of 600mg a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrexafungerp
2019
Completed Phase 3
~1220

Find a Location

Who is running the clinical trial?

Scynexis, Inc.Lead Sponsor
17 Previous Clinical Trials
2,328 Total Patients Enrolled
Lori TierneyStudy DirectorScynexis, Inc.
Lori TiernyStudy DirectorScynexis, Inc.

Media Library

Ibrexafungerp (Glucan Synthase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05399641 — Phase 3
Vaginal Yeast Infection Research Study Groups: Group A, Group B (3 Day dosing), Group b (7 Day dosing)
Vaginal Yeast Infection Clinical Trial 2023: Ibrexafungerp Highlights & Side Effects. Trial Name: NCT05399641 — Phase 3
Ibrexafungerp (Glucan Synthase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05399641 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you think Ibrexafungerp is a safe medication for patients?

"Ibrexafungerp has undergone Phase 3 clinical trials, meaning that there is both existing data supporting its efficacy and multiple rounds of safety testing. Consequently, our team rates Ibrexafungerp as a 3 in terms of safety."

Answered by AI

Do you think that this research is applicable to a Canadian context?

"Additionally, this clinical trial has 6 other sites besides Seattle Clinical Research Center in Seattle, Washington, Women Under Study in New Orleans, Louisiana and Clinical Research Prime in Idaho Falls."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
TMC Life Research, Inc
What portion of applicants met pre-screening criteria?
Met criteria
~53 spots leftby Mar 2025