Drugs / Tedizolid Phosphate
Tedizolid Phosphate
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | SIVEXTRO | — | 2019-03-06 – 2025-04-04 | fda.gov ↗ |
| Approved | EU (EMA) | Sivextro | — | 2015-03-23 | europa.eu ↗ |
| Approved | US (FDA) | SIVEXTRO | — | 2014-06-20 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT06609161 | Jul → Aug 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06733688 | Mar → Apr 2022 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT03217565 | Feb 2019 → Mar 2023 | gram-positive bacterial infections | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02750761 | May 2016 → Dec 2018 | gram-positive bacterial infections | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01442831 | Sep 2010 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00876655 | Feb → Mar 2009 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00666601 | Apr → Aug 2008 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03176134 | Jan 2019 → Jul 2023 | — | Merck Sharp & Dohme LLC | 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 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tedizolid phosphate | “Study TR701-108 was a relative bioavailability study in 12 subjects administered 150-mg tedizolid equivalents as TPD or tedizolid phosphate.” PMID 23926058 ↗ Aug 20137“Tedizolid phosphate is a novel antibacterial prodrug with potent activity against Gram-positive pathogens.” PMID 24875463 ↗ May 2014 “tedizolid (TR-700), the active moiety of the antimicrobial prodrug tedizolid phosphate (TR-701)” PMID 22584101 ↗ May 2012 |
| Known as | MK-1986 | “A Phase 1, Single- and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old” NCT03217565 ↗1“different oral formulations of tedizolid phosphate (MK-1986)” NCT06609161 ↗ |
| Known as | TR-701 | “tedizolid (TR-700), the active moiety of the antimicrobial prodrug tedizolid phosphate (TR-701)” PMID 22584101 ↗ May 2012 |
| Modality | Small molecule | “a novel oxazolidinone” PMID 22584101 ↗ May 2012 |
| Route | Oral | “Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701” NCT00666601 ↗ |