Drugs / Fidaxomicin
Fidaxomicin
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DIFICID | — | 2015-02-24 – 2020-01-24 | fda.gov ↗ |
| Approved | EU (EMA) | Dificlir | — | 2011-12-05 | europa.eu ↗ |
| Approved | US (FDA) | DIFICID | — | 2011-05-27 | fda.gov ↗ |
Trials 18 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02784002 Comparator | Dec 2014 → Aug 2016 | Clostridium infectious disease | Summit Therapeutics | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07328971 Comparator | Apr 2026 → Jun 2030 expected | Clostridium difficile colitis | McGill University Health Centre/Research Institute of the McGill University Health Centre | Recruiting | No outcome recorded |
| Phase 3 | NCT05266807 Background | Mar 2023 → Apr 2027 expected | Clostridium difficile colitis | Benoit Guery | Recruiting | No outcome recorded |
| Phase 3 | NCT05201079 Comparator | Oct 2021 → Nov 2023 | Clostridium difficile colitis, Clostridium infectious disease | Mikrobiomik Healthcare Company S.L. | Completed | No outcome recorded |
| Phase 3 | NCT03182907 Background | Mar 2018 → May 2022 | Clostridium difficile colitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02743234 Comparator | Apr 2016 → Feb 2019 | Clostridium difficile colitis | University of Aarhus | Completed | No outcome recorded |
| Phase 3 | NCT01691248 Comparator | Oct 2012 → Mar 2015 | Clostridium difficile colitis | Optimer Pharmaceuticals LLC | Completed | No outcome recorded |
| Phase 3 | NCT01513239 Background | Feb 2012 → May 2015 | Clostridium difficile colitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01241552 Background | Oct 2011 → Dec 2014 | Clostridium difficile colitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06794944 Comparator | Sep 2026 → Sep 2030 expected | Clostridium difficile colitis | Brigham and Women's Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT02692651 Comparator | May 2017 → May 2021 | Clostridium difficile colitis | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT02057198 Comparator | Jun 2014 → Jun 2017 | Clostridium difficile colitis, diarrheal disease, enterocolitis | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT01818141 Comparator | Oct 2012 → Dec 2014 | Clostridium difficile colitis | Hartford Hospital | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03053505 Comparator | Jan → Dec 2017 | Clostridium infectious disease | Sejtterapia Kozpont Kft. | Unknown | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fidaxomicin | “ABD is defined as the receipt of oral metronidazole, oral vancomycin, intravenous (IV) metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin...” NCT03182907 ↗29“SOC is defined as the receipt of oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV...” NCT01513239 ↗ “This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).” NCT00468728 ↗ “oral fidaxomicin” NCT01241552 ↗ |
| Known as | Dificid | ChEMBL registry synonym — accepted as the source's own label CHEMBL1255800 ↗ |
| Known as | Dificlir | ChEMBL registry synonym — accepted as the source's own label CHEMBL1255800 ↗ |
| Known as | Fidaxomicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1255800 ↗ |
| Known as | Fidaxomicine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1255800 ↗ |
| Known as | OPT-80 | “This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).” NCT00468728 ↗ |
| Known as | PAR-101 | “This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).” NCT00468728 ↗ |
| Modality | Other / unclassified | “OPT-80, a novel, minimally absorbed macrocycle” PMID 18955525 ↗ Oct 2008 |
| Route | Oral | “OPT-80 orally” PMID 18955525 ↗ Oct 2008 |