MedPath

Elagolix

Generic Name
Elagolix
Brand Names
Oriahnn 28 Day Kit, Orilissa
Drug Type
Small Molecule
Chemical Formula
C32H30F5N3O5
CAS Number
834153-87-6
Unique Ingredient Identifier
5B2546MB5Z

Overview

Elagolix has been used in trials studying the basic science and treatment of Endometriosis, Folliculogenesis, Uterine Fibroids, Heavy Uterine Bleeding, and Heavy Menstrual Bleeding. As of 24 July 2018, however, the U.S. Food and Drug Administration (FDA) approved AbbVie's elagolix under the brand name Orilissa as the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain . It has been determined that endometriosis is one of the most common gynecologic disorders in the United States . In particular, estimates suggest that one in ten women of reproductive age is affected by endometriosis and experience debilitating pain symptoms . Moreover, women who are affected by this condition can suffer for up to six to ten years and visit multiple physicians before receiving a proper diagnosis . Subsequently, as Orilissa (elagolix) was approved by the FDA under priority review , this expedited new approval gives healthcare professionals another valuable option for treating the potentially unmet needs of women who are affected by endometriosis, depending on their specific type and severity of endometriosis pain.

Indication

用于治疗子宫内膜异位症并伴有中度至重度疼痛。

Associated Conditions

  • Heavy Menstrual Bleeding
  • Moderate to severe pain

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/04/19
Phase 3
Recruiting
2024/02/12
Phase 4
Completed
2023/10/10
Phase 3
Recruiting
Nanjing Chia-tai Tianqing Pharmaceutical
2022/12/13
Phase 3
Recruiting
2021/09/09
Phase 4
Terminated
2021/04/23
N/A
Active, not recruiting
Medstar Health Research Institute
2020/11/03
Phase 2
Terminated
2020/06/24
Early Phase 1
Completed
2020/04/03
Phase 3
Recruiting
2019/11/21
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AbbVie Inc.
0074-0038
ORAL
150 mg in 1 1
6/8/2023
AbbVie Inc.
0074-0039
ORAL
200 mg in 1 1
6/8/2023

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

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Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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