Provider Briefing: Brexafemme (Ibrexafungerp) Availability in 2026

Brexafemme (Ibrexafungerp), the first-in-class triterpenoid antifungal approved for vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC), has been effectively unavailable since a 2023 recall. This briefing provides prescribers with an up-to-date picture of the shortage, its implications for clinical practice, and actionable steps to support patients who need antifungal treatment.

Timeline of Key Events

• June 2021: FDA approves Brexafemme (Ibrexafungerp) for treatment of VVC in adult and postmenarchal pediatric females — the first non-azole oral antifungal for VVC in over 20 years
• November 2022: Supplemental approval granted for reduction in incidence of RVVC
• 2023: Scynexis issues voluntary nationwide recall of two lots (LF21000008 and LF22000051) due to potential cross-contamination with a non-antibacterial beta-lactam drug substance
• 2023: FDA places clinical hold on Brexafemme
• January 2024: GSK and Scynexis amend their commercial license agreement in light of the prolonged marketing disruption
• May 2025: FDA lifts the 19-month clinical hold
• Late 2025: NDA transfer from Scynexis to GSK expected to be completed
• 2026: GSK expected to initiate regulatory discussions with FDA regarding return to commercial production

Prescribing Implications

The prolonged unavailability of Brexafemme has particular clinical significance for several patient populations:

Patients with Azole-Resistant VVC

Brexafemme's glucan synthase inhibition mechanism provided a genuinely novel option for patients with documented azole resistance. With Ibrexafungerp unavailable, clinicians managing resistant infections may need to consider:

• Compounded boric acid suppositories (600 mg intravaginal daily for 14 to 21 days)
• Topical Nystatin (100,000 units intravaginal daily for 14 days)
• Topical Amphotericin B (compounded, 50 mg intravaginal daily for 14 days)
• Referral to infectious disease for complex or refractory cases

Patients with RVVC

Brexafemme's once-monthly dosing for RVVC prevention was a significant convenience advantage over weekly Fluconazole maintenance. Current alternatives include:

• Fluconazole maintenance: 150 mg weekly for 6 months (generic, $4 to $15 per dose)
• Oteseconazole (Vivjoa): FDA-approved for RVVC prevention, though at substantially higher cost (~$900 per course) and also contraindicated in pregnancy

Pregnancy Considerations

Brexafemme was already contraindicated in pregnancy due to embryo-fetal toxicity in animal studies. However, providers should note that most oral antifungal alternatives share similar pregnancy limitations. For pregnant patients with VVC, topical azoles (Miconazole, Clotrimazole) remain the standard of care.

Current Availability Picture

As of early 2026, Brexafemme is listed as temporarily unavailable in the ASHP drug shortage database. Key facts:

• No new commercial batches have been produced since the recall
• No generic version of Ibrexafungerp exists
• The NDA transfer to GSK is the critical prerequisite for resumed production
• Individual pharmacies may theoretically have residual stock, though this is increasingly unlikely

Cost and Access Context

When Brexafemme was available, cost was already a significant barrier for many patients:

• Cash price: $450 to $600 per treatment course (4 tablets)
• Manufacturer copay assistance: Eligible commercially insured patients could pay as little as $30
• Insurance: Coverage varied; many plans required prior authorization and/or step therapy through Fluconazole
• No generic competition: Patent protection with no generic alternative available

By contrast, generic Fluconazole costs $4 to $15 per treatment, and OTC Miconazole costs $10 to $20 — making these the most accessible options for most patients.

Tools and Resources for Providers

To help patients navigate the shortage and find available treatments:

• Medfinder for Providers — Real-time medication availability search that can help identify pharmacies with stock of specific medications, including hard-to-find drugs
• ASHP Drug Shortage Database — For monitoring official shortage status updates
• FDA Drug Shortages page — For regulatory updates on Brexafemme and related products

For guidance on helping patients find medications during shortages, see our provider's guide on how to help patients find Brexafemme in stock.

Alternative Prescribing Summary

The following table summarizes key alternatives for providers to consider:

• Fluconazole (Diflucan): 150 mg oral x1 for uncomplicated VVC; 150 mg weekly x6 months for RVVC maintenance. Generic, $4-$15. First-line option.
• Miconazole (Monistat): Topical, 1- to 7-day courses. OTC, $10-$20. Good for mild cases and pregnancy.
• Clotrimazole: Topical, 3- to 7-day courses. OTC, $7-$15. Similar efficacy to Miconazole.
• Oteseconazole (Vivjoa): Oral, loading dose then weekly for RVVC prevention. ~$900+. Contraindicated in pregnancy.
• Boric acid suppositories: Compounded, 600 mg intravaginal x14-21 days. For resistant cases. Not FDA-approved for VVC.

For a patient-facing comparison, you can direct patients to our post on alternatives to Brexafemme.

Looking Ahead

The resolution of the Brexafemme shortage depends primarily on the successful completion of the NDA transfer to GSK and subsequent FDA regulatory clearance for resumed manufacturing. GSK has indicated plans to engage with the FDA in 2026, though no specific timeline for product return has been confirmed.

Clinicians should monitor updates from GSK, the ASHP shortage database, and the FDA. In the interim, maintaining familiarity with alternative treatment protocols — particularly for azole-resistant and recurrent infections — will be essential for optimal patient care.

For additional provider resources and real-time availability tools, visit Medfinder for Providers.

Final Thoughts

The Brexafemme shortage represents a meaningful gap in the antifungal armamentarium, particularly for patients with resistant or recurrent VVC. While the clinical hold has been lifted and corporate transitions are progressing, providers should plan for continued unavailability in the near term and ensure patients are informed about effective alternatives. We will continue to update this briefing as new developments emerge.