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elagolix

Generic: ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM·Brand: ORIAHNN (COPACKAGED), ORILISSA, Orilissa

elagolix: sourced relationships with 1 company · 2 clinical trials tracked · 2 FDA decisions.

elagolix evidence translation

What we can confirm

2 FDA records · 2 tracked trials

What it means

Source-backed records connect elagolix to ABBV; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could elagolix → ABBV affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Endometriosis

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
AbbVie Inc. (ABBV)
Reported 2018-07-23 · Current development: unknownSource
Approved
Clinical Trial Registry Records (2)

A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain

NCT04333576Registry updated 2026-06-12·Phase 3·ABBV
Active, not recruiting

Primary endpoint: Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale

InterventionalRandomizedquadruple800 targetStarted 2020-08Completion 2027-0750 sites · United StatesAbbVie

A Phase 1, Open-Label Study of the Effects of Elagolix on Ovarian Activity, Ovulation and Ovarian Reserve in Premenopausal Females

NCT01403038Registry updated 2013-01-08·Phase 1
Completed

Primary endpoint: Ovulation Classification

InterventionalRandomizedopen216 enrolledStarted 2011-06Completion 2012-1122 sites · Puerto Rico, United StatesAbbVie (prior sponsor, Abbott)
FDA Decisions2 records
Approval(ABBV)FDA ↗
NDA213388Type 4 - New CombinationStandardOralCapsule
Approval(ABBV)FDA ↗
NDA210450Type 1 - New Molecular EntityPriorityOralTablet

Frequently asked questions

Which companies have sourced relationships with elagolix?

elagolix has dated SEC/FDA relationship records for AbbVie Inc..

How many clinical trials involve elagolix?

BioSniper tracks 2 clinical trials involving elagolix.

What is elagolix's latest FDA decision?

The most recent tracked FDA decision for elagolix is Approval, dated May 29, 2020.