Drugs / Miconazole
Miconazole
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed oral candidiasis 1 milestone | |||||
| Filed | Japan (PMDA) | — | oral candidiasis | 2017-02-28 | “has submittted a New Drug Application for the marketing in Japan of SO-1105 (miconazole 50 mg, muco-adhesive tablet) for the treatment of oropharyngeal candidiasis yesterday.” nxera.life ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | MONISTAT | — | 1978-10-04 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02185456 | Sep 2014 → Jan 2016 | bacterial vaginosis | Wayne State University | Unknown | No outcome recorded |
| Phase 14 trials · 1 missed | ||||||
| Phase 1 | NCT06072716 | Jan → Jul 2023 | oral candidiasis | Yasmine gamil | Completed | Missed primary |
| Phase 1 | NCT02545452 | Sep 2015 → Mar 2016 | endometriosis | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02215395 | Mar 2014 → Apr 2015 | — | Population Council | Completed | No outcome recorded |
| Phase 1 | NCT00004575 | Feb 2000 → Oct 2001 | — | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04813822 | Sep 2021 → May 2022 | vulvovaginal candidiasis | Aesculape CRO Belgium BV | Unknown | No outcome recorded |
| Phase 2 | NCT04341402 | May 2020 → Mar 2021 | tinea unguium | William N Handelman | Unknown | No outcome recorded |
| Phase 2 | NCT04308161 | Nov 2019 → Oct 2020 | mouth disorder | Hams Hamed Abdelrahman | Unknown | No outcome recorded |
| Phase 2 | NCT01361048 | Dec 2011 → Aug 2012 | Trichomonas vaginitis urogenital infection | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04432376 | Jul 2020 → Nov 2021 | otomycosis | Hill Dermaceuticals, Inc. | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT00390780 | Jul 2006 → Dec 2007 | HIV infectious disease | Valerio Therapeutics | Completed | Missed primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT05916729 | May 2021 → Dec 2024 | oral candidiasis | University of Belgrade | Unknown | No outcome recorded |
| Phase 4 | NCT01661556 | Oct 2011 → Feb 2015 | hyperpigmentation of the skin | Autonomous University of San Luis Potosí | Unknown | No outcome recorded |
| Phase 4 | NCT01769339 | Jan → Jun 2009 | vulvovaginal candidiasis | Janssen Pharmaceutica | Completed | No outcome recorded |
| Phase 4 | NCT00194324 | Jul → Oct 2004 | vulvovaginal candidiasis | University of Pennsylvania | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00668538 | Apr → Aug 2008 | — | University of Southern Denmark | Completed | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT01731574 Comparator | Dec 2012 → Oct 2013 | HIV infectious disease | International Partnership for Microbicides, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06214273 Comparator | Apr → Jul 2024 | chemotherapy-induced oral mucositis | Cairo University | Unknown | No outcome recorded |
| Phase 2 | NCT04317183 Background | May 2019 → Mar 2020 | chemotherapy-induced oral mucositis | Hams Hamed Abdelrahman | Unknown | No outcome recorded |
| Phase 2 | NCT03130738 Comparator | Apr 2017 → Aug 2019 | otomycosis | Hill Dermaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05660382 Comparator | Mar 2023 → Dec 2024 | otomycosis | Hill Dermaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02818803 Comparator | Jan → Jun 2016 | denture stomatitis, oral candidiasis | University of Sao Paulo | Completed | No outcome recorded |
| Phase 3 | NCT02515656 Comparator | Sep 2015 → Aug 2016 | vaginitis | Laboratoire Innotech International | Completed | No outcome recorded |
| Phase 3 | NCT00741845 Comparator | Jun 2008 → Jun 2009 | bacterial vaginosis | Embil Pharmaceutical Co. Ltd | Terminated | No outcome recorded |
| — | NCT07813923 Comparator | Oct 2026 → Feb 2027 expected | head and neck cancer, mucositis | Alexandria University | Not yet recruiting | No outcome recorded |
| — | NCT04442633 Background | Apr → Aug 2019 | lichen planus | Hams Hamed Abdelrahman | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-09-25 | Nxera Pharma UK Limited | Regulatory Sosei Announces Approval of ORAVI Mucoadhesive Tablets 50mg for Oropharyngeal Candidiasis in Japan nxera.life ↗ |
| 2017-02-28 | Nxera Pharma UK Limited | Regulatory Sosei announces submission of marketing authorization application of SO-1105 for oropharyngeal candidiasis nxera.life ↗
Sosei announces submission of marketing authorization application of SO-1105 for oropharyngeal candidiasis |
| 2016-08-29 | Nxera Pharma UK Limited | Results Sosei announces completion of Japanese Phase III clinical study of SO-1105 for oropharyngeal candidiasis and achievement of principal endpoints nxera.life ↗
The cure rate after the completion of the targeted study medication period with SO-1105 was the same as the comparator in terms of the primary endpoint. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-09-25 | Nxera Pharma UK Limited | Sosei Announces Approval of ORAVI Mucoadhesive Tablets 50mg for Oropharyngeal Candidiasis in Japan nxera.life ↗ |
| 2017-02-28 | Nxera Pharma UK Limited | Sosei announces submission of marketing authorization application of SO-1105 for oropharyngeal candidiasis nxera.life ↗ |
| 2016-08-29 | Nxera Pharma UK Limited | Sosei announces completion of Japanese Phase III clinical study of SO-1105 for oropharyngeal candidiasis and achievement of principal endpoints nxera.life ↗ |
| 2014-01-23 | Valerio Therapeutics | FDA grants Validive® (clonidine Lauriad®) with a Fast Track Designation for the prevention and treatment of oral mucositis induced by anticancer treatments valeriotx.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | miconazole | “Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules...” NCT02515656 ↗25“Concurrent administration of vaginal antimycotic medication (Miconazole Nitrate) on the pharmacokinetics of Nestorone (NES) and ethinyl estradiol (EE) delivered by a...” NCT02215395 ↗ “Conventional supportive treatment consisting of miconazole oral gel, anti-inflammatory mouthwash, sodium bicarbonate mouthwash, BBC oral spray, Oracure gel, and systemic...” NCT07813923 ↗ “This study aimed to evaluate the therapeutic effects of topical application of miconazole and miconazole-loaded chitosan nanoparticles in treatment of diabetic patients with...” PMID 38321454 ↗ Feb 2024 “The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.” NCT01361048 ↗ “Daily Application antifungal gel of miconazole 3% and diclofenac sodium 1% and urea 40% to infected nails.” NCT04341402 ↗ “400 mg miconazole nitrate per day for 3 consecutive days” NCT02545452 ↗ “intravaginal metronidazole 750mg + 200mg miconazole” NCT00741845 ↗ |
| Known as | Brentan | “Brentan (miconazole)” NCT00668538 ↗ |
| Known as | drug: miconazole | “drug: miconazole” NCT04341402 ↗ |
| Known as | GYNODAKTARIN | “Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules...” NCT02515656 ↗1“comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%).” NCT04813822 ↗ |
| Known as | Lauriad | “The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14...” NCT00390780 ↗ |
| Known as | miconazole nitrate | “Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules...” NCT02515656 ↗1“Miconazole Nitrate 2% + Domiphen Bromide Low Dose” NCT04813822 ↗ |
| Action | Inhibit | “Miconazole stops production of EDHF” NCT00004575 ↗ |
| Modality | Small molecule | “an imidazole antifungal agent” NCT03130738 ↗ |
| Route | Other | “Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be given through the arterial catheter” NCT00004575 ↗ |