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Oncology · FDA Approved

Elagolix (Orilissa)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

Elagolix is an orally administered small-molecule, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist (PMID 28525302). While not a peptide itself, it blocks the same pituitary receptor as peptide GnRH antagonists, producing dose-dependent suppression of luteinizing hormone, follicle-stimulating hormone, and ovarian sex hormones.

It is approved for moderate to severe endometriosis pain and, in a combination product with estradiol and norethindrone acetate, for heavy menstrual bleeding associated with uterine fibroids. Its oral route distinguishes it from injectable peptide GnRH antagonists.

02 · Research summary & key findings

Elagolix (Orilissa) was FDA approved in July 2018 for moderate to severe endometriosis pain (PMID 30194661), and an elagolix, estradiol and norethindrone acetate combination (Oriahnn) was later approved for fibroid-associated heavy menstrual bleeding (PMID 33998300). In the Elaris EM-I and EM-II phase 3 trials (NEJM 2017), both doses produced significantly higher response rates than placebo for dysmenorrhea and non-menstrual pelvic pain at 3 months, with hypoestrogenic effects such as hot flushes and bone density loss (PMID 28525302). In the Elaris UF-1 and UF-2 trials, 68.5% and 76.5% of women on elagolix plus add-back therapy met the bleeding endpoint versus 8.7% and 10% on placebo (PMID 31971678).

03 · Regulatory status

Elagolix (Orilissa) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Elagolix (Orilissa) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Oral

References

  1. [1]Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist N Engl J Med, 2017. PMID 28525302
  2. [2]Elagolix: First Global Approval Drugs, 2018. PMID 30194661
  3. [3]Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids N Engl J Med, 2020. PMID 31971678
  4. [4]Oriahnn: New Drug Approved for Treating Heavy Menstrual Bleeding in Women With Uterine Fibroids Ann Pharmacother, 2022. PMID 33998300

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.