Last reviewed · How we verify
Brexafemme (IBREXAFUNGERP)
At a glance
| Generic name | IBREXAFUNGERP |
|---|---|
| Sponsor | GSK |
| Drug class | Triterpenoid Antifungal |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2021 |
Approved indications
- Candidiasis of vagina
- Vulvovaginal candidiasis
Common side effects
Key clinical trials
- A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole (PHASE3)
- Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp (PHASE1)
- Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (PHASE3)
- Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis (PHASE2)
- Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
- Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis (PHASE3)
- Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) (PHASE3)
- Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Brexafemme CI brief — competitive landscape report
- Brexafemme updates RSS · CI watch RSS
- GSK portfolio CI