Ibrexafungerp

Generic Name: Ibrexafungerp

Brand Names: Brexafemme

Drug Type: Small Molecule

Chemical Formula: C_₄₄H_₆₇N_₅O_₄

CAS Number: 1207753-03-4

Unique Ingredient Identifier: A92JFM5XNU

Background: Ibrexafungerp, also known as SCY-078 or MK-3118, is a novel enfumafungin derivative oral triterpene antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as a vaginal yeast infection. It was developed out of a need to treat fungal infections that may have become resistant to echinocandins or azole antifungals. Ibrexafungerp is orally bioavailable compared to the echinocandins caspofungin, micafungin, and anidulafungin; which can only be administered parenterally. Similar to echinocandins, ibrexafungerp targets the fungal β-1,3-glucan synthase, which is not present in humans, limiting the chance of renal or hepatic toxicity.

Ibrexafungerp was granted FDA approval on 1 June 2021.

Indication: Ibrexafungerp is indicated in the treatment of vulvovaginal candidiasis in post-menarchal patients. It is also indicated for the reduction in the incidence of recurrent vulvovaginal candidiasis.

Associated Conditions: Recurrent Vulvovaginal Candidiasis, Vulvovaginal Candidiasis

Clinical Trials

Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp

Phase 1

Completed

Conditions: Vulvovaginal Candidiasis
Candida Infection
Vaginal Candidiasis

Interventions: Drug: Ibrexafungerp

First Posted Date: 2025-05-01

Last Posted Date: 2025-05-01

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 5

Registration Number: NCT06954493

Locations: 🇺🇸
Woodland Research Northwest (WRN), Rogers, Arkansas, United States

ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects

Phase 1

Completed

Conditions: Fungal Disease

Interventions: Drug: Ibrexafungerp

First Posted Date: 2022-12-29

Last Posted Date: 2023-06-28

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 6

Registration Number: NCT05668429

Locations: 🇬🇧
Quotient Sciences Limited, Nottingham, United Kingdom

Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

Phase 3

Completed

Conditions: Vulvovaginal Candidiasis

Interventions: Drug: Ibrexafungerp

First Posted Date: 2022-06-01

Last Posted Date: 2024-07-10

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 150

Registration Number: NCT05399641

Locations: 🇺🇸
Jefferson University, Philadelphia, Pennsylvania, United States
🇺🇸
Wake (Mount Vernon Clinical Research), Atlanta, Georgia, United States
🇺🇸
Women's Healthcare Research, San Diego, California, United States

and more 21 locations

A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

Phase 3

Suspended

Conditions: Candidiasis, Invasive
Candidemia

Interventions: Drug: SCY-078
Drug: Fluconazole
Drug: Echinocandin

First Posted Date: 2022-01-05

Last Posted Date: 2023-11-18

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 220

Registration Number: NCT05178862

Locations: 🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States
🇧🇪
Saint Luc University Hospital, Brussels, Belgium

and more 69 locations

ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects

Phase 1

Completed

Conditions: Fungal Infection

Interventions: Drug: [14C]-Ibrexafungerp

First Posted Date: 2020-03-13

Last Posted Date: 2020-08-14

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 6

Registration Number: NCT04307082

Locations: 🇬🇧
Quotient Sciences, Nottingham, United Kingdom

Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

Phase 3

Completed

Conditions: Recurrent Vulvovaginal Candidiasis

Interventions: Drug: Fluconazole Tablet
Drug: Placebo oral tablet
Drug: IBREXAFUNGERP

First Posted Date: 2019-07-23

Last Posted Date: 2023-06-18

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 440

Registration Number: NCT04029116

Locations: 🇺🇸
Chattanooga Medical Research Inc, Chattanooga, Tennessee, United States
🇺🇸
Clinical Research Prime - ClinEdge - PPDS, Idaho Falls, Idaho, United States
🇺🇸
Women's Healthcare Research Corp, San Diego, California, United States

and more 22 locations

Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis

Phase 3

Completed

Conditions: Candida Vulvovaginitis

Interventions: Drug: Placebo
Drug: Ibrexafungerp

First Posted Date: 2019-06-17

Last Posted Date: 2021-09-08

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 455

Registration Number: NCT03987620

Locations: 🇺🇸
New Generation Medical Research, Hialeah, Florida, United States
🇺🇸
Physician Care Clinical Research LLC, Sarasota, Florida, United States
🇺🇸
Planned Parenthood Southeastern Pennsylvania The Elizabeth Blackwell Health Center, Philadelphia, Pennsylvania, United States

and more 37 locations

Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)

Phase 3

Completed

Conditions: Candida Vulvovaginitis

Interventions: Drug: Placebo
Drug: Ibrexafungerp

First Posted Date: 2018-11-08

Last Posted Date: 2021-09-08

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 376

Registration Number: NCT03734991

Locations: 🇺🇸
Women's Medical Research Group, Clearwater, Florida, United States
🇺🇸
Unified Women's Clinical Research Greensboro, Greensboro, North Carolina, United States
🇺🇸
Magnolia Ob/Gyn Research Center, LLC, Myrtle Beach, South Carolina, United States

and more 21 locations

Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis

Phase 2

Terminated

Conditions: Invasive Pulmonary Aspergillosis

Interventions: Drug: SCY-078
Drug: Voriconazole
Other: Oral Placebo Tablets

First Posted Date: 2018-09-14

Last Posted Date: 2024-08-09

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 22

Registration Number: NCT03672292

Locations: 🇩🇪
Universitaetsklinikum Koeln, Klinisches Studienzentrum 2 für Infektiologie, Klinik I für Innere Medizin Kerpener Str. 62, Bettenhaus Ebene 15 Raum 64, Köln, Germany
🇧🇪
Hematology Department AZ Sint-Jan Brugge - Oostende AV Campus Brugge Ruddershove 10 8000, Brugge, Belgium
🇨🇦
University Health Network at the University of Toronto, Toronto, Ontario, Canada

and more 5 locations

Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)

Phase 3

Completed

Conditions: Candidiasis, Invasive
Candidemia

Interventions: Drug: SCY-078

First Posted Date: 2017-12-06

Last Posted Date: 2024-07-03

Lead Sponsor: Scynexis, Inc.

Target Recruit Count: 30

Registration Number: NCT03363841

Locations: 🇺🇸
Scynexis, Inc., Jersey City, New Jersey, United States
🇮🇳
Amrita Institute of Medical Sciences (AIMS), Kanayannur, Kochi, India
🇮🇳
St John's Medical College and Hospital, Bangalore, Karnataka, India

and more 9 locations

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