GSK plc / SCYNEXIS, Inc.

Vulvovaginal candidiasis (VVC) and invasive candidiasis

1.4M US cases/yr · $21.0B Global antifungal therapy market forecast (2030) · 593 Total GSK-SCYNEXIS Brexafemme license deal (USD MM upfront + milestones)

Disease Overview

Vulvovaginal candidiasis is the second most common cause of vaginitis in the US, affecting approximately 1.4 million women annually in acute episodes and an estimated 138 million women globally each year; approximately 5-10% develop recurrent VVC (RVVC) with four or more episodes per year. First-line therapy has been oral fluconazole (Diflucan, generic) for more than 30 years, but Candida glabrata and Candida auris show rising azole resistance. Invasive candidiasis (candidemia and deep-tissue disease) affects approximately 25,000 US patients annually with mortality around 25-40% despite treatment, and carries an annual US healthcare cost burden of roughly $1.7B (CDC Antibiotic Resistance Threats 2019). Ibrexafungerp (Brexafemme) was the first novel antifungal class approved in over 20 years and the first oral triterpenoid glucan synthase inhibitor, FDA-approved in 2021 for acute VVC and expanded in November 2022 to reduce RVVC recurrence. The global antifungal market is approximately $16B in 2023, projected to exceed $21B by 2030.

Competitive Landscape

The antifungal landscape is structurally limited and slow-moving, which makes ibrexafungerp's novel-class status commercially meaningful. VVC first-line: oral fluconazole (Diflucan, Pfizer, generic) remains dominant; topical azoles (miconazole/Monistat, clotrimazole, terconazole) cover the over-the-counter segment. Novel oral VVC options: Brexafemme (ibrexafungerp, GSK/SCYNEXIS, first-in-class oral triterpenoid glucan synthase inhibitor, FDA-approved 2021 acute VVC and 2022 RVVC expansion) and oteseconazole (Vivjoa, Mycovia, approved 2022 for recurrent VVC in women without reproductive potential). Systemic and invasive antifungals: echinocandins micafungin (Mycamine, Astellas), caspofungin (Cancidas, Merck) and anidulafungin (Eraxis, Pfizer); triazoles voriconazole (Vfend, Pfizer), posaconazole (Noxafil, Merck) and isavuconazole (Cresemba, Astellas); amphotericin B including liposomal AmBisome (Gilead). Pipeline entrants: rezafungin (Rezzayo, Cidara/Melinta, approved 2023 as a once-weekly echinocandin), olorofim (F2G, novel orotomide class), fosmanogepix (Basilea, GPI anchor inhibitor) and opelconazole (Pulmatrix, inhaled voriconazole). Ibrexafungerp is the only oral agent with meaningful activity against azole-resistant Candida glabrata and Candida auris, a differentiation GSK can amplify via its established HIV and infectious-disease sales force and its women's health channel relationships.