Drugs / Ibrexafungerp
Ibrexafungerp
also known as
SCY-078 · Brexafemme · IBREXAFUNGERP CITRATE · MK 3118 · MK-3118 FREE BASE · SCY-078 citrate
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed vulvovaginal candidiasis 4 milestones | |||||
| Filed | China (NMPA) | — | vulvovaginal candidiasis | 2023-07-20 | “NMPA has accepted for reviewing a New Drug Application (NDA) for oral ibrexafungerp tablets” hspharm.com ↗ “China’s NMPA has accepted for review an NDA for oral ibrexafungerp tablets” scynexis.com ↗ “上市许可申请（NDA）获国家药品监督管理局（NMPA）受理” hansoh.cn ↗ |
| Filed | US (FDA) | BREXAFEMME | vulvovaginal candidiasis | 2022-06-08 | “SCYNEXIS filed a supplemental New Drug Application (sNDA) to expand BREXAFEMME’s labelling to include the prevention of recurrent vulvovaginal candidiasis (RVVC);” scynexis.com ↗ “SCYNEXIS filed a supplemental New Drug Application (sNDA) to expand BREXAFEMME’s label to include the prevention of recurrent vulvovaginal candidiasis (RVVC)” scynexis.com ↗ “SCYNEXIS filed a supplemental New Drug Application (sNDA) to expand BREXAFEMME’s labelling to include the prevention of recurrent vulvovaginal candidiasis” scynexis.com ↗ |
| Filed | US (FDA) | — | vulvovaginal candidiasis | 2020-12-07 | “FDA accepted SCYNEXIS’ New Drug Application (NDA) for oral ibrexafungerp for the treatment of vaginal yeast infections” scynexis.com ↗ |
| Filed | US (FDA) | — | vulvovaginal candidiasis | 2020-10-14 | “SCYNEXIS recently announced the submission of its NDA to the U.S. Food and Drug Administration (FDA) for oral ibrexafungerp for the treatment of VVC” scynexis.com ↗ “In December 2020, the U.S. Food and Drug Administration (FDA) accepted a New Drug Application for ibrexafungerp” hspharm.com ↗ |
| Clinical hold candidiasis, invasive 1 milestone | |||||
| Clinical hold | US (FDA) | — | candidiasis, invasive | — | “In late April, the FDA notified SCYNEXIS that the clinical hold on ibrexafungerp had been lifted” scynexis.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | BREXAFEMME | — | 2022-11-30 | fda.gov ↗ |
| Approved | US (FDA) | BREXAFEMME | — | 2021-06-01 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06954493 | Jul → Nov 2023 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05668429 | Dec 2022 → Jan 2023 | fungal infectious disease | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04307082 | Dec 2019 → May 2020 | fungal infectious disease | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04092751 | Nov → Dec 2019 | — | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04092725 | Sep 2019 → Jan 2020 | — | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 2 met primary | ||||||
| Phase 2 | NCT03672292 | Jan 2019 → Mar 2023 | invasive aspergillosis | Scynexis, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03253094 | Aug 2017 → May 2018 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | Met primary |
| Phase 2 | NCT02679456 | Nov 2015 → Aug 2016 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02244606 | Sep 2014 → Jun 2016 | candidemia | Scynexis, Inc. | Completed | Met primary |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT05178862 | Aug 2022 → Nov 2025 | candidemia | Scynexis, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT05399641 | May 2022 → May 2023 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04029116 | Oct 2019 → Sep 2021 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | Met primary |
| Phase 3 | NCT03987620 | Jun 2019 → Mar 2020 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | Met primary |
| Phase 3 | NCT03734991 | Jan → Aug 2019 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | Met primary |
| Phase 3 | NCT03363841 | Nov 2017 → Apr 2023 | candidemia | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03059992 | Apr 2017 → Aug 2023 | allergic bronchopulmonary aspergillosis, blastomycosis, candidiasis, invasive, chronic mucocutaneous candidiasis +4 | Scynexis, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 84
| Date | Issuer | Release |
|---|---|---|
| 2025-05-28 | Scynexis, Inc. | Regulatory SCYNEXIS Resumes Patient Dosing in Phase 3 MARIO Study scynexis.com ↗
The study has resumed following the manufacture of new clinical supplies at another site and the lifting of the clinical hold by the FDA. |
| 2023-07-21 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA AND SCYNEXIS ANNOUNCE NMPA ACCEPTANCE OF THE NEW DRUG APPLICATION FOR IBREXAFUNGERP IN CHINA hspharm.com ↗
Shanghai ,July 20, 2023 – Hansoh Pharma(03692.HK）, a leading innovation-driven pharmaceutical company in Greater China, today announced that China’s National Medical Products Administration (NMPA) has accepted for reviewing a New Drug Application (NDA) for oral ibrexafungerp tablets for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC) in Chinese mainland. |
| 2023-07-21 | Hansoh BioMedical R&D Company | Regulatory 翰森制药抗真菌类新药枸橼酸艾瑞芬净片上市申请获受理 hansoh.cn ↗
翰森制药集团有限公司（以下简称“翰森制药” ，03692. HK）今日宣布，公司提交的枸橼酸艾瑞芬净片（Ibrexafungerp Tablets；研发代号：HS-10366）上市许可申请（NDA）获国家药品监督管理局（NMPA）受理，拟用于成年和初潮后女性外阴阴道念珠菌病（VVC）的治疗. |
| 2023-07-20 | Scynexis, Inc. | Regulatory SCYNEXIS and Hansoh Pharma Announce NMPA Acceptance of the New Drug Application for Ibrexafungerp in China scynexis.com ↗
SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that China’s National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for oral ibrexafungerp tablets for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC) in the Chinese mainland. |
| 2022-12-01 | Scynexis, Inc. | Regulatory SCYNEXIS Announces FDA Approval of Second Indication for BREXAFEMME® (ibrexafungerp tablets) for Reduction in Incidence of Recurrent Vulvovaginal Candidiasis scynexis.com ↗
SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has approved a second indication for BREXAFEMME ® (ibrexafungerp tablets) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC). |
| 2022-11-03 | Scynexis, Inc. | Results Pooled Data from the Pivotal Phase 3 VANISH Program Published in the Journal of Women’s Health Demonstrate Significant Efficacy of Ibrexafungerp Over Placebo for Treatment of Vaginal Yeast Infection scynexis.com ↗
Clinical cure rates, in the pooled analysis, were statistically significantly greater for ibrexafungerp when compared with placebo (p < 0.0001). |
| 2022-10-24 | Scynexis, Inc. | Results SCYNEXIS Presents Positive Interim Data of Oral Ibrexafungerp for Severe Fungal Infections from Ongoing Phase 3 FURI Study During IDWeek 2022 scynexis.com ↗
Cumulative interim analysis of outcomes by fungal disease type highlighted in a platform presentation demonstrates 82.3% positive clinical outcomes in patients treated with ibrexafungerp. |
| 2022-09-08 | Scynexis, Inc. | Results SCYNEXIS Presents Positive Interim Data of Ibrexafungerp for Refractory Candida Infections from Ongoing Phase 3 FURI Study During the Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting scynexis.com ↗
Approximately 83% of FURI patients with refractory Candida infections had positive clinical outcomes, defined as complete/partial response (56%) or no disease progression (27%). |
| 2022-08-04 | Scynexis, Inc. | Results SCYNEXIS Presents Positive Data from Its Pivotal Phase 3 CANDLE Study of Oral Ibrexafungerp for Prevention of Recurrent Vaginal Yeast Infections During the 2022 IDSOG Annual Meeting scynexis.com ↗
The CANDLE study met its primary endpoint, with 65.4% of patients with recurrent vulvovaginal candidiasis (RVCC) who received monthly single-day ibrexafungerp treatment achieving clinical success with no recurrence at all, either culture-proven, presumed or suspected. |
| 2022-08-01 | Scynexis, Inc. | Regulatory SCYNEXIS Announces U.S. Food and Drug Administration Acceptance and Priority Review of the Supplemental New Drug Application for BREXAFEMME® (ibrexafungerp tablets) for Prevention of Recurrent Vaginal Yeast Infections scynexis.com ↗
The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022. |
| 2022-07-19 | Scynexis, Inc. | Results SCYNEXIS Presents Positive Data from Phase 3 CANDLE Nested Sub-Study Investigating Ibrexafungerp in Women with Recurrent Yeast Infections Who Failed Fluconazole During the ISSVD XXVI World Congress and International Vulvovaginal Disease Update scynexis.com ↗
Data show that 71% of 24 patients with recurrent vulvovaginal candidiasis (RVVC) who failed to respond to a three-day regimen of fluconazole achieved a substantial reduction or complete elimination of signs and symptoms after receiving a one-day treatment with ibrexafungerp. |
| 2022-06-08 | Scynexis, Inc. | Regulatory SCYNEXIS Announces Submission of Supplemental New Drug Application of ibrexafungerp to the U.S. Food and Drug Administration for an Expanded Indication for the Prevention of Recurrent Vaginal Yeast Infections scynexis.com ↗
today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) of an additional indication for BREXAFEMME ® (ibrexafungerp tablets) for the prevention of recurrent vulvovaginal candidiasis (RVVC). |
| 2022-05-10 | Scynexis, Inc. | Results SCYNEXIS Presents New Interim Positive Data of Ibrexafungerp for Refractory Vulvovaginal Candidiasis from Ongoing Phase 3 FURI Study at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting scynexis.com ↗
Data show that of the FURI study patients with refractory or relapsed vulvovaginal candidiasis (VVC) treated with ibrexafungerp, 71.4% had successful clinical outcomes. |
| 2022-04-27 | Scynexis, Inc. | Results SCYNEXIS Presents Data Analyses Showing Ibrexafungerp’s Potential to Fight Invasive Candidiasis and Candidemia, Including Infections Caused by Candida Auris, During the 32nd Annual European Congress of Clinical Microbiology & Infectious Diseases scynexis.com ↗
Interim data of the ongoing Phase 3 FURI and CARES studies of patients with invasive candidiasis and candidemia treated with ibrexafungerp is positive and consistent with previous analyses. |
| 2022-04-22 | Scynexis, Inc. | Results SCYNEXIS Announces Positive Interim Data from Phase 3 FURI and CARES Studies Highlighting Oral Ibrexafungerp's Potency Against Severe Fungal Infections scynexis.com ↗ |
| 2022-02-10 | Scynexis, Inc. | Results SCYNEXIS Announces Positive Results from Its Pivotal Phase 3 CANDLE Study of Oral Ibrexafungerp for Prevention of Recurrent Vaginal Yeast Infections, Clearing the Way for Regulatory Submission and Potential Approval of Additional Indication by End of 2022 scynexis.com ↗
Ibrexafungerp, the only fungicidal oral treatment for vaginal yeast infections, successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints. |
| 2021-12-15 | Scynexis, Inc. | Regulatory European Medicines Agency Grants Orphan Medicinal Product Designation for SCYNEXIS’ Innovative Antifungal Ibrexafungerp for the Indication of Invasive Candidiasis scynexis.com ↗
today announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation to ibrexafungerp for the indication of invasive candidiasis (IC). |
| 2021-11-23 | Scynexis, Inc. | Results SCYNEXIS Pivotal Phase 3 VANISH-306 Trial Results Published in the International Journal of Obstetrics and Gynaecology (BJOG) Demonstrate Statistical Superiority of BREXAFEMME® (Ibrexafungerp Tablets) Over Placebo for Vaginal Yeast Infection scynexis.com ↗
Results from the VANISH-306 study show that treatment with oral ibrexafungerp achieved superiority over placebo with a high degree of statistical significance on key study endpoints and was generally safe and well-tolerated. |
| 2021-11-10 | Scynexis, Inc. | Results SCYNEXIS Reports Third Quarter 2021 Financial Results and Provides Corporate Update scynexis.com ↗
Results from progressive ascending dosing to reach target exposure showed IV ibrexafungerp was generally well tolerated with no concerning safety findings, and SCYNEXIS is evaluating next steps toward the registrational program for this formulation. |
| 2021-11-09 | Scynexis, Inc. | Results SCYNEXIS Announces Successful Completion of Phase 1 Trial Evaluating Intravenous (IV) Formulation of Ibrexafungerp scynexis.com ↗
The liposomal IV formulation of ibrexafungerp was generally well tolerated with no serious adverse events reported. |
| 2021-10-21 | Scynexis, Inc. | Results SCYNEXIS Pivotal Phase 3 VANISH-303 Trial Results Published in Clinical Infectious Diseases Demonstrate Significant Superiority of Ibrexafungerp Over Placebo for Treatment of Vaginal Yeast Infection scynexis.com ↗
In the Phase 3 VANISH-303 study, ibrexafungerp demonstrated significantly higher rates of clinical cure and infection eradication versus placebo. |
| 2021-10-13 | Scynexis, Inc. | Results SCYNEXIS to Present Pooled Data Analysis Results Demonstrating Consistent Efficacy and Safety Outcomes Across Two Phase 3 VANISH Clinical Trials of Oral Ibrexafungerp Therapy for Vaginal Yeast Infection at October Medical Conferences scynexis.com ↗ |
| 2021-10-11 | Scynexis, Inc. | Results SCYNEXIS Announces Preclinical Data at the 10th Trends in Medical Mycology Meeting Supporting Potential of Ibrexafungerp to Treat Mucormycosis scynexis.com ↗
Additionally, the study found when ibrexafungerp was combined with amphotericin B, synergistic benefits were observed with a significant enhancement in median survival time and overall survival when compared to any one therapy alone. |
| 2021-10-07 | Scynexis, Inc. | Results SCYNEXIS to Present Clinical Data from Ongoing FURI and CARES Studies at the 10th Trends in Medical Mycology Meeting Showing Oral Ibrexafungerp Provides a Favorable Therapeutic Response in Patients with Severe Fungal Infections scynexis.com ↗ |
| 2021-09-29 | Scynexis, Inc. | Results SCYNEXIS Presents Interim Analysis from FURI at Virtual IDWeek 2021 Showing Favorable Therapeutic Response in Severe Hospital-Based Fungal Infections Treated with Oral Ibrexafungerp scynexis.com ↗
today announced an oral presentation of analyses of interim data from its ongoing Phase 3 FURI study showing favorable clinical activity of oral ibrexafungerp in severe hospital-based fungal infections across multiple serious fungal infections. |
| 2021-09-13 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA ANNOUNCES APPLICATION FOR PHASE 3 TRIAL OF IBREXAFUNGERP FOR THE TREATMENT OF VULVOVAGINAL CANDIDIASIS (VVC) hspharm.com ↗
the company has filed an investigational new drug (IND) application with the National Medical Products Administration (NMPA) of the People’s Republic of China for a Phase 3 study |
| 2021-09-13 | Scynexis, Inc. | Regulatory SCYNEXIS Announces Hansoh Pharma’s Application to National Medical Products Administration (NMPA) in China for Phase 3 Trial of Ibrexafungerp for Treatment of Vulvovaginal Candidiasis (VVC) scynexis.com ↗ |
| 2021-07-29 | Scynexis, Inc. | Results SCYNEXIS Announces Two Oral Presentations on Pooled Data from the BREXAFEMME (Ibrexafungerp tablets) Phase 3 VANISH Program Demonstrating Consistent Efficacy in the Treatment for Vaginal Yeast Infections at the IDSOG 2021 Virtual Annual Meeting scynexis.com ↗
The data presented demonstrate oral ibrexafungerp’s safety and efficacy as a treatment for vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. |
| 2021-07-12 | Scynexis, Inc. | Results SCYNEXIS Announces Three Oral Presentations of Ibrexafungerp Demonstrating Clinical and In Vitro Activity Against Candida Species at the 31st ECCMID scynexis.com ↗
These presentations continue to build on the positive responses we’ve seen in both the CARES and FURI studies and support ibrexafungerp’s potential to be the treatment option that patients need. |
| 2021-06-09 | Scynexis, Inc. | Regulatory SCYNEXIS Confirms that BREXAFEMME® (ibrexafungerp tablets) Qualifies for 10 Years of Regulatory Exclusivity for Vaginal Yeast Infections scynexis.com ↗
today announced that the U.S. Food and Drug Administration (FDA) granted BREXAFEMME (ibrexafungerp tablets), five years of exclusivity extension under the Generating Antibiotic Incentives Now (GAIN) Act. |
| 2021-06-02 | Scynexis, Inc. | Regulatory SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections scynexis.com ↗
Approval of BREXAFEMME (ibrexafungerp) represents the first approved drug in a novel antifungal class in more than 20 years |
| 2021-04-30 | Scynexis, Inc. | Results SCYNEXIS Presents Data at 2021 ACOG Demonstrating the Positive Outcome and Sustained Response of Investigational Oral Ibrexafungerp (Brexafemme™) in Difficult-to-Treat Patients with Vaginal Yeast Infections scynexis.com ↗
A single-day dose of oral ibrexafungerp demonstrates positive clinical outcomes in difficult-to-treat vulvovaginal candidiasis (VVC) patient populations: those with non- albicans Candida VVC and/or severe VVC |
| 2021-03-02 | Scynexis, Inc. | Results SCYNEXIS Announces Positive Results from Interim Analyses of Ongoing Phase 3 Studies (FURI and CARES), Demonstrating Oral Ibrexafungerp's Ability to Treat Severe Fungal Infections in the Hospital Setting scynexis.com ↗
Consistent with prior two interim analyses, FURI results confirm positive clinical activity of oral ibrexafungerp in patients with difficult-to-treat, severe, mucocutaneous and invasive fungal infections, including those caused by resistant strains |
| 2020-12-10 | Scynexis, Inc. | Regulatory SCYNEXIS Announces Advancement of Ibrexafungerp’s Intravenous Formulation to Clinical Stage and Provides Further Updates on its Clinical Studies in Patients with Life-Threatening Fungal Infections scynexis.com ↗
SCYNEXIS has been granted approvals from the health authority and ethics committee, with dosing anticipated to start in the first quarter of 2021. |
| 2020-12-07 | Scynexis, Inc. | Regulatory SCYNEXIS Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections scynexis.com ↗
SCYNEXIS, Inc. (NASDAQ: ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the SCYNEXIS’s New Drug Application (NDA) for ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infections. |
| 2020-10-14 | Scynexis, Inc. | Regulatory SCYNEXIS Announces Submission of New Drug Application to the U.S. Food and Drug Administration for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infection scynexis.com ↗ |
| 2020-08-13 | Scynexis, Inc. | Results SCYNEXIS Announces Presentations at 2020 IDSOG Virtual Annual Meeting Highlighting Ibrexafungerp’s Potential for the Treatment of Vulvovaginal Candidiasis scynexis.com ↗ |
| 2020-07-22 | Scynexis, Inc. | Results SCYNEXIS Announces Four Posters Presented at ASM Microbe 2020 Highlighting the Potential Clinical Utility of Ibrexafungerp scynexis.com ↗
Clinical and preclinical studies demonstrate ibrexafungerp’s broad-spectrum activity and potential to treat a range of serious and life-threatening fungal infections |
| 2020-05-06 | Scynexis, Inc. | Results SCYNEXIS Announces Six Abstracts Published by 30th ECCMID Highlighting the Potential Clinical Utility of Ibrexafungerp scynexis.com ↗
Findings indicate oral ibrexafungerp could potentially decrease length of hospital stays by reducing dependence on IV-administered antifungals |
| 2020-04-21 | Scynexis, Inc. | Results SCYNEXIS Announces Positive Top-Line Results from its Second Pivotal Phase 3 Study (VANISH-306) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (Vaginal Yeast Infection) scynexis.com ↗
today announced positive top-line results for its Phase 3 VANISH-306 study investigating the safety and efficacy of oral ibrexafungerp, a novel broad-spectrum antifungal, as a treatment for women with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. |
| 2020-03-05 | Scynexis, Inc. | Results SCYNEXIS Announces Preclinical Data on Ibrexafungerp and Azoles against Aspergillus Presented at the 9th Advances Against Aspergillosis and Mucormycosis Conference scynexis.com ↗
These in vitro data showed synergistic activity of ibrexafungerp in combination with azoles against Aspergillus isolates. |
| 2020-01-08 | Scynexis, Inc. | Results SCYNEXIS Announces Positive Results from the Second Interim Analysis of Ongoing Phase 3 FURI Study, Demonstrating Oral Ibrexafungerp's Ability to Treat Severe Fungal Infections in the Hospital Setting scynexis.com ↗
Consistent with the first interim analysis, results confirm clinical antifungal activity of oral ibrexafungerp in patients with difficult-to-treat, severe, mucocutaneous and invasive fungal infections, including those caused by resistant strains |
| 2019-11-07 | Scynexis, Inc. | Results SCYNEXIS Reports Positive Top-Line Results from First Phase 3 Registration Study of Oral Ibrexafungerp in Vulvovaginal Candidiasis (VANISH-303) scynexis.com ↗
Specifically, ibrexafungerp achieved superiority over placebo at a highly statistically significant level (p≤0.001) for the primary endpoint and key study endpoints required for regulatory approval of the VVC indication. |
| 2019-10-31 | Scynexis, Inc. | Results SCYNEXIS Announces Oral Presentation of Data from Ibrexafungerp Phase 2b DOVE Study at the 3rd ISIDOG Congress scynexis.com ↗
Presentation will detail ibrexafungerp's improved trend in signs and symptoms versus fluconazole on a per patient basis |
| 2019-10-02 | Scynexis, Inc. | Results SCYNEXIS to Present Data at IDWeek 2019 and the 9th Congress on Trends in Medical Mycology (TIMM-9) Highlighting Scientific and Clinical Evidence of Ibrexafungerp's Activity Against Resistant Fungal Pathogens, Including Candida auris scynexis.com ↗
The in vitro activity of ibrexafungerp (IBX) against C. auris was uniform with MICs displaying a Gaussian distribution spanning 0.06-2 mg/L suggesting an equal efficacy across the 122 isolates. |
| 2019-07-24 | Scynexis, Inc. | Regulatory SCYNEXIS Announces Special Protocol Assessment (SPA) Agreement with FDA for Phase 3 Study Evaluating Oral Ibrexafungerp for the Prevention of Recurrent Vulvovaginal Candidiasis (VVC) (CANDLE Study) scynexis.com ↗ |
| 2019-06-25 | Scynexis, Inc. | Results World-renowned Fungal Infection Expert Comments on Oral Ibrexafungerp Data Presented by SCYNEXIS at ASM Microbe 2019 scynexis.com ↗
In this animal model, orally administered ibrexafungerp showed superior penetration versus IV echinocandins, the current standard-of-care. |
| 2019-06-05 | Scynexis, Inc. | Results SCYNEXIS to Present Data at ASM Microbe 2019 Demonstrating the Broad Potential Utility of Ibrexafungerp for the Treatment and Prevention of Multiple Severe Fungal Infections scynexis.com ↗
In this study, ibrexafungerp penetrated significantly better into intra-abdominal abscesses as compared to micafungin. |
| 2019-05-06 | Scynexis, Inc. | Results SCYNEXIS Presents Data at ACOG 2019 Further Supporting a Future NDA Submission of Oral Ibrexafungerp for Vulvovaginal Candidiasis (VVC) scynexis.com ↗
Reproductive and developmental studies (fertility and early embryonic, embryo-fetal, peri- and post-natal) provide evidence that ibrexafungerp does not cause fetal or reproductive harm. |
| 2019-04-15 | Scynexis, Inc. | Results SCYNEXIS to Discuss ECCMID 2019 Clinical Data, Including Successful Case Studies in Candida auris and Other Difficult-to-Treat Infections, on Conference Call scynexis.com ↗
SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced results showing evidence of activity of the company's lead product candidate, ibrexafungerp, against fungal infections in multiple settings and indications. |
| 2019-04-08 | Scynexis, Inc. | Results SCYNEXIS Commends the New York Times for its Reporting on Candida auris and Other Drug-Resistant Pathogens scynexis.com ↗ |
| 2019-04-03 | Scynexis, Inc. | Results SCYNEXIS's Ibrexafungerp Shows Favorable Clinical Activity in Resistant Fungal Infections, Including Candida auris Cases from the CARES Study, in Data to be Presented at the 29th ECCMID scynexis.com ↗
After 54 days of oral ibrexafungerp treatment, the infection fully resolved. |
| 2019-02-28 | Scynexis, Inc. | Results SCYNEXIS to Present Pre-clinical Data Supporting Prophylactic Use of Ibrexafungerp at Superbugs and Superdrugs 2019 scynexis.com ↗
Oral ibrexafungerp demonstrates potent antifungal activity against Pneumocystis in vivo |
| 2019-01-30 | Scynexis, Inc. | Results SCYNEXIS Announces Positive Interim Results from Phase 3 Open-Label FURI Study, Showing Oral Ibrexafungerp's Ability to Treat Refractory Fungal Infections and to Provide an Alternative to Long-Term IV Therapies scynexis.com ↗
Oral ibrexafungerp showed clinical benefits in 17 out of 20 patients, with 11 patients achieving a complete or partial response and six patients a stable disease response. |
| 2018-10-23 | Scynexis, Inc. | Regulatory SCYNEXIS Announces FDA Agreement with Company-Proposed Phase 3 Vulvovaginal Candidiasis Program for Oral Ibrexafungerp scynexis.com ↗
The FDA has agreed with the Company's proposed overall design of the Phase 3 registration program to support approval of oral ibrexafungerp for the treatment of VVC and prevention of recurrent VVC. |
| 2018-09-04 | Scynexis, Inc. | Results SCYNEXIS, Inc. Presents Ibrexafungerp Data at the 2018 ESCMID/ASM Conference on Drug Development scynexis.com ↗
In vitro studies show activity of ibrexafungerp against echinocandin-resistant C. glabrata strains |
| 2018-07-10 | Scynexis, Inc. | Results SCYNEXIS Reports Positive Results from Phase 2b Dose-Finding Study of Oral SCY-078 in Vulvovaginal Candidiasis scynexis.com ↗
SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company developing innovative therapies for difficult-to-treat and often life-threatening infections, today announced positive results from its Phase 2b, dose-finding study (the DOVE study) evaluating oral SCY-078 for the treatment of vulvovaginal candidiasis (VVC). |
| 2018-06-27 | Scynexis, Inc. | Results SCYNEXIS Announces the Presentation of SCY-078 Data at the Teratology Society 58th Annual Meeting scynexis.com ↗
These studies provide evidence that SCY-078 does not exhibit developmental or reproductive toxicity when administered to animals before and/or during gestation. |
| 2018-06-14 | Scynexis, Inc. | Results SCYNEXIS to Present SCY-078 Data at Three Scientific Meetings in June/July 2018 scynexis.com ↗
SCY-078: A First-in-class, Orally-bioavailable, Glucan Synthase Inhibitor has Activity Alone and is Synergistic with Azole Antifungal Agents against Aspergillus spp. |
| 2018-06-11 | Scynexis, Inc. | Results SCYNEXIS Presents SCY-078 Data at ASM Microbe 2018 scynexis.com ↗
These results show that minimum inhibitory concentrations (MIC) for SCY-078 and caspofungin were lower in Sabouraud dextrose broth than in RPMI, a standard medium employed for this determination. |
| 2018-06-06 | Scynexis, Inc. | Results SCYNEXIS Announces the Publication of Phase 1 Study Results for SCY-078 in The Journal of Clinical Pharmacology scynexis.com ↗
In this open-label, two-period, crossover study, results demonstrated that co-administration of rosiglitazone with SCY-078 after repeat dosing had no clinically meaningful effect on rosiglitazone exposure compared with administration of rosiglitazone alone. |
| 2018-05-01 | Scynexis, Inc. | Regulatory SCYNEXIS's Oral SCY-078 Receives FDA QIDP and Fast Track Designations for the Treatment of VVC and Prevention of Recurrent VVC scynexis.com ↗
These designations from the FDA for the treatment of VVC and prevention of recurrent VVC highlight the significant unmet needs faced by women suffering from these widespread infections, |
| 2018-04-23 | Scynexis, Inc. | Results SCYNEXIS Data Presentations at ECCMID 2018 Show SCY-078 Potent and Synergistic Antifungal Activity Against Aspergillus and Pneumocystis scynexis.com ↗
SCY-078 demonstrated potent antifungal activity against these isolates independently and synergistic behavior was observed in combination with amphotericin B, voriconazole and isavuconazole. |
| 2018-02-01 | Scynexis, Inc. | Results SCYNEXIS Presents New In Vivo Data Highlighting the Potential of SCY-078 Used in Combination for the Treatment of Aspergillus Infections at AAA 2018 scynexis.com ↗
Data shows synergistic activity and improved outcomes of SCY-078 in combination with isavuconazole |
| 2017-10-05 | Scynexis, Inc. | Results SCYNEXIS Presents New Data Further Supporting SCY-078 as a Potential Treatment for Aspergillus and Candida Infections at IDWeek 2017 scynexis.com ↗ |
| 2017-08-14 | Scynexis, Inc. | Results SCYNEXIS Presents New Data Supporting Oral SCY-078 for the Clinical Treatment of Vulvovaginal Candidiasis Infections at the 2017 IDSOG Annual Meeting scynexis.com ↗
SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative anti-infective therapies for difficult-to-treat and often life-threatening infections, today reported data for SCY-078, the Company’s lead clinical development candidate, which were presented at the (IDSOG) Annual Meeting, August 10-12, 2017 in Park City, UT. |
| 2017-06-15 | Scynexis, Inc. | Results New Study Further Demonstrates In Vitro Activity of SCYNEXIS’ Lead Anti-Infective Candidate, SCY-078, Against Drug-Resistant Candida Fungal Strains scynexis.com ↗ |
| 2017-06-05 | Scynexis, Inc. | Results Eight Presentations at ASM Microbe 2017 Further Highlight the Strong Antifungal Effect and Promising Safety Profile of Lead Anti-Infective Candidate SCY-078 scynexis.com ↗
today announced the results of eight studies supporting the potent and broad antifungal activity and positive safety and tolerability profile of SCY-078, its lead candidate. |
| 2017-05-11 | Scynexis, Inc. | Results Potent in vitro Activity of SCYNEXIS’ SCY-078 Against Multidrug-Resistant Fungal Pathogen Candida auris Further Confirmed in an in vitro Study Conducted by the Centers for Disease Control and Prevention (CDC) scynexis.com ↗ |
| 2017-04-25 | Scynexis, Inc. | Results Eight Data Presentations at ECCMID Showcase the Broad Applicability of SCYNEXIS’ Lead Anti-infective Candidate SCY-078 scynexis.com ↗
SCY-078 demonstrated safety among all treatment groups and achieved a global response rate similar to standard-of-care. |
| 2017-03-02 | Scynexis, Inc. | Regulatory SCYNEXIS delays initiation of new clinical studies using the IV formulation of SCY-078 at FDA’s request scynexis.com ↗
The clinical hold decision was issued by the FDA following a review of three mild-to-moderate thrombotic events in healthy volunteers receiving the IV formulation of SCY-078 at the highest doses and highest concentrations in a Phase 1 study. |
| 2016-10-25 | Scynexis, Inc. | Results SCYNEXIS Completes Two Additional Clinical Studies Further Supporting the Favorable Safety Profile of SCY-078 scynexis.com ↗
Drug development company (Nasdaq:SCYX) today announced the completion of two additional Drug-Drug Interaction (DDI) studies, further demonstrating the favorable safety profile of SCY-078. |
| 2016-10-05 | Scynexis, Inc. | Results SCYNEXIS Announces Complete Results from Two Phase 2 Studies of Oral SCY-078 in Patients with Candida spp. Infections and Closing of a $15 Million Term Loan scynexis.com ↗
In the first study, treatment with oral SCY-078 in patients with vulvovaginal candidiasis (VVC), resulted in significantly better clinical cure rates and fewer recurrences of VVC at the four-month follow-up when compared to the standard of care (oral fluconazole). |
| 2016-08-24 | Scynexis, Inc. | Regulatory SCYNEXIS, Inc. Receives Orphan Drug Designation for SCY-078 for the Treatment of Invasive Aspergillus Infections scynexis.com ↗
SCYNEXIS, Inc. (Nasdaq:SCYX) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s novel triterpenoid broad-spectrum antifungal agent, SCY-078, for the treatment of invasive Aspergillus infections. |
| 2016-08-01 | Scynexis, Inc. | Results SCYNEXIS Announces Interim Results from Phase 2 Study of Oral SCY-078 in Patients with Invasive Candidiasis scynexis.com ↗
A once daily oral dose of 750mg of SCY-078 was identified as the dose that achieves the target exposure with favorable safety and tolerability in patients with invasive candidiasis. |
| 2016-06-20 | Scynexis, Inc. | Results SCYNEXIS Inc. Presents New Clinical and Non-Clinical Data Confirming the Potential of SCY-078 as a Novel Treatment for Life-threatening Fungal Infections scynexis.com ↗
The absolute oral bioavailability, defined as the ratio of the dose-normalized AUC0-∞ values for the oral to IV doses, was high (~ 35%), indicating SCY-078’s ability to reach target exposure (15 μM•h), when administered orally. |
| 2016-06-08 | Scynexis, Inc. | Results SCYNEXIS, Inc. Announces Positive Results in its Proof-of-Concept Phase 2 Study of SCY-078, the First Member of a Novel Class of Glucan Synthase Inhibitors scynexis.com ↗
The efficacy analysis provides compelling evidence of the antifungal effect of SCY-078 that appears comparable to fluconazole in the treatment of VVC. |
| 2016-05-13 | Scynexis, Inc. | Regulatory SCYNEXIS, Inc. Receives Orphan Drug Designation for SCY-078 for the Treatment of Invasive Candida Infections scynexis.com ↗
SCYNEXIS, Inc. (Nasdaq:SCYX) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s novel and structurally distinct glucan synthase inhibitor, SCY-078, for the treatment of invasive Candida infections, including candidemia. |
| 2016-04-15 | Scynexis, Inc. | Results SCYNEXIS Presents Data Supporting the Activity of its Lead Antifungal Drug Candidate SCY-078 Against Antifungal-resistant Candida Strains at the 13th ASM Conference on Candida and Candidiasis scynexis.com ↗
SCY-078 was active against more than 90% of fluconazole-resistant Candida spp. isolates. |
| 2016-04-06 | Scynexis, Inc. | Results SCYNEXIS to Present Data from Lead Antifungal Drug Candidate SCY-078 at 13th ASM Conference on Candida and Candidiasis scynexis.com ↗
SCY-078 Displays Potent in vitro Activity Against Candida glabrata Isolates with Mutations in fks Gene. |
| 2016-01-28 | Scynexis, Inc. | Regulatory SCYNEXIS, Inc. Receives FDA Fast Track and QIDP Designations for Intravenous Formulation of SCY-078 for the Treatment of Patients with Invasive Fungal Infections scynexis.com ↗ |
| 2015-09-21 | Scynexis, Inc. | Results SCYNEXIS Presents Data Supporting the Potential Clinical Utility of Antifungal Drug Candidate at ICAAC/ICC 2015 scynexis.com ↗
SCY-078 was well-tolerated when delivered intravenously in multiple species and showed low plasma clearance and high volume of distribution in tissues; |
| 2015-01-09 | Scynexis, Inc. | Regulatory SCYNEXIS, Inc. Receives FDA Fast Track Designation for Oral Formulation of SCY-078 for the Treatment of Patients With Invasive Fungal Infections scynexis.com ↗
SCYNEXIS, Inc. (Nasdaq:SCYX) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for the oral formulation of SCY-078, the Company's novel antifungal product in development for the treatment of invasive Candidiasis , including Candidemia and invasive Aspergillosis . |
| 2014-02-21 | Scynexis, Inc. | Regulatory SCYNEXIS Receives Qualified Infectious Disease Product (QIDP) Designation from the FDA for Antifungal Agent SCY-078 for Oral Use scynexis.com ↗
Drug discovery and development company SCYNEXIS, Inc., today announced that the Food and Drug Administration (FDA) designated SCY-078 as a Qualified Infectious Disease Product (QIDP) for oral use for the indications of invasive Candidiasis , including Candidemia , and invasive Aspergillosis . |
All press releases naming this drug 135 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 135 releases opens the full record — a long page | ||
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ibrexafungerp | “Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor, has demonstrated broad fungicidal Candida activity and a favorable tolerability profile.” PMID 34555149 ↗ Jul 202213“repeated oral doses of SCY-078 (Ibrexafungerp) on the pharmacokinetics of dabigatran administered orally to healthy subjects.” NCT04092725 ↗ “Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis” NCT02244606 ↗ “Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects” NCT04092751 ↗ “Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole” NCT02679456 ↗ “Ibrexafungerp” NCT05178862 ↗ |
| Known as | Brexafemme | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Known as | IBREXAFUNGERP CITRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Known as | MK 3118 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Known as | MK-3118 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Known as | SCY-078 | “Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis” NCT03253094 ↗7“Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis” NCT02244606 ↗ “Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole” NCT02679456 ↗ |
| Known as | SCY-078 citrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297513 ↗ |
| Action | Inhibit | “oral triterpenoid glucan synthase inhibitor” PMID 34555149 ↗ Jul 2022 |
| Modality | Small molecule | “Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor” PMID 34555149 ↗ Jul 2022 |
| Route | Oral | “750mg/day orally administered” NCT03059992 ↗ |