Anidulafungin Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 437

Clinical Trials

Anidulafungin has been evaluated in numerous Phase 1 through Phase 4 clinical trials assessing its safety, pharmacokinetics, and efficacy in conditions such as candidemia, invasive candidiasis, invasive aspergillosis, and systemic fungemia, as well as in morbidly obese patients. Sponsored by pharmaceutical leaders including Pfizer, Astellas Pharma, and Gilead Sciences alongside academic institutions like Radboud University Medical Center and Erasmus Medical Center, these investigations encompass recruitment statuses ranging from completed to terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04876716	TERMINATED	Invasive Aspergillosis	Erasmus Medical Center	2021-05-11	PHASE3
NCT04876716	Terminated	Invasive Aspergillosis	Erasmus Medical Center\|ZonMw: The Netherlands Organisation for Health Research and Development\|Stichting Hemato-Oncologie voor Volwassenen Nederland	2021-05-11	Phase 3
NCT00761267	COMPLETED	Candidemia	Pfizer	2009-02	PHASE3
NCT02021123	COMPLETED	Obesity Morbid	Radboud University Medical Center	2014-08	PHASE4
NCT01188759	WITHDRAWN	Aspergillosis; Invasive Pulmonary Aspergillosis; Neuroaspergillosis	Pfizer	2012-05	PHASE3
NCT02021123	Completed	Obesity Morbid	Radboud University Medical Center	2014-08	Phase 4
NCT01303549	COMPLETED	Liver Disease; Fungal Infection	Fundacion SEIMC-GESIDA	2011-11	PHASE4
NCT01734525	COMPLETED	Candidemia	Universidade Federal do Rio de Janeiro	2012-11	PHASE4
NCT00841971	COMPLETED	Mycoses; Fungemia; Central Nervous System Fungal Infections; Lung Diseases, Fungal	University of Pittsburgh	2010-02	PHASE4
NCT01236261	Completed	Fungemia	Fundacion SEIMC-GESIDA\|Astellas Pharma Inc\|Gilead Sciences\|Merck Sharp & Dohme LLC\|Pfizer	2013-03	--
NCT01270490	UNKNOWN	Candidemia	Radboud University Medical Center	2011-01	PHASE3
NCT01249820	COMPLETED	Leukemia; Myelodysplastic Syndrome; Leukemia, Myeloid, Acute	Radboud University Medical Center	2010-11	PHASE2
NCT01307930	COMPLETED	Obesity; Mycoses	Texas Tech University Health Sciences Center	2011-01	PHASE4
NCT01734525	Completed	Candidemia	Universidade Federal do Rio de Janeiro	2012-11	Phase 4
NCT00934934	TERMINATED	Ventilator Associated Pneumonia; Respiratory Tract Infection	Daren K. Heyland	2010-04	PHASE2
NCT00805740	TERMINATED	Candidiasis; Fungemia	Pfizer	2009-04	PHASE3
NCT01188759	Withdrawn	Aspergillosis\|Invasive Pulmonary Aspergillosis\|Neuroaspergillosis	Pfizer	2012-05	Phase 3
NCT01176058	TERMINATED	Candidemia	Pfizer	2010-12	PHASE3
NCT00806351	TERMINATED	Fungemia; Neutropenia; Candidiasis	Pfizer	2009-08	PHASE3
NCT01053884	TERMINATED	Hematologic Malignancies	Elisabethinen Hospital	2009-10	PHASE2
NCT00531479	COMPLETED	Aspergillosis	Pfizer	2008-07	PHASE3
NCT00672841	COMPLETED	Invasive Candidiasis	Duke University	2008-06
NCT00734500	COMPLETED	Invasive Fungal Infections	Michael Cohen-Wolkowiez	2008-01	PHASE1
NCT00496197	COMPLETED	Candidiasis	Pfizer	2007-07	PHASE4
NCT00689338	COMPLETED	Invasive Candidiasis	Pfizer	2008-07	PHASE3
NCT00892359	UNKNOWN	Acute Renal Failure; Infection	Medical University of Vienna	2009-04	PHASE2
NCT00548262	COMPLETED	Candidemia; Invasive Candidiasis	Pfizer	2008-02	PHASE4
NCT00537329	COMPLETED	Candidemia	Pfizer	2008-01	PHASE3
NCT00620074	TERMINATED	Aspergillosis	Pfizer	2008-08	PHASE4
NCT00940017	COMPLETED	Aspergillosis; Candidemia	Pfizer	2008-09	PHASE4
NCT00037206	COMPLETED	Aspergillosis	Pfizer	2002-05	PHASE2; PHASE3
NCT00068471	COMPLETED	Infection; Neutropenia; Unspecified Childhood Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2003-07	PHASE1; PHASE2
NCT00058682	COMPLETED	Candida; Candidiasis	National Cancer Institute (NCI)	2003-04	PHASE3
NCT00056381	COMPLETED	Neutropenia	Pfizer	2003-07	PHASE1; PHASE2
NCT00037219	COMPLETED	Candidiasis	Pfizer	2001-08	PHASE2
NCT00056368	COMPLETED	Candidiasis	Pfizer	2003-03	PHASE3
NCT00041704	COMPLETED	Candidiasis	Pfizer	2002-08	PHASE2

(data from https://clinicaltrials.gov, updated on 2024-05-07)

Check the Anidulafungin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Anidulafungin non-competitively binds to and inhibits the catalytic subunit of the enzyme (1,3)-β-D-glucan synthase, thereby blocking the synthesis of glucan polymers essential for maintaining fungal cell wall integrity. This loss of structural support induces osmotic fragility and subsequent fungal cell lysis, driving clinical efficacy against target fungal pathogens in conditions such as candidemia, invasive candidiasis, and invasive aspergillosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).