Drugs / Colistin
Colistin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | COLY-MYCIN S | — | 1962-05-17 | fda.gov ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07865871 | Oct 2026 → Oct 2027 expected | bacterial pneumonia | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02408185 | Oct 2011 → Oct 2013 | — | Andalusian Public Foundation for Health Research in Seville | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07524920 | Apr → Aug 2026 overdue | bacterial infectious disease | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT01035853 | Dec 2009 → Apr 2012 | Pseudomonas aeruginosa infectious disease, cystic fibrosis | University of Jena | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06843668 | Dec 2023 → Sep 2025 overdue | — | Mansoura University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03622450 | Jan 2016 → Jan 2018 | — | Nourhan Hassan Osama Thuraya Mohamed | Completed | No outcome recorded |
| Phase 2/3 | NCT01798537 | Jun 2013 → Jul 2015 | bacterial infectious disease with sepsis | Rambam Health Care Campus | Unknown | No outcome recorded |
| Phase 312 trials · 4 missed | ||||||
| Phase 3 | NCT05865743 | Oct 2024 → Dec 2027 expected | carcinoma of esophagus | Radboud University Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT02389036 | May 2017 → Apr 2023 | critical illness polyneuropathy, infectious disease with sepsis | The George Institute | Completed | No outcome recorded |
| Phase 3 | NCT02806141 | Sep 2016 → Oct 2017 | Acinetobacter infectious disease, chemotherapy-induced toxicity | Hat Yai Medical Education Center | Terminated | No outcome recorded |
| Phase 3 | NCT02619786 | Dec 2015 → May 2017 | bronchitis | Mahidol University | Unknown | No outcome recorded |
| Phase 3 | NCT03341741 | Mar 2014 → Dec 2015 | cystic fibrosis | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 3 | NCT02208154 | Dec 2013 → Oct 2017 | bacterial infectious disease with sepsis | MJM Bonten | Completed | Missed primary |
| Phase 3 | NCT01292031 | May 2012 → Dec 2015 | bacterial pneumonia | Andalusian Public Foundation for Health Research in Seville | Completed | Missed primary |
| Phase 3 | NCT01501968 | Jan 2012 → Dec 2013 | — | Mahidol University | Unknown | Missed primary |
| Phase 3 | NCT01577862 | Nov 2008 → Aug 2011 | bacterial pneumonia, digestive system infectious disorder | University of Campania Luigi Vanvitelli | Completed | Missed primary |
| Phase 3 | NCT00645723 | Apr 2008 → Apr 2011 | bacterial pneumonia, coinfection | Hospitales Universitarios Virgen del Rocío | Unknown | No outcome recorded |
| Phase 3 | NCT00920270 | Jun 2006 → Mar 2010 | pneumonia | Mahidol University | Unknown | No outcome recorded |
| Phase 3 | NCT00300560 | Feb → Dec 2006 | infectious disease | Mahidol University | Unknown | No outcome recorded |
| Phase 412 trials · 4 missed | ||||||
| Phase 4 | NCT05862402 | May 2023 → May 2024 | Klebsiella pneumonia | Phramongkutklao College of Medicine and Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05586815 | Jan 2023 → Jan 2024 | Acinetobacter infectious disease | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT05542446 | Sep 2022 → Jan 2024 | — | St. Anne's University Hospital Brno, Czech Republic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05586438 | Oct 2021 → Oct 2022 | bacterial infectious disease | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT04995133 | Jul 2021 → Jan 2022 | nosocomial infection | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Unknown | No outcome recorded |
| Phase 4 | NCT02966457 | Jan → Dec 2017 | primary bacterial infectious disease | Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology | Completed | Missed primary |
| Phase 4 | NCT02162966 | May 2014 → Oct 2016 | infectious disease | King Saud Medical City | Unknown | No outcome recorded |
| Phase 4 | NCT02117986 | Apr 2014 → Dec 2018 | gram-negative bacterial infections | Hospital Barros Luco Trudeau | Unknown | No outcome recorded |
| Phase 4 | NCT02081560 | Nov 2013 → Jul 2015 | infectious disease | University of Zurich | Unknown | No outcome recorded |
| Phase 4 | NCT01732250 | Mar 2013 → Jan 2017 | gram-negative bacterial infections | Mical Paul | Completed | Missed primary |
| Phase 4 | NCT01740947 | Jan 2013 → Mar 2017 | colorectal cancer | H. Jaap Bonjer, PhD | Terminated | Missed primary |
| Phase 4 | NCT00826670 | Jun 2009 → Aug 2012 | bacterial infectious disease | University Hospital, Geneva | Completed | Missed primary |
| Phase not applicable5 trials | ||||||
| — | NCT06819462 | Apr 2025 → Dec 2026 expected | — | Southeast University, China | Recruiting | No outcome recorded |
| — | NCT06051513 | Nov 2023 → Dec 2025 overdue | — | Southeast University, China | Recruiting | No outcome recorded |
| — | NCT04208945 | Dec 2019 → Apr 2021 | pneumonia caused by gram negative bacteria | University of Thessaly | Unknown | No outcome recorded |
| — | NCT03477292 | Mar 2018 → Oct 2024 | — | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| — | NCT03622918 | Oct 2016 → Sep 2017 | Acinetobacter infectious disease | Gangnam Severance Hospital | Completed | No outcome recorded |
| Comparator or background therapy31 trials | ||||||
| Phase 0 | NCT05279586 Comparator | Mar 2022 → Feb 2023 | hepatic encephalopathy | Madonna Magdy Fahmy | Unknown | No outcome recorded |
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02472600 Comparator | Feb 2016 → Nov 2017 | — | Stephen Harbarth | Unknown | No outcome recorded |
| Phase 2/3 | NCT06650384 Background | Nov 2024 → Jan 2026 | poisoning | Ain Shams University | Completed | No outcome recorded |
| Phase 2/3 | NCT02134106 Background | Jan → Oct 2015 | bacterial infectious disease, nosocomial infection | Tan Tock Seng Hospital | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT01931592 Comparator | Jan 2014 → Oct 2016 | cancer | Maria J.G.T. Vehreschild | Terminated | No outcome recorded |
| Phase 3 | NCT07326540 Comparator | Mar 2026 → Dec 2027 expected | Acinetobacter infectious disease, bacterial pneumonia | BioVersys SAS | Recruiting | No outcome recorded |
| Phase 3 | NCT07089186 Comparator | Apr 2025 → Dec 2026 expected | bacterial pneumonia, urinary tract infection | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05613361 Background | Jan 2023 → Apr 2024 | acute kidney injury | October 6 University | Unknown | No outcome recorded |
| Phase 3 | NCT05258851 Comparator | Jun 2022 → Apr 2023 | — | King Faisal Specialist Hospital & Research Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05689229 Comparator | Aug → Nov 2021 | opportunistic bacterial infectious disease | Beni-Suef University | Completed | No outcome recorded |
| Phase 3 | NCT03894046 Comparator | Sep 2019 → Jul 2021 | Acinetobacter infectious disease, bacterial pneumonia | Entasis Therapeutics | Completed | Met primary |
| Phase 3 | NCT03329092 Comparator | Apr 2018 → Feb 2023 | nosocomial infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03409679 Comparator | Mar 2018 → Jul 2019 | pneumonia | Polyphor Ltd. | Terminated | No outcome recorded |
| Phase 3 | NCT01970371 Comparator | Sep 2014 → Aug 2016 | acute pyelonephritis, bacterial pneumonia | Achaogen, Inc. | Completed | Missed primary |
| Phase 3 | NCT01597973 Comparator | Oct 2012 → Aug 2020 | bacterial infectious disease, pneumonia | University of Michigan | Completed | No outcome recorded |
| Phase 3 | NCT01297894 Comparator | Jun 2010 → May 2012 | — | Mahidol University | Unknown | No outcome recorded |
| Phase 3 | NCT01297855 Comparator | Jun 2010 → May 2012 | — | Mahidol University | Unknown | No outcome recorded |
| 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 | NCT05922124 Comparator | Sep 2024 → Jul 2026 overdue | Acinetobacter infectious disease | Rambam Health Care Campus | Recruiting | No outcome recorded |
| Phase 4 | NCT04882085 Comparator | Aug 2021 → Aug 2023 | acute pyelonephritis, bacterial pneumonia, infectious peritonitis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT06827756 Comparator | Mar → Dec 2021 | cirrhosis of liver, infectious peritonitis | Tanta University | Completed | No outcome recorded |
| Phase 4 | NCT04489459 Comparator | Sep 2019 → Jul 2020 | — | Al-Azhar University | Unknown | No outcome recorded |
| Phase 4 | NCT02894684 Background | Jan 2017 → Feb 2019 | Pseudomonas infection, cystic fibrosis | Liverpool Heart and Chest Hospital NHS Foundation Trust | Completed | Met primary |
| Phase 4 | NCT02918409 Comparator | Aug 2016 → Sep 2020 | cystic fibrosis | National Jewish Health | Completed | No outcome recorded |
| Phase 4 | NCT02683603 Comparator | Apr 2013 → Apr 2015 | — | Tunis University | Completed | No outcome recorded |
| — | NCT07671755 Comparator | Feb → Dec 2025 | — | Shaheed Mohtarma Benazir Bhutto Institue of Trauma | Completed | No outcome recorded |
| — | NCT04208763 Background | Dec 2019 → Dec 2021 | infectious peritonitis | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT01025921 Comparator | Nov 2009 → May 2013 | pneumonia, tracheobronchitis | University of Thessaly | Completed | No outcome recorded |
| — | NCT01266499 Comparator | Jul 2009 → Jan 2011 | Klebsiella infectious disease | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT00753558 Comparator | Nov 2008 → Jun 2010 | — | Soroka University Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-04-22 | Merck Sharp & Dohme LLC | Results Pivotal Phase 3 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Demonstrated Favorable Overall Response Against Certain Imipenem–Non-Susceptible Bacterial Infections merck.com ↗
Treatment-emergent nephrotoxicity was lower with IMI-REL (10%; 3/29 patients) compared to COL+IMI (56%; 9/16 patients) (p=0.002). |
All press releases naming this drug 1 release
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Colistin | “Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or...” NCT05862402 ↗65“A six-hourly topical application of 0.5g paste, containing colistin 10mg, tobramycin 10mg and nystatin 125,000 IU, to the buccal mucosa and oropharynx” NCT02389036 ↗ “Virtually no resistance towards colistin could be detected (data not published), such that colistin was chosen as the non-absorbable component.” NCT01931592 ↗ “main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem” NCT04882085 ↗ “Nephrotoxicity is a dose-limiting factor of colistin, a last-line therapy for multidrug-resistant Gram-negative bacterial infections.” PMID 25801556 ↗ Mar 2015 “SOD consists of application of a paste containing colistin, tobramycin in a 2% concentration and nystatin 1 x 10\^5 units.” NCT02208154 ↗ “Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin” NCT03409679 ↗ “14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin” NCT02894684 ↗ “Colistin sulphate (50mg 4x/d PO) + Neomycin (250mg 4x/day PO) for 10 days” NCT00826670 ↗ “Oral Colistin in Patients with Hematological Malignancies” PMID 29755707 ↗ May 2018 “nebulized colistin at the dose of 2 million units (MU)” NCT02134106 ↗ |
| Known as | CMS | “Colistin is the most widely used polymyxin antibiotic, it is administered as inactive prodrug colistimethate sodium (CMS) that is hydrolyzed to an active moiety of colistin...” NCT06843668 ↗1“Colistin, administered as intravenous colistimethate (CMS), is still used in the critical care setting” PMID 39340688 ↗ Sep 2024 |
| Known as | colimycin (colistin) | “colimycin (colistin)” NCT02683603 ↗ |
| Known as | colistimethate | “Colistin, administered as intravenous colistimethate (CMS), is still used in the critical care setting” PMID 39340688 ↗ Sep 2024 |
| Known as | colistimethate sodium | “Colistin (colistimethate sodium) is the inactive prodrug that is hydrolyzed to colistin that act as a cationic detergent and disrupt the bacterial cytoplasmic membrane...” NCT06650384 ↗1“Colistin is the most widely used polymyxin antibiotic, it is administered as inactive prodrug colistimethate sodium (CMS) that is hydrolyzed to an active moiety of colistin...” NCT06843668 ↗ |
| Known as | Colistimethate Sodium for Injection | “Drug: colistin, other name: Colistimethate Sodium for Injection” NCT06051513 ↗ |
| Known as | colistin sodium methanesulfonate | “Colistin (100 mg, colistin sodium methanesulfonate, SCD Pharm., Seoul, Korea) will be intravenously administered with 100 mL of normal saline with 8 hours interval.” NCT03622918 ↗ |
| Known as | colistin sulfate | “The SDD treatment comprises two oral liquids: an oral suspension containing amphotericin B and an oral solution containing both colistin sulfate and tobramycin.” PMID 41345690 ↗ Dec 2025 |
| Known as | Polymyxin E | “Colistin (Polymyxin E) 100mg x 4/d” NCT01266499 ↗ |
| Known as | Tadim | “Drug: colistin (Tadim)” NCT01025921 ↗ |
| Modality | Other / unclassified | “Colistin sulfate is a polymyxin antibiotic” NCT05279586 ↗ |
| Route | Inhaled | “Intravenous colistin and nebulized colistin” NCT00645723 ↗ |
| Route | Intravenous | “Intravenous colistin and nebulized colistin” NCT00645723 ↗ |