Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)

Women undergoing IVF/ICSI who are candidates for a GnRH-antagonist protocol are randomly assigned 1:1 to oral linzagolix or the standard injectable GnRH antagonist (ganirelix or cetrorelix). A third, non-randomized group of women with a clinical indication for progestin-primed ovarian stimulation (PPOS) - for example, a need for a freeze-all strategy - is enrolled concurrently as a comparator cohort. The randomized comparison (linzagolix vs. injectable antagonist) is the primary, non-inferiority analysis; the PPOS cohort provides an exploratory, non-randomized comparison, analyzed with adjustment for baseline differences.

Start Date01 Sep 2026

Sponsor / Collaborator

Centro A.M.B.R.A. - Associazione Medici e Biologi per la Riproduzione Assistita

NCT07698561

/ Not yet recruitingNot Applicable

Efficacy of Linzagolix 200 mg for 3 to 6 Months Prior to Embryo Transfer in Patients With Adenomyosis and Recurrent Implantation Failure: A Prospective Case Series

Adenomyosis is associated with impaired endometrial receptivity and reduced implantation rates in assisted reproduction, even when using high-quality embryos. Linzagolix (Yselty, 200 mg) is an oral GnRH receptor antagonist approved for uterine fibroids with a favourable tolerability profile and rapid elimination half-life (18-20 hours) compared to GnRH agonists.
This prospective case series evaluates the efficacy of linzagolix 200 mg administered for 3 to 6 months prior to embryo transfer in patients with confirmed adenomyosis and recurrent implantation failure (RIF), defined as ≥2 failed transfers with high-quality blastocysts (≥BB Gardner in oocyte donation, or PGT-A confirmed euploid in autologous cycles).
The primary endpoint is the live birth rate (LBR) per embryo transfer. Secondary endpoints include clinical pregnancy rate, miscarriage rate, morphological response of adenomyosis (uterine volume and junctional zone [JZ] thickness assessed by standardised transvaginal ultrasound), and tolerability profile. The study also explores the optimal treatment duration (3 vs 6 months) as a sub-analysis based on morphological response at the month-3 visit.
The study is conducted at three centres of Vida Fertility Institute (Madrid, Alicante and San Sebastián, Spain). Sample size: n=35 patients. Study duration: 24 months.

Start Date01 Sep 2026

Sponsor / Collaborator

Vida Fertility Institute SL

100 Clinical Results associated with Linzagolix choline

100 Translational Medicine associated with Linzagolix choline

100 Patents (Medical) associated with Linzagolix choline

Literatures (Medical) associated with Linzagolix choline

01 Oct 2026·Journal of Minimally Invasive Gynecology

Oral Gonadotropin-Releasing Hormone Antagonists for the Treatment of Endometriosis-Associated Pain: A Systematic Review and Meta-Analysis

Review

Author: Farrow, Monique ; Denny, Kathryn ; Hsu, Richard ; Han, Esther S ; Pacis, Michelle ; Swartz, Sarah

STUDY OBJECTIVE:

To evaluate the efficacy of oral gonadotropin-releasing hormone (GnRH) antagonists vs placebo for treatment of endometriosis-associated pain and to compare individual antagonists indirectly for dysmenorrhea and non-menstrual pelvic pain.

DESIGN:

Systematic review and meta-analysis of phase 3 randomized, double-blind, placebo-controlled trials of oral GnRH antagonists in people with moderate-to-severe endometriosis-associated pain, with dual screening, standardized data extraction, and risk of bias assessment using the Cochrane Risk of Bias 2 tool.

SETTING:

Multicenter phase 3 clinical trials conducted in outpatient gynecology and reproductive health settings across North America, Europe, and other international sites, identified through electronic databases and trial registries from inception through October 2025.

PATIENTS:

A total of 2060 participants with surgically or imaging-diagnosed endometriosis and moderate-to-severe baseline pain, with mean ages of 31 to 35 years, enrolled in five phase 3 trials (ELARIS, SPIRIT 1 and 2, and EDELWEISS-3).

INTERVENTIONS:

The included trials evaluated three oral GnRH antagonist regimens: elagolix 200 mg twice daily without add‑back, relugolix 40 mg once daily combination therapy, and linzagolix 200 mg once daily with add-back. Add-back and combination therapy were defined as co‑administration of estradiol 1 mg and norethindrone acetate 0.5 mg once daily. Each regimen was compared with a matching placebo for treatment durations up to 24 weeks.

MEASUREMENTS AND MAIN RESULTS:

Primary outcomes were binary responder rates for dysmenorrhea and non-menstrual pelvic pain, defined by prespecified reductions in daily pain scores with stable or reduced analgesic use. Fixed-effects meta-analysis with inverse-variance weighting yielded a pooled risk ratio of 3.06 (95% CI, 2.76-3.39; p <.001) and a number needed to treat (NNT) of 2 (95% CI, 2-3) for dysmenorrhea responders, and a pooled risk ratio of 1.53 (95% CI, 1.40-1.67; p <.001) and NNT of 5 (95% CI, 4-7) for non-menstrual pelvic pain responders, with no statistical heterogeneity (I² = 0%) for either outcome. Drug-level pooled risk ratios for dysmenorrhea were 3.49 (95% CI, 2.93-4.16) for elagolix 200 mg twice daily, 3.11 (95% CI, 2.32-4.17) for linzagolix 200 mg with add-back, and 2.61 (95% CI, 2.22-3.07) for relugolix combination therapy; corresponding pooled risk ratios for non-menstrual pelvic pain were 1.54 (95% CI, 1.31-1.80), 1.52 (95% CI, 1.15-2.01), and 1.52 (95% CI, 1.32-1.74), respectively. Bucher-adjusted indirect comparisons did not show robust differences in efficacy between agents for either pain domain, although elagolix was associated with a statistically significant higher dysmenorrhea response than relugolix combination therapy (risk ratio, 1.34; 95% CI, 1.05-1.70; p = .017).

CONCLUSION:

Oral GnRH antagonists provide consistent, significant, and clinically meaningful reductions in dysmenorrhea and non-menstrual pelvic pain compared with placebo, with low heterogeneity across trials and similar efficacy among elagolix, relugolix combination therapy, and linzagolix with add-back, supporting their use as effective second-line therapy for endometriosis-associated pain.

01 Sep 2026·HUMAN REPRODUCTION

Linzagolix versus leuprorelin in Japanese women with uterine leiomyomas: a phase 3, randomized, active-controlled, non-inferiority trial

Article

Author: Urabe, Mamoru ; Arakane, Futoshi ; Nishikawa, Akira ; Yamanaka, Akiyoshi ; Sawada, Mari ; Tanabe, Akiko ; Yoshida, Shohei ; Hirai, Kozo ; Oki, Akinori ; Hashimoto, Masaki ; Iwasaki, Shinya ; Umayahara, Kenji ; Uchida, Rikako ; Yoshioka, Masuo ; Kamiya, Takayuki ; Shimamura, Fumiya ; Kitanaka, Takashi ; Kawai, Asuka ; Hatta, Mariko ; Nagai, Ryuji ; Utsugisawa, Yukari ; Yasuda, Teruko ; Nojima, Shunji ; Teramoto, Mizue ; Sano, Masatoshi ; Hanashi, Hideki ; Tei, Chisei ; Sumi, Yukari ; Hayakawa, Jun ; Kashiwazaki, Yuji ; Maruyama, Masanori ; Osuga, Yutaka ; Oku, Hisato ; Yukawa, Sumie ; Nishiguchi, Sonoe ; Harada, Tasuku ; Tsushima, Ruriko ; Hosoi, Nobuyuki ; Takahashi, Hideomi ; Kitada, Fuminori ; Fukuhara, Masao ; Hasegawa, Akitoshi

Abstract:

STUDY QUESTION:

How does the efficacy of linzagolix (a gonadotropin-releasing hormone [GnRH] receptor antagonist) compare with leuprorelin (a GnRH agonist) for the treatment of heavy menstrual bleeding (HMB) in patients with uterine leiomyomas?

SUMMARY ANSWER:

Reductions in menstrual bleeding with linzagolix were rapidly achieved, non-inferior to leuprorelin at Weeks 6–12, and maintained over 24 weeks of treatment.

WHAT IS KNOWN ALREADY:

GnRH agonists are commonly used to manage the symptoms of uterine leiomyomas; however, they are also associated with bone mineral density (BMD) loss, an initial worsening of symptoms (flare-up effect), and delayed pituitary recovery after treatment cessation. Linzagolix is a GnRH receptor antagonist that may overcome the limitations of GnRH agonists, though comparative safety and efficacy have not yet been evaluated.

STUDY DESIGN, SIZE, DURATION:

This was a phase 3, active-controlled, multicentre, randomized, double-blind, parallel-group, non-inferiority study, conducted in Japan between October 2022 and August 2024. In total, 287 patients were randomized 1:1 to oral linzagolix 200 mg once daily (plus leuprorelin placebo; n = 143) or subcutaneous leuprorelin 1.88 mg every 4 weeks (plus linzagolix placebo; n = 144) for 24 weeks. Patients were randomized using an interactive web response system, stratified by the presence of pain symptoms.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Eligible patients were premenopausal women (aged ≥20 years) with uterine leiomyomas and HMB. Key assessments throughout the treatment period included menstrual bleeding (measured using the Pictorial Blood Loss Assessment Chart [PBAC]), pain (measured using a numeric rating scale), blood haemoglobin, myoma and uterine volumes (measured by transvaginal ultrasound), patient-reported symptom severity and quality of life, plasma oestradiol, adverse events (AEs), and BMD. At the end of treatment, patients entered a follow-up period of up to 24 weeks, during which plasma oestradiol, BMD, and menstrual recovery were assessed. The primary endpoint was the proportion of patients with a total PBAC score <10 from Weeks 6 to 12 of the treatment period (non-inferiority margin, −15%).

MAIN RESULTS AND THE ROLE OF CHANCE:

From Weeks 6 to 12, the proportion of patients with a total PBAC score <10 was 89.9% (95% CI, 83.7, 94.4) in the linzagolix group, which was non-inferior to 90.8% (84.7, 95.0) in the leuprorelin group (difference, −0.9% [−8.6, 6.9]). Reductions in menstrual bleeding were rapidly achieved with linzagolix; median time to a total PBAC score <10 was significantly shorter in the linzagolix group versus leuprorelin (6.0 vs 20.0 days; P = 0.023). Improvements in pain, haemoglobin, myoma/uterine volumes, and patient-reported outcomes were comparable between groups over 24 weeks, with earlier reductions in pain and myoma/uterine volumes observed in the linzagolix group. Mean plasma oestradiol levels were rapidly reduced to <20 pg/ml by Week 2 in the linzagolix group (without the flare-up effect seen in the leuprorelin group) and were maintained through Week 24. The incidence of AEs was comparable between the linzagolix and leuprorelin groups (97.2% and 96.5%, respectively). The most common AE was hot flush in the linzagolix group (53.8%) and breakthrough bleeding in the leuprorelin group (55.6%), and the incidence of these events was highest during the first 28 days of treatment. Following the end of study treatment, mean plasma oestradiol levels tended to recover earlier in the linzagolix group versus leuprorelin, which coincided with earlier recovery of hot flush AEs, reductions in BMD, and menstruation.

LIMITATIONS, REASONS FOR CAUTION:

Further studies are warranted to compare linzagolix with other GnRH receptor antagonists, and to evaluate the longer-term safety and efficacy of linzagolix, with or without hormonal add-back therapy, in Japanese women with uterine leiomyomas and HMB.

WIDER IMPLICATIONS OF THE FINDINGS:

This phase 3 study met its primary endpoint, and demonstrated the 24-week efficacy, safety, and pharmacodynamic effects of linzagolix in Japanese women with symptomatic uterine leiomyomas. While linzagolix offered comparable efficacy to leuprorelin over 24 weeks of treatment, its earlier onset of action may make linzagolix a favourable treatment option. In particular, rapid reductions in myoma and uterine volumes suggest that linzagolix may be a useful preoperative treatment. Moreover, earlier recovery of oestradiol levels and menstruation following linzagolix may be an important consideration for women planning pregnancy after treatment. Overall, these findings support the use of linzagolix over 24 weeks for the signs and symptoms of uterine leiomyomas.

STUDY FUNDING/COMPETING INTEREST(S):

Funding for the study and third-party medical writing support was provided by Kissei Pharmaceutical Co., Ltd. The study sponsor participated in the design of the study; the collection, analysis, and interpretation of data; and the development of the manuscript. Y.O. and T.H. report medical writing and clinical trial advisory fees from Kissei Pharmaceutical Co., Ltd. H.T. reports patent applications with Kissei Pharmaceutical Co., Ltd. H.T., A.K., and F.S. are employees of Kissei Pharmaceutical Co., Ltd.

TRIAL REGISTRATION NUMBER:

NCT05440383.

TRIAL REGISTRATION DATE:

27 June 2022.

DATE OF FIRST PATIENT’S ENROLMENT:

11 October 2022.

24 Jul 2026·EXPERT OPINION ON PHARMACOTHERAPY

GnRH antagonists for the treatment of fibroids and adenomyosis, current evidence and future perspectives

Review

Author: Ottonello, Silvia ; Vellone, Valerio Gaetano ; Perrone, Umberto ; Barra, Fabio ; Gazzo, Irene ; Rosato, Francesco Paolo ; Ferrero, Simone ; Olcese, Francesca

INTRODUCTION:

Uterine fibroids and adenomyosis are common estrogen- and progesterone-dependent disorders associated with heavy menstrual bleeding, pelvic pain, anemia, and impaired quality of life. Although surgery remains widely used, there is an increasing demand for effective uterus-preserving medical therapies. Oral gonadotropin-releasing hormone (GnRH) antagonists have recently emerged as a novel therapeutic option, allowing rapid, reversible, and dose-dependent suppression of ovarian steroidogenesis.

AREAS COVERED:

This narrative, based on a targeted PubMed/MEDLINE literature search and review of major guideline documents published up to May 2026, summarizes the pharmacological properties, mechanisms of action, and clinical evidence regarding GnRH antagonists (elagolix, relugolix and linzagolix) in uterine fibroids and adenomyosis. Evidence from randomized controlled, extension studies, and emerging literature was critically reviewed, focusing on control of heavy menstrual bleeding, pain reduction, quality of life, safety, and the role of add-back therapy.

EXPERT OPINION:

GnRH antagonists represent a major advance in the medical treatment of uterine fibroids and are highly effective in controlling heavy menstrual bleeding. Their role in adenomyosis appears promising, although evidence remains limited. These agents should currently be considered suppressive rather than curative therapies, as symptoms often recur after discontinuation. Long-term integration into individualized treatment strategies will require further safety and comparative effectiveness data.

News (Medical) associated with Linzagolix choline

24 Mar 2026

·allsci.com

Insilico partners with ASKA Pharma on AI-driven target discovery for gynecological diseases

Insilico Medicine and ASKA Pharmaceutical have entered a research collaboration to identify novel therapeutic targets for gynecological conditions including endometriosis, uterine fibroids, and adenomyosis. Cambridge, Massachusetts-based Insilico Medicine (HKEX: 3696), a clinical-stage company using generative AI for drug discovery, will deploy its PandaOmics target identification engine to generate and prioritize candidate targets. Tokyo-based ASKA Pharmaceutical, which focuses on internal medicine, obstetrics, and gynecology, will validate the AI-predicted targets for translational potential. The deal expands an existing relationship in which ASKA has been a user of Insilico’s AI software. Financial terms of the collaboration were not disclosed. The press release does not specify upfront payments, milestone structures, royalties, or equity components. The absence of disclosed economics is consistent with early-stage research collaborations where the primary deliverable is target nomination rather than compound development or clinical advancement. The collaboration operates at the earliest stage of drug discovery: target identification and validation. No specific drug candidate has been named. Insilico will use PandaOmics, its AI-driven biological data analysis platform, which integrates multi-modal omics data and biomedical text mining to generate disease hypotheses and rank candidate targets. The company recently introduced TargetPro, a framework within PandaOmics that builds disease-specific models to predict which targets are most likely to advance into clinical development. ASKA will then apply its gynecological disease expertise to experimentally validate the computationally nominated targets. The three indications covered by the deal represent areas with limited mechanistic diversity in approved therapies. Endometriosis affects approximately 190 million women globally according to World Health Organization estimates. Uterine fibroids and adenomyosis affect larger populations and frequently co-occur. Current pharmacological options include GnRH-based therapies, particularly in endometriosis and uterine fibroids, including AbbVie’s elagolix (Orilissa) and the Myovant Sciences/Pfizer relugolix combination (Myfembree). There is no US FDA-approved drug specifically indicated for adenomyosis; management typically relies on off-label hormonal therapy, symptom control, procedures, or surgery depending on severity and fertility goals. • Elagolix (Orilissa) — AbbVie — marketed for endometriosis pain; AbbVie’s elagolix-containing combination product Oriahnn is marketed for heavy menstrual bleeding associated with uterine fibroids. • Relugolix combination (Myfembree) — Myovant/Pfizer — marketed for endometriosis and uterine fibroids • Linzagolix (Yselty) — Gedeon Richter — marketed in the EU for uterine fibroids and symptomatic endometriosis Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Drug Approval

07 Oct 2025

·www.prnewswire.com

Apotex Strengthens Commitment to Women's Health with Exclusive Canadian Rights to "Linzagolix" for Uterine Fibroid Treatment

TORONTO, Oct. 7, 2025 /PRNewswire/ - Searchlight Pharma Inc.("Searchlight"), Apotex Inc's ("Apotex") Branded Medicines Division today announced it has entered into a strategic licensing agreement securing exclusive Canadian rights to linzagolix, a once-daily oral treatment developed by Kissei Pharmaceutical Co., Ltd. Linzagolix belongs to a class of medicines called GnRH antagonists. Under the agreement, Searchlight will lead efforts to pursue marketing authorization for linzagolix in Canada, following regulatory approval. "Securing the Canadian rights to linzagolix is a meaningful step in our strategy to expand access to innovative therapies," said Allan Oberman, President and CEO, Apotex. "By adding this treatment to our portfolio, we continue to build on our commitment to addressing areas of significant need and supporting the well-being of patients." "Our strategic focus is on delivering high-quality, novel therapies that meet the evolving needs of Canadian patients and complement our existing women's health portfolio," said Mark Nawacki, President, Searchlight Pharma. "Linzagolix represents a meaningful advancement in the treatment of uterine fibroids, offering a potential new option for women across the country. We're pleased to introduce this treatment option as part of our Journey of Health growth strategy and our ongoing commitment to improving patient outcomes and expanding access to innovative therapies." Uterine fibroids affect up to 70% of Canadian women by age 50, with an estimated 1.4 to 3.5 million experiencing symptoms that can adversely impact their quality of life.1 The introduction of linzagolix offers a much-needed treatment option for those affected, reinforcing Apotex's commitment to improving access to care in areas of high unmet need. About "Linzagolix" Linzagolix was launched in Europe under the brand name Yselty®. It is indicated for adult women of reproductive age for the treatment of moderate to severe symptoms of uterine fibroids, and for the symptomatic treatment of endometriosis in women with a history of prior medical or surgical treatment. Yselty contains the active substance linzagolix choline. Linzagolix works by lowering estrogen and progesterone levels, which helps reduce the size of uterine fibroids and relieve symptoms. It is indicated for adult women of reproductive age experiencing moderate to severe symptoms of uterine fibroids.2 About Apotex Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at About Kissei Pharmaceutical Co., Ltd. Kissei Pharmaceutical Co., Ltd., founded in 1946 and headquartered in Matsumoto, Japan, is a research-driven pharmaceutical company listed on the Tokyo Stock Exchange. Kissei specializes in the development and commercialization of innovative therapies in key areas including urology, dialysis, women's health, ophthalmology, endocrinology, and metabolism. In addition to pharmaceuticals, the company provides therapeutic and care foods, as well as services such as healthcare information and construction. Kissei maintains a global presence, including an overseas subsidiary in New Jersey, USA. SOURCE Apotex Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug Approval

02 May 2025

·pmlive.com

NHS patients to access Theramex’s endometriosis pill following NICE recommendation

NHS patients will soon be able to access Theramex’s once-a-day endometriosis pill Yselty (linzagolix), following final draft guidance from the National Institute for Health and Care Excellence (NICE). The health technology assessment agency has recommended the at-home treatment be used to manage endometriosis symptoms in patients across England, Wales and Northern Ireland with a history of previous medical or surgical treatment for their endometriosis. It will be given with add-back hormone therapy, which involves using low-dose hormone replacement therapy to minimise or eliminate menopause-like symptoms and bone loss. Affecting approximately 1.5 million women in the UK, endometriosis occurs when tissue similar to the lining of the uterus grows elsewhere in the body. Patients can experience a range of symptoms, including dysmenorrhoea (painful cramping, usually in the lower abdomen), heavy bleeding and pelvic pain. Yselty is designed to block the hormones that contribute to endometriosis symptoms. The drug is expected to be available in the coming months and could benefit more than 1,000 patients every year, according to NHS England. NICE’s decision was supported by results from the EDELWEISS 3 study, in which Yselty used alongside add-back therapy demonstrated statistically significant reductions in both co-primary endpoints of non-menstrual pelvic pain and dysmenorrhea compared to placebo. Sue Mann, national clinical director in women’s health for NHS England, said: “This is welcome news for women with endometriosis who haven’t found relief from previous therapies or surgery – it’s another treatment option which will help women take control of their health and better manage the symptoms of this often painful and debilitating condition.” NICE’s final guidance on Yselty is set to be published on 25 June, after which the NHS must make the treatment available within 90 days. The announcement comes less than two months after NICE recommended Gideon Richter’s Ryeqo (relugolix, estradiol and norethisterone) as the first long-term daily pill for endometriosis. Commenting on the agency’s latest decision, Emma Cox, chief executive at Endometriosis UK said: “Historic lack of research into women’s health means those with endometriosis have far too few options for managing their sometimes debilitating pain and other symptoms of endometriosis. “It’s good to see companies investing in research, and NICE approving a new drug for endometriosis, offering more choice for those considering medical menopause to manage symptoms.”

Clinical ResultPhase 3Drug Approval

100 Deals associated with Linzagolix choline

External Link

KEGG	Wiki	ATC	Drug Bank
D11609	-	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Uterine Fibroids	Japan	Kissei Pharmaceutical Co., Ltd.	22 Dec 2025
Endometriosis	European Union	Theramex Ireland Ltd.	20 Dec 2024
Endometriosis	Iceland	Theramex Ireland Ltd.	20 Dec 2024
Endometriosis	Liechtenstein	Theramex Ireland Ltd.	20 Dec 2024
Endometriosis	Norway	Theramex Ireland Ltd.	20 Dec 2024
Leiomyoma	European Union	Theramex Ireland Ltd.	14 Jun 2022
Leiomyoma	Iceland	Theramex Ireland Ltd.	14 Jun 2022
Leiomyoma	Liechtenstein	Theramex Ireland Ltd.	14 Jun 2022
Leiomyoma	Norway	Theramex Ireland Ltd.	14 Jun 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pelvic Pain	Phase 3	Japan	Kissei Pharmaceutical Co., Ltd.	15 Apr 2025
Pain	Phase 3	Japan	Kissei Pharmaceutical Co., Ltd.	11 Oct 2022
Primrose Syndrome	Phase 3	-	-	30 Aug 2021
Menorrhagia	Phase 3	United States	ObsEva SA	20 Apr 2017
Cohen Syndrome	Phase 2	China	Shanghai Baozheng Pharmaceutical Technology Co., Ltd.	15 Sep 2026
Cohen Syndrome	Phase 2	China	Kissei Pharmaceutical Co., Ltd.	15 Sep 2026
Infertility, Female	Phase 2	China	Kissei Pharmaceutical Co., Ltd.	15 Sep 2026
Infertility, Female	Phase 2	China	Shanghai Baozheng Pharmaceutical Technology Co., Ltd.	15 Sep 2026
Ovarian Hyperstimulation Syndrome	Phase 2	China	Shanghai Baozheng Pharmaceutical Technology Co., Ltd.	01 Aug 2023
Adenomyosis	Phase 2	France	ObsEva SA	23 Apr 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05440383 (Pubmed \| Hum Reprod)	Phase 3	Uterine Fibroids	287	Linzagolix 200 mg	hbosgbfzje(dqpzfarwid) = tkkltqptzq jfbtoojxxl (pztgytrzsb, 83.7 - 94.4) View more	Non-inferior	06 Jul 2026
				Leuprorelin 1.88 mg	hbosgbfzje(dqpzfarwid) = ljlihlouby jfbtoojxxl (pztgytrzsb, 84.7 - 95.0) View more
NCT04335591 (EDELWEISS 6, Pubmed \| Hum Reprod Open)	Phase 3	-	353	Placebo/75 mg Linzagolix	kemttntyum(hovrgxgwtv) = zkavkyifdg bxcqlabqgb (osrcxokeov ) View more	Positive	06 Apr 2026
				75 mg linzagolix	kemttntyum(hovrgxgwtv) = nhbrwutjnu bxcqlabqgb (osrcxokeov ) View more
NCT03070951 \| NCT03070899 (PRIMROSE 2, Pubmed \| Fertil Steril)	Phase 3	Uterine Fibroids	1,012	Linzagolix 100 mg	jstudrguci(wdwioafsrg) = hot flushes nbyildyczk (tmhqemfydc ) View more	Positive	01 Oct 2025
				Linzagolix 100 mg with ABT
NCT04372121 (EDELWEISS 5, CTgov)	Phase 3	Endometriosis	30	LGX (LGX 75 mg)	yeulbrrqgu(cpsxdojhdc) = syzypbqnaa nvbjzhuupr (jyutrozdnx, 0.0) View more	-	19 Mar 2025
				LGX (LGX 200 mg+ABT)	yeulbrrqgu(cpsxdojhdc) = ibcgsooigl nvbjzhuupr (jyutrozdnx, 0.0) View more
NCT03986944 (CTgov)	Phase 3	Endometriosis	85	Placebo capsule to match Add-back capsule	eqkdaushzm(cuihtlaany) = fiamzmsexh xkjjdnutpm (oizmdtrfvr, 0.5) View more	-	29 Oct 2024
NCT05445167 (KLH2302, NEWS)	-	Uterine Fibroids	89	Linzagolix	wfflodryxe(uwlnrcfabn) = Clinical results have reached the endpoint qzkpsitpng (bzfrquzgdh )	Positive	16 Jul 2024
				安慰剂
NCT03992846 (EDELWEISS 3, CTgov)	Phase 3	Endometriosis	486	Placebo capsule to match Add-back capsule	sjvolxwdjr = ypjrrifxrd eekzskqnql (nypofunuel, qtetlgpfrf - elcjkhxcvk) View more	-	29 May 2024
NCT04335591 (EDELWEISS 6, CTgov)	Phase 3	Endometriosis	356	LGX (LGX 75 mg)	bsbahrjjvh = jztyykmtgk priqoujmjs (kgxiknuxeb, cxxshuwkur - lucrsmdeci) View more	-	30 Apr 2024
				LGX (LGX 200 mg+ABT)	bsbahrjjvh = ytcxdlhrnu priqoujmjs (kgxiknuxeb, vdekyoklez - cqxjuszduv) View more
NCT03992846 (EDELWEISS 3, Pubmed)	Phase 3	Endometriosis \| Pain First line	486	Placebo	mkrtyxvvye(ctbimknlox) = engkhqiqai tuecfejcbx (mrkawhamsf )	Positive	22 Apr 2024
				Linzagolix 75 mg	mkrtyxvvye(ctbimknlox) = rqpyyqhbsu tuecfejcbx (mrkawhamsf )
NCT03070951 (PRIMROSE 2, GlobeNewswire) Manual	Phase 3	Uterine Fibroids	535	add-back therapy+linzagolix	hyjoytkssc(nhzduftyxa) = zeomlyojoc cfghofwprq (rbtwyijxvi )	Positive	06 Jul 2020
				linzagolix	hyjoytkssc(nhzduftyxa) = cljdqannle cfghofwprq (rbtwyijxvi )

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