Drugs / Nystatin
Nystatin
also known as
Mycostatin · Barstatin 100 · Candex · Infestat · Korostatin · L-nystatin · mikostatin · Multilind · +19 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MYCOSTATIN | — | 1964-07-08 | fda.gov ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02142543 | Mar → Dec 2012 | aphthous stomatitis | Texas A&M University | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT04550546 | May 2021 → Feb 2022 | dental caries | University of Rochester | Completed | No outcome recorded |
| Phase 1 | NCT00002097 | — | HIV infectious disease | Argus Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00002313 | — | HIV infectious disease | Argus Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06875791 | Dec 2025 → Dec 2026 expected | head and neck squamous cell carcinoma, mucositis | Fundacion Clinica Valle del Lili | Not yet recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03862079 | Jun 2020 → Dec 2021 | graft versus host disease | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04532060 | Feb → May 2015 | nosocomial infection | São Paulo State University | Completed | No outcome recorded |
| Phase 2 | NCT01198223 | Jul → Sep 2010 | denture stomatitis | Qazvin University Of Medical Sciences | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01798537 | Jun 2013 → Jul 2015 | bacterial infectious disease with sepsis | Rambam Health Care Campus | Unknown | No outcome recorded |
| Phase 38 trials · 1 missed | ||||||
| Phase 3 | NCT02389036 | May 2017 → Apr 2023 | critical illness polyneuropathy, infectious disease with sepsis | The George Institute | Completed | No outcome recorded |
| Phase 3 | NCT02515656 | Sep 2015 → Aug 2016 | vaginitis | Laboratoire Innotech International | Completed | No outcome recorded |
| Phase 3 | NCT02208154 | Dec 2013 → Oct 2017 | bacterial infectious disease with sepsis | MJM Bonten | Completed | Missed primary |
| Phase 3 | NCT00814359 | May 2009 → Sep 2010 | head and neck cancer, mucositis | Juravinski Cancer Centre Foundation | Completed | No outcome recorded |
| Phase 3 | NCT01867164 | Dec 2007 → Dec 2008 | infective vaginitis | Janssen-Cilag, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT00128323 | Nov 2002 → Apr 2005 | oral candidiasis | Kamuzu University of Health Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00001812 | Apr 1999 → Aug 2000 | digestive system disorder, oral candidiasis, stomatitis | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00002742 | Jan 1996 → Sep 2007 | infectious disease, leukemia, myelodysplastic syndrome, myeloproliferative neoplasm +1 | Aronex Pharmaceuticals | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03390374 | Oct 2010 → Nov 2012 | systemic mycosis | Dr Cipto Mangunkusumo General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02642900 | Jul 2009 → Feb 2011 | phototoxic dermatitis | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT02444481 | Apr → Nov 2009 | vaginitis | Laboratoire Innotech International | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT01718912 | Nov 2013 → Sep 2014 | periodontal disorder | Oravital Inc | Completed | No outcome recorded |
| — | NCT00002057 | — | HIV infectious disease, oral candidiasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| — | NCT00002112 | — | HIV infectious disease, oral candidiasis | Pfizer | Completed | No outcome recorded |
| — | NCT00002293 | — | HIV infectious disease, oral candidiasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| — | NCT00001998 | — | HIV infectious disease | Argus Pharmaceuticals | Completed | No outcome recorded |
| Comparator or background therapy20 trials | ||||||
| Phase 1 | NCT06616168 Background | Sep 2023 → Aug 2026 overdue | bacterial vaginosis | Danylo Halytsky Lviv National Medical University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03178149 Background | Jul 2018 → Dec 2027 expected | age-related macular degeneration | Astellas Institute for Regenerative Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT03399331 Background | Jul 2017 → Dec 2021 | chemotherapy-induced oral mucositis, leukemia | American University of Beirut Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00078559 Background | Nov 2003 → Feb 2010 | kidney disorder | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 2 | NCT07694024 Comparator | Jan → May 2016 | denture stomatitis, oral candidiasis | Kerman University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT07793331 Comparator | Jan → Dec 2016 | denture stomatitis, oral candidiasis | Kerman University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00845819 Comparator | Feb 2009 → Oct 2014 | chemotherapy-induced oral mucositis | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT00674999 Comparator | Jun 2005 → Sep 2008 | — | The University of Texas Medical Branch, Galveston | Withdrawn | No outcome recorded |
| Phase 3 | NCT06356311 Background | May 2024 → Jan 2027 expected | gastroesophageal cancer | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04837664 Comparator | Jul 2018 → Dec 2020 | candidiasis | King Saud University | Unknown | No outcome recorded |
| Phase 3 | NCT02186145 Background | Jan 2016 → Jan 2017 | bacterial vaginosis | Marjan Industria e Comercio ltda | Unknown | No outcome recorded |
| Phase 3 | NCT01427738 Comparator | Jun 2011 → Sep 2012 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 3 | NCT01699412 Background | Aug 2008 → Jul 2012 | graft versus host disease, mouth disorder | Grupo de Estudos Multicentricos em Onco-Hematologia | Completed | No outcome recorded |
| Phase 4 | NCT02662374 Background | Sep 2015 → Apr 2016 | chemotherapy-induced oral mucositis | Riyadh Colleges of Dentistry and Pharmacy | Unknown | No outcome recorded |
| Phase 4 | NCT01531192 Comparator | Jun 2012 → Apr 2013 | — | Zekai Tahir Burak Women's Health Research and Education Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01411748 Comparator | Jul → Dec 2011 | neonatal candidiasis | Zekai Tahir Burak Women's Health Research and Education Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01495039 Comparator | Nov 2008 → Aug 2009 | candidiasis | Policlinico Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00634166 Background | Sep 2007 → Dec 2013 | — | Mylan Inc. | Terminated | No outcome recorded |
| — | NCT01743690 Background | Mar 2012 → Dec 2015 | candidiasis, lichen planus, oral | University of Copenhagen | Completed | No outcome recorded |
Evidence & citations 29 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nystatin | “Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine...” NCT05894954 ↗41“'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin;...” NCT00634166 ↗ “One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night,...” NCT01867164 ↗ “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 ↗ “This arm will receive a Triple Mixture oral rinse (combination of 0.19% w/w Lidocaine, 0.29% w/w Nystatin, and 5.50% w/v Hydroxides).” NCT06875791 ↗ “Additionally, participants may receive mucoadhesive hydrogel and oral nystatin suspension or other topical antifungal agents.” NCT06356311 ↗ “SOD consists of application of a paste containing colistin, tobramycin in a 2% concentration and nystatin 1 x 10\^5 units.” NCT02208154 ↗ “Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU” NCT02515656 ↗ “powder included dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum” NCT02142543 ↗ “Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days” NCT01699412 ↗ “magic mouthwash (diphenhydramine, dexamethasone and nystatin) plus sucralfate” NCT00814359 ↗ |
| Known as | Barstatin 100 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Candex | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Infestat | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Korostatin | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | L-nystatin | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | mikostatin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01411748 ↗ |
| Known as | Multilind | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Mycostatin | “Control at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile...” NCT03399331 ↗2“All study participants will receive treatment for oral candidiasis using nystatin suspension (Brand name: Mycostatin), and be instructed to rinse the mouth with (6ml of 600,000...” NCT04550546 ↗ |
| Known as | Mykinac | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nilstat | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nistatina | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | NSC-150817 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nysert | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nyspes | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystaform | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystan triple pack | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystatin component of mycolog | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystatin component of mykacet | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystatin component of mytrex f | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystatin component of nystaform | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystatine | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystatinum | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystavescent | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystex | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Nystop | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Terrastatin | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Known as | Tinaderm m | ChEMBL registry synonym — accepted as the source's own label CHEMBL5465559 ↗ |
| Route | Oral | “nystatin swish and swallow immediately before initiation of IL-2” NCT00001812 ↗ |