Drugs / Tigecycline
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Tigecycline

Small molecule

Developed for
bacterial pneumonia · bacterial infectious disease · pulmonary non-tuberculous mycobacterial infection · abscess · gram-positive bacterial infections · infectious disease · nosocomial infection · skin infection
+23 more · acute myeloid leukemia · acute pyelonephritis · Clostridium difficile colitis · diarrheal disease · digestive system infectious disorder · gram-negative bacterial infections · intestinal infectious disease · Klebsiella pneumonia · methicillin-resistant staphylococcus aureus infectious disease · peritonitis · scrub typhus · skin disease caused by bacterial infection · skin disorder · ventilation pneumonitis · appendicitis · cholecystitis · diverticulitis · infectious disease with sepsis · infectious peritonitis · osteomyelitis · primary bacterial infectious disease · staphylococcal infection · urinary tract infection
Investigated by
Wyeth is now a wholly owned subsidiary of Pfizer · Pfizer · University of California, San Diego · The University of Queensland · Achaogen, Inc. · Ain Shams University
+36 more · Air Force Specialized Hospital, Cairo, Egypt · Australian Government Department of Health and Ageing · Beni-Suef University · Cairo University · Children's Hospital Foundation · Clinica Universidad de Navarra, Universidad de Navarra · Cystic Fibrosis Foundation · Department of Health and Human Services · Erasmus Medical Center · Gary E. Stein, Pharm.D. · Griffith University · Innoviva Specialty Therapeutics · Jin Soo Lee · Korean Center for Disease Control and Prevention · Mahidol University · Manjunath Prakash Pai · Memorial Sloan Kettering Cancer Center · Monash University · Murdoch Childrens Research Institute · National Institutes of Health (NIH) · Newcastle University · Phramongkutklao College of Medicine and Hospital · QIMR Berghofer Medical Research Institute · Shanghai 10th People's Hospital · Silpakorn University · South Australian Health and Medical Research Institute · Tanta University · The University of Texas Health Science Center at Tyler · Tianjin Medical University Cancer Institute and Hospital · University Health Network, Toronto · University of California, Los Angeles · University of Copenhagen · University of Kansas · University of Melbourne · University of Navarrra Hospital (Clinica Universitaria) · Zhejiang Hisun Pharmaceutical Co. Ltd.

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03950544 Jan 2019 → Aug 2020 bacterial infectious disease Shanghai 10th People's Hospital Unknown No outcome recorded
Phase 15 trials
Phase 1 NCT01332786 Mar 2011 → Oct 2014 acute myeloid leukemia University Health Network, Toronto Completed No outcome recorded
Phase 1 NCT01287793 Jan → May 2011 Pfizer Completed No outcome recorded
Phase 1 NCT00406237 Dec 2006 → Mar 2009 cirrhosis of liver Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 1 NCT00614679 Oct 2006 → Dec 2008 end stage renal failure University of California, San Diego Completed No outcome recorded
Phase 1 NCT00376324 Sep 2006 → Oct 2008 Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 25 trials
Phase 2 NCT07485010 Apr 2027 → Apr 2031 expected pulmonary non-tuberculous mycobacterial infection The University of Queensland Not yet recruiting No outcome recorded
Phase 2 NCT07524920 Apr → Aug 2026 overdue bacterial infectious disease Ain Shams University Not yet recruiting No outcome recorded
Phase 2 NCT00707239 Dec 2008 → Jun 2011 bacterial pneumonia Pfizer Terminated No outcome recorded
Phase 2 NCT00488345 Dec 2007 → Sep 2009 bacterial pneumonia, peritonitis, skin disease caused by bacterial infection Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 2 NCT00600600 Apr 2002 → Apr 2010 pulmonary non-tuberculous mycobacterial infection The University of Texas Health Science Center at Tyler Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT04310930 Mar 2020 → Jun 2029 expected pulmonary non-tuberculous mycobacterial infection The University of Queensland Recruiting No outcome recorded
Phase 2/3 NCT02191475 May 2014 → May 2017 digestive system infectious disorder Tianjin Medical University Cancer Institute and Hospital Unknown No outcome recorded
Phase 2/3 NCT02040818 Nov 2013 → Jan 2017 University of California, San Diego Withdrawn No outcome recorded
Phase 316 trials
Phase 3 NCT06739382 Jan → Dec 2021 ventilation pneumonitis Beni-Suef University Completed No outcome recorded
Phase 3 NCT01970371 Sep 2014 → Aug 2016 acute pyelonephritis, bacterial pneumonia Achaogen, Inc. Completed No outcome recorded
Phase 3 NCT01483872 Mar 2012 → Sep 2013 University of California, San Diego Terminated No outcome recorded
Phase 3 NCT00911573 Aug 2011 → May 2014 infectious disease, skin disorder Wyeth is now a wholly owned subsidiary of Pfizer Withdrawn No outcome recorded
Phase 3 NCT00914888 Jan 2011 → May 2014 bacterial pneumonia Wyeth is now a wholly owned subsidiary of Pfizer Withdrawn No outcome recorded
Phase 3 NCT01602874 Jan 2011 → May 2014 bacterial pneumonia Pfizer Withdrawn No outcome recorded
Phase 3 NCT00575094 Nov 2007 → Mar 2008 bacterial infectious disease Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 3 NCT00136201 Nov 2005 → Dec 2006 abscess Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 3 NCT00205816 Jan 2004 → Nov 2005 bacterial infectious disease Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 3 NCT00081575 Jan 2004 → Mar 2005 bacterial pneumonia, nosocomial infection Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 48 trials
Phase 4 NCT07258225 Apr 2024 → Feb 2026 overdue Air Force Specialized Hospital, Cairo, Egypt Active not recruiting No outcome recorded
Phase 4 NCT05862402 May 2023 → May 2024 Klebsiella pneumonia Phramongkutklao College of Medicine and Hospital Unknown No outcome recorded
Phase 4 NCT01721408 Nov 2012 → Oct 2015 intestinal infectious disease Pfizer Completed No outcome recorded
Phase 4 NCT01592032 May 2012 → Jan 2015 bacterial infectious disease, prosthesis-related infectious disease Clinica Universidad de Navarra, Universidad de Navarra Unknown No outcome recorded
Phase 4 NCT01560143 Mar → May 2012 obesity disorder Manjunath Prakash Pai Completed No outcome recorded
Phase 4 NCT01342731 Jul 2011 → Jun 2012 infectious disease Mahidol University Unknown No outcome recorded
Phase 4 NCT00488306 Aug 2006 → Aug 2007 abscess Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 4 NCT00488761 Jul 2006 → Aug 2007 skin infection Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase not applicable3 trials
NCT07366372 May 2023 → Nov 2024 Tanta University Completed No outcome recorded
NCT07513103 Sep 2022 → Jun 2024 scrub typhus Jin Soo Lee Completed No outcome recorded
NCT01401023 Jul 2011 → Jul 2013 Clostridium difficile colitis, diarrheal disease Gary E. Stein, Pharm.D. Completed No outcome recorded
Also used as a comparator or background therapy in 19 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 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.

FieldValueCited 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 tigecyclineNCT06051513

NCT00079989

NCT00228410

NCT04310930

NCT07258225

NCT07513103

NCT06893835

NCT01332786

NCT00600600

NCT01592032

NCT01970371

NCT01721408

NCT00079885

NCT06739382

NCT07485010

NCT07366372

NCT01287793

NCT00707239

NCT00914888

NCT01342731

NCT03950544

NCT00080496

NCT07495150

NCT01401023

NCT00406237

NCT04208763

NCT01602874

NCT03962920

NCT04489459

NCT00614679

NCT00419991

NCT00230971

NCT02040818

NCT00911573

NCT04042077

NCT00205816

NCT00575094

NCT07524920

NCT00079976

NCT00195351

NCT07004049

NCT00366249

NCT01560143

NCT02800785

NCT00488761

NCT00081744

NCT00136201

NCT00368537

NCT00488306

NCT00376324

NCT00081575

NCT00719810

NCT01483872

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 2012
2

“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
1

NCT00488345

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