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]

NCT05050084 / RecruitingPhase 3IIT

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.

Start Date03 Nov 2021

Sponsor / Collaborator

NRG Oncology

[+1]

100 Clinical Results associated with Flutamide

100 Translational Medicine associated with Flutamide

100 Patents (Medical) associated with Flutamide

3,438

Literatures (Medical) associated with Flutamide

31 Dec 2024·Journal of medical economics

Treatment patterns and healthcare resource utilization in patients with metastatic hormone-sensitive prostate cancer and nonmetastatic castration-resistant prostate cancer in China: a real-world observational study

Article

Author: Ban, Lu ; Niu, Yuanjie ; Lu, Yongji ; Liu, Chunxiao ; Liu, Chuan ; Wang, Yong

AIM:

This study assessed the treatment patterns, healthcare resource utilization (HRU), costs, and annual prevalence and incidence of metastatic hormone-sensitive prostate cancer (mHSPC) and nonmetastatic castration-resistant prostate cancer (nmCRPC) in China.

METHODS:

A retrospective study was conducted using electronic medical records (EMR) of patients with prostate cancer from three tertiary-care hospitals in China between January 2014 and March 2021. Descriptive statistics were used to analyze study outcomes.

RESULTS:

In total, 1086 patients with mHSPC and 679 patients with nmCRPC were included. From 2015 to 2020, the annual percentage of prevalent and incident cases of mHSPC decreased from 22.4% to 20.0% and 11.1% to 6.9%, respectively; for nmCRPC, these increased from 3.8% to 13.6% and 3.3% to 8.4%. Androgen-deprivation therapy and first-generation antiandrogens (bicalutamide or flutamide) were the most frequently prescribed prostate cancer-related medications at baseline and follow-up in patients with mHSPC. Bicalutamide was the most frequently prescribed prostate cancer-related medication during follow-up in patients with nmCRPC. For mHSPC, inpatient admission costs were the highest, with the median (interquartile range) costs per person-month being USD 403.00 (USD 85.50-1226.20), whereas outpatient visit costs were the highest for nmCRPC (USD 372.60 [USD 139.50-818.50]).

LIMITATIONS:

EMR-based study design did not capture treatment patterns, HRU and associated costs, and healthcare encounters that occurred outside of participating hospitals, which could have led to underestimation of the true disease burden.

CONCLUSIONS:

A contrasting trend of a decline in the prevalence and incidence of mHSPC and an increase in these for nmCRPC was observed between 2015 and 2020 in China. Androgen-deprivation therapy and first-generation antiandrogens were the most frequently prescribed prostate cancer-related medications. Healthcare resource utilization was driven by inpatient costs in mHSPC and outpatient costs in nmCRPC.

01 Dec 2024·PHYTOMEDICINE

Forsythoside A mitigates osteoarthritis and inhibits chondrocyte senescence by promoting mitophagy and suppressing NLRP3 inflammasome via the Nrf2 pathway

Article

Author: Deng, Zengfa ; Kang, Yan ; Long, Dianbo ; Li, Changzhao ; Lin, Zhencan ; Li, Ming ; Zhong, Yanlin ; Mao, Guping ; Li, Wei

BACKGROUND:

Chondrocyte senescence and inflammation are hallmarks of osteoarthritis (OA). Forsythiaside A (FTA), a phenylethanol glycoside isolated from air-dried fruits of Forsythia, has been reported to have significant anti-inflammatory and antioxidant properties. However, its protective effects against OA have not been elucidated.

PURPOSE:

We explored the therapeutic efficacy of FTA in inhibiting chondrocyte senescence and inflammation during OA, as well as the potential underlying mechanisms.

STUDY DESIGN:

This study aimed to investigate the novel mechanism of FTA in alleviating OA in both cell and animal models.

METHODS:

The protective effect of FTA against tert‑butyl hydroperoxide-induced chondrocyte damage was assessed, and the effects of FTA on cartilage aging and OA progression were evaluated using a medial meniscus (DMM)-induced knee OA mouse model. The regulatory effects of FTA on the NLRP3 Inflammasome, mitophagy, and the PKC/Nrf2 pathway were also explored.

RESULTS:

In vitro, FTA improved mitochondrial function, enhanced mitophagy, suppressed NLRP3 inflammasome activation, and inhibited chondrocyte senescence; however, these chondroprotective effects were partially reversed after mitophagy inhibition, NLRP3 inflammasome activation, and Nrf2 pathway inhibition. Furthermore, we found that FTA directly interacts with Nrf2 and enhances its phosphorylation by protein kinase C (PKC). In vivo, FTA attenuated the pathological signs of knee OA in a DMM-model mouse model, which was partially reversed by ML385.

CONCLUSION:

FTA inhibited chondrocyte senescence and OA progression by activating the PKC-Nrf2 pathway. Thus, FTA is a potential novel therapeutic agent for OA.

01 Nov 2024·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Androgen receptor regulates the differentiation of myoblasts under cyclic mechanical stretch and its upstream and downstream signals

Article

Author: Hu, Jing ; Qian, Zhenyu ; Fu, Shaoting ; Wang, Gang ; Wang, Xiaohui

Our previous studies have demonstrated the important roles of androgen receptor (AR) in myoblast proliferation regulated by 15 % (mimic appropriate exercise) and 20 % (mimic excessive exercise) mechanical stretches. Except for myoblast proliferation, differentiation is also an important factor affecting muscle mass and strength. But the role of AR in stretch-regulated myoblast differentiation and AR's upstream and downstream signals remain unknown. In the present study, firstly the differences of myogenic differentiation between C2C12 (with AR expression) and L6 (without AR expression) myoblasts induced by 15 % and 20 % mechanical stretches were compared; secondly, AR antagonist flutamide and AR agonist GTx-007 were used in 15 % and 20 % stretched myoblasts respectively to confirm AR's roles in stretch-regulated myoblast differentiation; thirdly, RNA-seq, molecular dynamic simulation (MD) and co-immunoprecipitation were performed to screen the downstream and upstream molecules of AR during stretches. We found that (1) 15 % stretch increased while 20 % stretch decreased myotube number in differentiating C2C12 and L6 myoblasts, with more significant changes in C2C12 cells than L6 cells; (2) in stretched C2C12 myoblasts, AR antagonist flutamide inhibited 15 % stretch-promoted differentiation while AR agonist GTx-007 reversed 20 % stretch-inhibited differentiation (reflected by changes in myotube number, MHC contents of fast-twitch and slow-twitch fiber, and the levels of myogenic regulatory factors (MRFs) such as MyoD and myogenin); (3) KEGG analysis of RNA-seq showed that the differently expressed genes (DEGs) in C2C12 cells induced by 15 % stretch were enriched in FoxO and JAK-STAT signaling pathways, while DEGs by 20 % stretch were enriched in FoxO and MAPK signaling pathways; (4) MD and co-immunoprecipitation showed that β1 integrin could interact with AR and influence AR's activity in C2C12 cells. In conclusion, AR plays important roles in myoblast differentiation promoted by 15 % stretch while inhibited by 20 % stretch, which was fulfilled through FoxO-MRFs. In addition, α7β1 integrin may be a bridge linking mechanical stretch and AR. This study is beneficial to deeply understand the roles and mechanisms of AR in stretch-regulated muscle mass and strength; and reports firstly that myoblasts sense mechanical stimulus and transmit into intracellular AR via α7β1 integrin.

News (Medical) associated with Flutamide

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

24 Oct 2023

·www.prnewswire.com

GOSERELIN INCLUDED IN THE NATIONAL COMPREHENSIVE CANCER NETWORK® (NCCN) HEAD AND NECK CANCERS GUIDELINES

DEERFIELD, Ill., Oct. 24, 2023 /PRNewswire/ -- TerSera Therapeutics LLC announced today that The National Comprehensive Cancer Network® (NCCN) Head and Neck Cancers Panel included a category 2B recommendation for goserelin as useful, in certain circumstances, for recurrent, unresectable, or metastatic salivary gland tumors (with no surgery or radiation therapy option) in Version 1.2024 of the Head and Neck Cancers Guidelines released on October 9, 2023.1 "The NCCN Head and Neck Cancers Panel has recognized goserelin as an option for patients with recurrent, unresectable, or metastatic salivary gland tumors," said Nancy Martin, MD, PharmD, Chief Medical Officer at TerSera. This recommendation is based on results from two Phase 2 clinical studies and a retrospective analysis evaluating the use of goserelin in combination with either antiandrogens or immunotherapy. The use of ZOLADEX® (goserelin implant) in patients with salivary gland carcinoma is investigational, and ZOLADEX has not been approved by the U.S. FDA for this use. In a Phase 2 study, 31 patients with far locally advanced or recurrent/metastatic and androgen receptor-expressing salivary gland carcinoma were treated with apalutamide 240 mg daily with goserelin 3.6 mg monthly.2 Although this study did not meet the predefined criteria of efficacy (overall response rate), clinically meaningful activity (clinical benefit rate and disease control rate of 50% and 70.8%, respectively) along with well-tolerated safety profile of apalutamide with goserelin was shown in 26 response-evaluable patients. In the second Phase 2 study, 9 patients with incurable recurrent or metastatic salivary gland carcinoma with at least 20% of tumor cells expressing androgen receptors were treated with goserelin 3.6 mg monthly and pembrolizumab 200 mg every 3 weeks.3 The study concluded that the combination of goserelin and pembrolizumab was well-tolerated and showed preliminary evidence of efficacy in the first stage of the trial given that 2/9 patients had a partial response and 6/9 stable disease for a clinical benefit rate of 88%. In a retrospective study, 35 patients who received androgen deprivation therapy were treated with bicalutamide 150 mg once daily or the combination of bicalutamide 50 mg once daily with goserelin 3.6 mg monthly.4 It was concluded that goserelin in androgen receptor-positive salivary duct carcinoma can be recommended given its response, clinical benefit, and median overall survival benefit as compared with patients treated with best supportive care. ZOLADEX has not been approved by any regulatory agency for the treatment of salivary gland carcinoma. Its safety and efficacy have not been established for this indication. Please see the full Prescribing Information for ZOLADEX 3.6mg and ZOLADEX 10.8mg and additional Important Safety Information below. About ZOLADEX® (goserelin implant) ZOLADEX is an injectable luteinizing hormone-releasing hormone agonist, used to treat prostate cancer, breast cancer, and certain benign gynecological disorders. First approved in the US 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.5,6 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 or call 1-800-FDA-1088. You can also contact TerSera Therapeutics at 1-844-334-4035 or [email protected]. 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 . References NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Head and Neck Cancers Version 1.2024. © National Comprehensive Cancer Network, Inc 2023. All rights reserved. [Accessed October 12, 2023]. 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. Honma Y, Monden N, Yamazaki K, et al. Yatagarasu: A single-arm, open-label, phase 2 study of apalutamide (APA) plus goserelin (GOS) for patients (Pts) with far locally advanced or recurrent/metastatic (FLa/RM) and androgen receptor (AR)-expressing salivary gland carcinoma (SGC). JCO. 2022;40(16_suppl):6079-6079. Patel M, Fujioka N, Pease DF, et al. BTCRC-HN17-111, A phase 2 trial of ADT (Goserelin) in combination with pembrolizumab for patients with advanced salivary gland tumors expressing androgen receptor (Ar). JCO. 2022;40(16_suppl): e18091-e18091. Boon E, van Boxtel W, Buter J, et al. Androgen deprivation therapy for androgen receptor-positive advanced salivary duct carcinoma: A nationwide case series of 35 patients in The Netherlands. Head & Neck. 2018;40(3):605-613. 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. ©2023 TerSera Therapeutics LLC. All rights reserved. For more information: Mark Leonard [email protected] 847-651-9682 SOURCE TerSera Therapeutics LLC

Clinical ResultPhase 2Drug ApprovalRadiation TherapyImmunotherapy

100 Deals associated with Flutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D00586	Flutamide	L02BB01	DB00499

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Cancer	US	Schering Corp.	27 Jan 1989

Clinical Result

Indication

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Evaluation

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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)	tzdftbnntg(ibvwnuwhtc) = aeobjmzpwx dpmgqpvmig (owzuteontk, acsaujjqid - tlphhvktwy) View more	-	21 May 2021
				Androgen deprivation therapy+Enzalutamide+Flutamide (Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT)	tzdftbnntg(ibvwnuwhtc) = gpprhsmfir dpmgqpvmig (owzuteontk, ypqcztitkb - irakaknhca) View more
NCT00611923 (CTgov)	Phase 4	Premenstrual Dysphoric Disorder \| Premenstrual Syndrome	115	lactose (Placebo)	crkknwxafw(qcqoxaarpl) = csrklplnbb ccqdqjpjem (qcodomrkjw, yufxsespms - kqugpztmpj) View more	-	19 Nov 2019
				Flutamide (Flutamide)	crkknwxafw(qcqoxaarpl) = ndprrwilzx ccqdqjpjem (qcodomrkjw, vvoasofngs - jsbmvorkif) View more
ASN2019	Not Applicable	Polycystic Kidney Diseases	-	Flutamide	gmaxxymgia(neopvxmewl) = jsrsisbmva xpubssyllt (hbwpsesytg ) View more	Positive	05 Nov 2019
NCT01428193 (CTgov)	Not Applicable	Androgen excess \| Polycystic Ovary Syndrome	4	Progesterone+Flutamide+estrace	unmqdgitbe(ewtbszkmty) = bnekfvymcw mlvmdbwpes (tqqoxugqny, hzlyazadey - bszpretjhb) View more	-	04 Jun 2018
NCT00223665 (IAS, CTgov)	Phase 2	Localized Prostate Carcinoma \| Non-metastatic prostate cancer	102	Flutamide+Leuprolide Acetate	rcrkjnintp(dhyzophevt) = wvixthwsnd uqahtswszq (xlrimrmvnq, ngmamvqpsf - gvfzjsqlhe) View more	-	14 May 2018
NCT00005044 (CTgov)	Phase 3	Prostatic Cancer	1,579	LHRH agonist+Casodex+Eulexin (TAS x 8 Weeks)	gfdgmrombk(pzjadcdqxf) = oirlxxazji avgqpkrrkc (elpdwvpsld, ylpxraqtrm - hzizduszaz) View more	-	31 Oct 2017
				LHRH agonist+Casodex+Eulexin (TAS x 28 Weeks)	gfdgmrombk(pzjadcdqxf) = jyrlrwjlku avgqpkrrkc (elpdwvpsld, gjskgdnwjm - krcsyxshvd) View more
NCT00528866 (RTOG 0621, CTgov)	Phase 2	Prostatic Cancer	80	3-dimensional conformal radiation therapy+Docetaxel+bicalutamide+flutamide	ovocwegcak(vsslhyptry) = jbmuumhtth schpvnfswj (emciflezml, elohhawpih - wmknyofidz) View more	-	06 Jun 2017
ASCO_GU2016	Not Applicable	Metastatic castration-resistant prostate cancer Second line	65	flutamide (Low risk group (0-2 risk factors present))	vpuilvdztq(kpwtkquzgu) = eespqpltnd vhfzzxvegd (fruqrqjbuu )	Positive	10 Jan 2016
				flutamide (High risk group (3-4 risk factors present))	vpuilvdztq(kpwtkquzgu) = xwgxmprvmh vhfzzxvegd (fruqrqjbuu )
NCT00442689 (CTgov)	Not Applicable	Metabolic Syndrome \| Polycystic Ovary Syndrome	97	ethinyl estradiol+drospirenone (Oral Contraceptive - 1)	lghzapheww(kummhncblq) = ltzylfjcvo dcavcktlfv (wpniljwwaq, jdlwjkrfyf - pgwgkenddf) View more	-	06 Jun 2014
				Flutamide - 2 (Flutamide - 2)	lghzapheww(kummhncblq) = pdgqkdrjpy dcavcktlfv (wpniljwwaq, tbblbwgkcd - cnhmqleuju) View more
NCT00388804 (CTgov)	Phase 3	Prostatic Cancer	39	Questionnaire (RT Group 1)	ameyhlsmlj(cfkoyxcake) = mbqovcplsf dshbhyawvf (njrxstekxr, zawemwcoiu - ynoommgluq) View more	-	08 Aug 2012
				Questionnaire+bicalutamide+Flutamide+leuprolide+Goserelin (RT Group 2 + Hormone Therapy)	ameyhlsmlj(cfkoyxcake) = qxabvnocck dshbhyawvf (njrxstekxr, kbqgyswzja - riwibyjznu) View more

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