Drugs / Anidulafungin
Anidulafungin
also known as
Eraxis · Ecalta · 14C-ANIDULAFUNGIN · Anidulafungina · Anidulafungine · D-70013 · LY-303366 · V-echinocandin · +1 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ERAXIS | — | 2020-09-22 | fda.gov ↗ |
| Approved | EU (EMA) | Ecalta | — | 2007-09-20 | europa.eu ↗ |
| Approved | US (FDA) | ERAXIS | — | 2006-02-17 | fda.gov ↗ |
Trials 29
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00734500 | Jan 2008 → Jun 2010 | fungal infectious disease | Michael Cohen-Wolkowiez | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00056381 | Jul 2003 → Jun 2004 | neutropenia | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT00068471 | Jul 2003 → Oct 2007 | childhood malignant neoplasm, infectious disease, neutropenia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT01249820 | Nov 2010 → Jan 2013 | acute myeloid leukemia, myelodysplastic syndrome | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01053884 | Oct 2009 → Sep 2011 | hematopoietic and lymphoid system neoplasm | Elisabethinen Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00892359 | Apr 2009 → Apr 2010 | acute kidney injury, infectious disease | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 2 | NCT00041704 | Aug 2002 → Aug 2004 | candidiasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00037219 | Aug 2001 → Nov 2002 | candidiasis | Pfizer | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00037206 | May 2002 → Feb 2003 | invasive aspergillosis | Pfizer | Completed | No outcome recorded |
| Phase 310 trials · 1 met primary · 3 missed | ||||||
| Phase 3 | NCT04876716 | May 2021 → May 2024 | invasive aspergillosis | Erasmus Medical Center | Terminated | No outcome recorded |
| Phase 3 | NCT01188759 | May 2012 → Aug 2014 | invasive aspergillosis, neuroaspergillosis | Pfizer | Withdrawn | No outcome recorded |
| Phase 3 | NCT00806351 | Aug 2009 → Oct 2011 | candidiasis, neutropenia | Pfizer | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT00805740 | Apr 2009 → Jun 2012 | candidiasis | Pfizer | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT00761267 | Feb 2009 → Feb 2018 | candidemia | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00689338 | Jul 2008 → May 2010 | candidiasis, invasive | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00531479 | Jul 2008 → Apr 2011 | aspergillosis | Pfizer | Completed | Missed primary |
| Phase 3 | NCT00537329 | Jan 2008 → Mar 2009 | candidemia | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00058682 | Apr 2003 → Jan 2005 | candidiasis | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00056368 | Mar 2003 → Oct 2004 | candidiasis | Pfizer | Completed | Met primary |
| Phase 49 trials · 1 missed | ||||||
| Phase 4 | NCT02021123 | Aug → Oct 2014 | morbid obesity | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01734525 | Nov 2012 → Dec 2013 | candidemia | Federal University of Rio de Janeiro | Completed | No outcome recorded |
| Phase 4 | NCT01303549 | Nov 2011 → May 2014 | fungal infectious disease, liver disorder | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT01307930 | Jan 2011 → Nov 2012 | fungal infectious disease, obesity disorder | Texas Tech University Health Sciences Center | Completed | No outcome recorded |
| Phase 4 | NCT00841971 | Feb 2010 → Jul 2013 | fungal lung infectious disease | University of Pittsburgh | Completed | Missed primary |
| Phase 4 | NCT00940017 | Sep → Oct 2008 | aspergillosis, candidemia | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00620074 | Aug 2008 → Feb 2009 | invasive aspergillosis | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT00548262 | Feb 2008 → Oct 2009 | candidemia | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00496197 | Jul 2007 → Jun 2010 | candidiasis | Pfizer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00672841 | Jun 2008 → Dec 2010 | candidiasis, invasive | Duke University | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT00934934 Comparator | Apr 2010 → Aug 2012 | respiratory tract infectious disorder | Daren K. Heyland | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05178862 Background | Aug 2022 → Nov 2025 | candidemia | Scynexis, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01176058 Comparator | Dec 2010 → Nov 2011 | candidemia | Pfizer | Terminated | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Anidulafungin | “Anidulafungin” NCT05178862 ↗ |
| Known as | 14C-ANIDULAFUNGIN | ChEMBL registry synonym — accepted as the source's own label CHEMBL264241 ↗ |
| Known as | Anidulafungina | ChEMBL registry synonym — accepted as the source's own label CHEMBL264241 ↗ |
| Known as | Anidulafungine | ChEMBL registry synonym — accepted as the source's own label CHEMBL264241 ↗ |
| Known as | D-70013 | ChEMBL registry synonym — accepted as the source's own label CHEMBL264241 ↗ |
| Known as | Ecalta | “Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection” NCT00806351 ↗1“Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection” NCT00805740 ↗ |
| Known as | Eraxis | “Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection” NCT00806351 ↗2“Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection” NCT00805740 ↗ “intravenous anidulafungin (Eraxis™)” NCT00496197 ↗ |
| Known as | LY-303366 | ChEMBL registry synonym — accepted as the source's own label CHEMBL264241 ↗ |
| Known as | V-echinocandin | ChEMBL registry synonym — accepted as the source's own label CHEMBL264241 ↗ |
| Known as | VER002 | “Anidulafungin, VER002” NCT00037206 ↗ |
| Action | Inhibit | “inhibit the synthesis of glucan polymers” NCT00892359 ↗ |
| Modality | Other / unclassified | “Anidulafungin is an antifungal agent of the echinocandin class” NCT00041704 ↗ |
| Route | Intravenous | “Intravenous Anidulafungin” NCT00037206 ↗ |