anidulafungin
Trade name: eraxis
Approved
Feb 17, 2006
Anidulafungin (brand names Eraxis (in U.S. and Russia) and Ecalta (in Europe)) is a semi-synthetic echinocandin with antifungal activity and it is active in vitro against many Candida, as well as some Aspergillus. Like other echinocandins, anidulafungin is not active against Cryptococcus neoformans, Trichosporon, Fusarium, or zygomycetes. This drug is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis; and for the treatment of esophageal candidiasis. Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3--D-glucan, an essential component of the fungal cell wall. — NCATS
Clinical trial activity
31 trials · 20 clinical orgs · 2 marketing orgs
Earliest trial started Aug 1, 2001 (NCT00037219)
Timeline
2000s
- Jan 1, 2001
- Jan 1, 2003
- Jan 1, 2003
- Feb 17, 2006
Pfizer — Earliest FDA Approval
- Feb 17, 2006
Vicuron Pharmaceuticals — Marketing Organization
- Feb 17, 2006
Vicuron Pharmaceuticals — NDA Secondary Org
- Feb 17, 2006
Pfizer — NDA Organization
Indications
Approved for
Studied for
- Acute Kidney Injury · Phase 2
- Aspergillosis · Phase 4
- Candida · Phase 3
- Candidiasis · Phase 4
- Candidiasis, Invasive · Phase 4
- Central Nervous System Fungal Infections · Phase 4
- Fungemia · Phase 4
- Hematologic Neoplasms · Phase 2
- Infections · Phase 2
- Invasive Fungal Infections · Phase 1
- Invasive Pulmonary Aspergillosis · Phase 3
- Leukemia · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Liver Diseases · Phase 4
- Lung Diseases, Fungal · Phase 4
- Mycoses · Phase 4
- Myelodysplastic Syndromes · Phase 2
- Neoplasms · Phase 1/Phase 2
- Neuroaspergillosis · Phase 3
- Neutropenia · Phase 3
- Obesity · Phase 4
- Obesity, Morbid · Phase 4
- Pneumonia, Ventilator-Associated · Phase 2
- Respiratory Tract Infections · Phase 2
Mechanism of action
- 1,3-beta-glucan synthaseINHIBITOR
GSC1 inhibitor
Approval history
- approvedFeb 17, 2006
Chemistry & pharmacology
SMILES
CCCCCOC1=CC=C(C=C1)C2=CC=C(C=C2)C3=CC=C(C=C3)C(=O)N[C@H]4C[C@@H](O)[C@@H](O)NC(=O)[C@@H]5[C@@H](O)[C@@H](C)CN5C(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H]6C[C@@H](O)CN6C(=O)[C@@H](NC4=O)[C@@H](C)O)[C@H](O)[C@@H](O)C7=CC=C(O)C=C7)[C@@H](C)O- Mol. weight
- 1140.2369 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaAnidulafungin ↗
- NCATS9HLM53094I ↗
- ChEMBLCHEMBL264241 ↗
Also known as
- (4r,5r)-4,5-dihydroxy-n²-[[4''-(pentyloxy)-p-terphenyl-4-yl]carbonyl]-l-ornithyl-l-threonyl-trans-4-hydroxy-l-prolyl-(s)-4-hydroxy-4(p-hydroxyphenyl)-l-threonyl-l-threonyl-(3s,4s)-3-hydroxy-4-methyl-l-proline cyclic (6->1)-peptide
- (4r,5r)-4,5-dihydroxy-n²-[[4''-(pentyloxy)-p-terphenyl-4-yl]carbonyl]-l-ornithyl-l-threonyl-trans-4-hydroxy-l-prolyl-(s)-4-hydroxy-4(p-hydroxyphenyl)-l-threonyl-l-threonyl-(3s,4s)-3-hydroxy-4-methyl-l-proline cyclic (6->1)-peptide
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungin
- anidulafungina
- anidulafungina
- anidulafungine
- anidulafungine
- anidulafunginum
- anidulafunginum
- ecalta
- ecalta
- ecalta
- eraxis
- eraxis
- eraxis
- eraxis
- eraxis
- ly303366
- ly 303366
- ly 303366
- ly-303366
- ly-303366
- n-[(3s,6s,9s,11r,15s,18s,20r,21r,24s,25s,26s)-6-[(1s,2r)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-11,20,21,25-tetrahydroxy-3,15-bis[(1r)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexaazatricyclo[22.3.0.09,13]heptacosan-18-yl]- 4-{4-[4-(pentyloxy)phenyl]phenyl}benzamide
- n-[(3s,6s,9s,11r,15s,18s,20r,21r,24s,25s,26s)-6-[(1s,2r)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-11,20,21,25-tetrahydroxy-3,15-bis[(1r)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexaazatricyclo[22.3.0.09,13]heptacosan-18-yl]- 4-{4-[4-(pentyloxy)phenyl]phenyl}benzamide
- v-echinocandin
- v-echinocandin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04876716 | Phase 3 | May 11, 2021 | Erasmus University Rotterdam, HOVON - Dutch Haemato-Oncology Association, ZonMw: The Netherlands Organisation for Health Research and Development |
| NCT02021123 | Phase 4 | Aug 1, 2014 | Radboud University |
| NCT01734525 | Phase 4 | Nov 1, 2012 | Federal University of Rio de Janeiro |
| NCT01188759 | Phase 3 | May 1, 2012 | Pfizer |
| NCT01303549 | Phase 4 | Nov 1, 2011 | Fundacion SEIMC-GESIDA, Pfizer, University of Barcelona |
| NCT01307930 | Phase 4 | Jan 1, 2011 | National Center for Research Resources (NCRR), Texas Tech University, The University of Texas, Dallas |
| NCT01176058 | Phase 3 | Dec 1, 2010 | Pfizer |
| NCT01249820 | Phase 2 | Nov 1, 2010 | Radboud University |
| NCT00934934 | Phase 2 | Apr 1, 2010 | Clinical Evaluation Research Unit at Kingston General Hospital, Pfizer, Queen's University, Belfast, The Physicians' Services Incorporated Foundation |
| NCT00841971 | Phase 4 | Feb 1, 2010 | University of Pittsburgh |
| NCT01053884 | Phase 2 | Oct 1, 2009 | KH Elisabethinen Linz, Pfizer |
| NCT00806351 | Phase 3 | Aug 1, 2009 | Pfizer |
| NCT00892359 | Phase 2 | Apr 1, 2009 | University of Vienna |
| NCT00805740 | Phase 3 | Apr 1, 2009 | Pfizer |
| NCT00761267 | Phase 3 | Feb 27, 2009 | Pfizer |
| NCT00940017 | Phase 4 | Sep 1, 2008 | Pfizer |
| NCT00620074 | Phase 4 | Aug 1, 2008 | Pfizer |
| NCT00531479 | Phase 3 | Jul 1, 2008 | Pfizer |
| NCT00689338 | Phase 3 | Jul 1, 2008 | Pfizer |
| NCT00672841 | N/A | Jun 1, 2008 | Duke University, Pfizer |
Organizations
Research & Development (20)
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Pfizer | For profit | NDA | Feb 17, 2006 |
| Vicuron Pharmaceuticals | For profit | MKTG | Feb 17, 2006 |
| Vicuron Pharmaceuticals | For profit | NDA2 | Feb 17, 2006 |
| Vicuron Pharmaceuticals | For profit | SYN | Feb 17, 2006 |