Drugs / Lysozyme
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | Neuzym | periodontitis, aggressive | 2011-12-21 | “submitted an application for partial change to the approved label for egg white lysozyme preparation Neuzym® to Japan's Ministry of Health” eisai.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT05519254 | Mar 2023 → Jul 2026 overdue | diarrheal disease, protein-energy malnutrition | University of Washington | Recruiting | No outcome recorded |
| Phase 3 | NCT03282045 | Oct 2016 → May 2018 | pharyngitis | Bosnalijek D.D | Completed | No outcome recorded |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT01715493 | Oct 2012 → Dec 2013 | asthma, chronic obstructive pulmonary disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01645800 | Aug 2012 → Jan 2015 | chronic obstructive pulmonary disease | Eisai Inc. | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT06106880 Comparator | May 2022 → Apr 2023 | Achoo syndrome, common cold, headache disorder, pharyngitis +1 | Applied Biological Laboratories Inc | Completed | No outcome recorded |
| Phase 3 | NCT05342272 Comparator | Sep 2017 → Jan 2018 | — | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2016-03-17 | Eisai Inc. | Regulatory NOTICE REGARDING DISCONTINUATION OF SALES AND VOLUNTARY RECALL OF EGG WHITE LYSOZYME PREPARATION NEUZYM® eisai.com ↗
As such, sales of the product have been discontinued, and a voluntary recall is being conducted as of today. |
| 2015-12-11 | Eisai Inc. | Regulatory MHLW APPROVES PARTIAL LABEL CHANGE FOR EGG-WHITE LYSOZYME PREPARATION NEUZYM® eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its partial label change application to remove chronic sinusitis as an approved indication for egg-white lysozyme preparation Neuzym® (lysozyme hydrochloride, “lysozyme”) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW). |
| 2015-05-29 | Eisai Inc. | Regulatory EISAI SUBMITS APPLICATIONS FOR REEVALUATION OF EFFICACY AND PARTIAL CHANGE TO LABEL OF EGG WHITE LYSOZYME PREPARATION NEUZYM® BASED ON RESULTS OF REEVALUATION STUDIES eisai.com ↗
At the same time, Sannova has also submitted an application for a partial label change to remove chronic sinusitis as an approved indication for Neuzym. |
| 2012-01-20 | Eisai Inc. | Regulatory MHLW APPROVES PARTIAL LABEL CHANGE FOR EGG WHITE LYSOZYME PREPARATION NEUZYM®, DESIGNATES DRUG FOR REEVALUATION eisai.com ↗
Additionally, the drug was designated for reevaluation for other indications not subject to removal. |
| 2011-12-21 | Eisai Inc. | Regulatory EISAI SUBMITS APPLICATION FOR PARTIAL CHANGE TO LABEL OF EGG WHITE LYSOZYME PREPARATION NEUZYM® eisai.com ↗ |
All press releases naming this drug 5 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lysozyme | “one press of the spray pump release 0.20 mL of the solution containing 4 mg lysozyme, 0.3 mg cetylpyridine and 0.1 mg lidocaine hydrochloride.” NCT03282045 ↗5“The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.” NCT06106880 ↗ |
| Route | Other | “The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.” NCT06106880 ↗ |