A Four-Part, Phase 1, First-in-Human, Single- and Multiple-Ascending Dose and Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral SCY-247 in Healthy Subjects: Part 4

Start Date05 Dec 2024

Sponsor / Collaborator

SCYNEXIS, Inc.

ACTRN12624001392550

/ Not yet recruitingPhase 1

Start Date05 Dec 2024

Sponsor / Collaborator

SCYNEXIS, Inc.

NCT06954493

/ CompletedPhase 1

Phase 1, Open-Label Pharmacokinetic Study in Healthy Lactating Women After Two Oral Doses of Ibrexafungerp Administered on a Single Day

This is a pharmacokinetic evaluation of lactating women after receiving two doses of Ibrexafungerp. The study population included healthy lactating females who were at least 10 days postpartum with a fully established milk supply and were between the ages of 18 and 50 years at the time of screening

Start Date12 Jul 2023

Sponsor / Collaborator

SCYNEXIS, Inc.

100 Clinical Results associated with SCYNEXIS, Inc.

0 Patents (Medical) associated with SCYNEXIS, Inc.

Literatures (Medical) associated with SCYNEXIS, Inc.

01 Dec 2025·AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY

A phase 3, multicenter, randomized, placebo-controlled trial of monthly oral ibrexafungerp to reduce the incidence of recurrent vulvovaginal candidiasis

Article

Author: Angulo, David A ; Nyirjesy, Paul ; Azie, Nkechi E ; Sobel, Ryan ; Sobel, Jack D ; Goje, Oluwatosin

BACKGROUND:

Recurrent vulvovaginal candidiasis develops in 5% to 9% of people assigned female at birth and has a serious impact on quality of life. Oral ibrexafungerp is a first-in-class, nonazole, triterpenoid antifungal approved in the United States for the treatment of postmenarchal females with acute vulvovaginal candidiasis and for the reduction in the incidence of recurrent vulvovaginal candidiasis.

OBJECTIVE:

This phase 3 study (CANDLE) describes the efficacy and safety of monthly oral ibrexafungerp vs placebo for reducing the incidence of recurrent vulvovaginal candidiasis.

STUDY DESIGN:

Participants with a history of recurrent vulvovaginal candidiasis experiencing an acute infection episode (confirmed by positive potassium hydroxide test) received 3 doses of oral fluconazole (150 mg once-daily every 3 days). Those who had culture-confirmed vulvovaginal candidiasis from the screening sample achieved substantial resolution of signs and symptoms (composite Vulvovaginal Signs and Symptoms score≤2) following fluconazole treatment and continued to meet all study eligibility criteria, entered a maintenance phase. In the maintenance phase, eligible participants were randomized (1:1) to oral ibrexafungerp (300 mg twice-daily for 1 day) or placebo, which was repeated once every 4 weeks for a total of 6 treatments (until week 20). Efficacy was assessed by the percentage of participants with no mycologically proven recurrence and the percentage of participants with clinical success (a participant with a Test-of-Cure [week 24] evaluation and no recurrence; mycologically proven, presumed, or suspected) by Test-of-Cure (4 weeks after last study drug dose). Safety and tolerability assessments included incidence of adverse events and treatment discontinuations. Participants were further assessed for recurrence during a 12-week follow-up phase.

RESULTS:

In the intent-to-treat population, 70.8% (n=92/130) of participants who received ibrexafungerp and 58.5% (n=76/130) who received placebo had no mycologically proven recurrence by Test-of-Cure (relative risk, 1.22; 95% confidence interval, 1.032, 1.430; P=0.019). The proportion of participants who achieved clinical success by Test-of-Cure was 65.4% (n=85/130) with ibrexafungerp and 53.1% (n=69/130) with placebo (relative risk, 1.24; 95% confidence interval, 1.034, 1.486; P=0.020). The benefit of ibrexafungerp over placebo was sustained over the 4 months following last study drug dose for both the no mycologically proven recurrence (65.4% [n=85/130] vs 53.8% [n=70/130]; relative risk, 1.22; 95% confidence interval, 1.021, 1.456; P=0.029) and clinical success (57.7% [n=75/130] vs 46.2% [n=60/130]; relative risk, 1.26; 95% confidence interval, 1.017, 1.555; P=0.034) endpoints. Overall, 64.6% (n=84/130) of participants who received ibrexafungerp and 58.5% (n=76/130) of participants who received placebo experienced ≥1 treatment-emergent adverse event. Treatment-related adverse events occurred in 14.6% (n=19/130) of participants in the ibrexafungerp group and 6.9% (n=9/130) of participants in the placebo group. No adverse events in the ibrexafungerp group led to treatment or study discontinuation. The most common adverse events reported in both the ibrexafungerp and placebo groups were headache, bacterial vaginosis, and diarrhea; these events were mostly mild in severity.

CONCLUSION:

Once-monthly oral ibrexafungerp was effective and well-tolerated in participants with recurrent vulvovaginal candidiasis.

02 May 2024·Antimicrobial agents and chemotherapy

Ibrexafungerp is efficacious in a neutropenic murine model of pulmonary mucormycosis as monotherapy and combined with liposomal amphotericin B

Article

Author: Gebremariam, Teclegiorgis ; Filler, Scott G. ; Ibrahim, Ashraf S. ; Najvar, Laura K. ; Gu, Yiyou ; Alkhazraji, Sondus ; Borroto-Esoda, Katyna ; Patterson, Thomas F. ; Wiederhold, Nathan P.

ABSTRACT:

Ibrexafungerp (formerly SCY-078) is the first member of the triterpenoid class that prevents the synthesis of the fungal cell wall polymer β-(1,3)-D-glucan by inhibiting the enzyme glucan synthase. We evaluated the in vivo efficacy of ibrexafungerp against pulmonary mucormycosis using an established murine model. Neutropenic mice were intratracheally infected with either Rhizopus delemar or Mucor circinelloides . Treatment with placebo (diluent control), ibrexafungerp (30 mg/kg, PO BID), liposomal amphotericin B (LAMB 10 mg/kg IV QD), posaconazole (PSC 30 mg/kg PO QD), or a combination of ibrexafungerp plus LAMB or ibrexafungerp plus PSC began 16 h post-infection and continued for 7 days for ibrexafungerp or PSC and through day 4 for LAMB. Ibrexafungerp was as effective as LAMB or PSC in prolonging median survival (range: 15 days to >21 days) and enhancing overall survival (30%–65%) vs placebo (9 days and 0%; P < 0.001) in mice infected with R. delemar . Furthermore, median survival and overall percent survival resulting from the combination of ibrexafungerp plus LAMB were significantly greater compared to all monotherapies ( P ≤ 0.03). Similar survival results were observed in mice infected with M. circinelloides . Monotherapies also reduce the lung and brain fungal burden by ~0.5–1.0log 10 conidial equivalents (CE)/g of tissue vs placebo in mice infected with R. delemar ( P < 0.05), while a combination of ibrexafungerp plus LAMB lowered the fungal burden by ~0.5–1.5log 10 CE/g compared to placebo or any of the monotherapy groups ( P < 0.03). These results are promising and warrant continued investigation of ibrexafungerp as a novel treatment option against mucormycosis.

10 Jun 2022·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303)

Article

Author: Gersten, Janet K ; Azie, Nkechi E ; Sobel, Jack D ; Ghannoum, Mahmoud A ; Lederman, Samuel N ; Moffett, Alfred H ; Harriott, Itzel A ; Chappell, B Todd ; Schwebke, Jane R ; Nyirjesy, Paul ; Jacobs, Mark A ; Angulo, David A ; Sobel, Ryan ; Sussman, Steven A ; Borroto-Esoda, Katyna ; Weinstein, David L

Abstract:

Background:

Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC.

Methods:

Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS] = 0) at test-of-cure (day 11 ± 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS ≤ 1) at test-of-cure, and symptom resolution at follow-up (day 25 ± 4).

Results:

Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P = .001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P < .001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P < .001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P = .009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for Black patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity.

Conclusions:

Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.

133

News (Medical) associated with SCYNEXIS, Inc.

19 Nov 2025

·www.globenewswire.com

SCYNEXIS Completes Transfer of BREXAFEMME® New Drug Application to GSK

GSK remains committed to the relaunch of BREXAFEMME, and following its relaunch, SCYNEXIS stands to receive up to $145.5 million in annual net sales milestones as well as royalties, net of payments to Merck, in the low to mid single digit range JERSEY CITY, N.J., Nov. 19, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the transfer of the BREXAFEMME (ibrexafungerp) New Drug Application (NDA) to GSK. “We are pleased to announce this important milestone for SCYNEXIS. With the transfer of the BREXAFEMME NDA now complete, GSK will be able to initiate regulatory interactions with the U.S. Food and Drug Administration (FDA) to discuss the relaunch of BREXAFEMME for vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) in the U.S. market,” said David Angulo, M.D., President and Chief Executive Officer. “Furthermore, SCYNEXIS stands to receive net sales milestones and royalties following the relaunch providing a significant future source of non-dilutive capital.” About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC. Additional antifungal assets from this novel class are currently in clinical, pre-clinical and discovery phases, including the compound SCY-247. For more information, visit www.scynexis.com. Forward-Looking Statements Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: receipt of milestones and royalties from GSK. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. CONTACT: Investor RelationsIrina KofflerLifeSci AdvisorsTel: 917-734-7387ikoffler@lifesciadvisors.com

Drug ApprovalNDALicense out/inAcquisition

15 Oct 2025

·www.fiercepharma.com

GSK makes nice with antifungal partner Scynexis with $22M payment to resolve trial dispute

In addition to its $22 million payout from GSK, Scynexis will collect another $2.3 million related to trial wind-down activities. Brexafemme (ibrexafungerp) partners GSK and Scynexis have worked out their quarrel related to a clinical trial that was previously put on hold, leaving Scynexis with a $22 million payout.Per the resolution, Scynexis will wind down its phase 3 MARIO study of Brexafemme in invasive candidiasis, the company said in an Oct. 15 press release. Besides the $22 million sum, the company stands to receive an additional $2.3 million related to trial wind-down activities, Scynexis said.Scynexis will not receive any further milestone payments from GSK in relation to the MARIO study.GSK is still on board with its Scynexis collaboration and plans to commercialize Brexafemme in its approved indications of vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC), according to Scynexis. After Scynexis transfers the drug’s regulatory application to GSK by the end of this year, the British company hopes to begin discussions with the FDA on a relaunch of the medicine.“While disappointed that the MARIO study will not continue, we’re pleased to have resolved this disagreement with GSK and that it remains committed to relaunching Brexafemme,” Scynexis CEO David Angulo, M.D., said in the release.GSK and Scynexis shook hands on a Brexafemme licensing deal in early 2023. Later that year, GSK found that the equipment used to make the drug was also used to produce a beta-lactam substance, which can trigger allergies in some people. Scynexis then recalled the drug due to the potential for cross-contamination.When the FDA lifted a clinical trial hold after 19 months this May, Scynexis quickly moved to resume the delayed study. GSK, for its part, wanted its partner to terminate the trial. GSK’s objections were still in play when Scynexis began dosing patients in the re-enrolled study, triggering a $10 million milestone payment under the original contract. GSK disputed the milestone but said it remained committed to marketing the drug.Brexafemme was approved in 2021 for VVC, bringing a new class of antifungal drugs to the indication. GSK paid Scynexis $90 million upfront to get in on the drug, but later cut down its milestone obligations as part of a 2024 deal amendment.

Phase 3License out/inDrug Approval

15 Oct 2025

·www.globenewswire.com

SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of the Phase 3 MARIO Study

SCYNEXIS to receive a $22 million payment as part of the resolution related to the restart of the Phase 3 MARIO study on invasive candidiasisScynexis will promptly wind-down and terminate the MARIO studyThe payment from GSK, combined with cash in hand and removal of future MARIO expenditures, extends the company’s cash runway to more than two yearsGSK remains committed to the commercialization of BREXAFEMME (ibrexafungerp tablets) JERSEY CITY, N.J., Oct. 15, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it will receive a $22 million payment from GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) as part of a resolution of the disagreement with GSK related to the restart of the Phase 3 MARIO study on invasive candidiasis. SCYNEXIS will not receive additional milestone payments from GSK associated with the MARIO study. SCYNEXIS will promptly commence appropriate wind-down activities associated with its termination and will receive an additional $2.3M payment in connection with these activities. GSK has also reiterated its commitment to continued collaboration with SCYNEXIS regarding other aspects of the GSK License Agreement, including with respect to the commercialization of BREXAFEMME (ibrexafungerp tablets) for the vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) indications. SCYNEXIS continues to progress the transfer of the BREXAFEMME NDA to GSK by the end of 2025. GSK anticipates being able to initiate regulatory interactions with the U.S. Food and Drug Administration in 2026 to discuss the relaunch of BREXAFEMME for VVC and rVVC in the U.S. market. “While disappointed that the MARIO study will not continue, we’re pleased to have resolved this disagreement with GSK and that it remains committed to relaunching BREXAFEMME. SCYNEXIS remains committed to developing novel antifungal solutions, including 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,” said David Angulo, M.D., President and Chief Executive Officer. “We want to thank all of the patients who participated in the MARIO study and the investigators for their continued support toward finding new antifungal agents in areas of significant unmet need.” About SCYNEXISSCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Additional antifungal assets from this novel class are currently in clinical, pre-clinical and discovery phases, including the compound SCY-247. For more information, visit www.scynexis.com. Forward-Looking StatementsStatements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: any advantages of SCY-247 over existing antifungals, continued development of SCY-247, and the Company’s cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. CONTACT: Investor RelationsIrina KofflerLifeSci AdvisorsTel: 917-734-7387ikoffler@lifesciadvisors.com

License out/inPhase 3Drug ApprovalNDA

100 Deals associated with SCYNEXIS, Inc.

100 Translational Medicine associated with SCYNEXIS, Inc.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 19 Dec 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 1

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ibrexafungerp Citrate ( 1,3-beta-glucan synthase )	Candidemia More	Phase 3
SCY-247 ( 1,3-beta-glucan synthase )	Mucormycosis More	Preclinical
SCY-575 ( CYPA )	Inflammation More	Discontinued
Selective estrogen receptor beta modulators(GlaxoSmithKline/Scynexis) ( ERβ )	Inflammation More	Pending
WS-635 ( CYPA )	Chronic hepatitis C genotype 1 More	Pending

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis