Tigecycline
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TYGACIL | — | 2009-03-20 | fda.gov ↗ |
| Approved | EU (EMA) | Tygacil | — | 2006-04-24 | europa.eu ↗ |
| Approved | US (FDA) | TYGACIL | — | 2005-06-15 | fda.gov ↗ |
Trials 41 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00719810 Comparator | Jun → Oct 2008 | skin disease caused by bacterial infection, skin infection, staphylococcal infection | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07089186 Comparator | Apr 2025 → Dec 2026 expected | bacterial pneumonia, urinary tract infection | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT04042077 Comparator | Sep 2019 → Oct 2020 | — | Menarini Group | Terminated | No outcome recorded |
| Phase 3 | NCT00366249 Comparator | Jan 2007 → Mar 2009 | bacterial infectious disease, osteomyelitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT07004049 Comparator | Apr 2025 → Dec 2028 expected | bacterial pneumonia, infectious disease with sepsis | National University of Singapore | Recruiting | No outcome recorded |
| Phase 4 | NCT06893835 Comparator | Dec 2024 → May 2025 overdue | primary bacterial infectious disease | Beni-Suef University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05977868 Comparator | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT05494957 Background | Aug 2022 → Aug 2024 | pulmonary non-tuberculous mycobacterial infection | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase 4 | NCT04882085 Comparator | Aug 2021 → Aug 2023 | acute pyelonephritis, bacterial pneumonia, infectious peritonitis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT04489459 Comparator | Sep 2019 → Jul 2020 | — | Al-Azhar University | Unknown | No outcome recorded |
| Phase 4 | NCT00419991 Comparator | Jan 2007 → May 2008 | staphylococcal infection | CPL Associates | Completed | No outcome recorded |
| Phase 4 | NCT00368537 Comparator | Sep 2006 → Sep 2008 | skin disease caused by bacterial infection | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00230971 Comparator | Oct 2005 → Sep 2008 | abscess, appendicitis, cholecystitis, diverticulitis +2 | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00195351 Comparator | Sep 2005 → Feb 2008 | appendicitis, cholecystitis, diverticulitis, nosocomial infection +1 | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07495150 Background | Apr 2026 → Apr 2027 expected | bacterial meningitis | yilong Wang | Not yet recruiting | No outcome recorded |
| — | NCT06051513 Background | Nov 2023 → Dec 2025 overdue | — | Southeast University, China | Recruiting | No outcome recorded |
| — | NCT03962920 Comparator | May 2020 → May 2025 overdue | infectious disease | Zealand University Hospital | Recruiting | No outcome recorded |
| — | NCT04208763 Background | Dec 2019 → Dec 2021 | infectious peritonitis | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT02800785 Comparator | May 2016 → Mar 2020 | appendicitis | University of Washington | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tigecycline | “Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or...” NCT05862402 ↗58“The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.” NCT07089186 ↗ “The basic regimen consists of bedaquiline, clofazimine, linezolid, and 2-3 drugs such as amikacin and tigecycline are selected according to the drug use history” NCT05494957 ↗ “main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem” NCT04882085 ↗ “Tigecycline (Haizheng Li Xing ®) combined with piperacillin / tazobactam (tazocin ®), with or without antifungal therapy” NCT02191475 ↗ “meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin” NCT05977868 ↗ “colistin combined with tigecycline” NCT06051513 ↗ |
| Known as | Haizheng Li Xing | “Tigecycline (Haizheng Li Xing ®) combined with piperacillin / tazobactam (tazocin ®), with or without antifungal therapy” NCT02191475 ↗ |
| Known as | tegecycline | “Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)” NCT07089186 ↗ |
| Known as | TGC | “This randomized, open-label, multi-center trial compared tigecycline (TGC), a broad-spectrum glycylcycline, with ceftriaxone-metronidazole (CTX/MET) for the treatment of...” PMID 22439781 ↗ Mar 20122“Tigecycline (TGC) has demonstrated clinical efficacy and safety, in comparison with imipenem/cilastatin in phase 3 clinical trials, for complicated intra-abdominal infection (cIAI).” PMID 20670293 ↗ Aug 2010 “Tigecycline (TGC), a glycylcycline, has expanded activity against Gram-positive and Gram-negative, anaerobic, and atypical bacteria.” PMID 18508226 ↗ May 2008 |
| Known as | Tigeciclina | ChEMBL registry synonym — accepted as the source's own label CHEMBL376140 ↗ |
| Known as | Tigecycline accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL376140 ↗ |
| Known as | tigecycline: tygacil 50 mg vial. | “tigecycline: tygacil 50 mg vial.” NCT01592032 ↗ |
| Known as | Tygacil | “Tigecycline (Tygacil)” NCT07513103 ↗ |
| Known as | WAY-GAR-936 | ChEMBL registry synonym — accepted as the source's own label CHEMBL376140 ↗ |
| Action | Inhibit | “demonstrates a broad spectrum of antibacterial activity by inhibiting multiply resistant gram-positive, gram-negative, anaerobic, and "atypical" bacteria” NCT00419991 ↗ |
| Modality | Small molecule | “Tigecycline, a glycylcycline antibiotic and an analog of the tetracycline minocycline” NCT00419991 ↗ |
| Route | Intravenous | “Hospitalized patients with community-acquired pneumonia (CAP) were randomized to intravenous (IV) TGC (100 mg followed by 50 mg bid) or IV levofloxacin (LEV) (500 mg bid).” PMID 18508226 ↗ May 2008 |