Delving into the Latest Updates on Ibrexafungerp Citrate with Synapse

RegulationFast Track (United States), Orphan Drug (United States), Qualified Infectious Disease Product (United States), Orphan Drug (European Union), Priority Review (United States)

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Structure/Sequence

Molecular FormulaC50H75N5O11

InChIKeyWKIRTJACGBEXBZ-FQGZCCSZSA-N

CAS Registry1965291-08-0

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]

100 Clinical Results associated with Ibrexafungerp Citrate

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100 Translational Medicine associated with Ibrexafungerp Citrate

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100 Patents (Medical) associated with Ibrexafungerp Citrate

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131

Literatures (Medical) associated with Ibrexafungerp Citrate

01 Dec 2025·Journal of Global Antimicrobial Resistance

In vitro evaluation of Ibrexafungerp against clinical and environmental isolates of cryptococcus neoformans and cryptococcus gattii

Letter

Author: Firacative, Carolina ; Ceballos-Garzon, Andrés

01 Oct 2025·Journal of Lower Genital Tract Disease

Vulvovaginal Candidiasis Caused by Candida krusei (Pichia kudriavzevii), Still a Formidable Challenge

Article

Author: Vempati, Yogitha Sai ; Sobel, Jack D

Objectives:

In recent years, the prevalence of non-albicans Candida vulvovaginitis has risen with Candida glabrata and Candida krusei (Pichia kudriavzevii) being prominent contributors. Candida krusei poses a significant challenge due to its intrinsic resistance to fluconazole, both in vitro and clinically. Practitioners face difficulties managing patients with chronic symptomatic vulvovaginal candidiasis who fail to respond to multiple courses of oral fluconazole and over the counter (OTC) antifungals.

Methods:

The authors analyzed retrospectively a cohort of women who had chronic vulvovaginal symptoms seen in their vaginitis clinic between 2017 and 2024. Clinical charts of 11 patients with positive C. krusei vaginal fungal isolates were reviewed. Antifungal susceptibility of isolates was assessed, and treatments, including novel antifungal agents oteseconazole and ibrexafungerp, were evaluated for their efficacy in symptom control.

Results:

In 10 of 11 patients, symptoms were attributed to C. krusei vaginitis, while in 1 patient, C. krusei was found to be an innocent bystander. Candida krusei vaginal isolates in vitro susceptibility testing demonstrated resistance not only limited to fluconazole but also to miconazole, ketoconazole, and other azole agents. Although itraconazole exhibited in vitro activity, treatment often failed to achieve clinical or mycologic remission. Despite the availability of new antifungal agents, vaginal boric acid emerged as the initial if not definitive treatment method of choice.

Conclusion:

Determining the antifungal susceptibility profile of C. krusei vaginal isolates may be required in selecting effective antifungal treatment of refractory vaginitis due to non-albicans Candida (NAC).

01 Sep 2025·CTS-Clinical and Translational Science

Ibrexafungerp: Mechanism of Action, Clinical, and Translational Science

Review

Author: Woodahl, Erica L. ; Dupuis, Lauren N. ; Killam, Shayna R. ; Walley, Adelynne H.

ABSTRACT:

Ibrexafungerp is a first‐in‐class triterpenoid antifungal that targets β‐(1,3)‐glucan synthase in fungal cell wall development. It is indicated for vulvovaginal candidiasis (VVC) and recurrent vulvovaginal candidiasis (RVVC) in adult and post‐menarchal pediatric females. The drug was approved in 2021 and 2022 for VVC and RVVC, respectively. Research is ongoing to evaluate the safety of ibrexafungerp in pregnancy and lactation as well as to explore intravenous and oral formulations for invasive candidiasis and invasive aspergillosis. Ibrexafungerp binds and inhibits β‐(1,3)‐glucan synthase that is essential for the synthesis of β‐(1,3)‐D‐glucan, a key polymer in the fungal cell wall, leading to cell lysis and death. This mechanism of action varies from that of the current VVC therapy, fluconazole, which makes ibrexafungerp a primary candidate for treating fluconazole‐resistant patient cases. The drug is distributed into vaginal tissue at higher concentrations and has increased efficacy at lower pH compared to fluconazole, indicating a therapeutic advantage for VVC. Ibrexafungerp was generally well‐tolerated in most participants throughout clinical trials. The most commonly reported treatment‐emergent adverse events were headache, dizziness, and gastrointestinal‐related effects. The efficacy of ibrexafungerp was found to be comparable to fluconazole and superior to placebo as seen in key clinical trials: DOVE (NCT03253094) and VANISH303 (NCT03734991). We reviewed the regulatory approval process of ibrexafungerp, including key clinical trials and in‐depth analyses of pivotal studies related to the drug's clinical efficacy and safety. Additionally, we reviewed the drug's unique mechanism of action and the pharmacokinetic and pharmacodynamic characteristics essential for its use in VVC and RVVC.

138

News (Medical) associated with Ibrexafungerp Citrate

22 Dec 2025

·www.globenewswire.com

SCYNEXIS Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Requirement

JERSEY CITY, N.J., Dec. 22, 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 received an additional 180-calendar-day extension from the Nasdaq Stock Market (“Nasdaq”) to regain compliance with the minimum bid price requirement, as outlined in Nasdaq Listing Rule 5550(a)(2). The Company now has until June 15, 2026, to meet the requirement for its shares of common stock to maintain a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days. Nasdaq granted the extension after determining that SCYNEXIS continues to meet all other continued listing criteria for the Nasdaq Capital Market, including the market value of publicly held shares, and has provided written notice of its intention to cure the deficiency within the extension period, if necessary, through a reverse stock split. “We are grateful for Nasdaq’s decision to grant this 180-day extension, which allows us to continue advancing our strategic objectives,” said David Angulo, M.D., President and Chief Executive Officer. “In the upcoming year we expect to leverage our balance sheet to complete a Phase 1 study of an intravenous (IV) formulation for our next-generation fungerp, SCY-247, as well as generate proof-of-concept Phase 2 data in the oral formulation of SCY-247 for invasive candidiasis infections. SCY-247 is an exciting investigational antifungal with the potential to benefit both hospitalized and community patients with challenging infections and is highly anticipated by the anti-infective scientific community. Lastly, SCYNEXIS remains committed to full compliance with all Nasdaq listing requirements and plans to take all necessary actions within the prescribed 180-day period to regain compliance.” 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: regaining Nasdaq compliance, completing a Phase 1 study of an IV formulation for SCY-247, generating proof-of-concept Phase 2 data in the oral formulation of SCY-247 for invasive candidiasis infections, and the potential benefits of SCY-247. 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 ApprovalPhase 2

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

100 Deals associated with Ibrexafungerp Citrate

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External Link

KEGG	Wiki	ATC	Drug Bank
D11544	-	J02AX	DB12471

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Candidiasis, Vulvovaginal	United States	Glaxosmithkline Plc /Suzhou Mfg. Facility/	01 Jun 2021
Candidiasis, Vulvovaginal	United States	GlaxoSmithKline LLC	01 Jun 2021

Developing

10 top R&D records.

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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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06954493 (CTgov)	Phase 1	Candidiasis, Vulvovaginal	5	Ibrexafungerp	lmciwednir(nchumehtpl) = doakkrduqi iqresztjoe (mhqqymqrvx, bvjrnsxzhc - nstdhvwylb) View more	-	08 Aug 2025
NCT03059992 (FURI, CTgov)	Phase 3	Candidiasis, Vulvovaginal \| Coccidioidomycosis \| Histoplasmosis ... View more	233	Ibrexafungerp	qolejyzqfv(ibwhcmopkc) = fimmduyfug bldkwlpgop (leftnhypio, rpfdzeklti - rkvwznwbug) View more	-	20 Nov 2024
CTR20220918 (Pubmed \| Infection) Manual	Phase 3	Candidiasis, Vulvovaginal	360	IbrexafungerpIbrexafungerp 300 mg	iobvlvyvum(oqoeaqdraj) = wxaarxaqzi ztzhdtfdio (bogwvxykpn ) View more	Positive	01 Oct 2024
				Placebo	iobvlvyvum(oqoeaqdraj) = hniyudjxxj ztzhdtfdio (bogwvxykpn ) View more
NCT03672292 (SCYNERGIA, CTgov)	Phase 2	Invasive Pulmonary Aspergillosis	22	Voriconazole+SCY-078 (SCY-078 Plus Voriconazole)	nquljkjchq = xgebkzfokh bktqpjhmda (rfkoktjeut, uzzdlfparp - fqwnzbtohq) View more	-	09 Aug 2024
				Oral Placebo Tablets+Voriconazole (Voriconazole Mono-therapy)	nquljkjchq = vhyvjfgiuf bktqpjhmda (rfkoktjeut, amjnfbkqfo - hkivimopry) View more
NCT05399641 (CTgov)	Phase 3	Candidiasis, Vulvovaginal	150	Ibrexafungerp (Group A)	smifoqysog = juoyjoobku qybdycexjx (evezjhcnqz, vhsoazkbxl - yzxjrrqhxg) View more	-	10 Jul 2024
				Ibrexafungerp (Group B (3 Day Dosing))	smifoqysog = vxtgmvnqkc qybdycexjx (evezjhcnqz, azbkwgoelt - ukentoohmh) View more
NCT03363841 (CARES, CTgov)	Phase 3	Candida Auris Infection \| Candidemia	30	Ibrexafungerp	furhdlpubu = mqrtjhfgol vanxpuopvk (uscuspmcyx, loopmigudl - tkglgimpsc) View more	-	03 Jul 2024
NCT02244606 (CTgov)	Phase 2	Candidemia	27	Ibrexafungerp (Ibrexafungerp 500-mg)	ibfzbstjws = ytkuyfuuja rhfclapxpl (lznpxcljbj, wbehdjyqrk - pmyllgnllh) View more	-	25 Jun 2024
				Ibrexafungerp (Ibrexafungerp 750-mg)	ibfzbstjws = wirdkdbdtg rhfclapxpl (lznpxcljbj, cvaatuqkbk - sildghljuu) View more
NCT04029116 (CANDLE, CTgov)	Phase 3	Candidiasis, Vulvovaginal	440	Fluconazole Tablet+IBREXAFUNGERP (Ibrexafungerp)	daviwobttd = fkclytesln jzmmnmqgqo (dipddjhjlm, wgffxgymac - urhkesqhwr) View more	-	18 Jun 2023
				Placebo oral tablet+Fluconazole Tablet (Placebo)	daviwobttd = vrdpocdvuh jzmmnmqgqo (dipddjhjlm, uuljdcvggx - cmieqnsljz) View more
NCT03734991 (VANISH 303 and VANISH 306, Pubmed \| J Womens Health (Larchmt))	Phase 3	Candidiasis, Vulvovaginal	376	Ibrexafungerp 300mg BID	jjokkryjhm(ixufknjdvj) = huijjquswt bwmqxtvysm (dbrfcqzokl ) View more	-	17 Oct 2022
				Placebo	jjokkryjhm(ixufknjdvj) = pisboqdmum bwmqxtvysm (dbrfcqzokl ) View more
NCT03363841 (CARES, Biospace) Manual	Phase 3	Candidiasis	18	Ibrexafungerp	royrwrjiyz(cbmtpgywos) = dawqopifkv ztpnepzhsm (lumnriscfi ) View more	Positive	08 Sep 2022