Drugs / E1
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | neuropathy, painful | 2020-05-26 | “submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the novel drug candidate (NRD135S.E1)” novaremed.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT00239187 | Sep 2005 → Jan 2007 | type 2 diabetes mellitus | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00239148 | Jun 2005 → Dec 2006 | type 1 diabetes mellitus | OPKO Health, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2020-12-22 | Novaremed Ltd. | Regulatory Novaremed receives Fast Track Designation from the FDA for NRD135S.E1 for treatment of Painful Diabetic Peripheral Neuropathy novaremed.com ↗
Novaremed AG (Novaremed), a clinical-stage Swiss biopharmaceutical company, announced today that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the development of NRD135S.E1 for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN). |
| 2020-07-01 | Novaremed Ltd. | Regulatory NOVAREMED announces US FDA Approval of IND Application novaremed.com ↗
Novaremed Announces U.S. FDA Approval of IND Application to Initiate Phase 2 Clinical Study of NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy |
| 2020-05-26 | Novaremed Ltd. | Regulatory Novaremed announces IND submission novaremed.com ↗
Novaremed Announces IND Submitted to U.S. FDA for Phase 2 Study of NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-12-22 | Novaremed Ltd. | Novaremed receives Fast Track Designation from the FDA for NRD135S.E1 for treatment of Painful Diabetic Peripheral Neuropathy novaremed.com ↗ |
| 2020-07-01 | Novaremed Ltd. | NOVAREMED announces US FDA Approval of IND Application novaremed.com ↗ |
| 2020-05-26 | Novaremed Ltd. | Novaremed announces IND submission novaremed.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | E1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00239187 ↗ |
| Route | Subcutaneous | “once daily subcutaneous injections of E1 plus G1, as separate injections” NCT00239148 ↗ |