Safety and Efficacy of Pembrolizumab in Combination with Flutamide Treatment for Advanced/Recurrence / Metastasis Head and Neck Squamous Cell Carcinoma: a Single-arm Clinical Study Trial

This study is a single center, single arm clinical trial for newly diagnosed patients with locally advanced head and neck squamous cell carcinoma. The main purpose is to evaluate the efficacy and safety of flutamide combined with standard immunotherapy for advanced / recurrent head and neck squamous cell carcinoma.
In our previous study, we found that AR can affect the occurrence and development of tumors by regulating the differentiation of cd8+t cells. We used three different castration drugs (flutamide, goserelin and abiraterone) in animal models to treat primary and tumor bearing head and neck squamous cell carcinoma mice respectively, and found that castration treatment could significantly inhibit the tumor growth of head and neck squamous cell carcinoma. In addition, in animal models, we compared the efficacy of the combination of castration therapy and low-dose cisplatin with that of the existing first-line chemotherapy drug cisplatin, and found that the combination of castration therapy and low-dose cisplatin can significantly improve the treatment effect of head and neck squamous cell carcinoma and reduce the adverse reactions brought by the drug. Therefore, we infer that flutamide combined with standard immunotherapy can fully inhibit the growth of HNSCC and improve the prognosis of HNSCC patients.

Start Date01 Dec 2024

Sponsor / Collaborator

Zhejiang Provincial Peoples Hospital

NCT05899699

/ Not yet recruitingPhase 2IIT

Potential Combination Topical Therapy of Acne Vulgaris: a Randomized Controlled Trial Comparing Efficacy of DAP/FLU Micro-emulsion vs. Standard Therapy of Adapalene.

The investigators propose a randomized, double-blind control trial study to evaluate the efficacy and safety of the optimized topical combination ME of the investigated drugs in the treatment of acne vulgaris containing DAP-FLU in comparison with standard therapy of Adapalene at Mansoura University Dermatology and Andrology Outpatient Clinic.

Start Date05 Jun 2023

Sponsor / Collaborator

Mansoura University

NCT04597099

/ RecruitingEarly Phase 1IIT

Ability of Androgen-receptor Blockade to Normalize Progesterone-induced Augmentation of Gonadotropin Secretion in PCOS (CRM010)

This study is trying to find out if flutamide (a medication that blocks the effects of testosterone) may help normalize an aspect of pituitary function (specifically, gonadotropin surge generation) in PCOS. This is a randomized, placebo-controlled, double-blinded, crossover study. The investigators hypothesize that in estradiol-pretreated women with PCOS, acute progesterone augmentation of FSH release (positive feedback) will be enhanced by flutamide.

Start Date26 Oct 2022

Sponsor / Collaborator

University of Virginia

[+1]

100 Clinical Results associated with Flutamide

100 Translational Medicine associated with Flutamide

100 Patents (Medical) associated with Flutamide

5,062

Literatures (Medical) associated with Flutamide

01 Mar 2025·Neuropharmacology

Neuroprotective effects of testosterone on sevoflurane-induced neurotoxicity in testosterone-deprived male mice

Article

Author: Long, Siwen ; Li, Dujuan ; Gong, Bingqing ; Li, Feixiang ; Yu, Jiafeng ; Yu, Yonghao ; Yang, Yongyan ; Yang, Yue

This study aims to investigate whether androgen deprivation, simulating conditions of aging or disease-induced low testosterone levels, increases the susceptibility of male mice to sevoflurane neurotoxicity, and whether testosterone supplementation can reverse the toxic effects of sevoflurane. In here, young male mice were subjected to orchiectomy (ORC) to induce testosterone deprivation. Various techniques, including western blotting, immunofluorescence, Morris Water Maze, Golgi staining, and neuronal signal measurement, were used to evaluate the effects of sevoflurane on long-term (ORC 10 weeks) and short-term (ORC 2 weeks) testosterone deprivation, and assess whether testosterone (1 mg/kg 1 h before sevoflurane exposure) could mitigate sevoflurane-induced neurotoxicity. Flutamide and anastrozole were administered to study testosterone's pathways of action. We found that sevoflurane increased tau phosphorylation and decreased the transient amplitude of Ca²⁺ signals and dendritic spine density in dorsal hippocampal CA1 (dCA1) neurons, leading to cognitive impairment in testosterone-deprived male mice. Testosterone treatment reversed the effects of sevoflurane in short-term testosterone-deprived male mice, but not in long-term testosterone-deprived male mice. Additionally, the neuroprotective effect of testosterone was blocked by flutamide rather than anastrozole. We have discovered for the first time that testosterone can mitigate the sevoflurane-induced neurotoxicity in testosterone-deprived male mice and that there exists a therapeutic time window, which may be mediated by androgen receptors. This may provide new insights into the neuroprotective role of sex hormones.

01 Mar 2025·Journal of Ultrasound in Medicine

Model Based on Ultrasound Radiomics and Machine Learning to Preoperative Differentiation of Follicular Thyroid Neoplasm

Article

Author: Deng, Yiwen ; Hu, Zhen ; Lai, Binghuang ; Zhang, Chunquan ; Guo, Liangyun ; Zeng, Qiao ; Zhao, Yu ; Zhan, Changmiao ; Huang, Zhiping ; Fu, Zhiyong

ObjectivesTo evaluate the value of radiomics based on ultrasonography in differentiating follicular thyroid carcinoma (FTC) and follicular thyroid adenoma (FTA) and construct a tool for preoperative noninvasive predicting FTC and FTA.MethodsThe clinical data and ultrasound images of 389 patients diagnosed with FTC or FTA postoperatively were retrospectively analyzed at 3 institutions from January 2017 to December 2023. Patients in our hospital were randomly assigned in a 7:3 ratio to training cohort and validation cohort. External test cohort consisted of data collected from other 2 hospitals. Radiomics features were used to develop models based on different machine learning classifiers. A combined model was developed combining radiomics features with clinical characteristics and a nomogram was depicted. The performance of the models was assessed by area under the receiver operating characteristic curve (AUC), calibration curve and decision curve.ResultsRadiomics model based on random forest showed best performance in discriminating FTC and FTA, with AUCs 0.880 (95% confidence interval [CI]: 0.8290–0.9308), 0.871 (95% CI: 0.7690–0.9734), and 0.821 (95% CI: 0.7036–0.9389) in training, validation, and test cohort, respectively. The combined model presented better efficacy comparing with clinical model and radiomics model, with AUCs 0.883 (95% CI: 0.8359–0.9295), 0.874 (95% CI: 0.7873–0.9615), and 0.876 (0.7809–0.9714) in training, validation, and test cohort, respectively. The calibration curves suggested good consistency and decision curves showed the highest overall clinical benefit for the combined model.ConclusionsUltrasound radiomics model based on random forest is feasible to differentiate FTC and FTA, and the combined model is an intuitively noninvasive tool for FTC and FTA preoperative identification.

01 Mar 2025·Separation and Purification Technology

Electrocatalytic degradation of flutamide an anti-prostate cancer drug and its metabolite 4-nitro-3-(trifluoromethyl) aniline using a simple graphite/β-PbO2 electrode

Author: Mohamadighader, Niloofar ; Nematollahi, Davood ; Roshani, Mahsa ; Ansari, Amin ; Hosseinpour, Mohana

Flutamide is an anti-androgen drug used to treat prostate cancer.This drug exists in aqueous environments at ng/L levels.However, the environmental impacts of flutamide (FLU) have not yet been determinedThis paper reports a simple electrocatalytic convergent-paired strategy for the degradation of FLU and its metabolite 4-nitro-3-(trifluoromethyl)aniline (NTA) using a simple graphite/β-PbO₂ anode.The prepared electrode has good electrochem. stability and lifetime (more than 60 h).The degradation efficiency of FLU and NTA under optimal conditions (pH 5.0, pollutant concentration 138 ppm and applied c.d. 4.9 mA/cm²) is 86 and 99 %, resp.Also, in the solution containing both FLU and NTA with a concentration of 138 ppm of each compound, the degradation efficiency of FLU and NTA is 82% and 92 %, resp.Also, the authors have comprehensively studied the electrochem. behavior of FLU and NTA and the authors compared the electrochem. similarities and differences of the drug with its metabolite, and also reported important data such as electrochem. reaction mechanism, pH-potential relation, and drug absorption/diffusion activity.

News (Medical) associated with Flutamide

12 Dec 2024

·www.businesswire.com

TerSera® Presents New Real-World Evidence on Treatment Outcomes of Goserelin (ZOLADEX®) in Women with Breast Cancer at the 2024 San Antonio Breast Cancer Symposium

DEERFIELD, Ill.--( BUSINESS WIRE )--TerSera Therapeutics LLC announced the presentation of new real-world analyses on the use of goserelin 3.6 mg and goserelin 10.8 mg in premenopausal women with breast cancer. These data were presented in a poster session at the 2024 San Antonio Breast Cancer Symposium, held December 10-13 in San Antonio, TX. 1 A copy of the poster is available here . This was a retrospective, observational, non-inferiority study using structured, de-identified, patient-level data and curated progress notes from U.S. electronic medical record (EMR) data from the ConcertAI Patient360™ Breast Cancer Dataset. The objective of this study was to compare real-world treatment outcomes among breast cancer patients treated with goserelin 3.6 mg and 10.8 mg. The primary outcome was the real-world event-free survival (rwEFS) rate at 12 months to assess the non-inferiority of the goserelin 10.8 mg dose given every 12 weeks vs. the 3.6 mg dose given every 4 weeks. The 12-month rwEFS rates for goserelin 3.6 mg and goserelin 10.8 mg, respectively, were 76.6% vs. 79.2% (treatment difference: 2.7% [95% CI: -1.8%, 7.0%]) which supports the non-inferiority of goserelin 10.8 mg to goserelin 3.6 mg at the prespecified -15% margin based on previously published oncology trials. In evaluating time to discontinuation, this study also found that more patients remained on goserelin 10.8 mg than 3.6 mg at years 1 and 2 post treatment initiation (51.2% vs. 39.6% and 32.4% vs. 23.1%, respectively), supporting previously published data in a separate real-world evidence analysis of breast cancer patients receiving goserelin 10.8 mg. 2 “Ovarian function suppression (OFS) with gonadotropin-releasing hormone agonists (GnRHas) is an essential component of therapy for a large proportion of pre- or perimenopausal women with hormone-sensitive breast cancer,” said Kelly E. McCann, M.D., Ph.D., assistant clinical professor of medicine at the UCLA Health David Geffen School of Medicine. “ZOLADEX 3.6 mg given every 4 weeks is the only FDA-approved GnRHa for women with breast cancer. Our data suggests that the 10.8 mg dose given every 12 weeks may also be an effective option.” U.S. INDICATIONS ZOLADEX 3.6 mg and ZOLADEX 10.8 mg are indicated for: Management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate in combination with flutamide. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Palliative treatment of advanced carcinoma of the prostate. ZOLADEX 3.6 mg is also indicated for: Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months. Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding. Palliative treatment of advanced breast cancer in pre- and perimenopausal women. IMPORTANT SAFETY INFORMATION Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients with a known hypersensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX. ZOLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with ZOLADEX treatment. ZOLADEX should not be given to women with undiagnosed abnormal vaginal bleeding. Pregnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking ZOLADEX. Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy. Transient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of breast cancer, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare. Hyperglycemia and an increased risk of developing diabetes or worsening of glycemic control in patients with diabetes have been reported in men receiving GnRH agonists like ZOLADEX. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice. Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists like ZOLADEX in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice. Hypercalcemia has been reported in some breast cancer patients with bone metastases after starting treatment with ZOLADEX. If hypercalcemia does occur, appropriate treatment measures should be initiated. Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with GnRH agonist analogues. ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation. GnRH agonists may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes. Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX. Extra care should be taken when administering ZOLADEX to patients with low BMI and/or to patients receiving full dose anticoagulation. Depression may occur or worsen in women receiving GnRH agonists. Treatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment. Data suggest a possibility of partial reversibility. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients. In women, the most frequently reported adverse reactions were related to hypoestrogenism. The adverse reaction profile was similar for women treated for breast cancer, dysfunctional uterine bleeding, and endometriosis. The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometriosis were: hot flashes (96%), vaginitis (75%), headache (75%), decreased libido (61%), emotional lability (60%), depression (54%), sweating (45%), acne (42%), breast atrophy (33%), seborrhea (26%), and peripheral edema (21%). The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometrial thinning were: vasodilation/hot flashes (57%), headache (32%), sweating (16%), and abdominal pain (11%). The most commonly reported adverse reactions with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), and malaise/fatigue/lethargy (5%). Injection site reactions were reported in less than 1% of patients. For ZOLADEX 3.6 mg: Hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%). For ZOLADEX 10.8 mg: Hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%). In the locally advanced carcinoma of the prostate clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone. Please see Full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg . You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/safety/medwatch or call 1-800-FDA-1088. You can also contact TerSera Therapeutics at 1-844-334-4035 or medicalInformation@tersera.com . About HR-positive breast cancer Breast cancer is the second most commonly diagnosed cancer and one of the leading causes of cancer-related deaths worldwide. 3 In the United States, over 310,000 women will be diagnosed with breast cancer this year; 40,000 will be under the age of 50. 4 Approximately 75% of diagnosed cases in women under age 50 are considered to be hormone positive (HR+) breast cancer. Compared to older women, young women generally face more aggressive cancers and lower survival rates. 5-7 Recent studies have shown that breast cancer before age 40 differs biologically from the cancer faced by older women. 6,7 About ZOLADEX® (goserelin implant) ZOLADEX is an injectable luteinizing hormone-releasing hormone agonist (LHRHa) used to treat prostate cancer, breast cancer, and certain benign gynecological disorders. First approved in the U.S. in 1989, ZOLADEX is available as a 3.6 mg implant dosed every 28 days or as a 10.8 mg implant dosed every 12 weeks. Worldwide, ZOLADEX 3.6 mg is approved for use in breast cancer in 125 countries. ZOLADEX 10.8 mg is approved for use in breast cancer in over 60 countries. About TerSera Therapeutics TerSera Therapeutics is a biopharmaceutical company with a focus in oncology and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. TerSera has been recognized as a 2024 Top Workplace. For additional information, please visit TerSera.com and follow us on LinkedIn . References McCann KE, Osman N, Cannon, J, et al. Real-world outcomes comparing 3-monthly with monthly goserelin implant in premenopausal women with breast cancer. Poster presented at: San Antonio Breast Cancer Symposium (SABCS); December 10-13, 2024; San Antonio, TX. Abstract #SESS-672; Poster ID: P1-08-09. McCann KE, Kaklamani V, Osman N, et al. Treatment patterns of goserelin 3.6 mg once monthly and 10.8 mg every three months in women with breast cancer: a real-world analysis. Poster presented at: American Society of Clinical Oncology (ASCO) Quality Care Symposium; September 27-28, 2024; San Francisco, CA. Abstract #391; Poster Session B Poster F19. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin . 2024;74(3):222-263. doi: 10.3322/caac.21834. National Cancer Institute. Surveillance, Epidemiology and End Results Program. Cancer stat facts: female breast cancer subtypes. https://seer.cancer.gov/statfacts/html/breast-subtypes.html . Accessed December 5, 2024. Varella L, Rosenberg S. Breast cancer disparities related to young age at diagnosis. Curr Breast Cancer Rep. 2022;14(3):174-179. doi:10.1007/s12609-022-00459-x. Tesch ME, Partridge AH. Treatment of breast cancer in young adults. Am Soc Clin Oncol Educ Book. 2022;42:795-803. doi:10.1200/EDBK_360970. Guzmán-Arocho YD, Rosenberg SM, Garber JE, et al. Clinicopathological features and BRCA1 and BRCA2 mutation status in a prospective cohort of young women with breast cancer. Br J Cancer . 2022;126(2):302-309. doi:10.1038/s41416-021-01597-2 . ZOLADEX® is a registered trademark of AstraZeneca or its affiliates and is used herein under license. ©2024 TerSera Therapeutics LLC. All rights reserved.

Clinical ResultDrug ApprovalASCORadiation Therapy

20 Jun 2024

·www.prnewswire.com

Polycystic Ovarian Syndrome Market to Advance at Moderate CAGR During the Study Period (2020-2034) | DelveInsight

According to DelveInsight's estimates, the increasing prevalence of diabetes, obesity, hormonal disorders, socioeconomic factors, changes in sedentary lifestyle, and growing consumption of unhealthy diets among women, is expected to fuel the polycystic ovary syndrome market. LAS VEGAS, June 20, 2024 /PRNewswire/ -- DelveInsight's Polycystic Ovarian Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, polycystic ovarian syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Polycystic Ovarian Syndrome Market Report According to DelveInsight's analysis, the market size for polycystic ovarian syndrome is expected to grow significantly by 2034. According to the data provided by the Centers for Disease Control and Prevention (CDC), PCOS is one of the most common causes of female infertility, affecting 6% to 12% of US women of reproductive age. According to the data published by NHS, PCOS is thought to be very common, affecting about 1 in every 10 women in the UK. Leading polycystic ovarian syndrome companies such as Spruce Biosciences, and others are developing novel polycystic ovarian syndrome drugs that can be available in the polycystic ovarian syndrome market in the coming years. The promising polycystic ovarian syndrome therapies in the pipeline include Tildacerfont, among others. Discover which therapies are expected to grab the major polycystic ovarian syndrome market share @ Polycystic Ovarian Syndrome Market Report Polycystic Ovarian Syndrome Overview Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in women, presenting a variety of signs, symptoms, and phenotypes. These can include reproductive, endocrine, and metabolic changes. PCOS is marked by dysfunction of the hypothalamic–pituitary–ovary axis and anovulation. Unlike other ovulatory failures characterized by inadequate ovarian follicle growth or suppressed gonadotropin secretion, PCOS usually involves androgen excess and subtle changes in serum levels of gonadotropins and estrogens that routine tests may not detect. The exact cause of PCOS remains unclear, but many women with the condition exhibit insulin resistance. Elevated insulin levels can lead to increased androgen production. Obesity can also raise insulin levels, exacerbating PCOS symptoms. PCOS often runs in families. Symptoms of PCOS may include missed or irregular periods, very light periods, enlarged ovaries or those with many cysts, excessive body hair (hirsutism) on the chest, stomach, and back, weight gain, particularly around the abdomen, acne or oily skin, and infertility. Polycystic Ovarian Syndrome Epidemiology Segmentation The polycystic ovarian syndrome epidemiology section provides insights into the historical and current polycystic ovarian syndrome patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The polycystic ovarian syndrome market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Polycystic Ovarian Syndrome Diagnosed Prevalent cases of Polycystic Ovarian Syndrome Treatable Cases of Polycystic Ovarian Syndrome Polycystic Ovarian Syndrome Treatment Market The primary goal of treating polycystic ovarian syndrome is to manage symptoms and lower the risk of long-term complications. Presently, most treatments target the patient's main concern. The focus of treatment is on alleviating symptoms of hyperandrogenism, regulating menstrual cycles, and facilitating conception. Maintaining a healthy weight by following a balanced diet and engaging in regular exercise can enhance insulin sensitivity and help regulate menstrual cycles in individuals with PCOS who are overweight or obese. Incorporating complex carbohydrates, lean proteins, and plenty of vegetables into the diet can be advantageous. Some women with PCOS might find a low-carbohydrate or low-glycemic index diet particularly beneficial. Physical activity also aids in improving insulin resistance and managing weight. Spironolactone and flutamide can help decrease excess hair growth and acne by inhibiting the effects of male hormones (androgens). While Metformin is not approved for PCOS treatment in the UK, it can be prescribed "off-label" due to its benefits for many women with PCOS who have insulin resistance. Metformin can aid in improving fertility, regulating menstrual cycles, and lowering miscarriage risks. Additionally, it offers long-term health benefits like reducing high cholesterol levels and decreasing the risk of heart disease. To know more about polycystic ovarian syndrome treatment guidelines, visit @ Polycystic Ovarian Syndrome Management Polycystic Ovarian Syndrome Pipeline Therapies and Key Companies The pipeline for PCOS is bleak with only a few companies working diligently. Of all the major market players, Spruce Biosciences is developing Tildacerfont. Tildacerfont is a CRF1 receptor antagonist developed to potentially provide significantly better disease management and reduce steroid use in patients with classic congenital adrenal hyperplasia and other conditions with elevated adrenocorticotropic hormone (ACTH) levels. It works by binding to CRF1 receptors in the pituitary gland, thereby inhibiting the overproduction of ACTH and reducing the production of adrenal androgens like androstenedione, a precursor to testosterone. Tildacerfont is typically well-tolerated in both healthy individuals and those with rare endocrine disorders. Spruce is carrying out the P.O.W.E.R. study, a randomized, placebo-controlled, dose-escalation trial to assess the safety and efficacy of tildacerfont titrated to 200 mg once daily compared to a placebo over 12 weeks in subjects with PCOS and elevated adrenal androgens, measured by baseline dehydroepiandrosterone sulfate (DHEAS) levels. PCOS is a common hormonal disorder in women of reproductive age, characterized by hirsutism, irregular menstrual cycles, infertility, and ovarian cysts. If approved, Tildacerfont could be beneficial for women with a rare form of PCOS resulting from hyperresponsiveness to adrenal androgens. Discover more about polycystic ovarian syndrome drugs in development @ Polycystic Ovarian Syndrome Clinical Trials Polycystic Ovarian Syndrome Market Dynamics The dynamics of the polycystic ovarian syndrome market are expected to change in the coming years. Rising awareness about PCOS and its associated complications, such as infertility, metabolic syndrome, and diabetes, has heightened the demand for effective diagnostic and treatment options. Advances in medical technology and diagnostics have also played a significant role, with improved imaging techniques and blood tests enabling earlier and more accurate detection of PCOS. Additionally, the growing emphasis on personalized medicine and tailored treatment regimens is fueling the market, as healthcare providers seek to offer more specific and effective therapies for managing PCOS symptoms. Furthermore, potential therapies are being investigated for the treatment of polycystic ovarian syndrome, and it is safe to predict that the treatment space will significantly impact the polycystic ovarian syndrome market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the polycystic ovarian syndrome market in the 7MM. However several factors may impede the growth of the polycystic ovarian syndrome market. One of the major challenges is the lack of standardized diagnostic criteria, which can lead to underdiagnosis or misdiagnosis, thus limiting the potential market size. Treatment adherence is another concern, as the chronic nature of PCOS often requires long-term management strategies that patients may find difficult to maintain. Furthermore, there is a need for more comprehensive and effective treatment options; current therapies primarily focus on symptom management rather than addressing the underlying causes of PCOS. Moreover, polycystic ovarian syndrome treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the polycystic ovarian syndrome market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the polycystic ovarian syndrome market growth. Scope of the Polycystic Ovarian Syndrome Market Report Therapeutic Assessment: Polycystic Ovarian Syndrome current marketed and emerging therapies Polycystic Ovarian Syndrome Market Dynamics: Key Market Forecast Assumptions of Emerging Polycystic Ovarian Syndrome Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Polycystic Ovarian Syndrome Market Access and Reimbursement Download the report to understand which factors are driving polycystic ovarian syndrome market trends @ Polycystic Ovarian Syndrome Market Trends Table of Contents Related Reports Polycystic Ovarian Syndrome Pipeline Polycystic Ovarian Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key polycystic ovarian syndrome companies, including Spruce Biosciences, Zydus Therapeutics, AbbVie, among others. Polycystic Ovarian Syndrome Epidemiology Forecast Polycystic Ovarian Syndrome Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted polycystic ovarian syndrome epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Type 2 Diabetes Pipeline Type 2 Diabetes Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key type 2 diabetes companies, including Sanofi, Eli Lilly and Company, Novartis, among others. Type 2 Diabetes Market Type 2 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 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 type 2 diabetes companies, including Eli Lilly and Company, Regor Pharmaceuticals Inc., AstraZeneca, Eccogene, Pfizer, Sciwind Biosciences USA Co., Ltd., MediciNova, Sparrow Pharmaceuticals, HighTide Biopharma Pty Ltd, Novo Nordisk A/S, Biomea Fusion Inc., Altimmune, Inc., Novartis, Amgen, Neuraly, Inc., Carmot Therapeutics, Inc., Inventiva Pharma, Inversago Pharma Inc, Applied Therapeutics, Inc. , 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

Drug Approval

05 Feb 2024

·www.biospace.com

Goserelin Dosing Options Included in the National Comprehensive Cancer Network® (NCCN) Breast Cancer Guidelines

DEERFIELD, Ill.--(BUSINESS WIRE)-- TerSera Therapeutics LLC announced today that The National Comprehensive Cancer Network® (NCCN) Breast Cancer Panel included both goserelin 3.6 mg every 4 weeks and goserelin 10.8 mg every 12 weeks, as methods for ovarian function suppression in Version 1.2024 of the Breast Guidelines revised as of January 25, 2024.1 "In addition to the 3.6 mg monthly dose, I am pleased to see that NCCN recognizes the role of goserelin 10.8 mg every 12 weeks as an option for premenopausal women with hormone receptor positive (HR+) breast cancer, ” said Virginia Kaklamani, MD, Professor of Medicine in the Division of Hematology and Medical Oncology at the University of Texas Health Sciences Center San Antonio and leader of the breast cancer program at the Mays Cancer Center, home to UT Health San Antonio MD Anderson. The inclusion of goserelin 10.8 mg every 12 weeks in the breast cancer guidelines as a method for ovarian function suppression is a category 2A recommendation. Multiple international studies have evaluated the safety and efficacy of goserelin 10.8 mg every 12 weeks for ovarian function suppression in premenopausal patients with HR+ breast cancer.2-5 In the United States, ZOLADEX® (goserelin implant) 3.6 mg is the only dosage form approved for use in breast cancer. ZOLADEX 10.8 mg is not approved by FDA for breast cancer. Please see the full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg and additional Important Safety Information below. Worldwide, ZOLADEX 3.6 mg is approved for use in breast cancer in 125 countries. Additionally, ZOLADEX 10.8 mg is approved for use in breast cancer in over 60 countries, with multiple additional regulatory reviews underway. This is the third update to NCCN guidelines regarding goserelin over the past few months related to head and neck cancers (V1.2024), ovarian cancer (V1.2024), and breast cancer (V1.2024). About ZOLADEX® (goserelin implant) ZOLADEX is an injectable luteinizing hormone-releasing hormone agonist (LHRHa) used to treat prostate cancer, breast cancer, and certain benign gynecological disorders. First approved in the U.S. in 1989, ZOLADEX is available as a 3.6 mg implant dosed every 28 days or as a 10.8 mg implant dosed every 12 weeks.6,7 U.S. INDICATIONS ZOLADEX 3.6 mg and ZOLADEX 10.8 mg are indicated for: Management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate in combination with flutamide. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Palliative treatment of advanced carcinoma of the prostate. ZOLADEX 3.6 mg is also indicated for: Management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months. Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding. Palliative treatment of advanced breast cancer in pre- and perimenopausal women. IMPORTANT SAFETY INFORMATION Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients with a known hypersensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX. ZOLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with ZOLADEX treatment. ZOLADEX should not be given to women with undiagnosed abnormal vaginal bleeding. Pregnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking ZOLADEX. Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy. Transient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of breast cancer, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare. Hyperglycemia and an increased risk of developing diabetes or worsening of glycemic control in patients with diabetes have been reported in men receiving GnRH agonists like ZOLADEX. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice. Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists like ZOLADEX in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice. Hypercalcemia has been reported in some breast cancer patients with bone metastases after starting treatment with ZOLADEX. If hypercalcemia does occur, appropriate treatment measures should be initiated. Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with GnRH agonist analogues. ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation. GnRH agonists may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes. Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, have been reported with ZOLADEX. Extra care should be taken when administering ZOLADEX to patients with low BMI and/or to patients receiving full dose anticoagulation. Depression may occur or worsen in women receiving GnRH agonists. Treatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment. Data suggest a possibility of partial reversibility. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients. In women, the most frequently reported adverse reactions were related to hypoestrogenism. The adverse reaction pro similar for women treated for breast cancer, dysfunctional uterine bleeding, and endometriosis. The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometriosis were: hot flashes (96%), vaginitis (75%), headache (75%), decreased libido (61%), emotional lability (60%), depression (54%), sweating (45%), acne (42%), breast atrophy (33%), seborrhea (26%), and peripheral edema (21%). The most commonly reported adverse reactions with ZOLADEX in clinical trials for endometrial thinning were: vasodilation/hot flashes (57%), headache (32%), sweating (16%), and abdominal pain (11%). The most commonly reported adverse reactions with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), and malaise/fatigue/lethargy (5%). Injection site reactions were reported in less than 1% of patients. For ZOLADEX 3.6 mg: Hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%). For ZOLADEX 10.8 mg: Hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%). In the locally advanced carcinoma of the prostate clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone. Please see Full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088. You can also contact TerSera Therapeutics at 1-844-334-4035 or medicalInformation@tersera.com. About TerSera Therapeutics TerSera Therapeutics is a biopharmaceutical company with a focus in oncology, acute care, and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. For more information about TerSera Therapeutics, please visit tersera.com. References NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer Version 1.2024. © National Comprehensive Cancer Network, Inc 2024. All rights reserved. [Accessed January 29, 2024]. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Noguchi S, Kim HJ, Jesena A, et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer. Breast Cancer. 2016; 23:771-779. Masuda N, Iwata H. Rai Y, et al. Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer. Breast Cancer Res Treat. 2011; 126:443-451. El Zawawy SF, Khedr G. 209P Efficacy and feasibility of long acting every three months goserelin for premenopausal breast cancer patients during COVID pandemic. Annals of Oncology. 2022;33: S631. Wu H, Bian L, Xie J, et al. 111P Goserelin 3 monthly depot is noninferior to goserelin monthly depot in the treatment of breast cancer: A real-world evidence study. ESMO Open. 2023;8(1):101335. ZOLADEX (goserelin implant) 3.6 mg prescribing information. TerSera Therapeutics LLC. ZOLADEX (goserelin implant) 10.8 mg prescribing information. TerSera Therapeutics LLC. ZOLADEX® is a registered trademark of AstraZeneca or its affiliates and is used herein under license. ©2024 TerSera Therapeutics LLC. All rights reserved.

Clinical ResultDrug ApprovalPhase 3Radiation Therapy

100 Deals associated with Flutamide

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KEGG	Wiki	ATC	Drug Bank
D00586	Flutamide	L02BB01	DB00499

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10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Cancer	Japan	Nippon Kayaku Co., Ltd.	05 Oct 1994

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02918968 (CTgov)	Phase 4	Metastatic castration-resistant prostate cancer	206	Androgen deprivation therapy+Enzalutamide+Flutamide (Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT)	gipcihzxbl(qkfsqoriff) = xtindwlrpx sutixcsygb (ibzoumsfly, anbsftditx - osngketkjl) View more	-	21 May 2021
				Androgen deprivation therapy+Enzalutamide+Flutamide (Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT)	gipcihzxbl(qkfsqoriff) = ptegvasbna sutixcsygb (ibzoumsfly, nxgvtkayvx - tpzzcctshh) View more
NCT02346578 (OCUU-CRPC, Pubmed \| Int J Clin Oncol)	Phase 2	Castration-Resistant Prostatic Cancer	103	Enzalutamide	trxjserign(enxqdvuezb) = bredytgpbz vningopjou (qcybqmaffq ) View more	Positive	01 Mar 2020
				Flutamide	trxjserign(enxqdvuezb) = fvhbflzout vningopjou (qcybqmaffq ) View more
NCT00611923 (CTgov)	Phase 4	Premenstrual Dysphoric Disorder \| Premenstrual Syndrome	115	lactose (Placebo)	sdopwwnlab(fiyiuyimgs) = rwudtwkoer kgmdxuhfxe (uzgyysbtqg, gcmswuxyhb - poyqwmfdrt) View more	-	19 Nov 2019
				Flutamide (Flutamide)	sdopwwnlab(fiyiuyimgs) = deoylqbmku kgmdxuhfxe (uzgyysbtqg, yymihpadze - tgkydeuezo) View more
ASN2019	Not Applicable	Polycystic Kidney Diseases	-	Flutamide	gyehtulitm(oyrovtrefk) = vdayzlpydz wzvwtctrqv (cswhtlzhkk ) View more	Positive	05 Nov 2019
NCT02346578 (OCUU-CRPC, ASCO2019)	Phase 2	Castration-Resistant Prostatic Cancer	103	Enzalutamide	pebhtjoitr(awrzcwrjnr) = The AEs of ENZA were consistent with those observed in prior phase 3 trials. yrlhgpfgin (ufsrsnefjl ) View more	Positive	26 May 2019
				Flutamide
NCT02346578 (OCUU-CRPC, ASCO_GU2019)	Phase 2	Castration-Resistant Prostatic Cancer Second line	104	Enzalutamide	asldvnvsdp(dbvsbbdqog): HR = 0.17 (95% CI, 0.05 - 0.47) View more	Positive	26 Feb 2019
				Flutamide
NCT02918968 \| NCT02346578 (ASCO_GU2019)	Not Applicable	Castration-Resistant Prostatic Cancer	55	Enzalutamide	ompkghjmmj(foqvgbptep): HR = 1.85 (95% CI, 0.53 - 0.64), P-Value = 0.02	Positive	26 Feb 2019
				Flutamide
NCT01428193 (CTgov)	Not Applicable	Hyperandrogenism \| Polycystic Ovary Syndrome	4	Progesterone+Flutamide+estrace	fdtecdeldj(rswnkfxrzj) = gzdwntktqh lgdbmbpyty (yvloeqxekb, vaexnaplse - amijntijuy) View more	-	04 Jun 2018
NCT00223665 (IAS, CTgov)	Phase 2	Localized Prostate Carcinoma \| Non-metastatic prostate cancer	102	Flutamide+Leuprolide Acetate	ovxygdgtlf(fcuispvqte) = nrackycmch nehrrnwooy (gaiptvplym, fmudcyphda - znsmfakjjy) View more	-	14 May 2018
NCT00005044 (CTgov)	Phase 3	Prostatic Cancer	1,579	LHRH agonist+Casodex+Eulexin (TAS x 8 Weeks)	nignakjjwj(rirwwtnjgc) = olnjjdzzjx mhabthdleu (cjtkfxfysx, hokoxklkxl - eeqfavcznu) View more	-	31 Oct 2017
				LHRH agonist+Casodex+Eulexin (TAS x 28 Weeks)	nignakjjwj(rirwwtnjgc) = kpmxxgxyko mhabthdleu (cjtkfxfysx, enmgcmtxow - edsyvevytu) View more

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