RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Qualified Infectious Disease Product (United States), Orphan Drug (European Union)

Structure/Sequence

Molecular FormulaC50H75N5O11

InChIKeyWKIRTJACGBEXBZ-FQGZCCSZSA-N

CAS Registry1965291-08-0

Clinical Trials associated with Ibrexafungerp Citrate

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.

CTR20223058

/ SuspendedPhase 3

一项在念珠菌血症和/或侵袭性念珠菌病患者中比较两项治疗方案（静脉注射棘白菌素后口服Ibrexafungerp 和静脉注射棘白菌素后口服氟康唑）的III 期、多中心、前瞻性、随机、双盲研究（MARIO）

[Translation] A phase III, multicenter, prospective, randomized, double-blind study comparing two treatment regimens (IV echinocandin followed by oral ibrexafungerp vs. IV echinocandin followed by oral fluconazole) in patients with candidemia and/or invasive candidiasis (MARIO)

主要研究目的：在念珠菌血症和/或侵袭性念珠菌病患者中，评估IV 棘白菌素后口服Ibrexafungerp 第30 天的全因死亡率（All Cause Moritality, ACM）非劣效于IV 棘白菌素后口服氟康唑的治疗方案；关键次要研究目的：在念珠菌血症和/或侵袭性念珠菌病患者中，评估IV 棘白菌素后口服Ibrexafungerp 第14 天的总体应答率（经数据审查委员会 [Data Review Committee, DRC] 判定的临床、影像学和真菌学方面的综合应答）非劣效于IV 棘白菌素后口服氟康唑的治疗方案；其他次要目的：根据第30天和抗真菌治疗结束时的总体应答、临床应答、真菌学应答、无复发、患者存活且真菌学清除指标来评估有效性；评估IV棘白菌素后口服Ibrexafungerp治疗的安全性；评估Ibrexafungerp的药代动力学（PK）特征。

[Translation]

The primary study objective was to evaluate the non-inferiority of oral ibrexafungerp after IV echinocandin to oral fluconazole in terms of all-cause mortality (ACM) at day 30 in patients with candidemia and/or invasive candidiasis. The key secondary study objective was to evaluate the non-inferiority of oral ibrexafungerp after IV echinocandin to oral fluconazole at day 14 in patients with candidemia and/or invasive candidiasis (composite clinical, radiological, and mycological responses as assessed by the Data Review Committee [DRC]). Other secondary objectives were to evaluate the efficacy based on overall response, clinical response, mycological response, freedom from relapse, patient survival, and fungal clearance at day 30 and at the end of antifungal treatment; to evaluate the safety of oral ibrexafungerp after IV echinocandin; and to evaluate the pharmacokinetic (PK) characteristics of ibrexafungerp.

Start Date18 Mar 2023

Sponsor / Collaborator

SCYNEXIS, Inc.

[+1]

ISRCTN51111674

/ RecruitingPhase 1

A phase I, open-label, single-centre study to evaluate the absorption, distribution, metabolism and excretion (ADME) of oral [14C]-ibrexafungerp in healthy male subjects after repeat dosing

Start Date15 Dec 2022

Sponsor / Collaborator-

100 Clinical Results associated with Ibrexafungerp Citrate

100 Translational Medicine associated with Ibrexafungerp Citrate

100 Patents (Medical) associated with Ibrexafungerp Citrate

140

Literatures (Medical) associated with Ibrexafungerp Citrate

11 Aug 2025·Future Microbiology

Review

Author: Bassetti, Matteo ; Vena, Antonio ; Giacobbe, Daniele Roberto ; Bartalucci, Claudia

Fluconazole resistance in Candida parapsilosis is an increasing global concern, with resistance rates varying widely and reaching up to 80% in some regions. This trend has led to hospital outbreaks, primarily driven by mutations in the ERG11 gene, especially the Y132F substitution. The clinical relevance of fluconazole resistance remains controversial, as studies have yielded conflicting results regarding its impact on mortality. While some studies described an increased mortality associated with resistant strains, others reported no significant difference. Treatment options are limited: echinocandins and liposomal amphotericin B (L-AmB) are commonly used alternatives, but their use is challenged by intrinsic and emerging echinocandin resistance and L-AmB toxicity and cost. These limitations emphasize the need for robust antifungal stewardship and the development of new therapies. Novel agents such as rezafungin, fosmanogepix, and ibrexafungerp have shown promising activity against fluconazole-resistant C. parapsilosis, though further clinical studies are needed to confirm their efficacy. This narrative review aims to summarize current evidence on the epidemiology, clinical implications, and therapeutic approaches for fluconazole-resistant C. parapsilosis infections.

01 Aug 2025·AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY

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.

04 Jun 2025·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

In vitro activity of novel antifungals, natamycin, and terbinafine against Fusarium

Article

Author: Aldejohann, Alexander Maximilian ; Kurzai, Oliver ; Walther, Grit ; Janevska, Slavica ; Garbe, Enrico ; Ullah, Ahsan

ABSTRACT:

The genus Fusarium includes several trans-kingdom pathogens, infecting plants, animals, and humans, with widespread occurrence. Invasive Fusarium infections are often destructive due to their prevalence in critically ill patients. Furthermore, severe superficial infections, like keratitis or endophthalmitis with potential loss of vision, are rising in incidence globally. Infections are difficult to treat due to the intrinsic resistance of Fusarium against echinocandins and often high minimal inhibitory concentrations (MICs) for azoles. In this article, we assessed the in vitro activity of the novel antifungals olorofim, manogepix, rezafungin, and ibrexafungerp, as well as the established but nonstandard drugs, natamycin and terbinafine, against a large set of molecularly identified clinical Fusarium isolates via EUCAST microdilution. The tested isolates represent the clinically most relevant species of the F. solani (FSSC), F. oxysporum (FOSC), F. fujikuroi (FFSC), F. incarnatum-equiseti (FIESC), F. dimerum (FDSC), and F. redolens (FRSC) species complexes. While rezafungin and ibrexafungerp showed no effect on the Fusarium spp. tested, a general antifungal susceptibility of Fusarium against natamycin and manogepix was found. Specific profiles were detailed for terbinafine and olorofim. While species from the FDSC, FSSC, and FIESC show high MICs for olorofim, specific susceptibility rates were found for species of the FFSC and FOSC. Furthermore, we report specific susceptibilities for terbinafine against FDSC, FFSC, and FOSC species. These findings of complex- and species-specific olorofim and terbinafine in vitro susceptibilities highlight the need for diagnostics below genus level.

130

News (Medical) associated with Ibrexafungerp Citrate

04 Sep 2025

·www.globenewswire.com

SCYNEXIS Announces Multiple Presentations Highlighting Data from its Second-Generation Fungerp, SCY-247, at the 12th Congress on Trends in Medical Mycology (TIMM-12)

Oral presentation will feature data demonstrating SCY-247 in vitro activity against C. auris strains, including isolates with mutations commonly associated with echinocandin-resistanceAdditional poster presentations highlight SCY-247’s broad spectrum of antifungal activity, against Candida species, including multidrug- and pandrug-resistant C. auris and Aspergillus speciesCompany anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data for SCY-247 (oral) in Q3 2025 JERSEY CITY, N.J., Sept. 04, 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 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. “Our six presentations at this year’s TIMM-12 Congress highlight the significant potential of SCY-247 to combat difficult, resistant Candida infections, including C. auris,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “We are developing SCY-247 to specifically address one of the most serious and challenging issues in infectious disease, and the data from these presentations provide highly encouraging evidence that SCY-247 has the potential to address these difficult-to-treat and life-threatening fungal infections. Later this quarter, we anticipate reporting results from our Phase 1 SAD/MAD trial of SCY-247, which represents an important next step in further advancing this exciting program.” SCY-247 data presentations at TIMM-12: TitleSCY-247, a Novel Second-Generation IV/Oral Triterpenoid Antifungal, Demonstrates In vitro Activity against C. auris, including the majority of FKS1 mutants Session:Oral Presentation, S15.5S Session Date:Saturday, September 20, 2025 Presentation Start Time17:25 Central European Time (CET) (10 minutes) Presenting AuthorEelco Meijer, MD, PhDAffiliations: Canisius-wilhelmina Hospital (CWZ)/Dicoon, Radboudumc-CWZ Center of Expertise for Mycology Summary:Candida auris is a public health concern causing large and persistent outbreaks in healthcare institutions, globally. High incidence of resistance to approved antifungals necessitates investigation of novel drugs for future patient care. Here, we performed antifungal susceptibility testing on the investigational compound SCY-247 and other antifungals, including echinocandins anidulafungin and micafungin against 65 unique FKS1 resistant C. auris isolates representing clades I, II, III, IV, and V. Overall, in comparison to the echinocandins, SCY-247 consistently demonstrated lower MICs for C. auris in isolates with commonly found FKS1 resistance mutations. TitleThree Months of SCY-247 EUCAST MIC Testing: Uniform Activity Against Candida Species and No Cross-Resistance to Echinocandins Poster #P052 Session DateSunday, 21 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorKarin Meinike Jørgensen PhDAffiliations: Statens Serum Institut SummaryWe present the first three months of EUCAST SCY-247 MICs compared to anidulafungin and micafungin MICs of 293 Candida isolates. SCY-247 displayed uniform activity against all Candida species included, with no indication of cross-resistance to the echinocandins. TitleIn vitro efficacy of second-generation triterpenoid antifungal, SCY-247 against multidrug- and pandrug-resistant Candida auris Poster #P053 Session DateSaturday, 20 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorVishnu Chaturvedi, PhDAffiliations: New York Medical College, Valhalla, New York Summary:Candida auris is a newly recognized global health threat by the CDC and WHO. In the USA, the New York –New Jersey metropolitan area remains a hotbed for multidrug- and pandrug-resistant C. auris strains. 300 C. auris isolates, mostly from New York area, were tested against SCY-247 and 10 other antifungal agents. SCY-247 demonstrated potent activity against C. auris including pandrug-resistant isolates. TitleThe Novel Second-Generation IV/Oral Triterpenoid SCY-247 Maintains In vitro and In vivo Activity against Resistant Candida glabrata Poster #P423 Session DateSaturday, 20 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorNathan Wiederhold, PhDAffiliations: University of Texas Health Science Center at San Antonio SummaryCandida glabrata is a major cause of invasive candidiasis and is considered a high priority pathogen by the WHO. In vitro susceptibility testing was performed against 29 echinocandin-resistant clinical strains of C. glabrata. SCY-247 maintained in vitro activity against echinocandin-resistant C. glabrata and also demonstrated in vivo efficacy in an invasive candidiasis mice model caused by an echinocandin- and fluconazole-resistant C. glabrata strain. TitleEfficacy of once or twice daily oral SCY-247, a second-generation triterpenoid antifungal, in a murine model of Candida auris infection Poster #P426 ThemeNew antifungal agents Session DateSunday, 21 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorMahmoud Ghannoum, PhDAffiliations: Case Western Reserve University and University Hospitals Cleveland Medical Center SummaryCandida auris is a multidrug resistant fungus exhibiting a 200% increase in incidence in the U.S from 2019 to 2023. The objective was to assess the activity of 7 days of once or twice daily oral SCY-247 treatment in lowering kidney fungal burden in a mouse model of C. auris infection. SCY-247 demonstrated in vivo efficacy against invasive C. auris candidiasis. Significant reductions in fungal burden were observed in the kidneys of mice treated with SCY-247 in a dose dependent fashion with similar activity observed between QD and BID doses. TitleIn vitro activity of SCY-247 and comparators against clinical isolates of Aspergillus spp. and Lomentospora prolificans Poster #P427 ThemeNew Antifungal Agents Session DateSaturday, 20 September 2025 Presentation Start Time11:15 CET (30 minutes) Presenting AuthorAnastasiia HrynzovskaAffiliations: Mycology Reference Laboratory, National Centre for Mycology, Bogomolets National Medical University SummaryThe aim of this study is to investigate the in vitro activity of SCY-247 against cryptic Aspergillus species and Lomentospora prolificans isolated from clinical samples. A total of 54 clinical isolates were analyzed including cryptic species of Aspergillus (n=48) and Lomentospora prolificans (n=6). SCY-247 activity was compared to 3 marketed antifungals. SCY-247 exhibited low MECs against cryptic Aspergillus species and moderately high MECs against L.prolificans. 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) 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. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. 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: Company anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data for SCY-247 (oral) in Q3, 2025. 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

Phase 1Drug ApprovalClinical Result

30 Jul 2025

·www.biospace.com

GSK to Inject ‘Tens of Billions’ in US Amid Trump’s Tariffs, Pipeline Reshuffles

iStock, Magdalena Wygralak CEO Emma Walmsley maintained that continued investment in the U.S. is a priority for the pharma to ensure its medicines for the country are supplied domestically. GSK will make a multi-billion-dollar investment in the U.S. in the coming years as the Trump administration’s tariffs materialize. “The U.S. is our number one priority market,” CEO Emma Walmsley told reporters on a media call Wednesday morning, while presenting the company’s second-quarter earnings report . “It’s in our plans to invest tens of billions [of] dollars in the U.S. over the next five years.” Walmsley did not reveal exactly how much money the company expects to spend, where it will go or what it will be used for. GSK continues to expand its footprint in the U.S., according to Walmsley, who noted that the pharma currently has five factories in the country and broke ground on a new manufacturing facility last quarter. GSK continues “to prioritize investments so that our portfolio in the U.S. is more and more supplied from the U.S,” she said. Walmsley’s statements come after the U.S. and the European Union arrived at a trade deal earlier this week, which adds a 15% tariff on pharmaceutical imports. Analysts expect these levies to cost the industry as much as $19 billion. GSK also reported on Wednesday a series of discontinuations in its pipeline. It is no longer investing in the anti-TIGIT antibody belrestotug, which it was developing alongside iTeos Therapeutics. The pharma in May broke off its engagement with the Massachusetts-based biotech following disappointing Phase II data in non-small cell lung cancer and head and neck cancer. GSK also revealed that it is pulling the plug on the antifungal agent ibrexafungerp, which it was advancing for invasive candidiasis in partnership with Scynexis. The FDA in September 2023 placed the Phase III MARIO study of ibrexafungerp in this indication under clinical hold due to a contamination issue. Scynexis revealed during its Q1 report in May that the hold had been lifted , but that GSK nevertheless wanted to terminate the study. GSK is also discontinuing the mid-stage vaccines GSK3437949 for malaria, GSK3536852 for shigella and GV118819 for tuberculosis. The pharma is also ending work on the Phase I vaccine GSK3536867 for salmonella. uygftv In the second quarter, GSK brought in £7.986 billion ($10.67 billion), representing a 6% year-on-year increase at constant exchange rates. Much of its growth was driven by its specialty medicines division, which jumped 15% to hit £3.327 billion ($4.45 billion) in the quarter. GSK’s vaccines business, earning £2.091 billion ($2.8 billion) in Q2, also delivered positive year-on-year growth. Some of GSK’s standout assets in Q2 include the asthma drug Trelegy Ellipta, which brought in £642 million ($858 million) in worldwide sales, and the lupus therapy Benlysta, which earned £372 million ($497 million). The pharma’s shingles vaccine Shingrix delivered £241 million ($322 million). Encouraged by what Walmsley called the company’s “strong momentum,” GSK raised its full-year turnover outlook. The pharma now expects to see growth toward the top end of its prior guidance, which is an increase of 3% to 5%.

VaccinePhase 2Phase 3Phase 1Clinical Result

28 May 2025

·www.fiercepharma.com

Scynexis says GSK on hook for $10M payment after phase 3 Brexafemme trial starts back up

New Jersey biotech Scynexis entered a Brexafemme licensing deal with GSK back in 2023. Two years later the companies are disputing milestone payments, which Scynexis says are owed. A month after the FDA lifted its clinical hold on GSK’s vaginal yeast infection drug Brexafemme (ibrexafungerp), the developer of the treatment, Scynexis, has resumed a phase 3 study in another use.The dosing of the first new patient in the MARIO study triggers a $10 million milestone payment from GSK and another $20 million due in six months, the Jersey City-based biotech said in a May 28 press release. GSK, for its part, is disputing the charges, according to Scynexis.Two weeks ago, when Scynexis presented its first-quarter earnings, CEO David Angulo, M.D., said GSK did not want the trial to resume after it had been delayed for 19 months.In its release this week, Scynexis said it's working with GSK to “resolve the disagreement." “The rapid resumption of patient enrollment, just a few days after the investigational sites were re-activated in the study, reflects the eagerness of the scientific community to have new treatment options for this life-threatening infection,” Angulo said in a statement.GSK reiterated its statement from two weeks ago on the dispute."We continue to work with Scynexis to commercialize Brexafemme," a company spokesperson said in an email. "With rates of resistance to other antifungal treatments rising, Brexafemme addresses a clear unmet need for new oral treatments and is an important asset of our growing anti-infectives portfolio."The MARIO trial is investigating Brexafemme as a potential step-down antifungal treatment following intravenous echinocandin for invasive candidiasis, which Scynexis describes as a “life-threatening infection.”“There is substantial need for new treatments for invasive candidiasis, particularly for Candida strains resistant to the currently approved antifungals,” Luis Ostrosky-Zeichner, M.D., a professor at UTHealth Houston, added in the release.In 2021, the FDA approved Brexafemme for vulvovaginal candidiasis (VVC), which is more commonly known as a yeast infection. A year later, the FDA tacked on a second nod for Brexafemme to reduce the risk of recurrent VVC.In 2023, GSK forged a partnership with financially strapped Scynexis, paying $90 million up front and agreeing to pay up to $503 million in potential milestones.A few months later, trouble between the companies began when GSK found that the equipment used to produce Brexafemme was also used to manufacture a beta-lactam substance. Beta-lactam compounds can trigger allergic reactions in some individuals. In September of 2023, the MARIO trial was put on hold shortly after Scynexis issued a voluntary recall of Brexafemme tablets due to the potential for cross-contamination.When Brexafemme was originally approved, some analysts believed it had blockbuster potential. But entering the commercial realm was a challenge for Scynexis, which cut 40% of its staff in 2022.After reporting sales of just $5 million for 2022, Scynexis struck the licensing deal with GSK in March 2023. Last year, GSK amended its deal with Scynexis, reducing the potential milestone payments.

License out/inPhase 3Drug ApprovalPriority Review

100 Deals associated with Ibrexafungerp Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D11544	-	J02AX	DB12471

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Candidiasis, Vulvovaginal	United States	SCYNEXIS, Inc.	01 Jun 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Candida Auris Infection	Phase 3	United States	SCYNEXIS, Inc.	15 Nov 2017
Candida Auris Infection	Phase 3	India	SCYNEXIS, Inc.	15 Nov 2017
Candida Auris Infection	Phase 3	Pakistan	SCYNEXIS, Inc.	15 Nov 2017
Candida Auris Infection	Phase 3	South Africa	SCYNEXIS, Inc.	15 Nov 2017
Candidemia	Phase 3	United States	SCYNEXIS, Inc.	15 Nov 2017
Candidemia	Phase 3	India	SCYNEXIS, Inc.	15 Nov 2017
Candidemia	Phase 3	Pakistan	SCYNEXIS, Inc.	15 Nov 2017
Candidemia	Phase 3	South Africa	SCYNEXIS, Inc.	15 Nov 2017
Aspergillosis, Allergic Bronchopulmonary	Phase 3	United States	SCYNEXIS, Inc.	01 Apr 2017
Aspergillosis, Allergic Bronchopulmonary	Phase 3	Austria	SCYNEXIS, Inc.	01 Apr 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06954493 (CTgov)	Phase 1	Candidiasis, Vulvovaginal	5	Ibrexafungerp	jbcorkwjun(ejmfyfrlrd) = idvgmklezd psafklphov (pjnefkpdzh, wlzwfmiuyq - xkejoraofz) View more	-	08 Aug 2025
NCT03059992 (FURI, CTgov)	Phase 3	Candidiasis, Vulvovaginal \| Coccidioidomycosis \| Histoplasmosis ... View more	233	Ibrexafungerp	chzkbksdvd(ngwfvalqra) = pfrawpkbfl abxwouwost (brspmemgbx, brfgnyrtpy - idvewmvtzg) View more	-	20 Nov 2024
CTR20220918 (Pubmed \| Infection) Manual	Phase 3	Candidiasis, Vulvovaginal	360	IbrexafungerpIbrexafungerp 300 mg	tnfnjlfwxa(tdfkoyoual) = hbuqetvxwz ibtikgrepo (wtyccnndcf ) View more	Positive	01 Oct 2024
				Placebo	tnfnjlfwxa(tdfkoyoual) = qldbkrlumq ibtikgrepo (wtyccnndcf ) View more
NCT03672292 (SCYNERGIA, CTgov)	Phase 2	Invasive Pulmonary Aspergillosis	22	Voriconazole+SCY-078 (SCY-078 Plus Voriconazole)	joycleoehi = juqgyusymq njteaewrnd (roybkrtiwi, whgfnmgvib - mssvfletja) View more	-	09 Aug 2024
				Oral Placebo Tablets+Voriconazole (Voriconazole Mono-therapy)	joycleoehi = arehjjjbaf njteaewrnd (roybkrtiwi, pwfjbrbqsl - osguyewpkm) View more
NCT05399641 (CTgov)	Phase 3	Candidiasis, Vulvovaginal	150	Ibrexafungerp (Group A)	czikoaqtck = zxpcboohhw wgeudydkzc (avkqpdouqv, ywrlvlttbd - wztaibaksr) View more	-	10 Jul 2024
				Ibrexafungerp (Group B (3 Day Dosing))	czikoaqtck = fhuyzrugyl wgeudydkzc (avkqpdouqv, lsefghclkj - ulyffhxhrq) View more
NCT02244606 (CTgov)	Phase 2	Candidemia	27	Ibrexafungerp (Ibrexafungerp 500-mg)	uvrwlcrciu = qtqnugdklg yqcvdxalov (eonhdygrgr, ffqfsigiwf - cwimqfuxny) View more	-	25 Jun 2024
				Ibrexafungerp (Ibrexafungerp 750-mg)	uvrwlcrciu = mxtnuxffwr yqcvdxalov (eonhdygrgr, kkvuidrefz - hkzjrogfha) View more
NCT04029116 (CANDLE, CTgov)	Phase 3	Candidiasis, Vulvovaginal	440	Fluconazole Tablet+IBREXAFUNGERP (Ibrexafungerp)	txsezuwijr = ukegukvtqi ivbhiumvge (lovamrlcik, qnkqllvvfn - asqoeneujo) View more	-	18 Jun 2023
				Placebo oral tablet+Fluconazole Tablet (Placebo)	txsezuwijr = ughgyynfnd ivbhiumvge (lovamrlcik, ghvylgfmpc - fbomuuquhm) View more
NCT03734991 (VANISH 303 and VANISH 306, Pubmed \| J Womens Health (Larchmt))	Phase 3	Candidiasis, Vulvovaginal	376	Ibrexafungerp 300mg BID	mqeakhguiw(gxmpsesjyt) = vymlstcsvp jubiktxhpl (zzmjofivav ) View more	-	17 Oct 2022
				Placebo	mqeakhguiw(gxmpsesjyt) = eaofiqxbmh jubiktxhpl (zzmjofivav ) View more
NCT03363841 (CARES, Biospace) Manual	Phase 3	Candidiasis	18	Ibrexafungerp	kwoebreaxu(xxhgtqstts) = oqkfndnkse apvscqzffv (yyfmgaezpq ) View more	Positive	08 Sep 2022

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