Brexafemme

(Ibrexafungerp)

Small molecule

GGlaxo Dba Glaxosmithkline

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Vulvovaginal Candidiasis4 trials

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

Completed·SScynexis, Inc.·Phase 3·NCT03734991·376 enrolled

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

Completed·SScynexis, Inc.·Phase 3·NCT03987620·455 enrolled

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

Completed·SScynexis, Inc.·Phase 3·NCT04029116·440 enrolled

Show 1 more trial

Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis

Completed·SScynexis, Inc.·Phase 3·NCT05399641·150 enrolled

Women1 trial

Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp

Completed·SScynexis, Inc.·Phase 1·NCT06954493·5 enrolled

Efficacy and Safety1 trial

Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment

Completed·SScynexis, Inc.·Phase 3·NCT03059992·233 enrolled

DME1 trial

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

Completed·SScynexis, Inc.·Phase 1·NCT05668429·6 enrolled

Regulatory

FDA Approval Timeline[3]

Jun 1, 2021

BREXAFEMME

NDA NDA214900

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Ibrexafungerp. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ibrexafungerp compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA214900). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Brexafemme. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: GGlaxo Dba Glaxosmithkline

Patent Landscape[4]

Patent Cliff

Aug 28, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8188085Aug 28, 2030

10370406Jan 19, 2035

10927142Jan 19, 2035

10174074Jan 19, 2035

11534433Jun 10, 2039