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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

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. '

The UK's National Institute for Health and Care Excellence (NICE) recommended Theramex’s Yselty (linzagolix) as a treatment option for moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age. Subsequent to the decision, the oral gonadotropin-releasing hormone (GnRH) receptor antagonist can now be routinely prescribed to eligible patients through the NHS in England and Wales.Backed by the two Phase III PRIMROSE trials, Yselty was approved in the EU and UK in 2022, making it the first GnRH antagonist offering a non-hormonal option for women with uterine fibroids. “Linzagolix offers greater flexibility as it can be taken either with or without hormone therapy and means clinicians can provide more personalised care,” said Jonathan Benger, NICE chief medical officer. Longer-term use onlyNICE noted that the drug is only recommended for longer-term use of over 6 months and is unsuitable for those requiring short-term treatment, such as before uterine fibroid surgery. Yselty carries an annual list price of £1097.20 ($1410) and £1040.00 ($1336) with and without hormonal add-back therapy, respectively.According to NICE, around a third of women are likely to develop symptomatic uterine fibroids during their lifetime and up to 30,000 women in England and Wales could benefit from the new treatment option. “We are continuing to work with NICE and the NHS in the hope that we can provide as many women as possible the opportunity to access this treatment, wherever they live,” remarked Tina Backhouse, UK general manager at Theramex.Originally an asset of Kissei Pharmaceutical, the GnRH antagonist was licensed to ObsEva in 2015 for commercialisation outside Asia. In 2022, ObsEva struck a deal with Theramex to support the drug’s commercialisation in markets excluding the US, Canada and Asia. However, ObsEva soon ran into trouble with the FDA regarding the drug’s US filing, resulting in a strategic restructuring and Theramex being assigned as Kissei’s ex-Asia licensing partner.