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

/ Unknown status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

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100 项与林扎戈利相关的转化医学

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100 项与林扎戈利相关的专利（医药）

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项与林扎戈利相关的文献（医药）

2025-10-01·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 ; Bestel, Elke ; Herrera, Francisco Carmona

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).

2025-08-01·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

作者: Boolell, Mitra ; Petraglia, Felice ; Dolmans, Marie‐Madeleine ; Becker, Sven ; 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

2025-06-07·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

作者: Becker, Sven ; Taylor, Hugh ; Carmona Herrera, Francisco ; 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.

项与林扎戈利相关的新闻（医药）

2025-10-07

·PRNewswire

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

引进/卖出上市批准

2025-09-26

·web.cms.net.cn

自研品种IND获批：康哲药业创新药GnRH受体拮抗剂CMS-D002获得子宫肌瘤适应症药物临床试验批准

康哲药业控股有限公司（“康哲药业”或“本集团”）欣然宣布，本集团自主研发的创新药CMS-D002胶囊（“CMS-D002”）于2025年9月25日获得中国国家药品监督管理局（“NMPA”）签发的药物临床试验批准通知书，于9月26日收到药物临床试验批准通知书。NMPA同意开展临床试验以评价CMS-D002治疗子宫肌瘤的安全性和有效性。关于产品CMS-D002 CMS-D002是小分子促性腺激素释放激素（GnRH）受体拮抗剂。GnRH是由下丘脑神经内分泌细胞合成的十肽激素，是调控生殖系统激素释放的重要因子。CMS-D002与内源性GnRH竞争性结合垂体上的GnRH受体，在中枢神经水平阻断垂体性腺轴，减少内源性促卵泡刺激素（FSH）和促黄体生成素（LH）的释放，从而抑制下游雌激素、黄体酮和睾酮的分泌，缓解性激素相关疾病的进展。CMS-D002在临床前研究中表现出优异的有效性和安全性。此前，CMS-D002已于2024年2月6日，获得NMPA签发的药物临床试验批准通知书，本集团正在稳步推进子宫内膜异位症的I期临床研究。近日，CMS-D002再次获得NMPA批准临床试验，适应症范围新增子宫肌瘤适应症。除子宫内膜异位症及子宫肌瘤外，CMS-D002未来可开发用于治疗前列腺癌等疾病。关于子宫肌瘤子宫肌瘤（Uterine fibroids, UFs）由子宫平滑肌组织增生而形成，是女性最常见的一种良性肿瘤，其病因尚不明确，可能与遗传易感性和性激素水平有关，高危因素包括年龄、种族、肥胖和饮食等。UFs发病年龄在15至59岁之间，以30至44岁的女性最为常见，发病率整体呈逐年升高趋势，育龄期妇女的患病率可达25%[1-2]。子宫肌瘤目前治疗手段包括手术治疗和药物治疗，手术治疗虽可明显改善子宫肌瘤患者症状，但存在失血及尿失禁等安全性问题；药物治疗包括对症治疗及内分泌治疗，对症治疗药物仅能改善子宫肌瘤疼痛或贫血等症状，无法缩小肌瘤体积；内分泌治疗如GnRH受体激动剂及孕激素受体调节剂虽可通过降低患者雌孕激素水平显著缩小肌瘤体积，但GnRH受体激动剂可能存在治疗初期患者症状加重（即点火效应）[3]；孕激素受体调节剂存在肝损及抗糖皮质激素效应等不良反应[4]。因此，目前子宫肌瘤的药物治疗仍面临巨大的未被满足的临床需求。与GnRH受体激动剂相比，GnRH受体拮抗剂无“点火效应”，可以快速竞争性结合GnRH受体并阻断其启动，快速抑制FSH和LH的释放，进而抑制下游雌激素的分泌，缓解子宫肌瘤的进展，在较低的剂量下可实现部分抑制，在更高的剂量下则达到完全抑制。此外，由于拮抗剂的作用可逆，在停药一段时间后，当内源性GnRH重新结合受体时，患者的性腺功能有望恢复正常[5]。CMS-D002作为一款口服非肽类小分子GnRH受体拮抗剂，结合其优异的临床前表现，有望为患者提供更优的治疗选择。 CMS-D002将进一步丰富本集团产品矩阵，为中国患者提供差异化用药选择，满足兼具良好疗效、安全性与良好患者依从性药物的临床需求，使患者受益。CMS-D002将有效增强本集团在妇科治疗领域的实力，依托现有专家网络与市场资源，提升该领域的竞争力与市场地位。本集团正积极准备开展相关临床试验工作，力争该产品尽快上市。参考文献/资料 Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: asystematic review. BJOG. 2017;124(10):1501-1512. Dai Y, Chen H, Yu J, et al. Global and regional trends in the incidence and prevalence of uterine fibroids and attributable risk factors at the national level from 2010 to 2019: A worldwide database study. Chin Med J (Engl). 2024;137(21):2583-2589. Schaer GN, Schmid T, Peschers U, Delancey JO. Intraurethral ultrasound correlated with urethral histology. Obstet Gynecol. 1998;91(1):60-64. 子宫肌瘤的诊治中国专家共识专家组. 子宫肌瘤的诊治中国专家共识[J]. 中华妇产科杂志,2017,52(12)：793-800. Donnez J, Taylor HS, Taylor RN, et al. Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone-antagonist: a randomized clinical trial. Fertil Steril. 2020;114(1):44-55. 康哲药业免责与前瞻性声明本新闻无意向您做任何产品的推广，非广告用途。本新闻不对任何药品和医疗器械和/或适应症作推荐。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。由康哲药业编制的此新闻不构成购买或认购任何证券的任何要约或邀请，不形成任何合约或任何其他约束性承诺的依据或加以依赖。本新闻由康哲药业根据其认为可靠之资料及数据编制，但康哲药业并无进行任何说明或保证、明述或暗示，或其他表述，对本新闻内容的真实性、准确性、完整性、公平性及合理性不应加以依赖。本新闻中讨论的若干事宜可能包含涉及本集团的市场机会及业务前景的陈述，该等陈述分别或统称为前瞻性声明。该等前瞻性声明并非对未来表现的保证，存在已知及未知的风险、不明朗性及难以预知的假设。本集团并不采纳本新闻包含的第三方所做的任何前瞻性声明及预测，本集团对该等第三方声明及预测不承担责任。

临床申请临床1期

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

100 项与林扎戈利相关的药物交易

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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,

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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

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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 UK 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

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03070951 \| NCT03070899 (PRIMROSE 2, Pubmed \| Fertil Steril)	临床3期	子宫肌瘤	1,012	Linzagolix 100 mg	醖簾糧膚網壓齋簾壓積(遞製鬱構顧鹹遞鏇襯選) = hot flushes 築遞鏇製繭築蓋鹽衊窪 (網醖膚構夢鹹鬱選繭構 ) 更多	积极	2025-10-01
				Linzagolix 100 mg with ABT
NCT04372121 (EDELWEISS 5, CTgov)	临床3期	子宫内膜异位症	30	LGX (LGX 75 mg)	壓遞襯鑰夢衊艱膚夢餘(鏇積製夢鬱衊範壓膚廠) = 膚鑰簾醖膚鏇顧範築淵餘遞膚衊鏇網範鏇憲壓 (選廠齋醖顧膚齋淵衊壓, 0.0) 更多	-	2025-03-19
				LGX (LGX 200 mg+ABT)	壓遞襯鑰夢衊艱膚夢餘(鏇積製夢鬱衊範壓膚廠) = 網壓鹹襯窪製鬱製醖積餘遞膚衊鏇網範鏇憲壓 (選廠齋醖顧膚齋淵衊壓, 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	淵鹽繭鬱艱襯淵襯鬱簾(繭製鹽鑰鹽鑰願齋窪顧) = 簾簾鹹築獵選淵餘構鹽顧構製齋膚製選鹽構衊 (廠蓋壓構製壓鹽選選膚, 0.5) 更多	-	2024-10-29
NCT05445167 (KLH2302, NEWS)	-	子宫肌瘤	89	Linzagolix	範製觸構鏇製憲範鹹鹹(衊鏇艱積窪衊糧積鑰襯) = Clinical results have reached the endpoint 繭遞築繭糧夢顧製構糧 (鑰夢醖衊廠夢鬱艱蓋選 )	积极	2024-07-16
				安慰剂
NCT03992846 (EDELWEISS 3, Pubmed)	临床3期	子宫内膜异位症 \| 疼痛一线	486	Placebo	鹽遞鬱夢膚構鬱鬱鬱鹽(構夢簾製齋鹹鬱遞夢衊) = 積願齋餘築築製觸選餘淵齋淵鬱網獵遞窪襯夢 (夢觸醖構範繭願構遞蓋 )	积极	2024-04-22
				Linzagolix 75 mg	鹽遞鬱夢膚構鬱鬱鬱鹽(構夢簾製齋鹹鬱遞夢衊) = 構壓憲鹹選鏇壓餘壓醖淵齋淵鬱網獵遞窪襯夢 (夢觸醖構範繭願構遞蓋 )
NCT03070951 (PRIMROSE 2, GlobeNewswire) 人工标引	临床3期	子宫肌瘤	535	add-back therapy+linzagolix	鹹獵獵鬱網襯範觸艱膚(範觸鏇鏇蓋醖衊鑰艱獵) = 淵襯繭鏇窪鏇餘範餘願齋簾齋觸範醖遞鏇顧醖 (餘衊齋鹹願獵夢糧鏇醖 )	积极	2020-07-06
				linzagolix	鹹獵獵鬱網襯範觸艱膚(範觸鏇鏇蓋醖衊鑰艱獵) = 艱壓廠獵鑰顧淵鑰鏇糧齋簾齋觸範醖遞鏇顧醖 (餘衊齋鹹願獵夢糧鏇醖 )