Drugs / DWRX2003
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04541485 | Dec 2020 → Mar 2021 | — | Daewoong Pharmaceutical Co. LTD. | Terminated | No outcome recorded |
| Phase 1 | NCT04524052 | Aug → Dec 2020 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2020-11-30 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains approval from Australia for clinical trial of niclosamide, a treatment for COVID-19 daewoong.co.kr ↗
Hence, full-scale clinical trials will begin in November. |
| 2020-11-23 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains approval from South Korea for clinical trial of niclosamide, a treatment for COVID-19 daewoong.co.kr ↗
Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) and its subsidiary Daewoong Therapeutics (CEO Minsuk Lee) have obtained approval for phase-1 clinical trial of DWRX2003 (active ingredient: niclosamide), a treatment for COVID-19, from the Ministry of Food and Drug Safety on the 8th. |
| 2020-11-17 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s Long-Acting Niclosamide Shows High Promise Against Upcoming COVID-19 ‘Twindemic’ daewoong.co.kr ↗
While 40% of the placebo-treated subjects died, both the preventive and therapeutic treatment groups injected with DWRX2003 12 hours before or 7 days after the infection resulted in full survivability. |
| 2020-10-14 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical confirms effect of niclosamide on influenza following COVID-19 daewoong.co.kr ↗
As a result, the mortality rate was confirmed as 40% in the control group and 0% in the niclosamide group. |
| 2020-09-16 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains approval for phase 1 clinical trials of COVID-19 drug niclosamide for patients in the Philippines daewoong.co.kr ↗
Daewoong obtained approval for phase 1 clinical trials of the COVID-19 drug DWRX2003 (niclosamide) from the Food and Drug Administration (FDA) of the Philippines on the 4th. |
| 2020-09-16 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains approval for phase 1 clinical trials of COVID-19 drug Niclosamide daewoong.co.kr ↗
Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) obtained approval for phase 1 clinical trials of the drug DWRX2003 (Niclosamide) for coronavirus disease 2019 (COVID-19) from the Indian Central Drugs Standard Control Organisation (CDSCO) on the 11th. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DWRX2003 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04541485 ↗ |
| Known as | Niclosamide | “Phase I Study to Evaluate the Safety, Tolerability, Pharmacodynamics (PD) and Pharmacokinetics (PK) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular...” NCT04524052 ↗1“DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients” NCT04541485 ↗ |
| Route | Intramuscular | “Intramuscularly injection at pre-defined injection sites” NCT04524052 ↗ |