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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Ibrexafungerp - LiverTox - NCBI Bookshelf</title>
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<meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]">
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yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK611675_"><span class="title" itemprop="name">Ibrexafungerp</span></h1><p class="fm-aai"><a href="#_NBK611675_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Ibrexafungerp.OVERVIEW"><h2 id="_Ibrexafungerp_OVERVIEW_">OVERVIEW</h2><div id="Ibrexafungerp.Introduction"><h3>Introduction</h3><p>Ibrexafungerp is a triterpenoid antifungal agent used to treat as well as prevent recurrent episodes of vulvovaginal candidiasis. Ibrexafungerp therapy has not been associated with elevations in serum enzyme elevations or with instances of jaundice or clinically apparent liver injury.</p></div><div id="Ibrexafungerp.Background"><h3>Background</h3><p>Ibrexafungerp (eye brex” a funj’ erp) is a triterpenoid antifungal agent used to treat acute vulvovaginal candidiasis well as prevent episodes of recurrent vulvovaginitis. Its mechanism of action is believed to be due to inhibition of β-1,3-D glucan synthetase, which weakens fungal cell wall formation and integrity causing fungal cell death. Ibrexafungerp inhibits growth of multiple candida species in cell culture and was found effective in treating candidiasis in animal models. In randomized controlled trials, ibrexafungerp led to clinical cures of acute candidal vulvovaginitis within two weeks in at least 50% of women and adolescent post-menarchal girls. Ibrexafungerp was approved as therapy for vulvovaginal candidiasis in post-menarchal females in the United States in 2021 and is available under the brand name of Brexafemme in tablets of 150 mg. The recommended dose for treatment of acute vulvovaginal candidiasis is 300 mg (two tablets) twice in one day, approximately 12 hours apart. Indications were expanded in 2022 to include prevention of recurrent vulvovaginal candidacies. The dose for prevention is the same regimen as for acute but given once a month for 6 months. Therapy is generally well tolerated, but side effects can include mild-to-moderate degrees of diarrhea, nausea, vomiting, abdominal discomfort, dizziness, headache, and fatigue. Ibrexafungerp causes fetal abnormalities in animals and has a boxed warning against its use during pregnancy. Females of child-bearing potential should be tested for pregnancy before starting ibrexafungerp and practice an effective means of contraception during therapy and for at least 4 days after the last dose.</p></div><div id="Ibrexafungerp.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In registration trials, liver test abnormalities occurred in less than 1% of patients treated with ibrexafungerp for acute vulvovaginal candidiasis. The elevations were transient and not associated with symptoms or jaundice and not significantly more common than with placebo (0.7% vs 0.4%). However, in phase 1 studies in healthy volunteers, 2 subjects developed marked ALT elevations within 11 days of a single dose accompanied by mild symptoms. The abnormalities resolved but remained unexplained. Liver test results during chronic administration of ibrexafungerp for prevention of recurrent vulvovaginal candidiasis have not been reported. Since its approval, there have been no reports of clinically apparent liver injury due to ibrexafungerp, but it has had only limited clinical use, and the treatment regimen for acute vulvovaginitis is for one day only.</p><p>Likelihood score: E (unlikely cause of clinically apparent liver injury).</p></div><div id="Ibrexafungerp.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The mechanism by which ibrexafungerp might cause liver injury is not known. Humans do not have glucan synthetase, so the enzyme inhibition is unlikely to be harmful. On the other hand, ibrexafungerp is a large, complex molecule and is metabolized in the liver by the cytochrome P450 system, predominantly CYP 3A4, which may generate toxic intermediates. Also, because it is a substrate of CYP 3A4, it is susceptible to drug-drug interactions with agents that inhibit or induce this microsomal enzyme, and the dose should be reduced to 150 mg given twice in one day for patients taking a moderate or strong CYP 3A4 inhibitor. Finally, the gastrointestinal symptoms related to ibrexafungerp may be due to alterations in the microbiome which could possibly have secondary effects.</p></div><div id="Ibrexafungerp.Outcome_and_Management"><h3>Outcome and Management</h3><p>Ibrexafungerp has not been linked to severe elevations in serum aminotransferase levels during therapy or to episodes of clinically apparent acute liver injury. Monitoring of liver tests is not recommended for women receiving ibrexafungerp either acutely for treatment or chronically for prevention of vulvovaginal candidiasis. The appearance of signs or symptoms of liver injury during or shortly after such therapy should lead to a search for the cause of the abnormalities, and temporary discontinuation until the cause is identified.</p><p>Drug Class: <a href="/books/n/livertox/AntifungalAgents/?report=reader">Antifungal Agents</a></p></div></div><div id="Ibrexafungerp.PRODUCT_INFORMATION"><h2 id="_Ibrexafungerp_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Ibrexafungerp – Brexafemme®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Antifungal Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Ibrexafungerp" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div><div id="Ibrexafungerp.CHEMICAL_FORMULA_AND_STRUC"><h2 id="_Ibrexafungerp_CHEMICAL_FORMULA_AND_STRUC_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figIbrexafungerpTc"><a href="/books/NBK611675/table/Ibrexafungerp.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img" rid-ob="figobIbrexafungerpTc"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="Ibrexafungerp.Tc"><a href="/books/NBK611675/table/Ibrexafungerp.Tc/?report=objectonly" target="object" rid-ob="figobIbrexafungerpTc">Table</a></h4></div></div></div><div id="Ibrexafungerp.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Ibrexafungerp_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 25 January 2025</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Ibrexafungerp.REF.zimmerman.1999">Zimmerman HJ. Antifungal agents. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 609-11.<div><i>(Expert review of hepatotoxicity of antifungal agents published in 1999 before the availability of ibrexafungerp).</i></div></div></li><li><div class="bk_ref" id="Ibrexafungerp.REF.moseley.2013">Moseley RH. Antifungal agents. Antibacterial and antifungal agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 470-3.<div><i>(Review of hepatotoxicity of antifungal agents before the availability of ibrexafungerp or other inhibitors of β-1,3,-D glucan).</i></div></div></li><li><div class="bk_ref" id="Ibrexafungerp.REF.rogers.2018">Rogers PD, Krysan DJ. Antifungal agents. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1987-1104.<div><i>(Textbook of pharmacology and therapeutics discusses the echinocandins (-fungins) which inhibit β-1,3-D glucan synthesis, but not ibrexafungerp).</i></div></div></li><li><div class="bk_ref" id="Ibrexafungerp.REF.multidiscipline_review.2021">FDA.
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Multi-Discipline Review. 2021. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214900Orig1s000MultidisciplineR.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.accessdata<wbr style="display:inline-block"></wbr>​.fda.gov/drugsatfda_docs<wbr style="display:inline-block"></wbr>​/nda/2021/214900Orig1s000MultidisciplineR.pdf</a><div><i>(FDA website with product label and multidiscipline review of ibrexafungerp based upon data submitted by the sponsor in support of its approval for use in vulvovaginal candidiasis, mentions that 2 healthy subjects in phase 1 trials of a single dose of ibrexafungerp developed ALT elevations [peak 575 and 275 U/L] with mild symptoms, that resolved spontaneously, and that the rate of ALT elevations in phase 3 trials of therapy of acute vulvovaginal candidiasis was 0.7% [4/575] on ibrexafungerp vs 0.4% [1/275] on placebo, and none of the elevations was associated with symptoms or jaundice).</i></div></div></li><li><div class="bk_ref" id="Ibrexafungerp.REF.lee.2021.1445">Lee
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A.
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Ibrexafungerp: first approval.
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Drugs.
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2021;81:1445-1450.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/34313977" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34313977</span></a>]<div><i>(Review of the mechanism of action, history of development, pharmacology, clinical efficacy, and safety of ibrexafungerp shortly after its approval for use in the US, mentions common adverse events of diarrhea [17%], nausea [12%], abdominal pain [11%], dizziness [3%], and vomiting [2%] and the lack of serious adverse events in registration trials; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Ibrexafungerp.REF6">Ibrexafungerp (Brexafemme) for vulvovaginal candidiasis.
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Med Lett Drugs Ther.
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2021;63:141-143.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/34550113" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34550113</span></a>]<div><i>(Concise review of the mechanism of action, clinical efficacy, safety, and costs of ibrexafungerp mentions the common adverse events of diarrhea, nausea and vomiting, abdominal pain, and dizziness, but does not mention ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Ibrexafungerp.REF.sobel.2022.412">Sobel
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R, Nyirjesy
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P, Ghannoum
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MA, Delchev
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DA, Azie
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NE, Angulo
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D, Harriott
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IA, et al.
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Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo-controlled superiority study (VANISH 306).
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BJOG. 2022;129:412-420.
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[<a href="/pmc/articles/PMC9299454/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9299454</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34676663" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34676663</span></a>]<div><i>(Among 272 women with acute vulvovaginitis treated with a one day course of ibrexafungerp [300 mg twice] or placebo, clinical cure was more frequent with drug [63% vs 44%], as was mycological eradication and improvement in symptoms, and while adverse events were more frequent with ibrexafungerp [15% vs 4%], side effects were mostly mild-to-moderate nausea or diarrhea, and there were no serious adverse events; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Ibrexafungerp.REF.schwebke.2022.1979">Schwebke
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JR, Sobel
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R, Gersten
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JK, Sussman
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SA, Lederman
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SN, Jacobs
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MA, Chappell
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BT, et al.
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Ibrexafungerp versus placebo for vulvovaginal candidiasis treatment: a phase 3, randomized, controlled superiority trial (VANISH 303).
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Clin Infect Dis.
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2022;74:1979-1985.
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[<a href="/pmc/articles/PMC9187327/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9187327</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34467969" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34467969</span></a>]<div><i>(Among 371 women with vulvovaginal candidiasis treated with a one day course of ibrexafungerp [300 mg twice] or placebo, clinical cure rates were higher with drug [51% vs 29%], as were rates of mycological eradication and improvement in symptoms, while adverse event rates were higher with ibrexafungerp [40% vs 17%] being largely nausea and diarrhea; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Ibrexafungerp.REF.nyirjesy.2022.2129">Nyirjesy
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P, Schwebke
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JR, Angulo
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DA, Harriott
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IA, Azie
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NE, Sobel
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JD. Phase 2 randomized Study of oral ibrexafungerp versus fluconazole in vulvovaginal candidiasis.
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Clin Infect Dis.
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2022;74:2129-2135.
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[<a href="/pmc/articles/PMC9258939/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9258939</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34555149" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34555149</span></a>]<div><i>(Among 186 patients with vulvovaginal candidiasis treated with 6 different 1- or 2-day regimens of ibrexafungerp vs fluconazole, efficacy and safety results were reported for the 62 who received the recommended regimen of each agent, the clinical cure rate at 10 days was 52% vs 58% and adverse event rate 47% vs 25%; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Ibrexafungerp.REF.goje.2023.178">Goje
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O, Sobel
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R, Nyirjesy
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P, Goldstein
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SR, Spitzer
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M, Faught
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B, Larson
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S, et al.
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Oral ibrexafungerp for vulvovaginal candidiasis treatment: an analysis of VANISH 303 and VANISH 306.
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J Womens Health (Larchmt). 2023;32:178-186.
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[<a href="/pmc/articles/PMC9940793/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9940793</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36255448" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36255448</span></a>]<div><i>(Summary of combined results of two clinical trials of ibrexafungerp [Sobel 2022; Schwebke 2022] for acute vulvovaginal candidiasis, mentions that safety results were similar to those reported in the trials and that mild-to-moderate gastrointestinal complaints were the most common adverse events).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK611675_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">January 25, 2025</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a></div></div><h3>Publisher</h3><p><a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Ibrexafungerp. [Updated 2025 Jan 25].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Ibalizumab/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/livertox/Ibrutinib/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="table-wrap" id="figobIbrexafungerpTc"><div id="Ibrexafungerp.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK611675/table/Ibrexafungerp.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Ibrexafungerp.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Ibrexafungerp.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Ibrexafungerp.Tc_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Ibrexafungerp.Tc_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Ibrexafungerp.Tc_1_1_1_4" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Ibrexafungerp.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Ibrexafungerp</td><td headers="hd_h_Ibrexafungerp.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/295371149" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">1207753-03-4</a>
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</td><td headers="hd_h_Ibrexafungerp.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C44-H67-N5-O4</td><td headers="hd_h_Ibrexafungerp.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/295371149" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=295371149" alt="image 295371149 in the ncbi pubchem database" /></a>
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