A single-centre, Phase 2, open-label study to investigate ovulation inhibition after the administration of different dosages of dienogest tablets in combination with different dosages of drospirenone tablets with regular intake and after intentional intake errors in healthy premenopausal female participants

Start Date10 Oct 2026

Sponsor / Collaborator-

NCT07732348

/ Not yet recruitingNot ApplicableIIT

Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist and Progestin-primed Ovarian Stimulation (PPOS) in Controlled Ovarian Stimulation for in Vitro Fertilization: a Prospective Comparative Observational Study

Preventing a premature rise in luteinizing hormone (LH) is essential during ovarian stimulation for in vitro fertilization (IVF), because such a rise can reduce the number of eggs collected. Current practice relies on either a daily injectable GnRH antagonist or an oral progestin (PPOS), which requires that all embryos be frozen.
Linzagolix is an oral GnRH antagonist already approved for uterine fibroids and endometriosis. It has not previously been used to control ovarian stimulation for IVF; this study represents its first use for this purpose.
This is an observational study: participants are not randomly assigned to a treatment. Each woman receives one of three approaches - oral linzagolix, an injectable GnRH antagonist (ganirelix or cetrorelix), or PPOS - chosen by the clinical team based on her individual situation. The three groups are then compared using statistical adjustment for baseline differences between them.
The study will enroll approximately 195 women undergoing IVF or ICSI, aged 18 to [42], who are not selected based on ovarian reserve. All participants receive individualized gonadotropin stimulation and standard monitoring; only the method used to prevent premature ovulation differs by group.
The main question is whether linzagolix leads to a similar number of mature eggs (MII) retrieved compared with the injectable antagonist. The study will also assess how well each approach suppresses LH, safety (including ovarian hyperstimulation), and the number of injections needed.

Start Date01 Sep 2026

Sponsor / Collaborator

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

CTR20262697

/ RecruitingPhase 1

一项在健康参与者中评估单次皮下注射HY-1016的安全性、耐受性、药代动力学特征的随机对照I期临床研究

[Translation] A randomized, controlled phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of a single subcutaneous injection of HY-1016 in healthy participants.

主要目的：评价在健康女性参与者中使用试验用药品后的安全性、耐受性。

[Translation]

Primary objective: To evaluate the safety and tolerability of the investigational drug in healthy female participants.

Start Date23 Jul 2026

Sponsor / Collaborator

Sichuan Huiyu Seacross Pharma Technology Ltd.

100 Clinical Results associated with Dienogest

100 Translational Medicine associated with Dienogest

100 Patents (Medical) associated with Dienogest

820

Literatures (Medical) associated with Dienogest

01 Dec 2026·FUNCTIONAL & INTEGRATIVE GENOMICS

An integrated computational-experimental approach identifies Malate Synthase G as therapeutic target to disrupt carbon metabolism in chronic Pseudomonas aeruginosa infection

Article

Author: Wang, Rui ; Mo, Jingyi ; Xu, Jun ; Chen, Geping ; Chen, Wenying ; Zhou, Haochuan ; Tan, Qiutong

Pseudomonas aeruginosa is a leading cause of nosocomial infections, particularly in individuals with a compromised immune system. Due to its strong adaptive ability, P. aeruginosa tends to develop antibiotic resistance and establish chronic infection, making its eradication through traditional antibiotics challenging. Thus, the development of novel therapeutic targets and corresponding inhibitors is urgently required. We conducted bioinformatics analyses of gene-chip datasets (GSE10362, GSE21966) of P. aeruginosa from patients with cystic fibrosis (CF) in the Gene Expression Omnibus (GEO) database, ranging from early to late stages of infection. Differentially expressed gene (DEG) analysis, Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment, and Weighted Gene Co-expression Network Analysis (WGCNA) were performed to identify key functional DEGs. Among these genes, candidate genes were refined using three machine learning algorithms: LASSO regression, random forest (RF), and support vector machine (SVM). Using this integrated approach and published reports, target gene was identified consequently. With reported inhibitors, a structure-based virtual screening model against the target protein was established to screen inhibitors from an FDA-approved drug library. Screened hits were experimentally validated through in vitro MIC and checkerboard broth microdilution assays to determine their antibacterial activity and the synergistic effect of tobramycin (TOB) and amikacin (AMK). Enzyme activity was measured to evaluate target protein inhibition. Transcriptome sequencing analysis was performed to explain the effect of target inhibition and reveal the possible mechanism of inhibition. We identified 210 upregulated genes in the late stage of infection. KEGG functional enrichment demonstrated that the up-regulated genes were mainly enriched in metabolic pathways. Eight metabolism-related key DEGs were obtained by the intersection of genes from metabolic pathways and genes from the key module of WGCNA. Machine learning algorithms (LASSO, RF, and SVM) and literature investigation results identified glcB, which encodes malate synthase G (MS), as a therapeutic target for developing inhibitors. In virtual screening, we formulated four rules for a screening model based on the docking results, and finally identified three FDA-approved drugs prednisolone, dienogest and carbinoxamine maleate salt (CAR) as candidates. In vitro MIC assay and checkerboard assay suggested that CAR had an antibacterial effect with a concentration-dependent trend and could enhance the effect of tobramycin and amikacin. Consistent with MIC assay, the inhibition rate in MS activity assay showed a concentration-dependent trend. Transcriptome sequencing analysis showed that carbon metabolism was remodeled when MS was inhibited, thus impairing the growth of P. aeruginosa, and the synergistic effect with TOB and AMK may be explained by the impaired ability to combat oxidative stress. This study identified and validated drug target glcB (encodes MS) and potential inhibitor CAR in treating chronic P. aeruginosa infection based on an integrated method of bioinformatics, virtual screening, and in vitro experiments.

01 Oct 2026·BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY

Efficacy and Safety of Elagolix Versus Dienogest for Treatment of Moderate‐to‐Severe Endometriosis Pain: A Phase III , Multicentric, Double‐Blind, Active‐Controlled, Non‐Inferiority Study

Article

Author: Srivastava, Shalini ; Patel, Piyush ; Saigal, Sweety ; Shetty, Apurva ; Rangaswamy, Manohar ; Dash, Mrinal Kanti ; Bhatt, Vidya V ; Savalia, Kartikbhai ; Lakhwani, Lalit ; Pandit, Sucheta ; Choudhary, Deepa ; Gupta, Neena ; Patel, Jaldhara ; Palve, Tushar ; Kamilya, Gourisankar ; Bhoir, Sneha ; Patil, Dipak ; Joglekar, Sadhana ; Saha, Shruti ; Shah, Parul ; Gupta, Tanusree ; Ghadge, Pravin ; Mehta, Suyog ; Ponnuru, Malathi ; Quadros, Reshma

ABSTRACT:

Objective:

To compare the efficacy, safety and tolerability of elagolix with dienogest in women with moderate‐to‐severe endometriosis‐associated pain.

Design:

A multicentre, double‐blind, double‐dummy, randomised, parallel‐group, active‐controlled, non‐inferiority phase III study.

Setting:

Nineteen clinical centres across India.

Study Population:

Women (18–49 years) diagnosed with endometriosis and experiencing moderate‐to‐severe pain.

Methods:

Participants were randomised (1:1) to receive oral elagolix (150 mg once daily) or dienogest (2 mg once daily) for 24 weeks.

Outcome Measures:

The primary outcome was change in endometriosis‐related pain (Numeric Rating Scale [NRS]) from baseline to Day 85. Secondary outcomes included changes in NRS (Day 169), dysmenorrhoea, non‐menstrual pelvic pain (NMPP) scores (Days 85 and 169), rescue medication use, patient global impression of change (PGIC), adverse events and bone mineral density.

Results:

Of 340 patients screened, 230 were randomised (115 per group). At Day 85, both arms showed similar reductions in NRS pain scores with a treatment difference of 0.04 (95% CI: −0.3, 0.37) [ p = 0.9747] demonstrating non‐inferiority as upper 95% CI was below pre‐specified margin of 1.5. At Day 169, both arms showed comparable improvements in overall pain, dysmenorrhoea and NMPP from baseline ( p = 0.9372, p = 0.8884, and p = 0.9616, respectively). Rescue medication use and PGIC were comparable between treatment arms. Adverse event incidence was similar (elagolix: 14.8%; dienogest: 19.1%), with no serious TEAEs or discontinuations. No significant bone mineral density changes were observed.

Conclusions:

Elagolix demonstrated non‐inferiority to dienogest with an acceptable safety and tolerability profile, supporting its use in managing endometriosis‐associated pain.

Trial Registration:

ClinicalTrials.gov identifier: CTRI/2023/01/049292

01 Sep 2026·INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS

Treatment selection for adenomyosis based on imaging findings and patient characteristics

Review

Author: Kobayashi, Hiroshi

Abstract:

Adenomyosis is an estrogen‐dependent disorder characterized by substantial heterogeneity in lesion distribution, symptom presentation, disease severity, and reproductive impact, which limits the effectiveness of uniform treatment strategies. To summarize recent evidence on pharmacological and minimally invasive treatments for adenomyosis and to propose a clinically practical framework for treatment selection based on magnetic resonance imaging (MRI)‐based lesion subtypes, symptom phenotypes, disease severity, and reproductive intentions. A narrative review of recent literature was conducted focusing on hormonal therapies, gonadotropin‐releasing hormone (GnRH) antagonists, the levonorgestrel‐releasing intrauterine system (LNG‐IUS), dienogest, and minimally invasive treatments such as high‐intensity focused ultrasound (HIFU) and endometrial ablation. Outcomes were evaluated in relation to MRI‐based lesion localization, predominant symptoms, uterine size, and fertility preservation goals. Pharmacological therapy remains the cornerstone of conservative management. Sequential strategies using short‐term GnRH antagonists followed by maintenance therapy have been explored, although robust evidence is limited. LNG‐IUS and dienogest are commonly selected according to bleeding‐ or pain‐dominant symptoms and MRI‐based lesion subtypes, but interindividual variability in treatment response persists. Minimally invasive treatments show favorable outcomes mainly in localized disease, whereas efficacy in diffuse adenomyosis remains inconsistent. Treatment strategies differ according to reproductive intentions, with time‐limited interventions being central in fertility‐preserving management. Treatment of adenomyosis should move beyond a uniform approach toward individualized strategies integrating imaging findings and patient characteristics. An MRI‐based framework may support more rational and effective clinical decision making.

News (Medical) associated with Dienogest

09 Dec 2024

·www.biopharmadive.com

Endometriosis drug research, long underfunded, confronts familiar problems in women’s health

Ally Schott felt lonely when she was diagnosed with endometriosis at the age of 12. With few treatment options and limited information to go on, she and her family had to become self-taught medical researchers.Even the diagnosis was the result of Schotts mother connecting the dots between the pain her daughter was experiencing and the symptoms described by women in a patient organization she had found.That's ultimately what convinced my parents that this is what I was dealing with seeing and reading about the experience of others, and recognizing that I was going through something similar, Schott said.In some ways, Schotts case is rare. Her diagnosis came early, unlike some women who dont learn they have endometriosis for a decade or more due to lack of disease awareness, misdiagnosis or even bias that assumes severe menstrual pain is normal.It's very, very easy to dismiss someone's discomfort if you believe something is meant to be uncomfortable, said Somer Baburek, CEO and co-founder of Hera Biotech, a biotechnology company developing a nonsurgical tool to diagnose endometriosis.Caused by the growth of uterine tissue outside of the uterus, endometriosis typically affects people who menstruate, but it can occur in post-menopausal women, too. The disease is characterized by chronic pelvic pain, especially during menstruation, but can also cause problems across other parts of the body. It is usually identified through a surgical procedure called a laparoscopy, as ultrasounds cant always image the abnormal tissue growth.Although physicians understanding of the disease has improved, endometriosis root causes remain debated even as it affects some 10% of women and girls globally.[Endometriosis research] has been very underfunded and so, despite the prevalence of this disease, it's not very well understood at all, said Marina R. Walther-Antonio, an assistant professor of surgery at the Mayo Clinic in Minnesota and a microbiome researcher.When Schott received her diagnosis, there was little she could do about it a reality that frustrated her and her family. I just felt like I finally had the answer, and that if we had the answer to what was wrong, there would be a solution, she said. Even since, only two new drugs for endometriosis-related pain have been approved in the U.S.That pattern is typical of diseases, like endometriosis, that primarily or only affect women. Insufficient funding of womens health research has stifled development of new products, resulting in prevalent conditions with hardly any available treatments. And while clinical trials are more inclusive than they were in the 1990s and earlier, studies are not always set up to tease out why or how disease symptoms may differ on the basis of biological sex.Information deficitsDevelopment of a drug is no easy feat for any condition. But the process is more difficult when the disorder isnt well understood, as with endometriosis.We're starting from multiple deficits, and one of them is an information deficit, said Heras Baburek. And I think that's something that all founders in women's health struggle from.For instance, researchers sometimes use biobanks collections of medical and biological data from tissue, blood and DNA samples to identify molecular markers of a disease, or develop effective diagnostics. If collected by a government-funded program, the data is often published or made available to scientists, providing a starting point for drug research.But such resources are more limited in endometriosis, according to Baburek and Joseph Nassif, an associate professor of obstetrics and gynecology at Baylor College of Medicine and a clinician. While such work has advanced further in other countries, the U.S. is just getting started.So now in the states, we're trying to do a database about all patients who have [endometriosis], Nassif said. We have banks for cancer and banks for other diseases. Once you have a lot of patients, we can study it better.With less of a foundation, drug developers taking aim at endometriosis, or other womens health conditions like polycystic ovary syndrome or premenstrual dysphoric disorder, can have a harder time starting out.When you're building the data story of your company, yours looks weaker than companies who are focused on indications outside of women's health, because they have access to all of those resources, Baburek said.Such information deficits have deep roots. Up until 30 years ago, the Food and Drug Administration recommended excluding women of childbearing age from participating in Phase 1 and 2 clinical trials, even if they were using contraception. The policies were made in response to birth defects caused by the drug thalidomide, which was prescribed to women to treat nausea in the 1950s and 1960s.A 1993 law mandated the inclusion of women and minorities in clinical research funded by the National Institutes of Health, but the effects of discouraging women from participating in trials have carried through to today.For example, a 2022 study found women made up 41% of participants in Phase 1 through Phase 3 trials for drugs and medical devices run between 2016 and 2019 in the U.S. Women were underrepresented compared to their estimated proportion of the overall patient population for a number of conditions, such as heart disease and psychiatric disorders.Those research gaps, and the knowledge deficits they can cause, ultimately put the lives of girls, women and their families at a huge disadvantage, Schott said.Federal efforts have tried to compensate. Most recently in February, the Biden administration committed to investing $100 million into womens health research. The FDA also recently updated draft guidance to ensure sponsors run more diverse clinical trials, supporting the Food and Drug Omnibus Reform Act of 2022, which requires specific documents and strategic plans.It's really important when you're going to try to understand the efficacy, tolerability and safety of a drug that you're testing it in the representative population of people who you anticipate actually using the product, said Katherine Seay, head of sales and operations at Clinical Trial Media, a patient recruitment and retention company.Limited optionsCompared to other areas of drug R&D, womens health remains underfunded. An analysis of NIH-backed research found that diseases largely affecting men received more funding. The conditions primarily affecting women that do get investment are typically within oncology, such as breast and ovarian cancer, and reproductive medicine.Baburek didnt intend to make reproduction Heras focus, for instance. But the company only gained interest from investors when she mentioned the negative impact endometriosis can have on fertility. While our reproductive organs may be involved in some of these chronic conditions, our ability to reproduce shouldn't be the focus, Baburek said.Hera's struggle for attention isn't an anomaly. Despite its prevalence, endometriosis remains low on drugmaker radar screens.Women with the disease typically take birth control, other hormonal therapies and pain medication to manage symptoms and their menstrual cycles. They may also turn to surgery to either remove the lesions endometriosis causes or, in severe cases, remove their uterus entirely.When Schott was young, the drug Lupron Depot, a hormonal therapy initially approved for the treatment of prostate cancer, was cleared in the U.S. to manage pain associated with endometriosis. The drug can cause side effects similar to that of menopause and was a horrific experience for Schott, who was about 13 years old when it was prescribed to her.Within the past decade, two other products have been approved by the FDA for pain management with endometriosis: AbbVies Orilissa in 2018, and Pfizer and partner Myovant Sciences Myfembree in 2022.The drugs come with hefty price tags: Orilissa and Myfembree each cost over $1,000 per month at their respective list prices. They also dont address the diseases roots, and use is limited to a maximum of two years due to their potential to decrease bone density.Those options are not widely discussed or celebrated because they're not actually treating the disease, Baburek said. [They are] just quieting some of the symptoms that make your life unbearable, but then you get a whole host of other symptoms that also might make your life unbearable.Schott was prescribed Myfembree as an adult, but never took it because of its limitations and potential effects on bone density. She says she likely wouldn't take Orilissa for the same reasons.For the moment being, we have some ways to manage [endometriosis], whether medical or surgical, definitely with some percentage of success and failure either way, said Nassif. But definitely, we need a lot of research for the future.Endometriosis involves the outgrowth of womb lining tissue in the pelvis or abdomen.OGPhoto via Getty ImagesA bare pipelineNeither Orilissa nor Myfembree are big sellers and dont seem to rate high on their makers priority lists.Three years after Orilissas approval, AbbVie tried to sell the womens health unit the drug was housed in, but the deal never materialized. Sales of the drug are no longer reported individually and are instead lumped in with other key products in AbbVies earnings report. The last time AbbVie reported Orilissas net revenue was for its 2021 fiscal year, when it recorded $139 million in U.S.sales.AbbVie did not provide additional details about the drugs development or sales when contacted by BioPharma Dive.In 2022, Japan-based Sumitomo Pharma agreed to acquire Myfembree developer Myovant Sciences for $2.9 billion. The drug is now sold by Sumitomo in Europe, while Pfizer jointly markets it in the U.S. and Canada.Pfizer doesnt report net sales, but lists Myfembree revenue as contributing to alliance revenue in financial filings.Myfembree is marketed for endometriosis pain by Pfizer and partner Sumitomo PharmaPermission granted by Sumitomo Pharma AmericaThe two drugs dont face much competition. Womens health company ObsEva had licensed a compound known as linzagolix from the Japan-based biotechnology company Kissei Pharmaceutical. However, the company terminated the deal and withdrew an approval application after the FDA informed it of deficiencies in its submission.ObsEva shut down operations earlier this year, one of several companies in womens health that had to refocus its research efforts recently.Pharma company Bayer has long sold a hormonal drug called Visanne for endometriosis-related pain, but the company has not submitted it for U.S. approval in that indication.We focus our research efforts on innovative options in areas of high unmet medical need, a Bayer spokesperson said in comments to BioPharma Dive. We regularly review our research and development portfolio to prioritize the advancement of the most promising projects.Working with researchers in the U.S. and U.K., Bayer also helped identify an inflammation gene that may be linked to endometriosis. While the discovery seemed to point to a possible non-hormonal drug target, further research did not end up moving forward into development, according to a Bayer spokesperson.Last year, Bayer shifted its focus away from womens health altogether. While new R&D could still yield womens health products, a Bayer executive told Reuters that the companys work in the field overall had fallen short of expectations.Elsewhere, Organon agreed in 2021 to acquire Forendo Pharma in a deal worth $75 million upfront, handing it a drug candidate targeting endometriotic lesions without affecting hormones. Other startups have emerged, including Gynica, FimmCyte and SLBST Pharma.Looking forwardWhile endometriosis research continues, Barburek argues that finding a non-hormonal target for treating the condition has to be a priority.We've got to mechanistically understand [endometriosis] so we know which levers to pull and which knobs to push, she said. So more research needs to go into the mechanistic side of it.There is some momentum. Alongside the $100 million the Biden administration pledged to womens health research, the Advanced Research Projects Agency for Health, or ARPA-H, also launched a sprint for womens health to fund health solutions for conditions that primarily or disproportionately affect women.Its not clear whether such efforts will remain a priority under President-elect Donald Trumps administration, however. Trump nominated Robert F. Kennedy Jr. to helm the Department of Health and Human Services, which oversees health agencies including the FDA. While Kennedy has made clear his views on vaccines and the pharmaceutical industry, his views on womens health research are less clear and his stance on abortion has been inconsistent.In a rally prior to the election, Trump said Kennedy is so into womens health, and would let him go wild on healthcare.Some experts worry state abortion bans might hinder recruitment into trials involving in vitro fertilization, or other conditions that might require documenting a womans medical history.I think, once you take that freedom of choice away from women and leave it in the hands of politicians, state or federal, it's not a great thing, Schott said. It's a devastating impact that's going to be further reaching than I think we even have the context to understand right now, and I do think that involves endometriosis.Amid such concerns, there is hope of progress in treating endometriosis. Yet, Baburek said, sustained interest and investment will require a concentrated effort to highlight, educate and draw attention to the issues or consequences of being a woman. '

Drug ApprovalAcquisition

23 Mar 2023

·www.pharmaceutical-technology.com

New medications for PCOS slowly edge toward development

Credit: Shutterstock/justesfir Polycystic ovarian syndrome (PCOS), sometimes known as polycystic ovarian disease (PCOD), is a common endocrine disorder experienced by approximately 5 to 13% of people of reproductive age worldwide. While lifestyle modifications play a key role in treating PCOS, the paucity of new treatments signal a need for breakthrough research. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. Research states that PCOS is typically characterized by hyperandrogenism, high levels of androgens; ovulatory dysfunction; and polycystic ovaries. Scientific research and a better understanding of the condition is driving new developments in medications. ”The condition’s symptoms are not homogeneous, and that makes drug development complicated,” Javier Szwarcberg, CEO of Spruce Biosciences, a rare disease company researching endocrine disorders, says. A growing body of research also highlights the condition’s impact on quality of life and mental wellbeing. It is associated with insulin resistance (IR), metabolic syndrome (MS), low-grade chronic inflammation, and an increased risk of non-alcoholic fatty liver disease. Unmet need for PCOS medications With limited research comes the perception that for decades, the pharmaceutical armamentarium for PCOS has been restricted to a handful of standard drugs. Hormonal contraceptives, and other drugs like clomiphene, eflornithine have been reported to ameliorate symptoms. As per GlobalData, practitioners typically turn to five drugs to treat PCOS ; the main drug is metformin, accounting for almost a quarter of trials (24.7%). GlobalData is the parent company of Pharmaceutical Technology. Standard medications used for the disorder have also raised questions over their ability to meet the condition’s heterogeneous nature. “There is definitely an unmet need… When you talk to PCOS patients, the therapies they take don’t fully address their disease,” details Szwarcberg. While the number of new investigational therapies specifically designed to treat PCOS is scant, some companies continue to repurpose hormonal medications. Florham Park, New Jersey-based Exeltis Pharmaceuticals is currently running a Phase III study (EudraCT-2021-002178-17) with LPRI-421, a fixed dose combination of dienogest, a synthetic progesterone, and ethinylestradiol, a synthetic estrogen. Current treatment options mainly address symptoms such as hyperandrogenemia, irregular menstruation, and infertility, and therefore support patients with functional ovarian hyperandrogenism (FOH), which is estimated to affect around 62% of patients with PCOS. With tildacerfont, Spruce aims to target PCOS patients with mixed pathology and primary functional adrenal hyperandrogenism (FAH), which are collectively experienced by approximately 30% of patients who have exaggerated levels of dehydroepiandrosterone sulphate (DHEAS), a type of androgen. A 2019 study has revealed that androgens play a key role in regulating female fertility and androgen receptors are prevalent in the origins of the condition. Spruce is currently studying the safety and efficacy of tildacerfont in a Phase II study (NCT05370521) in participants ages 18–40 years with PCOS and elevated adrenal androgens. The study’s results are anticipated for release in mid-2023. The idea that high adrenal androgen levels in women with PCOS could also be related to an increase in corticotropin (ACTH), a hormone released by the pituitary gland, has long been explored in this space. Using tildacerfont, which also acts as a modulator of ACTH release, Spruce aims to determine if modulating the amount of ACTH regulates the amount of adrenal androgens present in the context of PCOS. Research indicates that increased adrenal androgen production can result in cystic acne, hirsutism, male-type baldness, menstrual irregularities, oligoovulation or anovulation, infertility, and/or frank virilization. Conventional therapies don’t often address the management of hyperandrogenemia in the context of PCOS patients, says Szwarcberg. “We believe this study will provide information around biology and create the foundations by which a program can then be built around the potential benefits in hyperandrogenemia control.” Other novel therapeutic modalities for the management of PCOS include the use of newer insulin sensitizers viz, glucagon-like peptide-1(GLP-1) agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and sodium-glucose transport protein 2 (SGLT2) inhibitors, says Sayeed Akhtar, PhD, assistant professor, Department of Clinical Pharmacy at King Khalid University, Abha, Saudi Arabia. A research study found that Novartis’s aromatase inhibitor Femara (letrozole) currently appears to be more effective than clomiphene citrate, a common reference drug, in treating infertility caused by PCOS. The incidence of infertility in women with this condition varies between 70–80%, research has found. Managing PCOS symptoms The heterogeneous nature of metabolic and endocrine disorders is a key factor influencing the health sector’s ability to advise and provide specific guidance for managing PCOS. US educational platform Uterinekind has teamed up with the Cornell Ovary Lab to fund research on the condition and has developed an app to help people access resources and support their uterine health. Global healthcare better supports patients in managing their symptoms by “managing the different facets of issues developed due to PCOS”, says Akhtar. Making lifestyle changes is often the first line of treatment before the addition of an insulin-sensitizing drug may be advised. More research is needed. “[PCOS] is a difficult disease to address and I don’t see many companies investing time in finding more advanced treatments for PCOS patients,” says Szwarcberg. Commenting on why there is so little research despite the high incidence, Akhtar says this is due to “less focus on policy and funding”. A 2021 UK parliamentary discussion on PCOS and endometriosis stated it did not have plans to increase near-term funding, despite calls for support . Rather, it expressed the importance of increasing awareness and opening an important dialogue on PCOS. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. 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Phase 2Phase 3

100 Deals associated with Dienogest

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KEGG	Wiki	ATC	Drug Bank
D03799	Dienogest	G03DB08	DB09123

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Dysmenorrhea	Japan	Mochida Pharmaceutical Co., Ltd.	23 Jan 2020
Adenomyosis	Japan	Mochida Pharmaceutical Co., Ltd.	02 Dec 2016
Endometriosis	Japan	Mochida Pharmaceutical Co., Ltd.	19 Oct 2007

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Pain	Phase 3	China	Shanghai Huilun Life Science & Technology Co. Ltd.	01 May 2023
Metrorrhagia	Phase 3	United States	Bayer AG	01 Dec 2005
Metrorrhagia	Phase 3	Canada	Bayer AG	01 Dec 2005

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00225199 \| NCT00185341 (Pubmed \| BMJ Open)	Phase 2/3	Endometriosis	-	Dienogest daily	tluqvwdrot(cetprvmrck) = dmcagbvvko mvnsqfwits (rurfimjadl, 6.06 - 17.73)	-	01 Jul 2023
				Placebo	tluqvwdrot(cetprvmrck) = mmxqnxhifz mvnsqfwits (rurfimjadl, 0.22 - 14.08)
NCT02425462 (ENVISIOeN, Pubmed \| Reprod Sci)	Not Applicable	Endometriosis	887	Dienogest therapy	uwmrsyulnn(avtdncldqg) = vxixcovkjp rnahotdsrc (vlbkaaiwon )	Positive	02 Feb 2022
NCT04500743 (Pubmed \| BMC Pregnancy Childbirth)	Not Applicable	Endometriosis	134	progestins (Group A)	hchqvxbyff(tcrxgbomkd) = nijvpvgnal ilpbnntfdm (ugloxqoglu ) View more	Positive	30 Mar 2021
				progestins (Group B)	hchqvxbyff(tcrxgbomkd) = sobkxsiyir ilpbnntfdm (ugloxqoglu ) View more
NCT01822080 (Pubmed \| J Womens Health (Larchmt)) Manual	Phase 3	Endometriosis	220	Dienogest	ywtcwdiloj(rvdrucozmp) = yxfhwdimle fmhyilsrru (vyzxpiosvh, 26.54)	Positive	01 Feb 2019
				Placebo	ywtcwdiloj(rvdrucozmp) = onclxtmxjk fmhyilsrru (vyzxpiosvh, 31.15)
NCT00307801 (CTgov)	Phase 3	Metrorrhagia	231	Estradiol valerate+Dienogest (Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027))	kgnswplimg = zygbewlksr xhkmgkeulh (asclohicfz, emrgdbwxru - hdypjopgbk) View more	-	29 Jul 2011
				Placebo (Placebo)	kgnswplimg = ahtfnfkfab xhkmgkeulh (asclohicfz, ckgfmwxtuh - zkwubztnpk) View more
NCT00293059 (CTgov)	Phase 3	Metrorrhagia	190	Estradiol valerate+Dienogest (Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027))	mrldotwtmc = yermwiyown tqfckmhkls (cmvxdnkebd, yehrlujstm - ksqhfuffve) View more	-	06 Jun 2011
				Placebo (Placebo)	mrldotwtmc = yylmvxvqze tqfckmhkls (cmvxdnkebd, fxsggicqni - qpexlsqnet) View more

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