CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.
Elagolix: Orilissa
| Study Name | |||
|---|---|---|---|
| NBI-56418-0901 | Endometriosis | Phase 2 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 Na in Subjects with Endometriosis |
| NBI-56418-0703 | Endometriosis | Phase 2 | A Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects with Endometriosis |
| NBI-56418-0702 | Endometriosis | Phase 2 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects with Endometriosis |
| NBI-56418-0603 | Endometriosis | Phase 2 | A Phase II, Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects with Endometriosis |
| M12-821 | Endometriosis | Phase 3 | Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain |
| M12-667 | Endometriosis | Phase 3 | Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain |
| M12-671 | Endometriosis | Phase 3 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain |
| M12-665 | Endometriosis | Phase 3 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain |
| NBI-56418-0504 | Endometriosis | Phase 2 | A Phase II, Randomized, Double-Blind, Placebo-Controlled Twice-Daily Dosing Study of NBI-56418 in Endometriosis |
| NBI-56418-0501 | Endometriosis | Phase 2 | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis |