This section highlights FDA-related milestones and regulatory updates for drugs developed by SCYNEXIS (SCYX).
Over the past two years, SCYNEXIS has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SCY-247 and Ibrexafungerp. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
SCY-247 FDA Regulatory Timeline and Events
SCY-247 is a drug developed by SCYNEXIS for the following indication: For systemic fungal diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SCY-247
- Announced Date:
- February 26, 2026
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. announced that the first participants have been dosed in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial evaluating the intravenous formulation (IV) of its second-generation triterpenoid antifungal therapy, SCY-247, which is being developed as a treatment for invasive candidiasis (IC) and as a prophylaxis therapy for invasive fungal disease. Results from this trial are expected in 2026.
AI Summary
SCYNEXIS, Inc. announced that the first participants have been dosed in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial testing the intravenous (IV) formulation of SCY-247. SCY-247 is a second‑generation triterpenoid antifungal being developed as a treatment for invasive candidiasis and as a prophylactic option to prevent invasive fungal disease. The company is now in the early clinical stage, evaluating the new IV form in humans for the first time.
The trial marks an important step to assess the drug’s safety and appropriate dosing in people. SCYNEXIS plans to report results from this study in 2026. If the IV formulation proves safe and tolerable, it could advance into later trials to further test effectiveness against serious fungal infections that can be life‑threatening in vulnerable patients.
Read Announcement- Drug:
- SCY-247
- Announced Date:
- January 28, 2026
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. announced upcoming presentations highlighting data on the Company's second-generation fungerp drug candidate, SCY-247, at the inaugural Interdisciplinary Meeting on Antimicrobial Resistance and Innovation (IMARI), which is taking place from January 28 to 30, 2026, in Las Vegas, Nevada.
AI Summary
SCYNEXIS, Inc. announced it will present data on its second-generation fungerp drug candidate, SCY-247, at the inaugural Interdisciplinary Meeting on Antimicrobial Resistance and Innovation (IMARI). The presentations are scheduled during IMARI, which runs January 28–30, 2026, in Las Vegas, Nevada. SCY-247 is positioned as a follow-on candidate in the company’s antifungal program, and these sessions will highlight the latest findings the company has generated.
IMARI is a joint conference organized by the American Society for Microbiology (ASM) and the Infectious Diseases Society of America (IDSA). The meeting brings together researchers, clinicians, industry leaders, and policymakers to tackle antimicrobial resistance. SCYNEXIS’s presentations at this event are aimed at sharing progress on SCY-247 with peers and stakeholders working to address resistant infections and to foster scientific and clinical dialogue about new antifungal strategies.
Read Announcement- Drug:
- SCY-247
- Announced Date:
- January 21, 2026
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. announced that the U.S. Food and Drug Administration ("FDA") has granted the Company Qualified Infectious Disease Product (QIDP) and Fast Track Designations for its second-generation triterpenoid antifungal therapy, SCY-247.
AI Summary
SCYNEXIS announced that the U.S. Food and Drug Administration granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for its second-generation triterpenoid antifungal, SCY-247. The company said the QIDP status will ensure at least 10 years of market exclusivity for SCY-247 following approval. SCY-247 is being developed to treat serious, drug-resistant fungal infections and has shown activity against hard-to-treat pathogens such as Candida auris and echinocandin-resistant C. glabrata in preclinical work and early human studies.
The Fast Track designation can speed development by enabling more frequent FDA interactions, rolling review of applications, and potential eligibility for accelerated approval or priority review. SCYNEXIS plans to advance SCY-247 into additional clinical studies in 2026 and is pursuing funding to support the program as it seeks to address the growing public health threat from resistant fungal infections.
Read Announcement- Drug:
- SCY-247
- Announced Date:
- September 30, 2025
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. announced positive results from a Phase 1 study of SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation.
AI Summary
SCYNEXIS, Inc. announced positive results from a Phase 1 study of SCY-247, its second-generation triterpenoid antifungal. Designed for oral and IV use against invasive fungal infections, SCY-247 reached target drug levels at lower doses than its first-generation compound with no safety concerns or dose-limiting toxicities.
The study tested single ascending doses from 50 mg to 900 mg and multiple ascending doses from 50 mg to 300 mg once daily for seven days in healthy volunteers. Sixty-six participants received SCY-247 and 22 received placebo. SCY-247 was well tolerated, with only mild to moderate headaches and diarrhea reported, and no serious adverse events.
Pharmacokinetic data showed rapid absorption (Tmax 3–7 hours) and dose-proportional increases in exposure (Cmax and AUC). The 200 mg and 300 mg daily doses met or exceeded target exposures based on preclinical models of resistant fungi. These results support continued clinical development of SCY-247 for invasive fungal infections.
Read Announcement- Drug:
- SCY-247
- Announced Date:
- September 4, 2025
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. announced multiple upcoming presentations highlighting data on the Company's second-generation fungerp drug candidate, SCY-247, at the upcoming 12th Congress on Trends in Medical Mycology (TIMM-12), which is scheduled to take place from September 19th to 22nd, 2025, in Bilbao, Spain.
AI Summary
SCYNEXIS will present six studies of its second-generation antifungal SCY-247 at the TIMM-12 Congress, taking place September 19–22, 2025, in Bilbao, Spain. An oral session will show SCY-247’s potent in vitro activity against Candida auris strains, including FKS1 echinocandin-resistant isolates, with lower MICs than existing drugs.
Poster sessions will highlight SCY-247’s broad antifungal spectrum. Data cover uniform activity against diverse Candida species with no cross-resistance to echinocandins, strong efficacy against multidrug- and pandrug-resistant C. auris, and in vitro and in vivo potency against resistant Candida glabrata and Aspergillus species.
Another poster will report once- and twice-daily oral SCY-247’s ability to reduce kidney fungal burden in a murine C. auris model. SCYNEXIS expects to report Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) oral trial results in Q3 2025, marking a key step toward new treatments for life-threatening fungal infections.
Read Announcement- Drug:
- SCY-247
- Announced Date:
- April 8, 2025
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. announced the presentation of preclinical efficacy data on its second-generation fungerp candidate SCY-247 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Vienna, Austria being held from April 11-15, 2025.
AI Summary
SCYNEXIS, Inc. announced that it will present new preclinical efficacy data on its second-generation antifungal candidate, SCY-247, at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) conference in Vienna from April 11-15, 2025. SCY-247 is being developed to tackle systemic fungal infections, including those where current treatments are failing due to resistance. The preclinical studies showcased at the event focus on SCY-247’s ability to fight multi drug-resistant fungi, such as Candida auris and other resistant Candida species. The data, presented in detailed poster sessions, highlights SCY-247’s robust activity against various resistant fungal pathogens, suggesting it could offer a new treatment option for difficult-to-treat infections. This development is a promising step forward in the fight against antifungal resistance and may pave the way for more effective treatments in the future.
Read Announcement - Drug:
- SCY-247
- Announced Date:
- March 12, 2025
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. Provides Corporate Update
AI Summary
SCYNEXIS, Inc. provided a corporate update focusing on its progress in developing innovative antifungal treatments. The company initiated a Phase 1 trial in December 2024 for SCY-247, its second-generation triterpenoid antifungal intended to treat severe invasive fungal infections. Early findings have been promising in preclinical studies, and SCYNEXIS expects to release detailed data on single and multiple ascending doses in Q3 2025. Presentations on preclinical results are scheduled at the 2025 ESCMID Global congress in Vienna.
The update also highlighted plans to restart the Phase 3 MARIO study for invasive candidiasis once the FDA lifts the current clinical hold, anticipated in the second quarter of 2025. With $75.1 million in cash, cash equivalents, and investments as of the end of 2024, SCYNEXIS projects funding to support its operations through Q3 2026.
Read Announcement
Ibrexafungerp FDA Regulatory Events
Ibrexafungerp is a drug developed by SCYNEXIS for the following indication: For the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ibrexafungerp
- Announced Date:
- November 19, 2025
- Indication:
- For the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC)
Announcement
SCYNEXIS, Inc. announced that it has completed the transfer of the BREXAFEMME (ibrexafungerp) New Drug Application (NDA) to GSK.
Read Announcement- Drug:
- Ibrexafungerp
- Announced Date:
- May 28, 2025
- Indication:
- For the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC)
Announcement
SCYNEXIS, Inc. announced that patient dosing has resumed in the Phase 3 MARIO study, which is an innovative study to investigate oral ibrexafungerp as a potential step-down antifungal therapy following IV echinocandin for invasive candidiasis, a life-threatening infection.
AI Summary
SCYNEXIS, Inc. announced the resumption of patient dosing in its Phase 3 MARIO study after the FDA lifted a clinical hold. The study is testing oral ibrexafungerp as a potential step-down antifungal therapy after patients have received IV echinocandin for invasive candidiasis, a life-threatening infection. New clinical supplies were produced at a different site to address contamination concerns and meet updated FDA standards.
If the trial is successful and approved by the FDA, the new oral treatment could offer healthcare providers an important alternative to IV-only echinocandin therapies, improving patient care for invasive fungal infections. The restart of dosing also triggers a $10 million milestone payment from partner GSK, with an additional $20 million expected in six months, although there is a disagreement between the companies over these payments.
Read Announcement
