Drugs / Colistimethate

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Colobreathe 2012-02-13 europa.eu
Approved US (FDA) COLY-MYCIN M 1970-06-04 fda.gov

Trials 9 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT02156323 Jul 2014 → Mar 2015 Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT01863719 Aug 2013 → May 2017 pneumococcal infection, pneumonia National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 1 NCT01537614 Oct 2011 → Feb 2013 cystic fibrosis Poitiers University Hospital Completed No outcome recorded
Phase 1 NCT01449838 Oct → Dec 2010 Pseudomonas infection GlaxoSmithKline Completed No outcome recorded
Phase 21 trial
Phase 2 NCT01940731 Oct 2013 → Mar 2014 nosocomial infection Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT03460704 Jan 2018 → Mar 2022 bronchiectasis Zambon SpA Terminated No outcome recorded
Phase 41 trial
Phase 4 NCT03397914 Jan 2017 → Jan 2019 childhood malignant neoplasm, gram-negative bacterial infections National Cancer Institute, Egypt Completed No outcome recorded
Phase not applicable2 trials
NCT06834971 Jul 2025 → Sep 2026 expected Qilu Hospital of Shandong University Recruiting No outcome recorded
NCT02489955 Feb 2015 → Feb 2017 cystic fibrosis The Leeds Teaching Hospitals NHS Trust Unknown No outcome recorded
Also used as a comparator or background therapy in 10 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT07512596 Comparator Jul 2026 → Jul 2027 expected bacterial pneumonia Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT06368804 Background Sep 2024 → Mar 2025 overdue bronchiectasis Centre Hospitalier Intercommunal Creteil Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06488794 Comparator Jan 2027 → Dec 2028 expected University Hospital Fattouma Bourguiba Not yet recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT02452047 Comparator Aug 2015 → Sep 2017 bacterial infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 46 trials
Phase 4 NCT07694700 Comparator Dec 2025 → Aug 2026 overdue primary bacterial infectious disease Beni-Suef University Active not 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 NCT06570850 Comparator Apr 2023 → Mar 2025 overdue Acinetobacter infectious disease Chiang Mai University Recruiting No outcome recorded
Phase 4 NCT02047773 Comparator Jan 2014 → Feb 2020 bronchiectasis University of Edinburgh Completed No outcome recorded
Phase 4 NCT01844778 Comparator Aug 2013 → Oct 2015 cystic fibrosis Novartis Pharmaceuticals Completed No outcome recorded

Evidence & citations 27 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

FieldValueCited text
Known as Colistimethate ClinicalTrials.gov intervention name — accepted as the source's own label NCT01844778
Known as Alficetin ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as CMS CMS (colistimethate sodium, 75mg, solubilized in 4 mL 0.9% saline), twice daily.” NCT06834971
3

“Colistimethate sodium (CMS)” NCT02452047

NCT03460704

NCT02156323

Known as CMS-Na “intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in healthy Japanese male subjects.” NCT01449838
Known as Colimicina ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Colimycin ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as COLIMYCINE ClinicalTrials.gov intervention name — accepted as the source's own label NCT01537614
Known as Colistimetato de sodio ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Colistimethate sodique ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as colistimethate sodium colistimethate sodium (COLI), both administered via nebulizers” PMID 28614995 Jul 2017
12

“inhaled colistimethate sodium (CMS), administered twice a day” NCT03460704

“inhaled colistimethate sodium (Colistineb® 2x2 mill U daily)” NCT01400750

NCT02452047

NCT06893835

NCT06834971

NCT03397914

NCT01863719

NCT01449838

NCT07694700

NCT06488794

NCT01940731

NCT07512596

Known as Colistimethate Sodium for Injection Colistimethate Sodium for Injection is a prodrug of polymyxin E. After entering the body, polymyxin E mesylate is hydrolyzed to polymyxin E (colistin), which exerts...” NCT07512596
Known as Colistin methanesulfonate ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Colistin Methanesulfonate Sodium “intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in healthy Japanese male subjects.” NCT01449838
1

“multiple doses of colistin methanesulfonate sodium (CMS)” NCT02156323

Known as Colistin methanesulfonic acid ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Colistin Sodium Methanesulfonate ClinicalTrials.gov intervention name — accepted as the source's own label NCT06570850
Known as Colistin sodium methanesulphonate ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Colistin sulfomethate ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Colistin sulphomethate ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Colobreathe ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Colomycin ClinicalTrials.gov intervention name — accepted as the source's own label NCT02489955
1

NCT02047773

Known as Coly-mycin ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Methacolimycin ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as NSC-756688 ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as Promixin ChEMBL registry synonym — accepted as the source's own label CHEMBL6067483
Known as sodium colistimethate “nebulized sodium colistimethate (1 Million Units tw/d)” NCT06368804