Neomycin
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 27 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01638429 | Apr 2012 → Apr 2014 | diabetes mellitus, obesity disorder | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05449392 | Sep 2022 → Sep 2023 | COVID-19 | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT02001909 | Dec 2013 → Apr 2014 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06747611 | Aug 2025 → Mar 2028 expected | alopecia areata, alopecia totalis, alopecia universalis | University of Minnesota | Recruiting | No outcome recorded |
| Phase 2 | NCT05695261 | Jun 2023 → Jan 2027 expected | anaphylaxis, food allergy | Rima Rachid | Recruiting | No outcome recorded |
| Phase 2 | NCT02682485 | Mar 2017 | intestinal perforation, rectal cancer | University of Chicago | Withdrawn | No outcome recorded |
| Phase 2 | NCT02730962 | Jun 2016 → Jan 2018 | prediabetes syndrome | University of Minnesota | Terminated | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05874219 | Apr → May 2023 | — | Future University in Egypt | 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 33 trials | ||||||
| Phase 3 | NCT02515656 | Sep 2015 → Aug 2016 | vaginitis | Laboratoire Innotech International | Completed | No outcome recorded |
| Phase 3 | NCT00857688 | May → Jun 2011 | aphthous stomatitis | Azidus Brasil | Completed | No outcome recorded |
| Phase 3 | NCT00534391 | Sep 2007 → Dec 2008 | hordeolum | Chulalongkorn University | Unknown | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT06148025 | Nov 2023 → Oct 2027 expected | — | South Australian Health and Medical Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT04281667 | Mar 2020 → Nov 2022 overdue | necrotizing soft tissue infection, rectum adenocarcinoma | Helsinki University Central Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02652637 | Mar 2016 → Sep 2018 | — | Helsinki University Central Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02168478 | Jun 2014 | allergic disease | Noah Rosenberg, MD | Completed | No outcome recorded |
| Phase 4 | NCT00826670 | Jun 2009 → Aug 2012 | bacterial infectious disease | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 4 | NCT02444481 | Apr → Nov 2009 | vaginitis | Laboratoire Innotech International | Completed | No outcome recorded |
| Phase not applicable9 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 |
| — | NCT03593252 | Jan 2022 → Jan 2024 | Hirschsprung disease, inflammatory bowel disease, meconium ileus, necrotizing enterocolitis | McMaster University | Unknown | No outcome recorded |
| — | NCT03856671 | Jan 2019 → Dec 2022 | colorectal cancer | Third Affiliated Hospital, Sun Yat-Sen University | Completed | No outcome recorded |
| — | NCT02154061 | Apr 2015 → May 2017 | influenza | Emory University | Completed | No outcome recorded |
| — | NCT00997139 | Sep 2009 → Nov 2010 | — | Northwestern University | Completed | No outcome recorded |
| — | NCT00789971 | Mar 2007 → Mar 2008 | eye adnexa disorder | Sligo General Hospital | Completed | No outcome recorded |
| — | NCT00355602 | Jul 2006 → Dec 2008 | ulcerative colitis | University of Dundee | Completed | No outcome recorded |
| — | NCT00166868 | Dec 2003 → Jan 2012 | biliary atresia | National Taiwan University Hospital | Completed | No outcome recorded |
Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT03042091 Background | Sep 2016 → Oct 2020 | colorectal neoplasm, diverticulitis, inflammatory bowel disease | Thomas Jefferson University | Unknown | No outcome recorded |
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 0 | NCT01731236 Comparator | Feb 2011 → Dec 2027 expected | — | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT07490054 Background | Sep 2025 → Sep 2027 expected | heart failure | Melana Yuzefpolskaya, MD | Recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04729322 Background | Feb 2021 → Dec 2027 expected | colorectal adenocarcinoma, small intestine adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03476317 Background | Jul 2018 → Dec 2020 | Crohn disease | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 2 | NCT02765256 Background | Aug 2016 → Dec 2018 | Crohn disease | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT02472600 Comparator | Feb 2016 → Nov 2017 | — | Stephen Harbarth | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01227863 Background | Feb 2011 | bacterial conjunctivitis | Azidus Brasil | Unknown | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07180615 Comparator | Jun 2026 → Jan 2028 expected | — | University of Lucerne | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05593601 Comparator | Nov 2022 → Dec 2023 | — | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT05157113 Comparator | May 2022 → Jun 2026 overdue | cataract | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT03663504 Comparator | Oct 2018 → Aug 2026 overdue | — | Ottawa Hospital Research Institute | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03557008 Comparator | Jul 2018 → Jun 2022 | rabies | Emory University | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT05999955 Comparator | Dec 2022 → Apr 2023 | rhinitis, sinusitis | Huro Biotech Joint Stock Company | Completed | 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 |
| — | NCT00945334 Background | Aug 2009 → Jun 2013 | irritable bowel syndrome | Mark Pimentel, MD | Completed | No outcome recorded |
| — | NCT01097811 Comparator | Jun 2008 → Jun 2010 | cirrhosis of liver, hepatic encephalopathy, portal hypertension | UPECLIN HC FM Botucatu Unesp | Unknown | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Neomycin | “They will undergo an open label oral food challenge (OFC) to determine their threshold tolerated dose, after which they will start a week of antibiotics (Vancomycin and Neomycin).” NCT05695261 ↗39“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 ↗ “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 ↗ “Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)” NCT04281667 ↗ “Drug: Neomycin 1 gram, po, four times daily for 7 days (Other Names: Aminoglycoside)” NCT01731236 ↗ “Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate - Lab. Union Chemical” NCT01227863 ↗ “Colistin sulphate (50mg 4x/d PO) + Neomycin (250mg 4x/day PO) for 10 days” NCT00826670 ↗ “Neomycin” NCT02099240 ↗ |
| Known as | Neomycin Sulfate | “A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base),...” NCT02168478 ↗5“Bismuth sodium tartrate, neomycin sulfate, procain hydrocloride” NCT00857688 ↗ “Drug: Neomycin Sulfate” NCT07180615 ↗ |
| Known as | neomycin sulphate | “Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU” NCT02515656 ↗2“Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU” NCT05874219 ↗ “one month of topical G. Dexamethasone 0.1% with Neomycin sulphate 3500IU/g” NCT00789971 ↗ |
| Route | Oral | “Some oral antibiotics, like trimethoprim-sulfamethoxazole (TMP/SMZ) and neomycin have showed the effect to prevent against ascending cholangitis.” NCT00166868 ↗ |