Drugs / Fidaxomicin
Fidaxomicin
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Clostridium difficile colitis 1 milestone | |||||
| Filed | US (FDA) | DIFICID | Clostridium difficile colitis | 2019-10-02 | “the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for DIFICID ® (fidaxomicin) for oral suspension” merck.com ↗ “Merck announced FDA acceptance of a New Drug Application (NDA) for DIFICID (fidaxomicin) for oral suspension and a supplemental NDA (sNDA)” merck.com ↗ “Merck announced FDA acceptance of a New Drug Application (NDA) for DIFICID (fidaxomicin) for oral suspension” merck.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01813448 | Feb → Apr 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02083627 | Feb → Mar 2013 | disorder of metabolite absorption and transport | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03760484 | Jan 2019 → Mar 2020 | Clostridium difficile colitis | University of Alberta | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01591863 | Jun 2012 → Mar 2014 | Clostridium difficile colitis | Optimer Pharmaceuticals LLC | Completed | No outcome recorded |
| Phase 2 | NCT00097422 | Nov 2004 → Apr 2005 | diarrheal disease | Optimer Pharmaceuticals LLC | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT02395848 | Jul 2015 → Aug 2021 | Clostridium difficile colitis | McMaster University | Terminated | No outcome recorded |
| Phase 3 | NCT02218372 | Jan 2015 → Mar 2018 | Clostridium difficile colitis | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 3 | NCT02179658 | Jun 2014 → Sep 2016 | Clostridium difficile colitis | Astellas Pharma Inc | Completed | Missed primary |
| Phase 3 | NCT00468728 | Oct 2006 → Dec 2009 | Clostridium difficile colitis, diarrheal disease | Optimer Pharmaceuticals LLC | Completed | Met primary |
| Phase 3 | NCT00314951 | May 2006 → Jul 2008 | Clostridium infectious disease, diarrheal disease | Optimer Pharmaceuticals LLC | Completed | Met primary |
| Phase 47 trials · 1 met primary | ||||||
| Phase 4 | NCT02464306 | Jun → Dec 2018 | Clostridium difficile colitis, disease related to solid organ transplantation | University of Colorado, Denver | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT02667418 | Feb 2016 → Aug 2024 | Clostridium infectious disease | VA Office of Research and Development | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02437591 | Aug 2015 → May 2016 | Clostridium difficile colitis | Astellas Pharma Europe Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT02254967 | Nov 2014 → Mar 2016 | Clostridium difficile colitis | Astellas Pharma Europe Ltd. | Completed | Met primary |
| Phase 4 | NCT02355938 | Feb 2014 → Oct 2016 | Clostridium difficile colitis, spinal cord injury | Baylor College of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01775397 | Nov 2012 → Apr 2013 | Clostridium difficile colitis | Astellas Pharma Europe Ltd. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01552668 | Sep 2012 → Dec 2013 | Clostridium difficile colitis | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07120490 | Oct 2025 → Mar 2027 expected | Clostridium difficile colitis | Medical University of Warsaw | Not yet recruiting | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 2 | NCT02784002 Comparator | Dec 2014 → Aug 2016 | Clostridium infectious disease | Summit Therapeutics | Completed | No outcome recorded |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT01241552 Background | Oct 2011 → Dec 2014 | Clostridium difficile colitis | Merck Sharp & Dohme LLC | Completed | Mixed |
| 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 |
| — | NCT03053505 Comparator | Jan → Dec 2017 | Clostridium infectious disease | Sejtterapia Kozpont Kft. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2020-01-27 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s DIFICID® (fidaxomicin) to Treat Clostridioides difficile in Children Aged Six Months and Older merck.com ↗ |
| 2019-10-02 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts Two Applications for Merck’s DIFICID® (fidaxomicin) to Treat Children Aged Six Months Up to 18 years with Clostridium difficile Infections merck.com ↗
Both applications have received a priority review classification by the FDA. |
| 2018-07-02 | Astellas Pharma Inc | Regulatory Astellas Received Approval for Dafclir® Tablets for the Treatment of Infectious Enteritis Caused by Clostridium difficile in Japan astellas.com ↗ |
| 2017-07-31 | Astellas Pharma Inc | Regulatory Astellas Submits Application for Approval of fidaxomicin for the Treatment of Infectious Enteritis Caused by Clostridium difficile in Japan astellas.com ↗
today announced that it has submitted an application for marketing approval of fidaxomicin (generic name) |
All press releases naming this drug 9 releases
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 |