To verify the non-inferiority of KLH-2109 to leuprorelin acetate in a double-blind manner in terms of efficacy in endometriosis patients with pelvic pain.

Start Date09 Jun 2025

Sponsor / Collaborator

Kissei Pharmaceutical Co., Ltd.

NCT05738382

/ Unknown statusPhase 2

A Randomized, Double-blind, Open for Active Comparator, Parallel, Multi-center Phase II Study to Explore the Efficacy, Safety and Tolerability of BG2109 Compared With Cetrorelix During COH in Female Subjects Undergoing ART Procedures

To explore the optimal effective daily dose of BG2109 to suppress premature luteinizing hormone (LH) surge during COH in female subjects undergoing ART procedures.

Start Date01 Aug 2023

Sponsor / Collaborator

Shanghai Baozheng Pharmaceutical Technology Co., Ltd.

NCT05894135

/ Unknown statusPhase 3

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

The objective of this study is to demonstrate the efficacy and safety of BG2109 administered orally once daily at a dose of 100 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, while under randomized treatment, in the management of moderate to severe endometriosis-associated pain (EAP) in chinese women with surgically confirmed endometriosis

Start Date14 Jul 2023

Sponsor / Collaborator

Shanghai Baozheng Pharmaceutical Technology Co., Ltd.

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 2025·FERTILITY AND STERILITY

Linzagolix with and without hormonal add-back therapy for symptomatic uterine fibroids: PRIMROSE 1 & 2 long-term extension and withdrawal study

Article

Author: Satoshi Hori ; Hugh Taylor ; Francisco Carmona Herrera ; Elke Bestel ; Sven Becker ; Christian M Becker ; Marie-Madeleine Dolmans ; Felice Petraglia ; Jacques Donnez

OBJECTIVE:

To evaluate whether oral linzagolix administered once daily for up to 52 weeks (extension study) at a dose of 100 mg or 200 mg with or without hormonal add-back therapy (ABT) (1.0 mg estradiol; 0.5 mg norethisterone acetate) can maintain the efficacy and tolerability seen at 6 months of therapy and whether there is any recurrence of symptoms (bleeding and pain) after cessation of therapy (withdrawal study).

DESIGN:

PRIMROSE 1 and PRIMROSE 2 were essentially identical, randomized, parallel, double-blind, and placebo-controlled phase 3 trials conducted in women with uterine fibroid-associated heavy menstrual bleeding (HMB) (menstrual blood loss [MBL] of more than 80 mL per cycle over 2 menstrual cycles).

SUBJECTS:

In PRIMROSE 1 and 2, 1,012 women were included in the full analysis set. Eligible subjects were women aged 18 years or older with ultrasound-confirmed fibroids and HMB of at least 80 mL blood loss per cycle for a minimum of two cycles, as determined by the alkaline hematin method. Eligible participants had to have at least one fibroid measuring 2 cm in diameter or more (or multiple small fibroids with overall uterine volume exceeding 200 cm³), but no fibroids greater than 12 cm in diameter.

INTERVENTION:

Eligible women with uterine fibroid-associated HMB were randomly assigned at a 1:1:1:1:1 ratio to one of five masked daily treatment: placebo, 100 mg linzagolix alone, 100 mg linzagolix with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate), 200 mg linzagolix alone , or 200 mg linzagolix with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate). After 24 weeks, patients assigned to the placebo or 200 mg linzagolix alone groups were switched to 200 mg linzagolix with ABT, except in PRIMROSE 1, in which 50% of subjects on a placebo continued with the placebo (random selection) until week 52. All other women continued on the original study medication. Efficacy and safety were evaluated at week 52 (extension study) as well as week 64 (withdrawal study). Bone mineral density was also assessed at week 76 (6 months after cessation of therapy).

MAIN OUTCOME MEASURES:

The primary endpoint was decreased MBL to less than 80 mL and a reduction of more than 50% from baseline. Specifically, this study sought to determine whether the reduction in MBL and other secondary outcomes, such as uterine volume and pain, observed at 24 weeks could be maintained over an extended (52 weeks) treatment period and further withdrawal period.

RESULTS:

In the pooled data from PRIMROSE 1 and PRIMROSE 2 extension studies, the significantly higher proportion of women showing a reduction in HMB in all linzagolix (with or without ABT) treatment groups observed at week 24, was maintained until week 52. Percentages of women with reduced MBL at week 52 (based on the pooled week 52 full analysis set) were 55.0% in the 100 mg group, 86.1% in the 100 mg with ABT group, 76.7% in the 200 mg group/200 mg with ABT, and 89.9% in the 200 mg with ABT group. Of subjects previously treated with linzagolix and in amenorrhea by week 52, 88.8% reported their first bleed or heavy bleeding between weeks 52 and 64. In both PRIMROSE studies, the most common adverse events up to week 52 were hot flushes. Their incidence had returned to baseline values by week 64. Bone mineral density was well preserved in all groups at week 52. In women treated with 200 mg linzagolix alone up to week 24, initial bone mineral density loss (lumbar spine) recovered by week 52 after adding ABT from week 24 onwards.

CONCLUSION:

Findings at 52 weeks confirmed the benefits of treatment observed at 24 weeks. At 52 weeks, linzagolix 100 mg or 200 mg with or without ABT was found to reduce HMB, which is a burden for women with uterine fibroids. Their quality of life was improved. Risks of bone loss and vasomotor symptoms were minimized as a result of ABT administration. Partial suppression with once-daily linzagolix 100 mg without ABT potentially provides a unique option for chronic treatment of symptomatic uterine fibroids in women who do not wish to have ABT or in whom it is contraindicated. The relatively fast recurrence of uterine fibroid-associated symptoms after cessation of therapy is an argument in favor of long-term continuation of treatment.

TRIAL REGISTRATION:

PRIMROSE1 (NCT03070899) PRIMROSE 2 (NCT03070951).

01 Aug 2025·BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY

Pain Reduction in Linzagolix‐Treated Patients With Uterine Fibroids: A Secondary Mediation Analysis of the PRIMROSE 1 and 2 Phase 3 Trials

Article

Author: Boolell, Mitra ; Petraglia, Felice ; Becker, Sven ; Dolmans, Marie‐Madeleine ; Bestel, Elke ; Herrera, Francisco Carmona ; Ionescu‐Ittu, Raluca ; Donnez, Jacques ; Renner, Stefan P. ; Hori, Satoshi ; St‐Pierre, Julien

ABSTRACT:

Objective:

Among women with uterine fibroids (UFs), we assess the extent to which the linzagolix effect on pain alleviation is explained by its effect on reducing heavy menstrual bleeding (HMB) and fibroid volume (FV).

Design:

Post hoc analysis on the pooled data from two randomised double‐blind placebo‐controlled phase 3 trials.

Setting:

94 sites in the US (PRIMROSE 1 trial) and 95 sites in Europe/US (PRIMROSE 2 trial).

Population:

Women aged ≥ 18 years with ultrasound‐confirmed UFs and HMB (n = 1012).

Methods:

Participants were randomised to linzagolix (100 mg and 200 mg, with and without hormonal add‐back therapy) versus placebo. A post hoc mediation analysis was conducted on the pooled PRIMROSE 1 and PRIMROSE 2 data. The effect of linzagolix versus placebo on pain reduction was divided into three components (effect explained by HMB reduction associated with linzagolix, FV reduction associated with linzagolix, and remaining [not yet explained] treatment effect), with proportions of each component reported.

Main Outcome Measures:

The mediation analysis outcome was clinically significant pain reduction, defined as a change of ≥ 2 pain categories from baseline to Week 24 using the Numeric Rating Scale (pain categories: no pain (0), and mild (1–3), moderate (4–6), severe pain (7–10)).

Results:

In the mediation analysis, 28%–51% (depending on treatment arm) of linzagolix effect on pain reduction was explained by its effect on HMB reduction, while 2%–8% was explained by its effect on FV reduction. The residual proportion ranged between 44% and 67%, depending on treatment arm, and was statistically significant only in the linzagolix 200 mg without add‐back therapy arm (p = 0.002).

Conclusions:

This analysis showed that reductions in pain were significantly mediated by reductions in HMB (all doses) and FV (200 mg alone) in linzagolix‐treated women with UFs. Further research is needed to identify additional mediating factors.

Trial Registration:

ClinicalTrials.gov: NCT03070899 and NCT03070951

07 Jun 2025·Human Reproduction Open

Two-year follow-up study (PRIMROSE 3) to assess bone mineral density in subjects with uterine fibroids completing the PRIMROSE 1 and PRIMROSE 2 linzagolix trials

Article

Author: Becker, Sven ; Carmona Herrera, Francisco ; Taylor, Hugh ; Petraglia, Felice ; Bestel, Elke ; Becker, Christian ; Donnez, Jacques ; Hori, Satoshi ; Dolmans, Marie-Madeleine ; Paszkowski, Maciej

Abstract:

STUDY QUESTION:

How important was the change in lumbar spine (L1–L4), femoral neck, and total hip bone mineral density (BMD) from post-treatment baseline values to 24 months after the end of treatment in PRIMROSE 1 and PRIMROSE 2 study participants?

SUMMARY ANSWER:

In the present study (PRIMROSE 3), mean percentage changes in lumbar spine BMD from the post-treatment baseline to month 24 (primary endpoint) were small in most treatment groups and similar to variations in the placebo group.

WHAT IS KNOWN ALREADY:

Due to its mechanism of action, some BMD decreases are observed with oral GnRH antagonist treatment, depending on the dose administered and addition or not of add-back therapy (ABT) (1 mg oestradiol and 0.5 mg norethisterone acetate). In PRIMROSE 1 and PRIMROSE 2, no significant changes in BMD were observed in any of the three anatomic sites investigated (lumbar spine, femoral neck, and total hip) in any of the treated groups but one. Indeed, at 24 weeks, mean differences were most pronounced in the lumbar spine in participants given 200 mg linzagolix alone.

STUDY DESIGN, SIZE, DURATION:

PRIMROSE 3 is a long-term follow-up study on BMD in subjects who completed at least 20 weeks of treatment in the main linzagolix trials (PRIMROSE 1 or PRIMROSE 2) and underwent dual-energy X-ray absorptiometry (DEXA) within 35 days of their last treatment (week 24 or week 52 [extension study]). The primary endpoint was the change in lumbar spine (L1–L4), femoral neck, and total hip BMD from post-treatment baseline values to 24 months after the end of treatment in PRIMROSE 1 and PRIMROSE 2 study participants. The secondary endpoint was the change in lumbar spine (L1–L4), femoral neck, and total hip BMD from pre-treatment baseline values to 24 months after the end of treatment. The study involved an eligibility visit and up to three follow-up consultations at 12, 18 and/or 24 months after the end of treatment in either PRIMROSE 1 or PRIMROSE 2.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Patients given an end-of-treatment DEXA scan within 35 days of their last treatment were invited to participate in the PRIMROSE 3 study. Those who were pregnant or unable to undergo a DEXA scan on the same type of equipment as used for the end-of-treatment DEXA scan in PRIMROSE 1 or PRIMROSE 2 were not eligible for this trial. A total of 137 subjects were screened, 134 (97.8%) of whom were enrolled and 130 (94.9%) included in the safety analysis set. Subject groups were small and ranged from 7 subjects (placebo group) to 30 subjects (200 mg/200 mg+ABT group). Most subjects (n = 110, 80.3%) completed the study by evaluation of their BMD by DEXA at 2 years post-treatment.This study (EudraCT number: 2021-000452-19) was conducted at 3 sites in Bulgaria, 4 sites in the Czech Republic, 4 sites in Hungary, 1 site in Latvia, 6 sites in Poland, 1 site in Romania, 5 sites in Ukraine, and 32 sites in the USA.

MAIN RESULTS AND THE ROLE OF CHANCE:

The most notable percentage increase from the end of treatment to month 24 was in the 200 mg/200 mg+ABT treatment group, which was also the group showing the greatest mean percentage BMD loss during linzagolix treatment. This marked upturn in BMD after cessation of treatment demonstrated the crucial role of ABT.Percentage changes in lumbar spine BMD from the pre-treatment baseline to month 24 (secondary endpoint) remained above −2% in all linzagolix treatment groups. Small BMD modifications observed from both the post-treatment and pre-treatment baseline to month 24 after the end of therapy may not have any clinically relevant impact on overall bone health of linzagolix-treated individuals, since the Z-score of most subjects was within the expected range for age. In addition, changes in BMD values and Z-scores in the linzagolix treatment groups were mostly within the same range as in the placebo group.

LIMITATIONS, REASONS FOR CAUTION:

The number of patients is relatively small. Since interpretation of results from the month-12 and month-18 visits is limited due to the small number of subjects in each treatment arm at corresponding time points, giving rise to high data variability, this manuscript focuses on the month-24 visit only.

WIDER IMPLICATIONS OF THE FINDINGS:

It can be assumed that the small BMD changes observed from both the post-treatment and pre-treatment baseline to month 24 after cessation of therapy may not have any clinically relevant impact on overall bone health of linzagolix-treated individuals.Changes in BMD values and Z-scores in the linzagolix treatment groups were mostly within the same range as in the placebo group, indicating that there are no long-term consequences on BMD after the end of linzagolix treatment.

STUDY FUNDING/COMPETING INTEREST(S):

Funding for the PRIMROSE studies was provided by ObsEva (Geneva, Switzerland). Analysis of data was partially supported by ObsEva (Geneva, Switzerland), Theramex (London, UK), and Kissei (Japan). Grant 5/4/150/5 was awarded to M.-M.D. by the FNRS.J.D. was a member of the scientific advisory board of ObsEva and Preglem until 2023 and reports consulting fees from ObsEva, Gedeon Richter, and Theramex. F.P. has received consulting fees and honoraria for lectures from Theramex. H.T. has received grants from Abbvie, reports consulting fees from ObsEva and Gedeon Richter, has a patent on endometriosis biomarkers owned by Yale University, and was a past president of American Society of Reproductive Medicine (ASRM). C.B. was a member of the independent data monitoring board for the PRIMROSE trials and member of the advisory board for Spirit 1 and 2 trials. He was also the Chair for the ESHRE endometriosis guideline committee. Consulting fees from Myovant and Theramex went to the University of Oxford. S.B. has received consulting fees and honoraria for lectures from Theramex. F.C.H. reports consulting fees and honoraria for lectures, presentations, or educational events from Theramex and Gedeon Richter and receiving honoraria for participation in a data safety monitoring board for Organon. M.P. was a principal investigator in the ObsEva-sponsored PRIMROSE 2 and 3 trials. E.B. and S.H. are employees of Theramex. M.-M.D. has received fees for lectures from Gedeon Richter and Theramex.

TRIAL REGISTRATION NUMBER:

EudraCT number: 2021-000452-19.

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
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R&D Status

Approved

10 top approved records.

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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.

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Indication	Highest Phase	Country/Location	Organization	Date
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
Ovarian Hyperstimulation Syndrome	Phase 2	China	Shanghai Baozheng Pharmaceutical Technology Co., Ltd.	01 Aug 2023
Cohen Syndrome	Phase 2	China	Shanghai Baozheng Pharmaceutical Technology Co., Ltd.	27 Sep 2022
Cohen Syndrome	Phase 2	China	Kissei Pharmaceutical Co., Ltd.	27 Sep 2022
Infertility, Female	Phase 2	China	Kissei Pharmaceutical Co., Ltd.	27 Sep 2022
Infertility, Female	Phase 2	China	Shanghai Baozheng Pharmaceutical Technology Co., Ltd.	27 Sep 2022
Adenomyosis	Phase 2	France	ObsEva SA	23 Apr 2018
Liver Injury	Phase 1	United States	ObsEva SA	15 May 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03070951 \| NCT03070899 (PRIMROSE 2, Pubmed \| Fertil Steril)	Phase 3	Uterine Fibroids	1,012	Linzagolix 100 mg	zoanysigzc(cbvdzhvmvd) = hot flushes zxauhbqnte (lkayjmleyz ) View more	Positive	01 Oct 2025
				Linzagolix 100 mg with ABT
NCT04372121 (EDELWEISS 5, CTgov)	Phase 3	Endometriosis	30	LGX (LGX 75 mg)	mrhwavywxy(rhzmznpxxr) = nldbhjiyjz sufirxywki (kqcsvhbqvf, 0.0) View more	-	19 Mar 2025
				LGX (LGX 200 mg+ABT)	mrhwavywxy(rhzmznpxxr) = auoykdpplq sufirxywki (kqcsvhbqvf, 0.0) View more
NCT03986944 (CTgov)	Phase 3	Endometriosis	85	Placebo capsule to match Add-back capsule	xbgwalmpqe(khcrzirmmi) = begoxdhldm duqdqdlqim (iwumqdtzex, 0.5) View more	-	29 Oct 2024
NCT05445167 (KLH2302, NEWS)	-	Uterine Fibroids	89	Linzagolix	coepqjzglv(vwhqturddl) = Clinical results have reached the endpoint soddkzazde (cqrcftkywa )	Positive	16 Jul 2024
				安慰剂
NCT03992846 (EDELWEISS 3, CTgov)	Phase 3	Endometriosis	486	Placebo capsule to match Add-back capsule	oxweokehdo = briqlwduyr ofmiglnrxm (rjwvxfqlaz, nksptkxnfm - cguuhiemdr) View more	-	29 May 2024
NCT04335591 (CTgov)	Phase 3	Endometriosis	356	LGX (LGX 75 mg)	evoxszbptc = zhyjsagioh zwnhrsjavl (tlwavmoimn, ohluylaazc - ipevtcfgja) View more	-	30 Apr 2024
				LGX (LGX 200 mg+ABT)	evoxszbptc = dxhkmcwnmp zwnhrsjavl (tlwavmoimn, ybxeqbavho - sriwdalwfg) View more
NCT03992846 (EDELWEISS 3, Pubmed)	Phase 3	Endometriosis \| Pain First line	486	Placebo	zbzxmpnfbl(iotmqcpgwj) = oxkhdeyepb yndchfbdkd (bmadoqxqxo )	Positive	22 Apr 2024
				Linzagolix 75 mg	zbzxmpnfbl(iotmqcpgwj) = usgaozquqd yndchfbdkd (bmadoqxqxo )
NCT03070951 (PRIMROSE 2, GlobeNewswire) Manual	Phase 3	Uterine Fibroids	535	add-back therapy+linzagolix	tftakufasx(fhojxvwunc) = hihcjwcseo rnfomhzbov (fzgjbkmmmv )	Positive	06 Jul 2020
				linzagolix	tftakufasx(fhojxvwunc) = vlmsvudcmf rnfomhzbov (fzgjbkmmmv )

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