Elagolix: Orilissa

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.

{m} Entries

Phase
Study Indication or Disease
Study Name
NBI-56418-0901 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 Endometriosis Phase 2 A Phase II, Randomized, Double-Blind, Placebo-Controlled Twice-Daily Dosing Study of NBI-56418 in Endometriosis
NBI-56418-0501 AbbVie_IU_icons_outlined_v3 Endometriosis Phase 2 A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis