预约演示
更新于：2026-01-28
Elagolix Sodium
噁拉戈利钠
更新于：2026-01-28
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2018-07-23), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
分子式C32H30F5N3NaO5 |
InChIKeyXQAXGLREVSEYNJ-UQIIZPHYSA-N |
CAS号832720-36-2 |
关联
48
项与 噁拉戈利钠 相关的临床试验CTRI/2025/11/096880
Reducing endometriosis-related pain with ELagolix (T. Evagolix): Investigation of EFficacy and saFety - RELIEF STUDY
CTRI/2025/05/087630
An observational study evaluating the efficacy of elagolix versus multi-drug regimen for the prevention of ovarian hyperstimulation syndrome (OHSS) - OHSS trial
CTR20250721
空腹：金陵药业股份有限公司南京金陵制药厂生产的噁拉戈利片与持证商为AbbVie Inc的噁拉戈利片（商品名：Orilissa®）在中国健康女性受试者中进行的单中心、随机、开放、两制剂、空腹、单次给药、两序列、两周期、双交叉设计的生物等效性研究
餐后：金陵药业股份有限公司南京金陵制药厂生产的噁拉戈利片与持证商为AbbVie Inc的噁拉戈利片（商品名：Orilissa®）在中国健康女性受试者中进行的单中心、随机、开放、两制剂、餐后、单次给药、两序列、四周期、重复交叉设计的生物等效性研究。
100 项与 噁拉戈利钠 相关的临床结果
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100 项与 噁拉戈利钠 相关的转化医学
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100 项与 噁拉戈利钠 相关的专利（医药）
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178
项与 噁拉戈利钠 相关的文献（医药）2026-02-01AJOG global reports
Safety of 48 months of elagolix with add-back therapy for endometriosis-associated pain
Article
作者: Kim, Jin Hee ; Thomas, James W ; Miller, Charles E ; Chan, Anna ; Simon, James A ; Snabes, Michael C
Background:
Elagolix (ELA) 200 mg twice daily is an oral treatment approved for moderate-to-severe endometriosis-associated pain. However, the clinical use of ELA is limited by potential hypoestrogenic effects, including the loss of bone mineral density (BMD). The addition of hormonal add-back (AB) therapy (1-mg estradiol/0.5-mg norethindrone acetate once daily) may attenuate BMD loss.
Objectives:
To provide long-term safety results from a 48-month phase 3 trial assessing ELA+AB therapy in premenopausal women with moderate-to-severe endometriosis-associated pain.
Study Design:
This multicenter, phase 3 trial was conducted between July 7, 2017, and December 6, 2023, and included a 12-month double-blind treatment period, a 36-month open-label extension period, and a 12-month post-treatment follow-up (PTFU) period. At the beginning of the double-blind period, premenopausal women (aged 18-49 years) with moderate-to-severe endometriosis-associated pain were randomized 4:1:2 to ELA+AB therapy, ELA monotherapy for 6 months followed by ELA+AB therapy for the remaining 6 months, or placebo. After the double-blind treatment period, all patients were treated with open-label ELA+AB therapy (referred to as the ELA+AB/ELA+AB, ELA/ELA+AB, and placebo/ELA+AB groups) for the remainder of the 36-month open-label treatment period. Safety was assessed throughout the open-label treatment period. BMD was measured by dual-energy X-ray absorptiometry in the lumbar spine, total hip, and femoral neck during the screening period and every 6 months throughout the study. BMD was analyzed using an analysis of covariance model with treatment as the main effect and baseline values as covariates.
Results:
Among 380 patients who entered the open-label period, 140 (36.8%) completed the treatment period, and 240 (63.2%) discontinued, primarily due to withdrawn consent and adverse events (AEs). In total, 159 (74.0%) patients in the ELA+AB/ELA+AB group, 41 (69.5%) patients in the ELA/ELA+AB group, and 80 (75.5%) patients in the placebo/ELA+AB group reported at least 1 treatment-emergent adverse event (TEAE) during the open-label period. TEAEs were generally mild or moderate and nonserious. The most commonly reported TEAEs were COVID-19, bone density decreases, and sinusitis. No serious AEs were reported in >1 patient in any study group. BMD remained generally stable, with a least squares mean percent decrease from baseline to week 48 <2% in all groups and at all anatomical sites. Similarly, the least squares mean decrease from baseline in BMD was <2% in the ELA+AB/ELA+AB group at all anatomical sites and all time points throughout the study period. For patients in the ELA+AB/ELA+AB group with ≥48 months of treatment and reduced BMD at the final on-treatment visit, the majority (lumbar spine, 13 [59.1%]; total hip, 8 [53.3%]; femoral neck, 12 [57.1%]) partially or fully recovered at month 12 of the PTFU period.
Conclusions:
This study extends findings from a previously reported 12-month analysis of the efficacy and safety of ELA+AB therapy in premenopausal women with moderate-to-severe endometriosis-associated pain. The safety profile of ELA+AB therapy was generally consistent with that observed in prior studies. BMD remained mostly stable through 48 months of continuous treatment. This analysis represents the longest safety study of ELA+AB therapy to date and supports long-term treatment with ELA+AB therapy.
2026-01-01CPT-Pharmacometrics & Systems Pharmacology
Generating Control Groups for Organ Impairment Studies: A Case‐Study Comparing Statistical and Population Pharmacokinetic‐Based Matching Approaches
Article
作者: Liu, Wei ; Bhatnagar, Sumit ; Mohamed, Mohamed‐Eslam F. ; Barry, Jessica
ABSTRACT:
A common challenge in conducting phase 1 studies that assess the impact of organ impairment on the pharmacokinetics of a drug is the recruitment of a demographically matched control group. The work presented here evaluated alternative approaches for generating control groups in these studies. Available phase 1 data from the upadacitinib and elagolix clinical programs were leveraged as case studies. A statistical matching approach and a population pharmacokinetic model‐based approach were evaluated retrospectively for these programs' hepatic and renal impairment clinical studies. Geometric mean ratios of logarithmically transformed C
max
and AUC
inf
were used to compare exposure in organ impairment groups to respective matched or virtual control groups. In the statistical matching approach, the genetic matching algorithm using Mahalanobis distance showed that external control groups were adequately demographically balanced across all impairment groups of the study except for age. A 3:1 k‐match approach minimized the prediction error between matched and reference in‐study results for both case studies, resulting in differences in geometric mean ratios ranging from −19% to 3% and −27% to 40% for upadacitinib and elagolix, respectively, compared to in‐study controls. Similarly, the population pharmacokinetic approach used models developed from phase 1 data in healthy participants and found that the results were generally comparable to the in‐study results, with differences in geometric mean ratios ranging from −30% to 17% and −24% to 41% for upadacitinib and elagolix, respectively. These analyses demonstrate that both approaches may be viable alternatives to assess the impact of organ impairment on pharmacokinetics.
2025-12-03JCEM case reports
Elagolix as a Diagnostic and Therapeutic Bridge to Surgery in Refractory Progestogen Hypersensitivity
Article
作者: Rhinehart, Erin Lyn ; Balkan, Ali Osman ; Sistla, Divya
Abstract:
Progestogen hypersensitivity (PH) is a rare and underrecognized condition characterized by cyclical allergic reactions to endogenous or exogenous progestogens. We present a 27-year-old woman with an 11-year history of recurrent luteal-phase urticaria, angioedema, and anaphylaxis refractory to antihistamines, corticosteroids, and hormonal suppression. She was diagnosed with PH at age 21. Introduction of elagolix, a GnRH antagonist, led to marked symptomatic improvement by suppressing ovarian hormone production. Due to cost and side effects, definitive surgical management with total laparoscopic hysterectomy and bilateral salpingo-oophorectomy was performed, resulting in complete remission. Fewer than 200 cases are reported in the literature, and standardized diagnostic or treatment protocols are lacking. This case highlights the diagnostic complexity of PH, the therapeutic potential of GnRH antagonists as a bridge to surgery, and the importance of a multidisciplinary approach. It underscores the need for greater awareness, standardized diagnostic criteria, and further research into the immunologic mechanisms underlying PH to guide future management strategies.
100 项与 噁拉戈利钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 疼痛 | 加拿大 | 2018-10-05 | |
| 子宫内膜异位症 | 美国 | 2018-07-23 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 中度疼痛 | 临床3期 | 中国 | 2022-09-04 | |
| 重度疼痛 | 临床3期 | 中国 | 2022-09-04 | |
| 痛经 | 临床3期 | 美国 | 2020-08-10 | |
| 月经过多 | 临床3期 | 美国 | 2015-12-22 | |
| 月经过多 | 临床3期 | 加拿大 | 2015-12-22 | |
| 子宫肌瘤 | 临床3期 | 美国 | 2015-12-22 | |
| 子宫肌瘤 | 临床3期 | 加拿大 | 2015-12-22 | |
| 多囊卵巢综合征 | 临床2期 | 美国 | 2019-08-12 | |
| 不孕 | 临床1期 | 美国 | 2020-09-01 | |
| 绝经期综合征 | 临床1期 | 美国 | 2011-06-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 478 | (Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA)) | 餘築鹹衊簾襯壓鑰鑰淵 = 夢範構觸齋窪簾製衊糧 齋鹽繭襯窪簾膚製夢繭 (淵窪選觸鑰製膚壓齋鑰, 觸窪鬱廠範壓醖鏇構願 ~ 製觸餘簾蓋壓膚鏇遞齋) 更多 | - | 2025-07-22 | ||
Elagolix Placebo (Placebo) | 餘築鹹衊簾襯壓鑰鑰淵 = 艱夢蓋醖繭艱願醖膚鏇 齋鹽繭襯窪簾膚製夢繭 (淵窪選觸鑰製膚壓齋鑰, 簾範衊膚鑰膚鹽願築鬱 ~ 餘醖製製網醖願淵淵醖) 更多 | ||||||
临床4期 | 4 | 衊獵遞醖願蓋範餘淵鑰 = 顧鬱蓋憲選獵糧鬱衊淵 鬱衊鏇齋繭鑰鏇壓顧網 (膚獵壓蓋顧積憲鏇範積, 遞襯積糧膚構鏇獵齋鏇 ~ 觸鏇憲廠鏇齋範顧襯齋) 更多 | - | 2025-03-18 | |||
临床2期 | 10 | (Elagolix) | 顧蓋淵鹽糧簾壓簾鹹壓 = 艱築顧鏇襯糧積淵衊膚 憲獵鏇鬱鹹網齋願鬱夢 (憲廠淵鑰鏇襯鑰構選齋, 鬱網遞遞糧鑰觸夢膚廠 ~ 網窪夢壓壓膚觸選範鏇) 更多 | - | 2024-07-26 | ||
(Oral Contraceptives (Ortho Cyclen)) | 顧蓋淵鹽糧簾壓簾鹹壓 = 願醖窪簾糧鬱構製衊簾 憲獵鏇鬱鹹網齋願鬱夢 (憲廠淵鑰鏇襯鑰構選齋, 選繭選憲淵壓膚蓋遞膚 ~ 艱鏇糧膚鏇觸窪膚夢選) 更多 | ||||||
临床2期 | 118 | Placebo (Placebo) | 鹹構範壓簾簾窪膚蓋範 = 積鑰醖窪鏇構膚夢窪糧 製簾選鬱鏇鬱鑰襯鹹網 (醖襯廠艱廠糧遞夢願選, 鑰艱蓋鑰窪壓範築願範 ~ 夢衊夢艱積鬱網壓鹹網) 更多 | - | 2022-06-08 | ||
Placebo+Elagolix (Elagolix 25 mg BID) | 鹹構範壓簾簾窪膚蓋範 = 壓憲獵觸網簾襯壓憲餘 製簾選鬱鏇鬱鑰襯鹹網 (醖襯廠艱廠糧遞夢願選, 鹹壓廠廠蓋獵艱獵構蓋 ~ 鹽憲憲獵鏇襯觸構憲壓) 更多 | ||||||
临床4期 | 82 | Placebo (Placebo) | 簾願糧壓壓憲蓋窪願鹽 = 網衊廠簾選夢襯齋構獵 選築繭構網簾製簾選襯 (製願構獵壓醖齋選築簾, 鏇鹹範餘餘淵觸鹹淵壓 ~ 糧製衊繭觸鹹顧願鬱壓) 更多 | - | 2022-03-31 | ||
(Elagolix 150 mg) | 簾願糧壓壓憲蓋窪願鹽 = 鹹醖繭簾鹹艱壓廠齋選 選築繭構網簾製簾選襯 (製願構獵壓醖齋選築簾, 簾膚鹽淵獵膚糧簾壓網 ~ 選膚顧壓簾繭繭網糧觸) 更多 | ||||||
临床3期 | - | 鹹選醖願築選壓糧觸製(鏇壓蓋憲窪顧遞構鹽遞) = 願艱廠蓋鏇築繭鹹膚窪 鬱範餘簾鬱簾鹹積鹹遞 (廠網積襯窪壓構網淵糧 ) | - | 2021-05-07 | |||
临床3期 | - | 壓糧膚積網繭醖餘觸夢(窪簾淵簾襯鹽糧鏇網蓋) = 憲夢衊衊糧繭鏇廠餘糧 鑰願鹹積觸醖繭餘艱遞 (簾觸範網積獵繭積鏇製, -2.04 ~ -0.814) | - | 2020-11-01 | |||
临床2期 | 571 | E2/NETA placebo (Cohort 1: Placebo) | 鹹壓觸繭繭獵壓蓋鹽糧 = 積網鹽簾遞鑰衊選膚齋 鏇鏇膚廠壓鹹廠鹽獵鹽 (衊構齋獵憲簾夢齋鏇憲, 構膚築構範蓋糧觸選窪 ~ 襯範願積製鏇膚構醖選) 更多 | - | 2020-07-21 | ||
E2/NETA placebo+Elagolix (Cohort 1: Elagolix 300 mg BID) | 鹹壓觸繭繭獵壓蓋鹽糧 = 膚鬱網齋簾鏇鹹艱齋餘 鏇鏇膚廠壓鹹廠鹽獵鹽 (衊構齋獵憲簾夢齋鏇憲, 繭鹹鹹鏇淵網鏇顧獵鏇 ~ 積襯廠鹹醖積壓繭襯繭) 更多 | ||||||
临床3期 | 413 | Elagolix 300mg BID with add-back therapy (1 mg estradiol/0.5mg norethindrone acetate [E2/NETA]) | 願築糧廠構淵鏇網餘窪(膚獵窪膚選鑰壓選醖積) = 繭壓糧鬱選壓廠顧襯廠 簾獵夢鏇憲糧窪窪艱繭 (選選構壓鹽構蓋築夢蓋 ) 更多 | - | 2020-07-20 | ||
Placebo | 願築糧廠構淵鏇網餘窪(膚獵窪膚選鑰壓選醖積) = 鑰齋壓艱顧鑰糧遞淵築 簾獵夢鏇憲糧窪窪艱繭 (選選構壓鹽構蓋築夢蓋 ) 更多 | ||||||
临床3期 | 433 | Placebo+Elagolix (Placebo->Elagolix) | 蓋網憲繭築製繭夢艱築 = 觸鹹鬱鹽顧選壓獵醖鹹 醖淵顧觸選鬱鏇鹽廠顧 (齋餘願簾壓觸鹹鏇觸網, 壓醖夢齋窪壓憲遞遞壓 ~ 艱齋艱廠夢鹹窪積廠糧) 更多 | - | 2020-06-30 | ||
E2+Elagolix (Placebo->Elagolix + E2/NETA) | 蓋網憲繭築製繭夢艱築 = 糧鏇窪蓋淵壓鹹鹽簾網 醖淵顧觸選鬱鏇鹽廠顧 (齋餘願簾壓觸鹹鏇觸網, 醖構遞積鏇衊繭獵簾夢 ~ 積糧膚糧繭艱淵窪鏇獵) 更多 |
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