A Phase 3 interventional study of SCY-078 and Fluconazole in Candidiasis, Invasive and Candidemia, sponsored by Scynexis, Inc.. Terminated at 101 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Scynexis, Inc. · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis including candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.
73 studies on the registry are indexed under Candidemia; 5 are open to participants now.
This study's enrollment of 68 is close to the median of 63 across 44 interventional studies indexed under Candidemia.
Browse Candidemia studies →Scynexis, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Compared within Candidemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Candidiasis, Invasive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
Subject has any of the following forms of invasive candidiasis at Screening:
Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.
o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SCY-078 · Drug: Echinocandin
Drug: Fluconazole · Drug: Echinocandin
Oral ibrexafungerp (SCY-078) as step-down therapy.
Also known as: Ibrexafungerp
Oral fluconazole (SCY-078) as step-down therapy.
Also known as: Diflucan
Intravenous echinocandin
Also known as: Caspofungin, Micafungin, Anidulafungin
All-cause Mortality
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
Time frame: Day 30
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Time frame: Up to 6 weeks
Global Response at Day 14
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Time frame: Day 14
| Milestone | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy |
|---|---|---|
| Started | 36 | 32 |
| Completed | 18 | 17 |
| Not completed | 18 | 15 |
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
| Participants | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy |
|---|---|---|
| Alive | 28 | 28 |
| Deceased | 4 | 3 |
| Not Known | 4 | 1 |
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
| Participants | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy |
|---|---|---|
| Global Response at End of Treatment (EU European Medicines Agency [EMA] Only) | 0 | 0 |
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
| Participants | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy |
|---|---|---|
| Global Response at Day 14 | 0 | 0 |
Collected over For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | 4/36 (11.1%) | 20/36 (55.6%) | 27/36 (75%) |
| IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy | 3/32 (9.4%) | 20/32 (62.5%) | 28/32 (87.5%) |
| Event | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy |
|---|---|---|
| SepsisInfections and infestations | 0/36 | 6/32 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/36 | 0/32 |
| Pneumonia aspirationInfections and infestations | 0/36 | 2/32 |
| NauseaGastrointestinal disorders | 0/36 | 2/32 |
| VomitingGastrointestinal disorders | 0/36 | 2/32 |
| Atrial fibrillationCardiac disorders | 0/36 | 2/32 |
| HypokalaemiaMetabolism and nutrition disorders | 1/36 | 2/32 |
| Device dislocationProduct Issues | 1/36 | 2/32 |
| Acute kidney injuryRenal and urinary disorders | 1/36 | 2/32 |
| HypotensionVascular disorders | 1/36 | 2/32 |
| Event | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy |
|---|---|---|
| SepsisInfections and infestations | 0/36 | 7/32 |
| VomitingGastrointestinal disorders | 6/36 | 7/32 |
| DiarrhoeaGastrointestinal disorders | 6/36 | 3/32 |
| NauseaGastrointestinal disorders | 5/36 | 5/32 |
| Acute kidney injuryRenal and urinary disorders | 5/36 | 3/32 |
| HypokalaemiaMetabolism and nutrition disorders | 3/36 | 4/32 |
| HypotensionVascular disorders | 1/36 | 4/32 |
| PneumoniaInfections and infestations | 4/36 | 1/32 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/36 | 1/32 |
| Abdominal painGastrointestinal disorders | 1/36 | 3/32 |
| Age, Continuous(years) | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy | Total |
|---|---|---|---|
| Mean | 55.5 ± 16.5 | 60 ± 14.65 | 57.6 ± 15.71 |
| Sex: Female, Male(Participants) | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy | Total |
|---|---|---|---|
| Female | 22 | 15 | 37 |
| Male | 14 | 17 | 31 |
| Race (NIH/OMB)(Participants) | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 2 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 10 |
| White | 25 | 22 | 47 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 4 | 4 |
| Ethnicity (NIH/OMB)(Participants) | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 35 | 26 | 61 |
| Unknown or Not Reported | 0 | 4 | 4 |
| Height(centimeters) | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy | Total |
|---|---|---|---|
| Mean | 169.59 ± 9.508 | 166.20 ± 11.933 | 168.02 ± 10.744 |
| Weight(kilograms) | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy | Total |
|---|---|---|---|
| Mean | 82.57 ± 25.563 | 71.23 ± 22.331 | 77.29 ± 24.575 |
| Body Mass Index (BMI)(kilograms per meter squared) | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy | Total |
|---|---|---|---|
| Mean | 28.5 ± 7.903 | 26.54 ± 12.280 | 27.59 ± 10.13 |
| Modified Acute Physiology and Chronic Health Evaluation (APACHE) II Score(Participants) | IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) | IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy | Total |
|---|---|---|---|
| </= 20 | 31 | 31 | 62 |
| >20 | 5 | 1 | 6 |
11 further baseline measures are reported on the registry.
Showing the first 100 of 101 sites across 13 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ibrexafungerp
Scynexis, Inc.