Drugs / Polymyxin B
Polymyxin B
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NEO-POLYCIN | — | 1954-04-19 | fda.gov ↗ |
Trials 17 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03950544 | Jan 2019 → Aug 2020 | bacterial infectious disease | Shanghai 10th People's Hospital | Unknown | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT07502144 | Apr → Oct 2026 expected | — | Venus Remedies Limited | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07580586 | Mar → Sep 2026 expected | — | BioVersys SAS | Recruiting | No outcome recorded |
| Phase 1 | NCT05449392 | Sep 2022 → Sep 2023 | COVID-19 | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT05359627 | Jul 2022 → Mar 2023 | poisoning | TTY Biopharm | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07431307 | Jul 2026 → Mar 2028 expected | bacterial meningitis, bacterial pneumonia | BioVersys AG | Not yet recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07326540 | Mar 2026 → Dec 2027 expected | Acinetobacter infectious disease, bacterial pneumonia | BioVersys SAS | Recruiting | No outcome recorded |
| Phase 3 | NCT03159078 | May 2017 → Dec 2019 | — | University of Puerto Rico | Unknown | No outcome recorded |
| Phase 3 | NCT02515656 | Sep 2015 → Aug 2016 | vaginitis | Laboratoire Innotech International | Completed | No outcome recorded |
| Phase 3 | NCT01429701 | May → Jun 2012 | dermatitis | EMS | Completed | No outcome recorded |
| Phase 3 | NCT00534391 | Sep 2007 → Dec 2008 | hordeolum | Chulalongkorn University | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02328183 | Dec 2014 → Nov 2015 | nosocomial infection | Mahidol University | Unknown | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07549828 | Apr 2026 → Mar 2029 expected | acne, atopic eczema, psoriasis, seborrheic dermatitis | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07698938 | Feb → Mar 2025 | — | Hospital Universitario Dr. Jose E. Gonzalez | Completed | No outcome recorded |
| — | NCT04839653 | May 2021 → Apr 2022 | acute respiratory distress syndrome, bacterial infectious disease, infectious disease with sepsis, pneumonia | MEDSI Clinical Hospital 1, ICU | Unknown | No outcome recorded |
| — | NCT02186457 | Nov 2014 → Apr 2019 | infectious disease | Indiana University | Completed | No outcome recorded |
| — | NCT00997139 | Sep 2009 → Nov 2010 | — | Northwestern University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT05063422 Background | Aug 2022 → Aug 2023 | — | Altamash Institute of Dental Medicine | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05685615 Background | Apr 2023 → Nov 2024 | — | BioVersys AG | Completed | No outcome recorded |
| Phase 2 | NCT02641236 Comparator | Mar 2016 → Apr 2021 | acute graft versus host disease | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02134106 Comparator | Jan → Oct 2015 | bacterial infectious disease, nosocomial infection | Tan Tock Seng Hospital | Withdrawn | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02809131 Comparator | Apr 2016 → Mar 2021 | sick sinus syndrome, systolic heart failure, third-degree atrioventricular block | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01227863 Background | Feb 2011 | bacterial conjunctivitis | Azidus Brasil | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05157113 Comparator | May 2022 → Jun 2026 overdue | cataract | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07495150 Background | Apr 2026 → Apr 2027 expected | bacterial meningitis | yilong Wang | Not yet recruiting | No outcome recorded |
| — | NCT02424357 Background | Jul 2015 → Jan 2016 | strabismus | University of Miami | Completed | No outcome recorded |
| — | NCT02344732 Background | Oct 2013 → Oct 2014 | corneal disorder | Universiti Sains Malaysia | Completed | No outcome recorded |
| — | NCT01843920 Background | Jun 2011 → Apr 2013 | — | Jason Hsu, MD | Completed | No outcome recorded |
| — | NCT00000635 Background | ? → Apr 1992 | HIV infectious disease, herpes simplex infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | polymyxin-B | “A strip of neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic ointment will be then applied into the lower conjunctival fornix to patients in both groups.” NCT02424357 ↗26“Many operators use an antibacterial solution (e.g., polymyxin-B/bacitracin) to irrigate the pocket during device implantation.” NCT02809131 ↗ “Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU” NCT02515656 ↗ “Neomycin/Polymyxin B ophthalmic solution: one drop to the operative eye four times daily for 1 week, then stop” NCT05157113 ↗ “Neosporin is neomycin, bacitracin and polymyxin B with formulation 3.5mg/400 units/5,000 units.” NCT05449392 ↗ “The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim” NCT01843920 ↗ “Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate - Lab. Union Chemical” NCT01227863 ↗ “Polymyxin B” NCT02099240 ↗ |
| Known as | Poly-MxB | “Commercially available Polymyxin B 500,000 IU (Poly-MxB)” NCT07502144 ↗ |
| Known as | Polymyxin B sulfate | “Polymyxin B for Injection (Polymyxin B sulfate) is a polypeptide antibiotic that is derived from Bacillus polymyxa (more recently termed Paenibacillus polymyxa).” NCT07580586 ↗ |
| Known as | polymyxin B sulphate | “Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU” NCT02515656 ↗ |
| Modality | Peptide | “Polymyxin B sulfate) is a polypeptide antibiotic” NCT07580586 ↗ |
| Route | Topical | “Polymyxin B sulfate/bacitracin zinc ointment is then applied over the trifluridine.” NCT00000635 ↗ |