Drugs / TR-701
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00671359 | Mar → May 2008 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00671814 | Jan → Jun 2008 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00761215 | Sep 2008 → Feb 2009 | skin disease caused by bacterial infection, skin infection | Merck & Co., Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2015-01-26 | Merck Sharp & Dohme LLC | Regulatory Merck Announces CHMP Issues Positive Opinion for Investigational Antibiotic SIVEXTRO® (tedizolid phosphate) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO ® (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2015-01-26 | Merck Sharp & Dohme LLC | Merck Announces CHMP Issues Positive Opinion for Investigational Antibiotic SIVEXTRO® (tedizolid phosphate) merck.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TR-701 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00671359 ↗ |
| Known as | tedizolid phosphate | “Tedizolid (TR-700, formerly torezolid) is the active moiety of the prodrug tedizolid phosphate (TR-701), a next-generation oxazolidinone, with high potency against...” PMID 22687509 ↗ Jun 2012 |
| Modality | Small molecule | “a next-generation oxazolidinone” PMID 22687509 ↗ Jun 2012 |
| Route | Oral | “Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water following a high-fat meal preceded by at least a 10-hour fast.” NCT00671359 ↗ |