Drugs / Colistimethate sodium
Colistimethate sodium
also known as
CMS · Colistin Methanesulfonate Sodium · Colomycin · CMS-Na · COLIMYCINE · Colistimethate · Colistimethate Sodium for Injection · Colistin Sodium Methanesulfonate · +1 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 missed | ||||||
| Phase 3 | NCT03460704 | Jan 2018 → Mar 2022 | bronchiectasis | Zambon SpA | Terminated | Missed primary Stop: Enrollment |
| 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 overdue | — | 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 |
| Comparator or background therapy10 trials | ||||||
| Phase 2 | NCT07512596 Comparator | Jul 2026 → Jul 2027 expected | bacterial pneumonia | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06368804 Background | Sep 2024 → Mar 2025 overdue | bronchiectasis | Centre Hospitalier Intercommunal Creteil | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06488794 Comparator | Jan 2027 → Dec 2028 expected | — | University Hospital Fattouma Bourguiba | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02452047 Comparator | Aug 2015 → Sep 2017 | bacterial infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 |
| Phase 4 | NCT01400750 Comparator | Aug 2001 → Aug 2010 | cystic fibrosis | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-09-13 | Zambon SpA | Results Zambon Announces Publication of Phase 3 PROMIS I and II Study Results in The Lancet Respiratory Medicine Showing Efficacy Results of CMS I-neb in Patients with Non-Cystic Fibrosis Bronchiectasis Colonized with P. aeruginosa zambon.com ↗
Inhalation of colistimethate sodium via the I-neb ® Adaptive Aerosol Delivery System (CMS I-neb) significantly reduced pulmonary exacerbations and improved quality of life in non-cystic fibrosis bronchiectasis (NCFB) patients colonized with P. aeruginosa |
| 2023-07-18 | Zambon SpA | Results Zambon Presents Results from the Two Phase 3 PROMIS Studies of CMS I-neb in Patients with Non-Cystic Fibrosis Bronchiectasis at World Bronchiectasis Conference 2023 zambon.com ↗
The studies, which examined the use of CMS powder for nebulizer solution, delivered by the I-neb AAD system (hereafter referred to as “CMS I-neb”) for the reduction of the incidence of pulmonary exacerbations in adult patients with NCFB and Pseudomonas aeruginosa chronic infection, showed CMS I-neb reduced the annual rate of exacerbations. |
| 2022-04-21 | Zambon SpA | Regulatory Zambon Receives U.S. FDA Breakthrough Therapy Designation for CMS I-neb® in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFB) zambon.com ↗ |
| 2021-09-08 | Zambon SpA | Results Positive Results from Phase 3 PROMIS-I Study of CMS I-neb® in Patients with Non-Cystic Fibrosis Bronchiectasis Presented at European Respiratory Society (ERS) Annual Meeting zambon.com ↗
The primary endpoint was met, the annual rate of exacerbations was significantly lower in patients receiving CMS I-neb ® vs placebo (0.58 per patient per year vs 0.95, rate ratio (RR) 0.61 95% CI 0.46-0.82, p=0.00101) |
| 2018-12-11 | Zambon SpA | Regulatory NON–CYSTIC FIBROSIS BRONCHIECTASIS (NCFB) FDA GRANTS “FAST-TRACK” AND “QIPD” TO ZAMBON FOR COLISTIMETHATE SODIUM POWDER FOR NEBULIZER SOLUTION DELIVERED BYTHE I-NEB AAD SYSTEM. zambon.com ↗ |
All press releases naming this drug 5 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | colistimethate sodium | “colistimethate sodium (COLI), both administered via nebulizers” PMID 28614995 ↗ Jul 201712“inhaled colistimethate sodium (CMS), administered twice a day” NCT03460704 ↗ “inhaled colistimethate sodium (Colistineb® 2x2 mill U daily)” NCT01400750 ↗ |
| Known as | CMS | “CMS (colistimethate sodium, 75mg, solubilized in 4 mL 0.9% saline), twice daily.” NCT06834971 ↗ |
| Known as | CMS-Na | “intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in healthy Japanese male subjects.” NCT01449838 ↗ |
| Known as | COLIMYCINE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01537614 ↗ |
| Known as | Colistimethate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01844778 ↗ |
| 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 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 Sodium Methanesulfonate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06570850 ↗ |
| Known as | Colomycin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02489955 ↗ |
| Known as | sodium colistimethate | “nebulized sodium colistimethate (1 Million Units tw/d)” NCT06368804 ↗ |
| Route | Intravenous | “by intravenous infusion” NCT01449838 ↗ |