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Glucan Synthase Inhibitor
Ibrexafungerp for Histoplasmosis (FURI Trial)
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 42, day 84
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests ibrexafungerp, a new medication for adults with severe fungal infections who haven't responded to other treatments. It works by breaking down the fungus's cell walls, helping to stop the infection.
Eligible Conditions
- Histoplasmosis
- Invasive Pulmonary Aspergillosis
- North American Blastomycosis
- Yeast infection
- Coccidioidomycosis
- ABPA
- Invasive Candidiasis
- Valley Fever
- Oral Thrush
- Blastomycosis
- Chronic Pulmonary Aspergillosis
- Emerging Fungal Infections
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 42, day 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 42, day 84
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of Global Response
Secondary study objectives
Assessment of Recurrence of Baseline Fungal Infection
Assessment of survival
Side effects data
From 2019 Phase 3 trial • 376 Patients • NCT0373499126%
Diarrhoea
16%
Nausea
9%
Headache
7%
Abdominal pain
6%
Abdominal discomfort
5%
Bacterial vaginosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrexafungerp (SCY-078)
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ibrexafungerp (SCY-078)Experimental Treatment1 Intervention
Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrexafungerp
2019
Completed Phase 3
~1220
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Who is running the clinical trial?
Scynexis, Inc.Lead Sponsor
17 Previous Clinical Trials
2,245 Total Patients Enrolled
David Angulo, MDStudy DirectorSponsor GmbH
7 Previous Clinical Trials
957 Total Patients Enrolled
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