Drug

Anidulafungin

Approved · EMA

Late-stage development

Also known as Eraxis, Anidulafungina, Anidulafungine, Anidulafunginum.

RxNorm341018 ChEMBLCHEMBL264241UNII9HLM53094I

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Azole-echinocandin Combination Therapy for Invasive Aspergillosis A Randomized Pragmatic Superiority Trial

Clinical trial2024-05-01Terminated · ClinicalTrials.gov

A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients

Clinical trial2019-07-08Results posted · ClinicalTrials.gov

A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA

Clinical trial2019-04-04Results posted · ClinicalTrials.gov

Population Pharmacokinetic Analysis of Anidulafungin in Normal, Overweight and Obese Volunteers

Clinical trial2019-01-09Results posted · ClinicalTrials.gov

Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial

Clinical trial2014-12-17Results posted · ClinicalTrials.gov

A Prospective, Randomized Trial Comparing The Safety, Tolerability, And Efficacy Of Voriconazole And Anidulafungin In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Invasive Aspergillosis in Pediatric Subjects Aged 2 to 17 Years

Clinical trial2014-08-01Withdrawn · ClinicalTrials.gov

Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients

Clinical trial2014-05-01Completed · ClinicalTrials.gov

Anidulafungin PK in Infants and Toddlers

Clinical trial2012-11-21Results posted · ClinicalTrials.gov

Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment (The CANTREAT Study): A Prospective, Randomized, Double Blind, Placebo Controlled Pilot Study

Clinical trial2012-08-01Terminated · ClinicalTrials.gov

A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis

Clinical trial2012-04-30Results posted · ClinicalTrials.gov

Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis

Clinical trial2011-10-03Results posted · ClinicalTrials.gov

Approval: Ecalta (EMA)

Regulatory2007-09-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Anidulafungin

Aliases & brands

EraxisAnidulafunginaAnidulafungineAnidulafunginum

RxNorm CUI

341018

ChEMBL ID

CHEMBL264241

UNII

9HLM53094I

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2007-09-20

Latest approval

2007-09-20

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2007-09-20Approval

Approval: Ecalta (EMA)

Indication: Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

21 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2018

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 21

Phase 11Phase 1 / 22Phase 23Phase 38Phase 47

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial

CompletedPH IVUniversity of Pittsburghn=2002014

Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients

CompletedPH IVFundacion SEIMC-GESIDAn=612014

A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients

CompletedPH IVUniversidade Federal do Rio de Janeiron=852013

Population Pharmacokinetic Analysis of Anidulafungin in Normal, Overweight and Obese Volunteers

CompletedPH IVTexas Tech University Health Sciences Centern=202012

Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis

CompletedPH IVPfizern=2822010

Recent completions

Trials that read out recently, adding to the completed evidence base.

A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA

CompletedPH IIIPfizern=702018

Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial

CompletedPH IVUniversity of Pittsburghn=2002014

Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients

CompletedPH IVFundacion SEIMC-GESIDAn=612014

A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients

CompletedPH IVUniversidade Federal do Rio de Janeiron=852013

Population Pharmacokinetic Analysis of Anidulafungin in Normal, Overweight and Obese Volunteers

CompletedPH IVTexas Tech University Health Sciences Centern=202012

CompletedPH IIIPfizern=4592011

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.