INDV-6001 (3-MONTH LONG-ACTING INJECTABLE BUPRENORPHINE)
October 11, 2023: acquisition of the exclusive global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.’s portfolio of long-acting injectable formulations of buprenorphine, which includes its lead 3-month injectable candidate ALA-1000 (now INDV-6001).
Key milestones 2024:
▪ Ongoing technical transfer
▪ Optimization of Drug Substance and Drug Product manufacturing to support clinical Phase 3 studies
▪ Initiation of multiple dose PK study to support clinical Phase 3 studies
▪ Initiation of Developmental and Reproductive Toxicology (DART) studies
中譯如下:
2024 主要里程碑為:
1.繼續執行技術轉移
2.優化原料藥與成品的製造用以支持臨床三期試驗
3.啟動多劑量藥物動力學試驗用以支持臨床三期試驗
4.啟動生殖與發育毒試驗(DART)
更多訊息請參閱 : https://www.indivior.com/resources/dam/id/1326/FY%202023%20Financial%20Results%20-%20Presentation.pdf