Overview
Anidulafungin or Eraxis is an anti-fungal drug manufactured by Pfizer that gained approval by the Food and Drug Administration (FDA) in February 21, 2006; it was previously known as LY303366. There is preliminary evidence that it has a similar safety profile to caspofungin.
Indication
用于治疗食管念珠菌感染,念珠菌性败血症,念珠菌引起的腹腔脓肿及念珠菌性腹膜炎。
Associated Conditions
- Bloodstream Infections (BSI)
- Candidemia
- Candidiasis
- Esophageal Candidiasis
- Fungal peritonitis caused by Candida
- Intraabdominal Abscess caused by Candida
- Invasive Aspergillosis
- Oropharyngeal Candidiasis
Research Report
Anidulafungin (DB00362): A Comprehensive Pharmacological and Clinical Review
I. Executive Summary & Key Characteristics
Anidulafungin is a second-generation, semi-synthetic echinocandin antifungal agent administered intravenously for the treatment of serious Candida infections. It is distinguished within its class by a unique, non-enzymatic degradation pathway, which confers a highly favorable drug interaction profile and obviates the need for dose adjustments in patients with hepatic or renal impairment.[1] This characteristic positions anidulafungin as a first-line therapeutic option, particularly in critically ill patients with complex comorbidities and polypharmacy.
Key attributes of anidulafungin include its potent and selective inhibition of fungal (1→3)-β-D-glucan synthase, an enzyme essential for fungal cell wall integrity but absent in mammals, which results in fungicidal activity against most Candida species.[1] Its pharmacokinetic profile is characterized by a long terminal half-life of 40–50 hours, low systemic clearance, and a unique metabolic profile dominated by slow chemical degradation at physiological temperature and pH, independent of hepatic cytochrome P450 (CYP450) and renal elimination pathways.[1]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
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2008/02/21 | Phase 4 | Terminated | |||
2007/10/23 | Phase 4 | Completed | |||
2007/10/01 | Phase 3 | Completed | |||
2007/09/18 | Phase 3 | Completed | |||
2007/07/04 | Phase 4 | Completed | |||
2007/06/26 | N/A | Completed | |||
2003/09/11 | Phase 1 | Completed | |||
2003/04/11 | Phase 3 | Completed | |||
2003/03/12 | Phase 3 | Completed | |||
2003/03/12 | Phase 1 | Completed |
FDA Drug Approvals
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EMA Drug Approvals
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NMPA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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