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Anidulafungin

Generic Name
Anidulafungin
Brand Names
Ecalta, Eraxis
Drug Type
Small Molecule
Chemical Formula
C58H73N7O17
CAS Number
166663-25-8
Unique Ingredient Identifier
9HLM53094I

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

Published: Aug 3, 2025

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]

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Roerig
0049-2242
INTRAVENOUS
100 mg in 30 mL
9/1/2023
Roerig
0049-0116
INTRAVENOUS
100 mg in 30 mL
5/18/2023
Roerig
0049-0114
INTRAVENOUS
50 mg in 15 mL
5/18/2023

EMA Drug Approvals

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.

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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