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.

开始日期2025-06-01

申办/合作机构

Kissei Pharmaceutical Co., Ltd.

NCT05738382

/ Unknown status临床2期

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.

开始日期2023-08-01

申办/合作机构

上海葆正医药科技有限公司

NCT05894135

/ Recruiting临床3期

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

开始日期2023-07-14

申办/合作机构

上海葆正医药科技有限公司

100 项与林扎戈利相关的临床结果

登录后查看更多信息

100 项与林扎戈利相关的转化医学

登录后查看更多信息

100 项与林扎戈利相关的专利（医药）

登录后查看更多信息

项与林扎戈利相关的文献（医药）

2025-06-01·FERTILITY AND STERILITY

Linzagolix rapidly reduces heavy menstrual bleeding in women with uterine fibroids: an analysis of the PRIMROSE 1 and 2 trials

Article

作者: Boolell, Mitra ; Ionescu-Ittu, Raluca ; Becker, Christian M ; Mangler, Mandy ; Bestel, Elke ; Petraglia, Felice ; Donnez, Jacques ; Paszkowski, Tomasz ; St-Pierre, Julien ; Paszkowski, Maciej ; Hori, Satoshi

OBJECTIVE:

To study the timing of the effect of linzagolix, an oral gonadotropin-releasing hormone receptor antagonist, on significant reduction in heavy menstrual bleeding (HMB) in women with uterine fibroids.

DESIGN:

The study used pooled data from PRIMROSE 1 and PRIMROSE 2, two double-blind, similar placebo-controlled trials of linzagolix in the United States and Europe, respectively. Eligible participants were randomized equally across four treatment arms (linzagolix 100 mg and 200 mg, with and without concomitant hormonal add-back therapy [ABT] consisting of 1-mg estradiol and 0.5-mg norethisterone acetate) and one placebo arm. The cumulative incidence of achieving clinically significant HMB reduction and maintaining it to week 24 was compared between the linzagolix arms and the placebo arm using the Kaplan-Meier plots adjusted for confounding by race and study (PRIMROSE 1 vs. PRIMROSE 2).

SUBJECTS:

The PRIMROSE trials randomized 1,012 women aged ≥18 years with ultrasound-confirmed uterine fibroids and HMB.

INTERVENTION:

Linzagolix (100 mg and 200 mg, with and without hormonal ABT) vs. placebo.

MAIN OUTCOME MEASURES:

The main outcome of this analysis was the time to achievement of clinically significant HMB reduction and its maintenance up to week 24.

RESULTS:

The onset of action in achieving and maintaining clinically significant HMB reduction was significantly more rapid for the linzagolix treatment arms than for the placebo arm, with a median time of <4 weeks for most linzagolix doses (except 100 mg alone). The fastest onset was seen with linzagolix 200 mg with or without ABT doses, with a median time of only 3 days. The cumulative incidence of achieving clinically significant HMB reduction by week 4 and maintaining it to week 24 was also significantly higher for the linzagolix treatment arms than for the placebo arm. Specifically, across four linzagolix treatment arms, 23.2%-68.1% achieved clinically significant HMB reduction by week 4 and maintained it to week 24 vs. 7.8% for the placebo arm.

CONCLUSION:

Linzagolix was associated with a quick effect on reducing clinically significant HMB compared with placebo. Linzagolix, thus, offers a novel noninvasive treatment approach for the rapid management of HMB symptoms in patients with uterine fibroids.

2025-06-01·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

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

OBJECTIVES:

To evaluate 1) 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 2) whether there is any recurrence of symptoms (bleeding and pain) after cessation of therapy (withdrawal study).

STUDY DESIGN:

PRIMROSE 1 and PRIMROSE 2 were essentially identical, randomized, parallel, double-blind, placebo-controlled phase 3 trials conducted in women with uterine fibroid-associated heavy menstrual bleeding (menstrual blood loss of more than 80 ml per cycle over 2 menstrual cycles). Eligible women with uterine fibroid-associated heavy menstrual bleeding were randomly assigned at a 1:1:1:1:1 ratio to one of five masked daily treatments: (1)placebo, (2)100 mg linzagolix alone, (3)100 mg linzagolix with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate), (4) 200 mg linzagolix alone (with ABT after 24 weeks), or (5) 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, where 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).

SETTING:

A total of 94 clinical sites in the USA (PRIMROSE 1) and 95 in Europe and the USA (PRIMROSE 2).

PARTICIPANTS:

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 heavy menstrual bleeding of at least 80 ml blood loss per cycle for a minimum of two cycles, as determined by the alkaline haematin 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.

MAIN OUTCOMES MEASURES:

The primary endpoint was decreased menstrual blood loss to less than 80 ml and a reduction of more than 50% from baseline. Specifically, this study sought to determine whether the reduction in menstrual blood loss 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.

MAIN RESULTS:

In the pooled data from PRIMROSE 1 and PRIMROSE 2 extension studies, the significantly higher proportion of women showing a reduction in heavy menstrual bleeding in all linzagolix (with or without ABT) treatment groups observed at week 24, was maintained until week 52. Percentages of women with reduced menstrual blood loss 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 amenorrhoea 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 BMD loss (lumbar spine) recovered by week 52 after adding ABT from week 24 onwards.

CONCLUSIONS:

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 heavy menstrual bleeding, 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 favour of long-term continuation of treatment.

2024-10-01·REPRODUCTIVE BIOMEDICINE ONLINE

Why do oestrogens matter: systematic review and meta-analysis assessing GnRH antagonists, considering add-back therapy, for endometriosis-associated pain

Review

作者: Benagiano, Giuseppe ; Pluchino, Nicola ; Viviano, Manuela ; Guo, Sun-Wei

Gonadotrophin-releasing hormone (GnRH) antagonists have been demonstrated to reduce endometriosis-associated pain. Because of the hypo-oestrogenic state they induce, however, higher dosages of GnRH antagonists are not recommended for used long term. This unwanted effect may be eliminated by so-called add-back therapy (ABT). This review was conducted to assess the safety and efficacy of GnRH antagonists, with or without add-back hormonal replacement therapy. Out of the 345 studies selected through the initial search, seven randomized controlled trials were included, comparing different oral GnRH antagonists at varying dosages, from a minimum of 50 mg to a maximum of 200 mg once or twice daily. Women treated with the lowest dose of GnRH antagonists had significantly greater mean pain score reductions from baseline throughout treatment compared with those treated with placebo (odds ratio [OR] -13.12, 95% CI -17.35 to -8.89 and OR -3.08, 95% CI -4.39 to -1.76 for dysmenorrhoea and non-menstrual pelvic pain, respectively). Compatible with the dose-response effect, a positive correlation was found between response rates and adverse event rates. While GnRH antagonists offer an advantage in terms of pain reduction for endometriosis, the more recent literature suggests using GnRH antagonists with ABT, which, while mitigating the hypo-oestrogenic effects of GnRH antagonists, maintain their efficacy, while allowing their long-term use.

项与林扎戈利相关的新闻（医药）

2025-05-02

·PMLiVE

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.”

临床结果临床3期上市批准

2025-01-29

·PRNewswire

Endometriosis Clinical Trial Pipeline Gains Momentum as 15+ Key Companies at the Forefront | DelveInsight

Approximately 10% of women of reproductive age worldwide are affected by endometriosis, equating to about 190 million individuals. This substantial patient population necessitates effective treatments, propelling market demand this increasing disease prevalence is driving the market for endometriosis. LAS VEGAS, Jan. 29, 2025 /PRNewswire/ -- DelveInsight's ' Endometriosis Pipeline Insight 202 5 ' report provides comprehensive global coverage of pipeline endometriosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the endometriosis pipeline domain. Key Takeaways from the Endometriosis Pipeline Report DelveInsight's endometriosis pipeline report depicts a robust space with 15+ active players working to develop 20+ pipeline therapies for endometriosis treatment. Key endometriosis companies such as Kissei Pharmaceutical, Mithra Pharmaceuticals, Gesynta Pharma, Jiangsu Hengrui Medicine Co., Ferring Pharmaceuticals, Hope Medicine (Nanjing) Co., Ltd, VaRi Bioscience, SWK Holdings, Ananda Developments, TiumBio, Ironwood Pharmaceuticals, Chugai Pharmaceutical, Viramal, Organon, Mitsubishi Tanabe Pharma, Antev, Foraviset, ValiRx, EpicentRx, Temple Therapeutics, Celmatix, BCI Pharma, Gynica, PrecisionLife, Flightpath Biosciences, and others are evaluating new endometriosis drugs to improve the treatment landscape. Promising endometriosis pipeline therapies such as Linzagolix, Estelle, Vipoglanstat, SHR7280, Quinagolide, HMI-115, VR103, Ovarest, MRX1, TU2670, IW-3300, AMY-109, VML 0501, OG-6219, Teverelix trifluoroacetate, Raviset, VAL301, Nibrozetone, TTX334e, IntraVagS302, IntraVagS301, FP-300, and others are under different phases of endometriosis clinical trials. In October 2024, Lisata Therapeutics, Inc. announced that it has entered into a sponsored research agreement with the University of Cincinnati to investigate Lisata's novel cyclic peptide product candidate, certepetide, in combination with bevacizumab (a VEGF inhibitor) in a preclinical animal model for the treatment of endometriosis. In October 2024, Hope Medicine Inc. announced positive results from an interim analysis of a global Phase II study, " A Randomized, Multicenter, Double-Blind, Placebo -Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women with Moderate to Severe Endometriosis Associated Pain Over a 12-Week Treatment Period". HMI-115 is a monoclonal antibody that blocks the prolactin receptor. It is a first-in-class treatment for endometriosis. Notably, HMI-115 has been granted Breakthrough Therapy Designation by the National Medical Products Administration ("NMPA") in China. In May 2024, Neurocrine Biosciences, Inc. announced the initiation of its Phase I first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of neurological and neuropsychiatric conditions. In May 2024, TiumBio Co., Ltd. focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced positive topline results from its Phase 2a clinical trial of Merigolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in patients with moderate to severe endometriosis-associated pain. Request a sample and discover the recent advances in endometriosis treatment drugs @ Endometriosis Pipeline Report The endometriosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage endometriosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the endometriosis clinical trial landscape. Endometriosis Overview Endometriosis is a condition where tissue similar to the endometrium, which lines the uterus, grows outside of it. This often occurs in the lower abdomen or pelvic region but can occasionally be found elsewhere in the body. It commonly causes pelvic pain and may lead to infertility. The condition can begin with a person's first menstrual cycle and persist until menopause. The exact cause of endometriosis remains unknown, and there is currently no way to prevent it. While there is no cure, symptoms can be managed through medications or, in some cases, surgery. Not all individuals with endometriosis experience symptoms, but common ones include pelvic pain, painful periods, discomfort during sexual intercourse, and challenges with conception. Approximately 10% of women of reproductive age are affected, though the true prevalence is difficult to determine as diagnosis often requires laparoscopic surgery to confirm the presence of lesions. Endometriosis is a complex and widespread condition affecting women worldwide, regardless of ethnicity or social status. It is believed to result from multiple factors, including retrograde menstruation and cellular metaplasia, where cells outside the uterus transform into endometrial-like tissue. The condition is also heavily influenced by estrogen, which promotes inflammation, growth, and pain associated with the disease. Diagnosing endometriosis typically involves assessing a patient's menstrual and pelvic pain history. Although various diagnostic tools have been proposed, none are fully validated to identify individuals with certainty. Symptoms can mimic other conditions, leading to diagnostic delays. Imaging techniques like ultrasonography or MRI may be used to detect ovarian endometriomas, adhesions, or deep nodular lesions. Histologic confirmation, often following laparoscopic visualization, helps confirm the diagnosis but should not delay the initiation of empirical medical treatment. Treatment options range from conservative approaches, such as non-steroidal anti-inflammatory drugs (e.g., ibuprofen) to manage pain, to hormone-based medications that help control symptoms. Surgical intervention can both diagnose and treat endometriosis, with procedures to remove or destroy lesions and scar tissue, potentially alleviating pain and restoring normal pelvic anatomy. Find out more about endometriosis treatment drugs @ Drugs for Endometriosis Treatment A snapshot of the Endometriosis Pipeline Drugs mentioned in the report: Learn more about the emerging endometriosis pipeline therapies @ Endometriosis Clinical Trials Endometriosis Therapeutics Assessment The endometriosis pipeline report proffers an integral view of the endometriosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Endometriosis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Monoclonal antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: LHRH receptor antagonists, Estrogen receptor agonists, Hormone replacements, Mineralocorticoid receptor antagonists, Progesterone receptor agonists, Testosterone congener inhibitors, Prostaglandin-E synthase inhibitors, Gonadotropin-releasing hormone inhibitors, Dopamine D2 receptor agonists, Prolactin receptor antagonists, Key Endometriosis Companies: Kissei Pharmaceutical, Mithra Pharmaceuticals, Gesynta Pharma, Jiangsu Hengrui Medicine Co., Ferring Pharmaceuticals, Hope Medicine (Nanjing) Co., Ltd, VaRi Bioscience, SWK Holdings, Ananda Developments, TiumBio, Ironwood Pharmaceuticals, Chugai Pharmaceutical, Viramal, Organon, Mitsubishi Tanabe Pharma, Antev, Foraviset, ValiRx, EpicentRx, Temple Therapeutics, Celmatix, BCI Pharma, Gynica, PrecisionLife, Flightpath Biosciences, and others. Key Endometriosis Pipeline Therapies: Linzagolix, Estelle, Vipoglanstat, SHR7280, Quinagolide, HMI-115, VR103, Ovarest, MRX1, TU2670, IW-3300, AMY-109, VML 0501, OG-6219, Teverelix trifluoroacetate, Raviset, VAL301, Nibrozetone, TTX334e, IntraVagS302, IntraVagS301, FP-300 and others. Dive deep into rich insights for new drugs for endometriosis treatment, visit @ Endometriosis Drugs Table of Contents For further information on the endometriosis pipeline therapeutics, reach out @ Endometriosis Treatment Drugs Related Reports Endometriosis Market Endometriosis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key endometriosis companies including AbbVie, Neurocrine Biosciences, ObsEva, Kissei Pharmaceuticals, SWK, Enteris BioPharma, Bayer, Hope Medicine, Tiumbio, Organon, among others. Endometriosis Epidemiology Forecast Endometriosis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted endometriosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Endometriosis Pain Market Endometriosis Pain Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others. Endometriosis Pain Pipeline Endometriosis Pain Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床结果突破性疗法临床1期

2024-12-20

·theramex.com

Theramex Announces European Commission Approval for Yselty® (linzagolix) for Symptomatic Treatment of Endometriosis in Women with a History of Previous Medical or Surgical Treatment for their Endometriosis

For Media and Investors only. Ireland, December 20th, 2024 – Theramex, a global pharmaceutical company dedicated to women’s health, is pleased to announce that the European Commission (EC) has approved an extended indication for Yselty®(linzagolix), an oral gonadotropin-releasing hormone (GnRH) antagonist, for the symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis.1 This approval, effective immediately, applies to EU markets (excluding the UK and non-EU markets). Theramex in-licensed Linzagolix from Kissei Pharmaceutical Co., Ltd. in 2022, and this achievement underscores Theramex’s unwavering commitment to advancing women’s health. Endometriosis is a chronic and often painful condition that affects millions of women globally, and can significantly impact their quality of life.2 “We are delighted that the European Commission has approved the extended indication for Yselty®(linzagolix), providing women with endometriosis an additional treatment option to manage their symptoms,” said Robert Stewart, Theramex CEO. “This marks another important step in our commitment to improving women’s health by offering more choices for treatment. At Theramex, we remain dedicated to empowering women to take control of their health and enhance their quality of life.” The EC approval follows the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) positive opinion in October 2024,3 based on results from the EDELWEISS 3 study.4 The approval for amending the marketing authorisation was granted by Decision C(2022) 4199(final). About EDELWEISS 34 The efficacy of linzagolix was evaluated in a Phase 3, randomised, double-blind, placebo-controlled study (EDELWEISS 3) involving 484 women aged 18–49 with moderate to severe endometriosis-associated pain, treated for up to six months. The daily dose of 200 mg linzagolix with add-back therapy (ABT) met the primary efficacy objectives, demonstrating clinically meaningful and statistically significant reductions in dysmenorrhea and non-menstrual pelvic pain at three months, with stable or reduced use of analgesics. At three months, 73% of participants in the 200 mg linzagolix with ABT group responded to treatment for dysmenorrhea (P < 0.001 versus placebo) and 47% showed a response for non-menstrual pelvic pain (P = 0.007 versus placebo) – compared with rates of 24% and 31% of participants in the placebo group respectively. The most frequent adverse event reported was headache, occurring at similar rates in both the linzagolix 200 mg with ABT and placebo groups (10.5% versus 8.0%, respectively). Hot flashes and fatigue were reported more frequently in the linzagolix 200 mg with ABT group compared to the placebo group (6.8% each for linzagolix versus 2.5% each for placebo). About Yselty® (linzagolix)1 Linzagolix is a once daily, oral GnRH receptor antagonist. Since June 2022, it has been approved in the EU for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.In December 2024, the indication was extended in the EU to include the symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis. About Theramex Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women of all ages by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause, and osteoporosis. Theramex’s vision is to be a lifetime partner for women and the healthcare professionals who treat them, and is committed to listening to and understanding its patients, serving their needs, and offering effective healthcare solutions that care for and support women through different stages of their lives. For further information about Theramex, please contact:info@theramex.com About Kissei: Kissei is a Japanese pharmaceutical company based on the management philosophy “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees.” As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynecology and rare/intractable diseases. Linzagolix has been discovered by Central Research Laboratories of Kissei Pharmaceutical Co., Ltd. References View all news

上市批准临床结果临床3期

100 项与林扎戈利相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11609	-	-	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
子宫内膜异位症	欧盟	Theramex Ireland Ltd.	2024-12-20
子宫内膜异位症	冰岛	Theramex Ireland Ltd.	2024-12-20
子宫内膜异位症	列支敦士登	Theramex Ireland Ltd.	2024-12-20
子宫内膜异位症	挪威	Theramex Ireland Ltd.	2024-12-20
平滑肌瘤	欧盟	Theramex Ireland Ltd.	2022-06-14
平滑肌瘤	冰岛	Theramex Ireland Ltd.	2022-06-14
平滑肌瘤	列支敦士登	Theramex Ireland Ltd.	2022-06-14
平滑肌瘤	挪威	Theramex Ireland Ltd.	2022-06-14

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
子宫肌瘤	申请上市	澳大利亚	Theramex HQ U.K Ltd.	-
子宫肌瘤	申请上市	中国台湾	健乔信元医药生技股份有限公司	-
疼痛	临床3期	日本	Kissei Pharmaceutical Co., Ltd.	2022-10-11
月经过多	临床3期	美国	ObsEva SA	2017-04-20
卵巢过度刺激综合征	临床2期	中国	上海葆正医药科技有限公司	2023-08-01
Cohen综合征	临床2期	中国	上海葆正医药科技有限公司	2022-09-27
Cohen综合征	临床2期	中国	Kissei Pharmaceutical Co., Ltd.	2022-09-27
女性不孕症	临床2期	中国	Kissei Pharmaceutical Co., Ltd.	2022-09-27
女性不孕症	临床2期	中国	上海葆正医药科技有限公司	2022-09-27
终末期肾脏病	临床1期	美国	ObsEva SA	2019-05-15

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04372121 (EDELWEISS 5, CTgov)	临床3期	子宫内膜异位症	30	LGX (LGX 75 mg)	範網窪繭襯願願鑰鹽淵(壓選憲簾繭艱獵鬱繭艱) = 網蓋淵範鏇餘簾積築鹽築淵夢鑰選壓蓋餘積獵 (範獵觸廠夢窪餘網鏇製, 0.0) 更多	-	2025-03-19
				LGX (LGX 200 mg+ABT)	範網窪繭襯願願鑰鹽淵(壓選憲簾繭艱獵鬱繭艱) = 鏇鏇選膚觸醖淵齋獵網築淵夢鑰選壓蓋餘積獵 (範獵觸廠夢窪餘網鏇製, 0.0) 更多
NCT03986944 (CTgov)	临床3期	子宫内膜异位症	85	Placebo capsule to match Add-back capsule	構選獵廠壓壓製觸衊艱(鬱願廠鹽壓廠窪遞願餘) = 蓋遞築觸廠艱衊鏇艱壓膚壓齋遞積廠壓鑰網膚 (齋積膚襯鏇網網鑰窪窪, 0.5) 更多	-	2024-10-29
NCT03992846 (EDELWEISS 3, Pubmed)	临床3期	子宫内膜异位症 \| 疼痛一线	486	Placebo	淵膚築壓廠願鏇鏇顧鹽(鬱鏇廠鬱繭齋範廠願艱) = 齋壓築構構醖襯淵鏇獵繭夢衊廠網膚艱襯範窪 (遞製鏇窪糧蓋壓鹽遞蓋 )	积极	2024-04-22
				Linzagolix 75 mg	淵膚築壓廠願鏇鏇顧鹽(鬱鏇廠鬱繭齋範廠願艱) = 鑰獵繭獵憲鹽襯選淵壓繭夢衊廠網膚艱襯範窪 (遞製鏇窪糧蓋壓鹽遞蓋 )
NCT03070951 (PRIMROSE 2, GlobeNewswire) 人工标引	临床3期	子宫肌瘤	535	add-back therapy+linzagolix	淵夢襯鬱鬱廠襯淵醖簾(鏇醖鏇窪顧餘壓構膚選) = 願淵積廠糧鏇繭蓋壓繭願構願衊夢鬱築齋網顧 (積鏇廠鑰廠鑰鹹糧醖鬱 )	积极	2020-07-06
				linzagolix	淵夢襯鬱鬱廠襯淵醖簾(鏇醖鏇窪顧餘壓構膚選) = 衊蓋淵夢繭願構鏇鑰繭願構願衊夢鬱築齋網顧 (積鏇廠鑰廠鑰鹹糧醖鬱 )