Elagolix

(Orilissa®)

Orilissa®

Drug updated on 10/29/2024

Dosage FormTablet (oral; 150 mg, 200 mg)
Drug ClassGonadotropin-releasing hormone (GnRH) receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the management of moderate to severe pain associated with endometriosis.

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Summary
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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Elagolix 400 mg demonstrated effectiveness in reducing pelvic pain, dysmenorrhea, dyspareunia, and non-menstrual pelvic pain in premenopausal women with moderate to severe endometriosis-associated pain, with no significant differences in effectiveness among different population types or subgroups noted in the studies.
  • When compared to other treatments, Elagolix 400 mg was found to be comparable to ASP1707 15 mg for reducing pelvic pain and dysmenorrhea but less effective than relugolix 40 mg for dysmenorrhea. Other treatments, such as dienogest and GnRH analogues, ranked higher for pelvic pain reduction at 3 and 6 months, respectively.
  • Elagolix 400 mg had a lower incidence of treatment-emergent adverse events (TEAEs) compared to relugolix 40 mg, but it was still associated with significant adverse events, including hot flush and headache, particularly at higher doses. Elagolix 250 mg was linked to significantly decreased spinal bone mineral density (BMD).
  • There was a significant incidence of ovarian hypoestrogenic effects associated with both GnRH analogues and elagolix, expressed in a dose-dependent manner.
  • There is no population types or subgroups information available in the reviewed studies.