Drugs / Tedizolid
Tedizolid
also known as
TR 701 FA · Sivextro · tedizolid phosphate · BAY119-2631 · TR-701 free acid · tedizolid phosphate disodium · torezolid · TR-700
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 26
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT02620787 | Feb 2016 → Mar 2017 | diabetes mellitus, skin infection | Hartford Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02477514 | Jun → Aug 2015 | skin disease caused by bacterial infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01623401 | May → Aug 2012 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01577459 | Apr → Jun 2012 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01539473 | Feb → May 2012 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01496677 | Jan → Feb 2012 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01461460 | Nov → Dec 2011 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01452828 | Oct 2011 → Mar 2012 | impaired renal function disease | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01431833 | Aug 2011 → May 2012 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01271998 | Dec 2010 → Jan 2011 | bacterial infectious disease | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01156077 | Jun 2010 → Sep 2011 | bacterial infectious disease | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00983255 | Sep 2009 → Jan 2010 | bacterial infectious disease | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00666601 | Apr → Aug 2008 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05534750 | Apr 2023 → Apr 2026 overdue | multidrug-resistant tuberculosis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT03009045 | Feb 2017 → Mar 2021 | osteomyelitis | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01519778 | Feb → Aug 2012 | cellulitis, erysipelas | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 36 trials · 3 met primary | ||||||
| Phase 3 | NCT02276482 | Mar 2015 → Sep 2018 | skin disease caused by bacterial infection, skin infection | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02066402 | Mar 2014 → Mar 2016 | bacterial infectious disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT02019420 | Jan 2014 → Jun 2018 | pneumonia | Merck & Co., Inc. | Completed | Met primary |
| Phase 3 | NCT01967225 | Nov 2013 → Oct 2016 | skin infection | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01421511 | Sep 2011 → Jan 2013 | skin disease caused by bacterial infection | Merck & Co., Inc. | Completed | Met primary |
| Phase 3 | NCT01170221 | Aug 2010 → Sep 2011 | skin disease caused by bacterial infection | Merck & Co., Inc. | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT05398679 | Aug 2022 → Dec 2026 expected | infective endocarditis | Fundacion Clinic per a la Recerca Biomédica | Recruiting | No outcome recorded |
| Phase 4 | NCT03746327 | Feb 2020 → Jan 2024 | periprosthetic joint infection | Fundacion Clinic per a la Recerca Biomédica | Completed | No outcome recorded |
| Phase 4 | NCT02444234 | Jul 2015 → Dec 2017 | cystic fibrosis | University of Southern California | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03378427 | Aug 2018 → Oct 2020 | periprosthetic joint infection | Tourcoing Hospital | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT02342418 Comparator | Mar → Sep 2015 | obesity disorder | Amit.Pai | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2015-03-27 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 수퍼박테리아 타깃 항생제 ‘시벡스트로’ 유럽 판매허가 승인 donga-st.com ↗
동아에스티(대표이사 사장 박찬일)는 유럽 현지 기준 지난 23일, 수퍼박테리아 타깃 항생제 ‘시벡스트로(SIVEXTRO™, 성분명: Tedizolid Phosphate)’가 유럽연합 집행위원회(European Commission)로부터 유럽 판매허가 승인을 받았다고 27일 밝혔다. |
| 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. |
| 2014-06-22 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 수퍼박테리아 타깃항생제 시벡스트로 미 FDA 신약허가 승인 donga-st.com ↗
동아에스티(대표이사 사장 박찬일)는 지난 2007년 1월 미국 트리어스 테라퓨틱스(Trius Therapeutics, 현재 큐비스트)社에 아웃라이센싱한 수퍼박테리아 타깃 항생제 ‘테디졸리드(tedizolid phosphate)’가 미국 FDA로부터 신약 허가 승인을 받았다고 22일 밝혔다. |
| 2014-04-01 | Dong-A ST Co., Ltd. | Regulatory Dong-A ST obtained Advisory Committee’ Support for FDA Approval for its Tedizolid donga-st.com ↗
At a meeting of the advisory committee held on the morning of March 31, Eastern Standard Time of the USA, all 14 members unanimously supported the FDA approval of ‘SIVEXTRO.’ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-03-27 | Dong-A ST Co., Ltd. | 동아ST, 수퍼박테리아 타깃 항생제 ‘시벡스트로’ 유럽 판매허가 승인 donga-st.com ↗ |
| 2015-01-26 | Merck Sharp & Dohme LLC | Merck Announces CHMP Issues Positive Opinion for Investigational Antibiotic SIVEXTRO® (tedizolid phosphate) merck.com ↗ |
| 2014-06-22 | Dong-A ST Co., Ltd. | 동아ST, 수퍼박테리아 타깃항생제 시벡스트로 미 FDA 신약허가 승인 donga-st.com ↗ |
| 2014-04-01 | Dong-A ST Co., Ltd. | Dong-A ST obtained Advisory Committee’ Support for FDA Approval for its Tedizolid donga-st.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tedizolid | “To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one...” NCT03746327 ↗17“Tedizolid, a novel oxazolidinone with activity against a wide range of Gram-positive pathogens, was evaluated in two noninferiority phase 3 acute bacterial skin and skin...” PMID 25421472 ↗ Nov 2014 “This study assessed the pulmonary disposition of tedizolid, an oxazolidinone, in adult volunteers receiving 200 mg of the prodrug tedizolid phosphate orally every 24 h for 3...” PMID 22330925 ↗ Feb 2012 “Tedizolid phosphate is approved for the treatment of acute bacterial skin and skin structure infections in adults.” PMID 29319932 ↗ Jan 2018 “Tedizolid is a novel oxazolidinone antibacterial that may have reduced the potential for mitochondrial toxicity.” PMID 27941424 ↗ Mar 2017 “tedizolid (TR-700), the active moiety of the antimicrobial prodrug tedizolid phosphate (TR-701)” PMID 22584101 ↗ May 2012 |
| Known as | BAY119-2631 | “Tedizolid Phosphate (Sivextro, BAY1192631)” NCT01967225 ↗1“Tedizolid (BAY119-2631)” NCT02066402 ↗ |
| Known as | Sivextro | “tedizolid (Sivextro, Merck & Co.), a novel oxazolidinone antibiotic” NCT02620787 ↗3“Tedizolid Phosphate (Sivextro, BAY1192631)” NCT01967225 ↗ “Tedizolid Phosphate 200 MG [Sivextro]” NCT03378427 ↗ “Tedizolid (SIVEXTRO®)” NCT05534750 ↗ |
| Known as | tedizolid phosphate | “This study compared the safety and efficacy of tedizolid (administered as tedizolid phosphate) with active antibacterial comparators for the treatment of ABSSSIs in adolescents.” PMID 33395210 ↗ Mar 20213“We evaluated the efficacy and safety of tedizolid (administered as tedizolid phosphate) for treatment of gram-positive ventilated HABP/VABP.” PMID 33720350 ↗ Aug 2021 “Tedizolid Phosphate (Sivextro, BAY1192631)” NCT01967225 ↗ “Tedizolid Phosphate 200 MG [Sivextro]” NCT03378427 ↗ |
| Known as | tedizolid phosphate disodium | “tedizolid phosphate disodium (TPD)” PMID 23926058 ↗ Aug 2013 |
| Known as | torezolid | “Skin and soft tissue concentrations of tedizolid (formerly torezolid), a novel oxazolidinone, following a single oral dose in healthy volunteers.” PMID 22584101 ↗ May 2012 |
| Known as | TR 701 FA | “This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18...” NCT01519778 ↗9“Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period” NCT01577459 ↗ |
| Known as | TR-700 | “tedizolid (TR-700), the active moiety of the antimicrobial prodrug tedizolid phosphate (TR-701)” PMID 22584101 ↗ May 2012 |
| Known as | TR-701 free acid | “This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched...” NCT01431833 ↗1“oral TR-701 free acid (FA) versus placebo” NCT01461460 ↗ |
| Modality | Small molecule | “a novel oxazolidinone” PMID 22584101 ↗ May 2012 |
| Route | Other | “A TR-700 solution will be locally administered via a microdialysis probe into the skeletal muscle and subcutanous tissue (just under the skin) at a concentration of...” NCT00666601 ↗ |