Drugs / Xifaxan
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | XIFAXAN | — | 2015-05-27 | fda.gov ↗ |
| Approved | US (FDA) | XIFAXAN | — | 2004-05-25 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 missed | ||||||
| Phase 1 | NCT01695174 | Aug 2012 → Dec 2013 | primary sclerosing cholangitis | Mayo Clinic | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| — | NCT00577772 Comparator | Nov 2007 → Jul 2010 | small intestinal bacterial overgrowth, stomach disorder | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
Press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Xifaxan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00577772 ↗ |
| Known as | rifaximin | “Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary Sclerosing Cholangitis.” PMID 24914504 ↗ Jan 2017 |
| Route | Oral | “400 mg by mouth” NCT00577772 ↗ |