Drugs / TV-46000
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03893825 | Apr 2019 → Dec 2021 | schizophrenia | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03503318 | Apr 2018 → Sep 2020 | schizophrenia | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-04-19 | MedinCell S.A | Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM medincell.com ↗ |
| 2022-04-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM tevapharm.com ↗ |
| 2021-10-30 | Teva Branded Pharmaceutical Products R&D, Inc. | New Phase 3 Data Presented at Psych Congress 2021 Showed TV-46000/mdc-IRM Significantly Prolonged Time to Impending Relapse Compared to Placebo in Patients with Schizophrenia tevapharm.com ↗ |
| 2021-08-31 | MedinCell S.A | Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia medincell.com ↗ |
| 2021-08-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia tevapharm.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 | TV-46000 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03503318 ↗ |
| Route | Subcutaneous | “TV-46000 administered subcutaneously (SC)” NCT03503318 ↗ |