Effects of ibrexafungerp: A Synthesis of Findings from 19 Studies

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Original Abstract of the Article

Major Research Findings

Ibrexafungerp is a novel antifungal medication that has shown promising results in treating vulvovaginal candidiasis (VVC), a common fungal infection in women. 15 , 13 , 12 , 10 . It is a first-in-class oral triterpenoid glucan synthase inhibitor, meaning it works differently than the traditional azole antifungals that have been the mainstay of treatment for decades. 15 , 12 , 10 . Ibrexafungerp has been shown to be effective in treating both acute and recurrent VVC. 15 , , 10 . In clinical trials, ibrexafungerp demonstrated a higher clinical cure rate and mycologic cure rate compared to placebo. 19 , 13 , 11 . Additionally, ibrexafungerp has shown to be well-tolerated with mild side effects, mainly gastrointestinal. 10 , 7 . However, like other antifungals, it should be used cautiously in pregnant or potentially pregnant women. 10 .

Benefits and Risks

Benefit Summary

Ibrexafungerp offers a new and effective treatment option for VVC, especially for women who have experienced recurrent infections or have allergies or sensitivities to azole antifungals. 15 , , 10 . It has demonstrated efficacy in both acute and recurrent VVC, with a favorable safety profile. 19 , 13 , 11 , 10 , 7 . This makes it a potentially valuable addition to the treatment options for VVC.

Risk Summary

The most common side effects of ibrexafungerp are gastrointestinal and mild in nature. 10 , 7 . However, like other antifungals, it should be used cautiously in pregnant or potentially pregnant women. 10 .

Comparison Across Studies

Commonalities

Multiple studies agree on ibrexafungerp's effectiveness in treating VVC. 19 , 18 , 13 , 11 . Additionally, all studies consistently highlight its generally favorable safety profile. 7 .

Differences

There are variations in the dosage, treatment duration, and patient demographics across studies. 19 , 18 , 13 , 11 . These differences may influence the specific outcomes and require careful consideration when interpreting results. 19 , 18 , 13 , 11 .

Consistency and Contradictions

Multiple studies consistently demonstrate ibrexafungerp's effectiveness in treating VVC, with a generally safe profile. 19 , 18 , 13 , 11 , 7 . However, variations in dosage, treatment duration, and patient demographics necessitate cautious interpretation of results. 19 , 18 , 13 , 11 .

Practical Application Notes

While ibrexafungerp shows promise as a treatment option for VVC, it's crucial to consult with a healthcare professional before using it. 19 , 18 , 13 , 11 . They can assess your individual needs, determine if ibrexafungerp is a suitable treatment option, and discuss potential risks and side effects. 10 . They can also advise on any potential drug interactions, especially if you are already taking other medications.

Current Research Limitations

While ibrexafungerp is showing promising results, further research is needed to understand its long-term effects and safety. 19 , 18 , 13 , 11 . Additional research is also required to determine its efficacy across various VVC subtypes and to understand potential drug interactions. 19 , 18 , 13 , 11 .

Future Research Directions

Future research should focus on long-term efficacy and safety of ibrexafungerp, its effectiveness across different VVC subtypes, and the potential for drug interactions. 19 , 18 , 13 , 11 , 10 . These studies will provide a more comprehensive understanding of ibrexafungerp's role in managing VVC.

Conclusion

Ibrexafungerp is a promising new treatment option for VVC, particularly for women who have experienced recurrent infections or have allergies to azole antifungals. 15 , , 10 . It is important to consult with a healthcare professional to determine if ibrexafungerp is appropriate for you, discuss potential risks and side effects, and address any concerns regarding drug interactions. 19 , 18 , 13 , 11 . Continued research is necessary to fully understand ibrexafungerp's potential and to optimize its use in treating VVC.

Literature analysis of 19 papers
Positive Content
18
Neutral Content
1
Negative Content
0
Article Type
6
1
0
7
19
1.

Dose dependent effects on bone resorption and formation of intermittently administered intravenous ibandronate.

Author: ChristiansenC, TankóL B, WarmingL, MoelgaardA, ChristgauS, QvistP, BaumannM, WieczorekL, HoyleN

Treats osteoporosis

Ibandronate is a bisphosphonate used to treat osteoporosis. This study looked at the effects of intermittent intravenous ibandronate on bone turnover markers in postmenopausal women. The results show that ibandronate effectively suppressed bone resorption, but the effect was not sustained. The suppression of bone formation was less than the suppression of bone resorption, which may contribute to the inefficacy of this dosing regimen.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies.

Author: BodyJ J, DielI J, LichinitzerM, LazarevA, PecherstorferM, BellR, TripathyD, BergstromB

Dosing convenience
Good tolerability
Prevention of skeletal complications
Upper GI AEs

Oral ibandronate, a bisphosphonate, was shown to be an effective and well-tolerated treatment for preventing skeletal complications in patients with metastatic bone disease. It offers similar efficacy to intravenous bisphosphonates with fewer side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

3.

Comparison of the effects of three oral bisphosphonate therapies on the peripheral skeleton in postmenopausal osteoporosis: the TRIO study.

Author: PaggiosiM A, PeelN, McCloskeyE, WalshJ S, EastellR

Bone density increase

This study compared the effects of oral alendronate, ibandronate, and risedronate on bone health over 2 years. Ibandronate and alendronate were found to have a greater effect on the central skeleton (spine) than risedronate, while all three drugs had similar effects on the peripheral skeleton (hip). These findings suggest that ibandronate may be a more effective option for increasing bone density at the spine compared to risedronate.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Dose-Effectiveness Relationships Determining the Efficacy of Ibandronate for Management of Osteoporosis: A Meta-Analysis.

Author: HouYanjie, GuKe, XuChao, DingHuiyong, LiuChangxin, TuohetiYilihamu

Improved BMD
Reduced bone resorption
Ineffective doses

This meta-analysis evaluated the efficacy of ibandronate, a medication used to treat osteoporosis, across different dosing regimens. Ibandronate significantly improved bone mineral density in the lumbar spine and total hip.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Effects of discontinuing oral bisphosphonate treatments for postmenopausal osteoporosis on bone turnover markers and bone density.

Author: NaylorK E, BradburnM, PaggiosiM A, GossielF, PeelN F A, McCloskeyE V, WalshJ S, EastellR

This study looked at the effects of stopping different types of bisphosphonate medications (ibandronate, alendronate, risedronate) used to treat osteoporosis in postmenopausal women. After stopping treatment, all groups experienced an increase in bone turnover markers (BTMs), indicating increased bone breakdown, and a decrease in bone mineral density (BMD) in the hip, although levels did not return to their original levels before treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

6.

Antifungal resistance, combinations and pipeline: oh my!

Author: StoverKayla R, HawkinsBrandon K, KeckJ Myles, BarberKatie E, CretellaDavid A

Fungal infection treatment
Drug limiting side effects

This review discusses the need for novel antifungal therapies to address rising fungal resistance, particularly in Candida spp., and highlights the potential of new agents such as fosmanogepix, ibrexafungerp, olorofim, and rezafungin.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

The Role of Novel Antifungals in the Management of Candidiasis: A Clinical Perspective.

Author: OrdayaEloy E, ClementJosh, VergidisPaschalis

Convenient treatment
Effective against resistant strains

This review discusses novel antifungal agents with distinct mechanisms of action and pharmacokinetic/pharmacodynamic properties that hold promise for the treatment of candidiasis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Structural and mechanistic insights into fungal β-1,3-glucan synthase FKS1.

Author: HuXinlin, YangPing, ChaiChangdong, LiuJia, SunHuanhuan, WuYanan, ZhangMingjie, ZhangMin, LiuXiaotian, YuHongjun

Fungal cell wall biosynthesis

This study provides cryo-electron microscopy structures of Saccharomyces cerevisiae FKS1, a key enzyme involved in fungal cell wall biosynthesis. The structures reveal the active site and glucan translocation pathway, suggesting active FKS1-membrane interactions. Echinocandin-resistant mutations are clustered near TM5-6 and TM8 of FKS1, and the structure of the mutant FKS1(S643P) reveals altered lipid arrangements in this region, suggesting a drug-resistant mechanism.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306.

Author: GojeOluwatosin, SobelRyan, NyirjesyPaul, GoldsteinSteven R, SpitzerMark, FaughtBrooke, LarsonShelagh, KingThomas, AzieNkechi E, AnguloDavid, SobelJack D

Symptom resolution
VVC treatment
Vulvovaginal candidiasis

Ibrexafungerp is a new antifungal drug that can effectively treat acute vulvovaginal candidiasis (VVC) with a single-day oral dose. It is safe and well-tolerated by patients, regardless of race, body mass index, baseline symptoms, or the specific *Candida* species involved.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Ibrexafungerp in the Treatment of Vulvovaginal Candidiasis.

Author:

VVC Treatment
None

This review evaluated the pharmacology, efficacy, and safety of ibrexafungerp in treating vulvovaginal candidiasis (VVC). Ibrexafungerp demonstrated similar efficacy to fluconazole in a phase 2 study and superior efficacy to placebo in two phase 3 studies. Ibrexafungerp was well tolerated and is a potential treatment option for VVC.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

Ibrexafungerp for the treatment of vulvovaginal candidiasis.

Author: SobelJack D

Ibrexafungerp efficacy
None reported

Ibrexafungerp is a first-in-class oral triterpenoid glucan synthase inhibitor for the treatment of acute vulvovaginal candidiasis (VVC). Clinical trials have shown that ibrexafungerp is effective and well-tolerated.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

The Antifungal Pipeline: Fosmanogepix, Ibrexafungerp, Olorofim, Opelconazole, and Rezafungin.

Author: HoeniglMartin, SpruteRosanne, EggerMatthias, ArastehfarAmir, CornelyOliver A, KrauseRobert, Lass-FlörlCornelia, PrattesJuergen, SpecAndrej, ThompsonGeorge R, WiederholdNathan, JenksJeffrey D

Antifungal drug development
Invasive fungal infection treatment
Drug resistance
Drug-drug interactions
Toxicity

New antifungal drugs are needed to address the growing threat of drug-resistant fungal infections. This review highlights the most promising new antifungal drugs in development, including fosmanogepix, ibrexafungerp, olorofim, opelconazole, and rezafungin. These drugs have different mechanisms of action and pharmacokinetic profiles.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

In vitro activity of ibrexafungerp against Candida species isolated from blood cultures. Determination of wild-type populations using the EUCAST method.

Author: MesquidaAina, Díaz-GarcíaJudith, Sánchez-CarrilloCarlos, MuñozPatricia, EscribanoPilar, GuineaJesús

Candida infection treatment

Ibrexafungerp is a new oral antifungal drug that shows activity against Candida species, including those resistant to other antifungal drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

18.

Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis.

Author: NyirjesyPaul, SchwebkeJane R, AnguloDavid A, HarriottItzel A, AzieNkechi E, SobelJack D

Vulvovaginal candidiasis treatment

Ibrexafungerp, a novel oral triterpenoid glucan synthase inhibitor, holds promise as a treatment for vulvovaginal candidiasis. This study aims to identify the optimal dose of ibrexafungerp for patients with acute vulvovaginal candidiasis.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

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

Author: SchwebkeJane R, SobelRyan, GerstenJanet K, SussmanSteven A, LedermanSamuel N, JacobsMark A, ChappellB Todd, WeinsteinDavid L, MoffettAlfred H, AzieNkechi E, AnguloDavid A, HarriottItzel A, Borroto-EsodaKatyna, GhannoumMahmoud A, NyirjesyPaul, SobelJack D

Vulvovaginal candidiasis

Ibrexafungerp, a new antifungal drug, is being evaluated for its efficacy and safety in treating acute vulvovaginal candidiasis compared to placebo.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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