Drugs / MOSEDIPIMOD
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02700360 | Aug → Oct 2015 | neutropenia | Enzychem Lifesciences Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02496143 | Jul → Dec 2015 | neutropenia | Enzychem Lifesciences Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02532712 | Mar → Dec 2015 | neutropenia | Enzychem Lifesciences Corporation | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03104595 | Oct 2017 → Nov 2019 | neutropenia | Enzychem Lifesciences Corporation | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT06487000 | May 2025 → Oct 2026 expected | atopic eczema | Enzychem Lifesciences Corporation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04569227 | Apr → Sep 2021 | pneumonia | Enzychem Lifesciences Corporation | Unknown | No outcome recorded |
| Phase 2 | NCT04500132 | May 2020 → Feb 2021 | COVID-19 | Enzychem Lifesciences Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03200340 | Jul 2018 → May 2021 | stomatitis | Enzychem Lifesciences Corporation | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2022-03-09 | Enzychem Lifesciences Corporation | Results Enzychem Lifesciences Announces Completion of Clinical Study Report (CSR) for Phase 2 Study of EC-18 in Chemoradiation-Induced Oral Mucositis enzychem.com ↗
The primary efficacy endpoint demonstrated that the median duration of SOM (defined as WHO Grades 3 or 4) from baseline through short-term follow-up period (STFU) was 0.0 days in the EC-18 group versus 13.5 days in the placebo group (100% reduction). |
| 2021-11-08 | Enzychem Lifesciences Corporation | Regulatory Enzychem Files for FDA Breakthrough Therapy Designation for EC-18 for the Treatment of Chemoradiation-Induced Oral Mucositis enzychem.com ↗
Enzychem Lifesciences (KOSDAQ: 183490), a late-stage biotechnology company, announced today that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of its lead investigational candidate in chemoradiation-induced oral mucositis (CRIOM). |
| 2021-10-20 | Enzychem Lifesciences Corporation | Results Enzychem Lifesciences Announces Positive Results for Phase 2 U.S. Study of EC-18 in Chemoradiation-Induced Oral Mucositis enzychem.com ↗ |
| 2021-02-08 | Enzychem Lifesciences Corporation | Results Enzychem Lifesciences Announces Poster Presentation At AACR Virtual Annual Meeting 2021 enzychem.com ↗ |
| 2020-10-02 | Enzychem Lifesciences Corporation | Results ENZYCHEM LIFESCIENCES SELECTED TO PRESENT AT 2020 RADIATION RESEARCH SOCIETY ANNUAL MEETING enzychem.com ↗
Mice administered with the highest dose of EC-18 showed about a 50% increase in survival compared to the control group. |
| 2020-08-13 | Enzychem Lifesciences Corporation | Regulatory ENZYCHEM LIFESCIENCES ANNOUNCES FDA ACCEPTANCE OF PHASE 2 STUDY OF EC-18 IN PREVENTING ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) DUE TO COVID-19 PNEUMONIA enzychem.com ↗
Enzychem Lifesciences (KOSDAQ: 183490) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate its lead therapeutic candidate EC-18, in a Phase 2 clinical trial in patients with Acute Respiratory Disease Syndrome (ARDS) due to COVID-19 pneumonia. |
| 2020-07-14 | Enzychem Lifesciences Corporation | Regulatory ENZYCHEM LIFESCIENCES FILES IND APPLICATION TO FDA FOR PHASE 2 STUDY OF EC-18 IN PREVENTING ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) DUE TO COVID-19 PNEUMONIA enzychem.com ↗
Enzychem Lifesciences (KOSDAQ: 183490) today announced that it has filed an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of EC-18 as a preventative therapeutic against Acute Respiratory Disease Syndrome (ARDS) due to COVID-19 pneumonia. |
| 2020-05-14 | Enzychem Lifesciences Corporation | Regulatory ENZYCHEM LIFESCIENCES INITIATES PHASE 2 STUDY FOR EC-18 IN PREVENTING ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) DUE TO NOVEL CORONAVIRUS PNEUMONIA enzychem.com ↗
today announced that the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration), has accepted its Investigational New Drug (IND) application to initiate a Phase 2 study for its lead therapeutic candidate, EC-18 |
| 2020-05-01 | Enzychem Lifesciences Corporation | Results ENZYCHEM LIFESCIENCES ANNOUNCES PUBLICATION OF PRECLINICAL STUDY OF EC-18 IN GOUTY ARTHRITIS IN FRONTIERS IN IMMUNOLOGY enzychem.com ↗
The publication reports results from a study, examining a mitigating effect of PLAG on gouty inflammation, one of the sterile inflammations caused by MSU crystal, a substance thought to be DAMP (Damage-associated molecular pattern). |
| 2019-11-21 | Enzychem Lifesciences Corporation | Results ENZYCHEM LIFESCIENCES PRESENTS EC-18 NASH DEVELOPMENT UPDATE AT THE LIVER MEETING 2019 enzychem.com ↗
Enzychem Lifesciences Corporation (KOSDAQ: 183490), highlighted promising nonclinical data from its NASH candidate EC-18 at The Liver Meeting 2019, hosted annually by the American Association for the Study of Liver Diseases (AASLD). |
| 2018-01-22 | Enzychem Lifesciences Corporation | Regulatory ORPHAN DRUG DESIGNATION GRANTED TO POTENTIAL ACUTE RADIATION SYNDROME TREATMENT enzychem.com ↗
Enzychem Lifesciences has announced that EC-18, a potential therapy for Acute Radiation Syndrome (ARS), has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). |
| 2018-01-19 | Enzychem Lifesciences Corporation | Regulatory ENZYCHEM LIFESCIENCES ANNOUNCES THE FDA ORPHAN DRUG DESIGNATION GRANTED TO EC-18 ON ACUTE RADIATION SYNDROME (ARS) enzychem.com ↗ |
| 2017-12-27 | Enzychem Lifesciences Corporation | Regulatory ENZYCHEM GRANTED ORPHAN DRUG DESIGNATION FOR NEUTROPENIA TREATMENT enzychem.com ↗
Enzychem Lifesciences said on Dec. 27 that the US Food and Drug Administration has granted orphan drug designation for EC-18, which is being developed as a treatment for patients with acute radiation syndrome. |
All press releases naming this drug 24 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MOSEDIPIMOD | ChEMBL registry synonym — accepted as the source's own label CHEMBL157366 ↗ |
| Known as | EC-18 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06487000 ↗ |
| Modality | Small molecule | — CHEMBL157366 ↗ |
| Route | Oral | “by oral administration” NCT02496143 ↗ |