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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/06/22 | N/A | Recruiting | Poznan University of Medical Sciences | ||
2021/05/06 | Phase 3 | Terminated | |||
2013/12/27 | Phase 4 | Completed | |||
2012/11/27 | Phase 4 | Completed | |||
2011/03/03 | Phase 4 | Completed | |||
2011/02/24 | Phase 4 | Completed | |||
2010/11/30 | Phase 2 | Completed | |||
2010/09/15 | N/A | Completed | |||
2010/08/25 | Phase 3 | Withdrawn | |||
2010/01/22 | Phase 2 | Terminated | Elisabethinen Hospital |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 9/20/2007 | ||
Authorised | 9/20/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
ANIDACCORD 100 POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG | SIN16106P | INJECTION, POWDER, FOR SOLUTION | 100 mg | 2/19/2021 | |
ANIDULAFUNGIN FRESENIUS KABI POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL | SIN16803P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100mg/vial | 6/9/2023 | |
Eraxis 100mg For Injection | SIN13585P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100mg/vial | 12/17/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ANIDULAFUNGIN JUNO anidulafungin 100 mg powder for injection vial | 353950 | Medicine | A | 3/11/2022 | |
ERAXIS anidulafungin 100 mg powder for injection vial | 134398 | Medicine | A | 4/3/2009 | |
Anidulafungin Accord anidulafungin 100 mg powder for injection vial | 390552 | Medicine | A | 2/24/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ERAXIS | 02330695 | Powder For Solution - Intravenous | 100 MG / VIAL | 1/25/2010 | |
GD-ANIDULAFUNGIN | genmed a division of pfizer canada ulc | 02441683 | Powder For Solution - Intravenous | 100 MG / VIAL | N/A |
ERAXIS | 02302160 | Powder For Solution - Intravenous | 100 MG / VIAL | 1/25/2008 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
ANIDULAFUNGINA NORMON 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | Laboratorios Normon S.A. | 83990 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
ANIDULAFUNGINA TEVA 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 83018 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
ANIDULAFUNGINA DIAMED 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | Diamed Beratungsgesellschaft Fuer Pharmazeutische Unternehmen Mbh | 83651 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
ANIDULAFUNGINA MYLAN 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | Mylan Pharmaceuticals S.L. | 84834 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
ANIDULAFUNGINA STADA 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | Laboratorio Stada S.L. | 82950 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
ECALTA 100 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION | 07416002 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
ANIDULAFUNGINA ACCORD 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 83666 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
ANIDULAFUNGINA FRESENIUS KABI 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIÓN EFG | Fresenius Kabi España, S.A.U. | 84619 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
ANIDULAFUNGINA SWANPOND INVESTMENTS 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | Swan Pond Investments Limited | 85815 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
ANIDULAFUNGINA NORMOGEN 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | Laboratorios Normon S.A. | 83849 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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