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Glucan Synthase Inhibitor

Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (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 vulvovaginal candidiasis: day 17. chronic mucocutaneous candidiasis: eot up to day 84. chronic pulmonary aspergillus and allergic bronchopulmonary aspergillosis: eot up to day 90. all other diseases: eot up to day 180. all days measured from baseline.
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
  • Coccidioidomycosis
  • Histoplasmosis
  • Invasive Pulmonary Aspergillosis
  • North American Blastomycosis
  • Yeast infection
  • ABPA
  • Invasive Candidiasis
  • Valley Fever
  • Oral Thrush
  • Blastomycosis
  • Chronic Pulmonary Aspergillosis
  • Emerging Fungal Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~vulvovaginal candidiasis: day 17. chronic mucocutaneous candidiasis: eot up to day 84. chronic pulmonary aspergillus and allergic bronchopulmonary aspergillosis: eot up to day 90. all other diseases: eot up to day 180. all days measured from baseline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and vulvovaginal candidiasis: day 17. chronic mucocutaneous candidiasis: eot up to day 84. chronic pulmonary aspergillus and allergic bronchopulmonary aspergillosis: eot up to day 90. all other diseases: eot up to day 180. all days measured from baseline. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease.
Secondary study objectives
Describe Ibrexafungerp Plasma Concentrations
Percentage of Participants Surviving at Day 30 or Day 42
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.
+11 more

Side effects data

From 2023 Phase 3 trial • 233 Patients • NCT03059992
70%
Diarrhoea
48%
Nausea
39%
Vomiting
16%
Headache
13%
Pyrexia
11%
Abdominal Pain
9%
Fatigue
9%
Urinary Tract Infection
8%
Abdominal Pain Upper
7%
Dizziness
7%
Acute Kidney Injury
6%
Rash
6%
Decreased Appetite
6%
Cough
6%
COVID-19
5%
Hyperkalaemia
5%
Dyspnoea
3%
Respiratory failure
3%
Acute kidney injury
2%
Pneumonia
2%
Urinary tract infection
2%
Dehydration
2%
Septic shock
2%
Sepsis
1%
Abdominal infection
1%
Pleural effusion
1%
Multiple organ dysfunction syndrome
1%
Febrile neutropenia
1%
Acute respiratory failure
1%
Cardiac failure
1%
Haematuria
1%
Anaemia
1%
Acute myocardial infarction
1%
Cardiac arrest
1%
Pain
1%
Osteonecrosis
1%
Cardiac failure chronic
1%
Cerebral infarction
1%
Atrial fibrillation
1%
Bacteraemia
1%
Bronchopulmonary aspergillosis
1%
Enterococcal bacteraemia
1%
Haemoptysis
1%
Hypoglycaemia
1%
Hyponatraemia
1%
Liver abscess
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrexafungerp (SCY-078)

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), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.
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
2,245 Total Patients Enrolled
David Angulo, MDStudy DirectorSponsor GmbH
7 Previous Clinical Trials
957 Total Patients Enrolled
~27 spots leftby Dec 2025
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