nystatin
Trade name: mycostatin
Approved
Jul 8, 1964
Nystatin, sold under the brand name Mycostatin among others, is an antifungal medication. It is used to treat Candida infections of the skin including diaper rash, thrush, esophageal candidiasis, and vaginal yeast infections. It may also be used to prevent candidiasis in those who are at high risk. Nystatin may be used by mouth, in the vagina, or applied to the skin. — Wikipedia
Clinical trial activity
41 trials · 62 clinical orgs · 65 marketing orgs
Earliest trial started Jan 1, 1996 (NCT00002742)
Timeline
1960s
1970s
- Apr 14, 1971
Glenmark Pharmaceuticals — NDA Secondary Org
- Apr 14, 1971
Chartwell Pharmaceuticals — NDA Secondary Org
- Sep 30, 1974
Holland Rantos — Marketing Organization
- May 25, 1976
Cosette — Marketing Organization
- May 25, 1976
G & W Laboratories Inc. — Marketing Organization
- May 25, 1976
ACP Nimble — Marketing Organization
- Feb 1, 1979
Fougera — Marketing Organization
- Dec 11, 1979
Perrigo — Marketing Organization
- Dec 11, 1979
Padagis Us — Marketing Organization
1980s
- Feb 11, 1980
Watson Pharmaceuticals — Marketing Organization
- Jul 28, 1983
Taro Pharmaceuticals — Marketing Organization
- Dec 22, 1983
DAVA Pharmaceuticals — NDA Secondary Org
- Dec 22, 1983
Heritage Pharma — Marketing Organization
- Dec 22, 1983
Strides Pharma Science — NDA Secondary Org
- Jan 16, 1984
Teva — Marketing Organization
- Jul 6, 1984
Savage Labs — Marketing Organization
- Oct 29, 1984
Wockhardt — Marketing Organization
- Jan 16, 1985
Pharmafair — Marketing Organization
- May 15, 1985
Mylan — Marketing Organization
- Oct 17, 1985
Odyssey Pharmaceuticals — Marketing Organization
- Nov 26, 1985
Paddock Laboratories — Marketing Organization
- Nov 26, 1985
Chartwell Pharmaceuticals — Marketing Organization
- Nov 13, 1987
Actavis — Marketing Organization
- Dec 22, 1988
Sun Pharmaceuticals — Marketing Organization
1990s
- Dec 27, 1991
Socorro Pharmaceuticals — Marketing Organization
- Dec 27, 1991
Nivagen Pharmaceuticals Inc. — Marketing Organization
- Dec 27, 1991
DASTECH INTL — Marketing Organization
- Sep 11, 1992
Sandoz — Marketing Organization
- Feb 28, 1994
Hi Tech Pharmaceuticals — Marketing Organization
- Jan 1, 1996
Earliest Phase 3 Sponsor(trial)
- Jun 25, 1998
VistaPharm, Inc. — Marketing Organization
- Jan 1, 1999
Earliest Phase 1 Sponsor(trial)
2000s
- Jul 15, 2004
Mayne Pharma — Marketing Organization
- Jul 23, 2004
Lupin — Marketing Organization
- Dec 17, 2004
X Gen Pharmaceuticals — Marketing Organization
- Dec 17, 2004
BEOWULF ASSET — Marketing Organization
- Jan 1, 2005
Earliest Phase 2 Sponsor(trial)
- May 3, 2005
Upsher-Smith Laboratories — Marketing Organization
- Jun 28, 2005
Lannett Company, Inc. — Marketing Organization
- Jun 28, 2005
Genus Oncology, LLC — Marketing Organization
- May 31, 2006
Vintage — Marketing Organization
- Aug 18, 2006
Nesher Pharms — Marketing Organization
2010s
- Jan 7, 2016
Pharmaceutical Associates — Marketing Organization
- Jun 23, 2016
Glenmark Pharmaceuticals — Marketing Organization
- Oct 26, 2016
Dr. Reddy's Laboratories — Marketing Organization
- Dec 29, 2016
Rising Pharmaceuticals — Marketing Organization
- Dec 29, 2016
ANDA Repository — Marketing Organization
- Dec 30, 2016
Teligent Pharmaceuticals — Marketing Organization
- May 30, 2017
Lyne Laboratories — Marketing Organization
- Aug 4, 2017
Akorn, Inc. — Marketing Organization
- Sep 26, 2017
Crown Laboratories, Inc. — Marketing Organization
- Jan 29, 2018
Strides Pharma Science — Marketing Organization
- Feb 15, 2018
Amneal Pharmaceuticals — Marketing Organization
- Apr 30, 2018
Epic Pharma Llc — Marketing Organization
- May 25, 2018
Zydus Discovery DMCC — Marketing Organization
- May 25, 2018
Cadila Healthcare — Marketing Organization
- Jan 28, 2019
Torrent Pharmaceuticals Limited — Marketing Organization
- Nov 18, 2019
Vitruvias Therapeutics — Marketing Organization
2020s
- Jan 14, 2021
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Jan 14, 2021
Neogen — Marketing Organization
- Mar 31, 2021
Alembic — Marketing Organization
- Mar 10, 2022
Leading Pharma Llc — Marketing Organization
Indications
Approved for
Studied for
- Anastomotic Leak · Phase 2
- Bacteremia · Phase 2/Phase 3
- Bacterial Infections · Phase 3
- Breast Neoplasms · Phase 2
- Burns · Phase 4
- Candidiasis · Phase 4
- Candidiasis, Oral · Phase 3
- Cigarette Smoking · Phase 3
- Critical Illness · Phase 4
- Cross Infection · Phase 2
- Dental Caries · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Gastrointestinal Diseases · Phase 3
- General Surgery · Phase 4
- Graft vs Host Disease · Phase 2
- HIV Infections · Phase 3
- Infections · Phase 3
- Kidney Diseases · Phase 1/Phase 2
- Kidney Failure, Chronic · Phase 4
- Kidney Transplantation · Phase 1/Phase 2
- Leukemia · Phase 3
- Live Birth · Phase 4
- Lymphoma · Phase 3
- Multiple Myeloma · Phase 3
- Mycoses · Phase 4
- Mycosis Fungoides · Phase 4
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 3
- Pneumonia, Ventilator-Associated · Phase 3
- Sepsis · Phase 3
- Shock, Septic · Phase 3
- Stomatitis · Phase 4
- Stomatitis, Aphthous · Early Phase 1
- Stomatitis, Denture · Phase 2
- Vagina · Phase 3
- Vaginitis · Phase 4
- Vaginosis, Bacterial · Phase 3
Mechanism of action
- ErgosterolDISRUPTING AGENT
Ergosterol disrupting agent
Combination products
mycolog-ii
with triamcinolone
Also known as myco-triacet ii, mykacet, mytrex f
nystaform
with clioquinol
Approval history
- approvedJul 8, 1964
Chemistry & pharmacology
SMILES
C[C@@H]1OC(=O)C[C@H](O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@]2(O)C[C@H](O)[C@H]([C@H](C[C@@H](O[C@H]3O[C@@H](C)[C@H](O)[C@@H](N)[C@H]3O)\C=C\C=C\C=C\C=C\CC\C=C\C=C\[C@H](C)[C@@H](O)[C@H]1C)O2)C(=O)O- Mol. weight
- 926.11 g/mol
- Lipinski Ro5
- 3 violation(s)
- Rule of 3
- No
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaNystatin ↗
- NCATSBDF1O1C72E ↗
- ChEMBLCHEMBL229383 ↗
Also known as
- barstatin 100
- barstatin 100
- candex
- candex
- candex
- infestat
- infestat
- korostatin
- korostatin
- multilind
- myco 20
- mycostatin
- mycostatin
- mycostatin
- mykinac
- mykinac
- nilstat
- nilstat
- nistatina
- nistatina
- nys
- nys
- nysert
- nysert
- nyspes
- nystaform
- nystaform
- nystan triple pack
- nystatin
- nystatin
- nystatin
- nystatin
- nystatin
- nystatin
- nystatin
- nystatin
- nystatin
- nystatin a1
- nystatin a1
- nystatin a1
- nystatin a1
- nystatin a1
- nystatin a1
- nystatine
- nystatine
- nystatine
- nystatinum
- nystatinum
- nystavescent
- nystavescent
- nystex
- nystex
- nystop
- nystop
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06616168 | Phase 1 | Sep 1, 2023 | Lviv National Medical University |
| NCT04909437 | N/A | May 19, 2021 | Medical Network M. Woynarowski, J. Kierkuś Spółka jawna (MED-NET), Nature Science Sp. z o.o. |
| NCT04839653 | N/A | May 1, 2021 | Medsi Clinic #1, Moscow, MEDSI Clinical Hospital 1, ICU |
| NCT04550546 | Phase 1 | Nov 1, 2020 | University of Rochester |
| NCT03862079 | Phase 2 | May 21, 2019 | National Cancer Institute (NCI), University of Texas at Houston |
| NCT04837664 | Phase 3 | Jul 3, 2018 | King Saud University |
| NCT02389036 | Phase 3 | Mar 1, 2017 | Medical Research Institute of New Zealand, University of New South Wales, University of Toronto |
| NCT02186145 | Phase 3 | Jan 1, 2016 | Marjan Industria e Comercio ltda |
| NCT02662374 | Phase 4 | Sep 1, 2015 | King Faisal Specialist Hospital, Riyadh Colleges of Dentistry and Pharmacy |
| NCT02515656 | Phase 3 | Sep 1, 2015 | Fournier Labs, International Clinical Trials Association, Laboratoire Innotech International, Venn Life Sciences |
| NCT04532060 | Phase 2 | Feb 1, 2015 | São Paulo Research Foundation (FAPESP), Sao Paulo State University |
| NCT02229136 | Phase 2 | Sep 4, 2014 | Novartis, US Oncology |
| NCT02208154 | Phase 3 | Dec 1, 2013 | Paris 12 Val de Marne University, UMC Utrecht, UPEC Paris, Utrecht University |
| NCT01718912 | N/A | Nov 1, 2013 | Oravital Inc |
| NCT01798537 | Phase 2/Phase 3 (Phase 3) | Jun 1, 2013 | Technion University |
| NCT01531192 | Phase 4 | Jun 1, 2012 | Zekai Tahir Burak Hospital |
| NCT02142543 | Early Phase 1 (Phase 1) | Mar 1, 2012 | Texas A&M University |
| NCT01743690 | N/A | Mar 1, 2012 | University of Copenhagen |
| NCT01411748 | Phase 4 | Jul 1, 2011 | Zekai Tahir Burak Hospital |
| NCT01427738 | Phase 3 | Jun 1, 2011 | AIDS Clinical Trials Group, Case Western Reserve University, Eastman Dental Hospital, Joint Clinical Research Centre, Kampala, Uganda, National AIDS Research Institute, Pune, National Institute of Allergy and Infectious Diseases (NIAID), Parirenyatwa Hospital |
Organizations
Research & Development (62)
Marketing (90)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | May 25, 1976 |
| ANDA Repository | For profit | MKTG | Dec 29, 2016 |
| Actavis | For profit | MKTG | Nov 13, 1987 |
| Akorn, Inc. | For profit | MKTG | Aug 4, 2017 |
| Alembic | For profit | MKTG | Mar 31, 2021 |
| Alembic | For profit | SYN | Mar 31, 2021 |
| Alpharma | For profit | MKTG | — |
| Amneal Pharmaceuticals | For profit | MKTG | Feb 15, 2018 |
| Amneal Pharmaceuticals | For profit | SYN | Feb 15, 2018 |
| BARLAN | For profit | MKTG | — |
| BEOWULF ASSET | For profit | MKTG | Dec 17, 2004 |
| Bayer | For profit | NDA2 | — |
| Bayer | For profit | MKTG | — |
| Cadila Healthcare | For profit | MKTG | May 25, 2018 |
| Chartwell Pharmaceuticals | For profit | MKTG | Nov 26, 1985 |
| Chartwell Pharmaceuticals | For profit | SYN | Apr 14, 1971 |
| Chartwell Pharmaceuticals | For profit | NDA2 | Apr 14, 1971 |
| Cosette | For profit | MKTG | May 25, 1976 |
| Crown Laboratories, Inc. | For profit | MKTG | Sep 26, 2017 |
| DASTECH INTL | For profit | MKTG | Dec 27, 1991 |
| DAVA Pharmaceuticals | For profit | NDA2 | Dec 22, 1983 |
| Dr. Reddy's Laboratories | For profit | MKTG | Oct 26, 2016 |
| Dr. Reddy's Laboratories | For profit | SYN | Oct 26, 2016 |
| Dr. Reddy's Laboratories | For profit | SYN | Jul 15, 2004 |
| Epic Pharma Llc | For profit | MKTG | Apr 30, 2018 |
| Fougera | For profit | MKTG | Feb 1, 1979 |
| Fougera | For profit | SYN | Jun 7, 1984 |
| G & W Laboratories Inc. | For profit | MKTG | May 25, 1976 |
| Genus Oncology, LLC | For profit | MKTG | Jun 28, 2005 |
| Glenmark Pharmaceuticals | For profit | NDA2 | Apr 14, 1971 |
| Glenmark Pharmaceuticals | For profit | MKTG | Jun 23, 2016 |
| Heritage Pharma | For profit | MKTG | Dec 22, 1983 |
| Heritage Pharma | For profit | SYN | Dec 22, 1983 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Feb 28, 1994 |
| Holland Rantos | For profit | MKTG | Sep 30, 1974 |
| Lannett Company, Inc. | For profit | MKTG | Jun 28, 2005 |
| Leading Pharma Llc | For profit | MKTG | Mar 10, 2022 |
| Lederle | For profit | MKTG | — |
| Lupin | For profit | MKTG | Jul 23, 2004 |
| Lupin | For profit | SYN | May 31, 2018 |
| Lyne Laboratories | For profit | MKTG | May 30, 2017 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Jan 14, 2021 |
| Mayne Pharma | For profit | MKTG | Jul 15, 2004 |
| Morton Grove Pharmaceuticals | For profit | MKTG | — |
| Mylan | For profit | MKTG | May 15, 1985 |
| Mylan | For profit | SYN | May 15, 1985 |
| Mylan | For profit | SYN | Dec 27, 1991 |
| Neogen | For profit | MKTG | Jan 14, 2021 |
| Nesher Pharms | For profit | MKTG | Aug 18, 2006 |
| Nivagen Pharmaceuticals Inc. | For profit | MKTG | Dec 27, 1991 |
| Odyssey Pharmaceuticals | For profit | MKTG | Oct 17, 1985 |
| Padagis Us | For profit | MKTG | Dec 20, 2016 |
| Padagis Us | For profit | MKTG | Dec 11, 1979 |
| Paddock Laboratories | For profit | MKTG | Nov 26, 1985 |
| Perrigo | For profit | MKTG | Dec 11, 1979 |
| Perrigo | For profit | SYN | Dec 20, 2016 |
| Pharmaceutical Associates | For profit | MKTG | Jan 7, 2016 |
| Pharmaceutical Associates | For profit | SYN | Dec 30, 2016 |
| Pharmaderm | For profit | MKTG | — |
| Pharmafair | For profit | MKTG | Jan 16, 1985 |
| Quantum Pharmaceutical | For profit | MKTG | — |
| Rising Pharmaceuticals | For profit | MKTG | Dec 29, 2016 |
| Rising Pharmaceuticals | For profit | SYN | Dec 29, 2016 |
| Sandoz | For profit | MKTG | Sep 11, 1992 |
| Savage Labs | For profit | MKTG | Jul 6, 1984 |
| Socorro Pharmaceuticals | For profit | MKTG | Dec 27, 1991 |
| Strides Pharma Science | For profit | MKTG | Jan 29, 2018 |
| Strides Pharma Science | For profit | NDA2 | Dec 22, 1983 |
| Sun Pharmaceuticals | For profit | MKTG | Dec 22, 1988 |
| Taro Pharmaceuticals | For profit | MKTG | Jul 28, 1983 |
| Taro Pharmaceuticals | For profit | SYN | Feb 29, 1988 |
| Teligent Pharmaceuticals | For profit | MKTG | Dec 30, 2016 |
| Teligent Pharmaceuticals | For profit | SYN | Dec 30, 2016 |
| Teva | For profit | MKTG | Jan 16, 1984 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Jan 28, 2019 |
| Upsher-Smith Laboratories | For profit | MKTG | May 3, 2005 |
| Upsher-Smith Laboratories | For profit | SYN | Nov 26, 1985 |
| Vintage | For profit | MKTG | May 31, 2006 |
| VistaPharm, Inc. | For profit | MKTG | Jun 25, 1998 |
| Vitruvias Therapeutics | For profit | MKTG | Nov 18, 2019 |
| Warner Chilcott | For profit | NDA2 | — |
| Watson Pharmaceuticals | For profit | MKTG | Feb 11, 1980 |
| Wockhardt | For profit | MKTG | Oct 29, 1984 |
| X Gen Pharmaceuticals | For profit | MKTG | Dec 17, 2004 |
| X Gen Pharmaceuticals | For profit | SYN | Dec 17, 2004 |
| Zydus Discovery DMCC | For profit | MKTG | May 25, 2018 |
| Zydus Discovery DMCC | For profit | SYN | Nov 8, 2018 |
| delcor | For profit | NDA2 | Jul 8, 1964 |
| delcor | For profit | NDA | Jul 8, 1964 |
| delcor | For profit | MKTG | Jul 8, 1964 |