This is a multicenter open-label, pilot study to evaluate the safety and tolerability of bromocriptine, a dopamine D2/D3 receptor and serotonin 5-HT2C receptor agonist, as an adjunct to preexisting standard-of-care antipsychotic drug (APD) regimens in the management of APD-associated impaired glucose tolerance (IGT)/insulin resistance (IR). The ultimate aim of the study team is to evaluate the efficacy of bromocriptine in treating the metabolic disturbances associated with APDs and the hypothesis is that bromocriptine will be a well-tolerated, safe, and inexpensive way to ameliorate these metabolic complications and prevent or delay the onset of type 2 diabetes (T2D). This study will be a small, short-duration pilot focusing on safety and tolerability. A total of 15 psychiatrically stable APD-treated adult outpatients, VA Pittsburgh , aged 18 to 65 years old, with a confirmed diagnosis of schizophrenia and comorbid IGT will be recruited and receive 6 weeks of bromocriptine (flexibly titrated, 2.5-5.0 mg PO daily). Key inclusion criteria are: 1) currently being treated with second generation APDs for 3 or more months with no change in dose in the 1 month prior to enrollment, 2) fasting glucose 100 to 125mg/dL and/or hemoglobin A1c (HbA1c) 5.7-6.4%. Key exclusions are: 1) prior APD nonadherence, 2) drug/alcohol abuse in the 3 months prior to screening, 3) a history of violent behavior/psychoses, 4) pregnancy, or 5) a diagnosis of diabetes. Subjects on other dopamine agonists or on medications that may interact with bromocriptine and those taking corticosteroids or other medications that may alter glucose levels will be excluded. The purposes of the study are to demonstrate safety/tolerability, demonstrate feasibility, provide proof of concept, and provide an open-label assessment of the metabolic and psychiatric effects of bromocriptine in patients with schizophrenia treated with APDs. The primary metabolic outcome measures will be change in IR as measured by the HOMA-IR and change in IGT measured by HbA1c. Secondary metabolic outcome measures include body weight, fasting lipids, and prolactin. The specific aims are as follows: Specific aim 1: To establish the safety and tolerability of bromocriptine in patients with schizophrenia and IGT/IR treated with APDs. Specific aim 2: To demonstrate feasibility/proof of concept for an improvement in APD-induced IGT/IR with bromocriptine.

Start Date01 Jul 2024

Sponsor / Collaborator

Va Pittsburgh Healthcare System

CTR20241736 / Active, not recruitingNot Applicable

甲磺酸溴隐亭片在健康受试者餐后状态下进行的随机、开放、单中心、单剂量、四周期、两序列、完全重复交叉的生物等效性试验

[Translation] A randomized, open-label, single-center, single-dose, four-period, two-sequence, completely repeated crossover bioequivalence study of bromocriptine mesylate tablets in healthy volunteers in the fed state

主要研究目的：在健康受试者体内，餐后状态下，以Bridging Pharma GmbH持证的甲磺酸溴隐亭片（商品名：Parlodel ®，规格：2.5 mg（以溴隐亭（C32H40BrN5O5）计））为参比制剂，研究北京福元医药股份有限公司研制的甲磺酸溴隐亭片（受试制剂，规格：2.5 mg（以溴隐亭（C32H40BrN5O5）计））的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main study objectives: In healthy subjects, in the postprandial state, using the bromocriptine mesylate tablets (trade name: Parlodel ®, specification: 2.5 mg (calculated as bromocriptine (C32H40BrN5O5)) certified by Bridging Pharma GmbH as the reference preparation, to study the absorption rate and extent of bromocriptine mesylate tablets (test preparation, specification: 2.5 mg (calculated as bromocriptine (C32H40BrN5O5)) developed by Beijing Fuyuan Pharmaceutical Co., Ltd., and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary study objectives: Observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date15 May 2024

Sponsor / Collaborator

Beijing Winsunny Pharmaceutical Co., Ltd.

NCT06250257 / RecruitingPhase 3IIT

Effectiveness of Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age: A Hospital-Based Randomized Open Label Clinical Trial

Dilated cardiomyopathy (DCM) is a condition associated with Left and /or right ventricular (LV) dilatation and systolic dysfunction without coronary artery disease or abnormal loading circumstances proportionate to the severity of LV impairment. It is one of the leading causes of heart failure in younger adults, often requiring cardiac transplantation, and is caused by various factors, including myocarditis, alcohol, drug, and metabolic disturbances. About 35% of patients have genetic mutations affecting cytoskeletal, sarcomere, and nuclear envelope proteins. The prognosis depends on the severity and heart remodeling, with the worst outcomes in patients with low ejection fractions or severe diastolic dysfunction.
Although it is more common in men, DCM also occur in women, and hence hormonal factors can play a role in the development of DCM in women. Bromocriptine has been suggested as a potential treatment option. Bromocriptine is a dopamine agonist that is primarily used to treat conditions such as hyperprolactinemia, and acromegaly. However, it has also been studied in the context of heart failure, and some studies have suggested that it may be beneficial in women with Peripartal cardiomyopathy (PPCM), a form of DCM that occurs in the last month of pregnancy or up to five months postpartum.
The mechanism by which bromocriptine may improve left ventricular function in DCM is not fully understood, but it is thought to be related to its ability to reduce prolactin levels. Prolactin is a hormone that has been shown to be elevated in some cases of DCM, and it may contribute to the development and progression of the condition. To date, the use of bromocriptine is recommended for the treatment of pregnancy-related cardiomyopathy (PPCM) due to a significant increase in prolactin levels. However, prolactin level may increase during menstrual cycles of reproductive-age women, which candidates the use of bromocriptine in women of all reproductive ages. The aims of this study is to assess the use of bromocriptine in terms of LV function improvement, overall improvement of heart failure symptoms and reduced mortality and improved quality of life, in dilated cardiomyopathy among women of reproductive age.

Start Date01 Dec 2023

Sponsor / Collaborator

Jimma University

100 Clinical Results associated with Bromocriptine Mesylate

100 Translational Medicine associated with Bromocriptine Mesylate

100 Patents (Medical) associated with Bromocriptine Mesylate

7,860

Literatures (Medical) associated with Bromocriptine Mesylate

01 May 2024·Neural regeneration research

Bromocriptine protects perilesional spinal cord neurons from lipotoxicity after spinal cord injury.

Article

Author: Xu, Nixi ; Jiang, Chang ; Peng, Ying ; Li, Zhuoxuan ; Chen, Yinglun ; Lin, Haodong ; Cao, Yuanwu ; Zhang, Zhiyang ; Chen, Zixian ; Wang, Renyuan

Recent studies have revealed that lipid droplets accumulate in neurons after brain injury and evoke lipotoxicity, damaging the neurons. However, how lipids are metabolized by spinal cord neurons after spinal cord injury remains unclear. Herein, we investigated lipid metabolism by spinal cord neurons after spinal cord injury and identified lipid-lowering compounds to treat spinal cord injury. We found that lipid droplets accumulated in perilesional spinal cord neurons after spinal cord injury in mice. Lipid droplet accumulation could be induced by myelin debris in HT22 cells. Myelin debris degradation by phospholipase led to massive free fatty acid production, which increased lipid droplet synthesis, β-oxidation, and oxidative phosphorylation. Excessive oxidative phosphorylation increased reactive oxygen species generation, which led to increased lipid peroxidation and HT22 cell apoptosis. Bromocriptine was identified as a lipid-lowering compound that inhibited phosphorylation of cytosolic phospholipase A2 by reducing the phosphorylation of extracellular signal-regulated kinases 1/2 in the mitogen-activated protein kinase pathway, thereby inhibiting myelin debris degradation by cytosolic phospholipase A2 and alleviating lipid droplet accumulation in myelin debris-treated HT22 cells. Motor function, lipid droplet accumulation in spinal cord neurons and neuronal survival were all improved in bromocriptine-treated mice after spinal cord injury. The results suggest that bromocriptine can protect neurons from lipotoxic damage after spinal cord injury via the extracellular signal-regulated kinases 1/2-cytosolic phospholipase A2 pathway.

01 Feb 2024·Physical medicine and rehabilitation clinics of North America

Pharmacology in Treatment of Patients with Disorders of Consciousness

Review

Author: Marino, Michael H

Pharmacologic treatment of disorders of consciousness remains a critical but challenging task for clinicians. Amantadine has been shown to promote the rate of neurologic recovery for patients with traumatic disorders of consciousness when administered between 4 and 16 weeks, as demonstrated by a well-designed randomized control trial. While there are no large, randomized controlled trials to support the use of other dopaminergic medicines (bromocriptine, levodopa, apomorphine), there is a large body of literature implicating their role in improving alertness and responsiveness in disorders of consciousness. Zolpidem can increase the level of consciousness in a small subset of patients. Zolpidem and intrathecal baclofen likely increase the level of consciousness via the mesocircuit pathway. Psychostimulant medications can be initiated in patients, even without strong evidence to support their use, as long as basic principles of brain injury medicine are followed, and there are systems in place to evaluate therapeutic response.

Endocrine

Subcutaneous adipose tissue dopamine D2 receptor is increased in prediabetes and T2D

Article

Author: Kristófi, Robin ; Svensson, Maria K ; Vranic, Milica ; Hetty, Susanne ; Pereira, Maria J ; Mokhtari, Dariush ; Ahmed, Fozia ; Eriksson, Jan W

Abstract:

Purpose:

To evaluate the dopaminergic signaling in human adipose tissue in the context of obesity and type 2 diabetes (T2D) and potential direct implications in adipose tissue metabolism.

Methods:

mRNA and protein expression of dopamine receptors D1 and D2 (DRD1 and DRD2) were determined in subcutaneous adipose tissue from subjects without or with T2D and with different body weight, and correlated with markers of obesity, hyperglycemia, and insulin resistance. Glucose uptake and lipolysis were measured in adipocytes ex vivo following short-term exposure to dopamine, DRD1 receptor agonist (SKF81297), or DRD2 receptor agonist (bromocriptine).

Results:

DRD1 and DRD2 gene expression in subcutaneous adipose tissue correlated positively with clinical markers of insulin resistance (e.g. HOMA-IR, insulin, and triglycerides) and central obesity in subjects without T2D. Protein expression of DRD2 in subcutaneous adipose tissue, but not DRD1, is higher in subjects with impaired fasting glucose and T2D and correlated positively with hyperglycemia, HbA1c, and glucose AUC, independent of obesity status. DRD1 and DRD2 proteins were mainly expressed in adipocytes, compared to stromal vascular cells. Dopamine and dopaminergic agonists did not affect adipocyte glucose uptake ex vivo, but DRD1 and DRD2 agonist treatment inhibited isoproterenol-stimulated lipolysis.

Conclusion:

The results suggest that protein expression of DRD2 in subcutaneous adipose tissue is up-regulated with hyperglycemia and T2D. Whether DRD2 protein levels contribute to T2D development or occur as a secondary compensatory mechanism needs further investigation. Additionally, dopamine receptor agonists inhibit adipocyte beta-adrenergic stimulation of lipolysis, which might contribute to the beneficial effects in lipid metabolism as observed in patients taking bromocriptine.

News (Medical) associated with Bromocriptine Mesylate

14 Jun 2024

·www.globenewswire.com

Chiesi Global Rare Diseases Showcases Ongoing Commitment to Multiple Rare Diseases Communities at ENDO 2024 Meeting Debut

• Results presented from a large, pooled database from three Phase 3 clinical trials evaluating MYCAPSSA (octreotide) for the treatment of people living with acromegaly • Additional presentations provide insights into the validation of the Lipodystrophy Severity Scoring tool and the Chiesi Management of Acromegaly (MACRO) registry BOSTON, June 14, 2024 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced updates from their rare endocrine disease portfolio with two late-breaking poster presentations and one oral presentation during the Endocrine Society’s ENDO 2024 Meeting that was held June 1-4, 2024, in Boston, Massachusetts. Presentations included a post hoc analysis of three Phase 3 clinical trials (CH-ACM-01, OPTIMAL, MPOWERED) studying MYCAPSSA (octreotide) as well as real-world MYCAPSSA use data from the Chiesi Management of Acromegaly (MACRO) registry and presentation of the Lipodystrophy Severity Scoring tool designed to assess the disease burden of lipodystrophy. "We're thrilled to support this community of people living with burdensome rare endocrine diseases through the innovation of new resources and validated medicines to aid in disease management," said Giacomo Chiesi, Head of Chiesi Global Rare Diseases. "As we approach the four-year anniversary of MYCAPSSA being on the market later this month, our commitment remains steadfast to commercializing solutions for the acromegaly and lipodystrophy patient communities.” Oral PresentationTitle: Biochemical Response, Symptom Control, and Safety of Oral Octreotide Capsules Treatment in Acromegaly: A Post Hoc Analysis of a Large Pooled Database from Three Phase 3 Clinical Trials2Key Highlights: MYCAPSSA demonstrated a 72% response rate in patients entering the studies with IGF-I values of ≤ 1x the upper limit of normal. A patient’s prior dose level of injectable medication did not significantly impact response rates.In this post-hoc analysis, symptom improvement was notable with significant reductions in joint pain (36% to 22%) and swelling (15% to 10%) in patients responding to MYCAPSSA. Median decrease of one symptom per patient and a mean decrease of 0.8 in Acromegaly Index of Severity (AIS) further underscored symptom improvement.Safety analysis revealed gastrointestinal issues as the most common adverse events with a median duration and time to onset of roughly two weeks for the first occurrence and a low rate of discontinuation. Late-Breaker Poster PresentationsTitle: Real-world Biochemical And Symptoms Outcomes With Oral Octreotide: Management Of Acromegaly (MACRO) Registry Experience3Key Highlights: Of the 230 patients participating in Chiesi Management of Acromegaly (MACRO) registry, 32 (14%) received MYCAPSSA at baseline, with an additional 26 (11%) initiating post-baseline. Common reasons for initiation included patient preference and lack of symptom or biochemical control.The mean time on OOC was 19.7 months, with the majority receiving treatment for at least 6 months. Most patients remained well-controlled biochemically and symptomatically, with 87% biochemically controlled and 71% symptomatically controlled at the last follow-up.The discontinuation rate was 33% and in cases attributed to a lack of biochemical or symptom control, dose titration to 80mg/day was not implemented in many cases.Overall, OOC demonstrated efficacy in maintaining or achieving biochemical control with the majority of newly-initiated patients reporting well-controlled symptoms. Title: Lipodystrophy Severity Score: Validation Of A Tool To Assess Disease Burden In Lipodystrophy4Key Highlights: The lipodystrophy severity score (LDS) is a validated tool that captures severity in patients with diverse manifestations of lipodystrophy. The LDS allows comparisons among patient groups and changes within patients over time.The LDS is a tool designed to quantify the diverse complications of lipodystrophy, a group of rare, potentially life-threatening disorders that affect how the body accumulates and stores fat.The LDSs showed high reliability and strong correlation with the Clinical Global Impression (CGI) of severity, effectively capturing the severity of lipodystrophy and changes over time. This tool is intended to compare patient groups, and monitor individual progress with future analysis involving in real-world data sets.Development into an online platform enhances functionality – a versatile and valuable resource for the lipodystrophy community.Future work will assess the LDS using real-world datasets. MYCAPSSA IMPORTANT SAFETY INFORAMATION INDICATION AND USAGE MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. CONTRAINDICATIONS Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected. Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly. Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted. ADVERSE REACTIONS The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis. DRUG INTERACTIONS The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA. Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA. PREGNANCY Advise premenopausal females of the potential for an unintended pregnancy. Please contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About AcromegalyAcromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision, and enlargement of the hands, feet, tongue, and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders, and cardiac and cerebrovascular disease. Acromegaly affects over 25,000 people in the United States alone with roughly 8,000 being treated with injectable somatostatin receptor ligands (iSRLs). A significant percentage of these people experience burdens associated with receiving iSRLs including prolonged injection-related pain and poorly-controlled symptoms. About LipodystrophyLipodystrophy syndromes are a heterogeneous group of rare, potentially life-threatening disorders that affect how the body accumulates and stores fat. These syndromes are categorized into two main forms: generalized lipodystrophy, characterized by the near-complete absence or progressive loss of fat (adipose) tissue, and partial lipodystrophy, where the tissue loss is more limited, typically impacting areas like limbs or upper body. Lipodystrophy is also categorized by etiology with inherited and acquired forms1. About Chiesi Global Rare DiseasesChiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have a therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. For more information visit www.chiesirarediseases.com. About Chiesi GroupChiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit www.chiesi.com Garg A. Acquired and inherited lipodystrophies. N Engl J Med. 2004 Mar 18;350(12):1220-34. Doi: 10.1056/NEJMra025261. PMID: 15028826.Fleseriu M, et al. Biochemical Response, Symptom Control, and Safety of Oral Octreotide Capsules Treatment in Acromegaly: A Post Hoc Analysis of a Large Pooled Database from Three Phase 3 Clinical Trials. Presented at: Endocrine Society’s ENDO 2024 Meeting; June 1-4, 2024; Boston, Massachusetts.Yuen K, et al. Real-world Biochemical And Symptoms Outcomes With Oral Octreotide: Management Of Acromegaly (MACRO) Registry Experience. Presented at: Endocrine Society’s ENDO 2024 Meeting; June 1-4, 2024; Boston, Massachusetts.Brown R, et al. Lipodystrophy Severity Score: Validation Of A Tool To Assess Disease Burden In Lipodystrophy. Presented at: Endocrine Society’s ENDO 2024 Meeting; June 1-4, 2024; Boston, Massachusetts. Chiesi Group Media ContactChiara TravaginRare Communication ManagerTel: +39 348 8818985Email c.travagin@chiesi.com Sky Striar LifeSci CommunicationsTel: 617-797-6672Email sstriar@lifescicomms.com

Clinical ResultPhase 3

13 Jun 2024

·www.sciencedaily.com

Study hints at tools to prevent diabetes caused by psychiatric meds

New research points to a potential approach to reducing the risk of diabetes associated with widely prescribed antipsychotic medications. The study presents early evidence in support of co-administering antipsychotic medications that block dopamine receptors in the brain alongside drugs that stop antipsychotics from blocking those same receptors in the pancreas. This approach could limit metabolic side effects, including impaired control over blood sugar, or dysglycemia. New University of Pittsburgh research points to a potential approach to reducing the risk of diabetes associated with widely prescribed antipsychotic medications. The study presents early evidence in support of co-administering antipsychotic medications that block dopamine receptors in the brain alongside drugs that stop antipsychotics from blocking those same receptors in the pancreas. This approach, published today in Diabetes, could limit metabolic side effects, including impaired control over blood sugar, or dysglycemia. This research may also explain why weight control medications, including new neuropeptide drugs Wegovy and Ozempic, may not be as effective as hoped in controlling dysglycemia caused by antipsychotic drugs. Patients who are experiencing the weight gain associated with antipsychotic medications might be tempted to take these new drugs to control satiety -- but they may miss an important underlying cause of the drug-induced deglycation. "Antipsychotic medications don't just stop working below the neck," said senior author Zachary Freyberg, M.D., Ph.D., associate professor of psychiatry and cell biology at Pitt's School of Medicine. "Maintaining glucose metabolism requires the brain to be in constant communication with the rest of the body, and vice versa. Next-generation antipsychotic drugs can be modified as a new strategy to control dysglycemia and diabetes." Most prescription antipsychotic medications work by blocking the class of brain receptors that respond to a neurotransmitter called dopamine -- a cornerstone molecule of the brain's reward system and brain-directed movement control. However, the subtype of dopamine receptors that respond to antipsychotic medications, called dopamine D2 receptors, are not exclusive to the brain. As Freyberg's earlier research has shown, antipsychotic medications also block D2 receptors in the pancreas. Freyberg's dogma-breaking discovery highlighted that pancreatic dopamine plays a key role in controlling blood sugar by interacting with D2 receptors on the surface of pancreatic cells that control production and secretion of hormones insulin and glucagon. When the fragile balance between glucose-raising and -lowering hormones is destabilized by antipsychotic medications, dysglycemia and diabetes may follow. However, peripheral dopamine signaling can be harnessed for therapeutic good. In collaboration with researchers at the National Institutes of Health's National Institute on Drug Abuse (NIH NIDA), the team created a molecule that can limit antipsychotic drugs from blocking D2 receptors in organs like the pancreas, but not in the brain. This molecule, called bromocriptine methiodide, or BrMel, is structurally similar to bromocriptine -- an FDA-approved drug to treat type 2 diabetes -- but has a modification that makes it less likely to pass through the brain-blood barrier if administered systemically, therefore limiting its activity to the periphery. Early studies in mice suggest that dopamine's effects on glucose metabolism require communication between the brain and the peripheral organs including the pancreas. Experiments have shown that, unlike systemically administered bromocriptine that improves the glucose pro insulin-resistant mice, peripherally-limited BrMeI, or bromocriptine delivered directly to the brain, failed to show improvements. Drugs like BrMeI that can stop antipsychotic medications from acting on peripheral targets may therefore be useful in preventing, or even reversing, dysglycemia. Freyberg and his collaborators at Pitt are in the early stages of a safety clinical trial to ensure that the therapeutic effects of antipsychotic drugs are preserved when these psychiatric medications are administered in tandem with bromocriptine since it is already FDA approved. They hope to launch a bigger trial to test the efficacy of BrMel and similar molecules for limiting dysglycemia in the next several years. "The fact that both the brain and the body are required to maintain stable glycemic control provides a novel dimension in understanding neuropsychiatry and begins to integrate disparate pieces of knowledge about different organ systems into a coherent whole," said Freyberg. "The majority of psychiatric medications are prescribed by general practitioners and not psychiatrists," he added. "We hope that our research builds awareness about the importance of communication between the brain and the rest of the body in maintaining physiological functions and reminds clinicians that they should also consider that drugs designed to act on targets in the brain, like psychiatric medications, may also have significant actions outside of the brain when making prescription recommendations." Other authors of this research are Zachary Farino, M.S., Despoina Aslanoglou, Ph.D., and José Mantilla-Rivas, M.D., all of Pitt; Alessandro Bonifazi, Ph.D., Michael Ellenberger, J.D., Comfort Boateng, Ph.D., and Amy Hauck Newman, Ph.D., all of NIDA; Rana Rais, Ph.D., and Barbara Slusher, Ph.D., both of Johns Hopkins University; Sandra Pereira, Ph.D., and Margaret Hahn, M.D., Ph.D., both of the University of Toronto; Amy Eshleman, Ph.D., and Aaron Janowsky, Ph.D., both of the Oregon Health & Science University; and Gary Schwartz, Ph.D., of Albert Einstein College of Medicine. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

27 Feb 2023

·www.prnewswire.com

DelveInsight Evaluates a Robust Alzheimer's Disease Pipeline as 150+ Influential Pharma Players to Set Foot in the Domain

LAS VEGAS, Feb. 27, 2023 /PRNewswire/ -- The prevalence of Alzheimer's disease has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Alzheimer's disease and the growing research and development activities to develop novel therapies to treat Alzheimer's disease to drive the market. The companies developing the potential therapies in the last stage of development include Eli Lilly and Company, AB Sciences, AZTherapies, and several others. DelveInsight's ' Alzheimer's Disease Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline Alzheimer's disease therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Alzheimer's disease pipeline domain. Key Takeaways from the Alzheimer's Disease Pipeline Report DelveInsight's Alzheimer's disease pipeline report depicts a robust space with 150+ active players working to develop 160+ pipeline therapies for Alzheimer's disease treatment. Key Alzheimer's disease companies such as Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., and others are evaluating new Alzheimer's disease drugs to improve the treatment landscape. Promising Alzheimer's disease pipeline therapies in various stages of development include ALZT-OP1, Tricaprilin, Bryostatin-1, INB03, Sumifilam, Neflamapimod, Pegylated exenatide, NLY-02, Masitinib, Atuzaginstat, COR588, Blarcamesine, NDX-1017, Bromocriptine, DNL788, AL002, CMS121, LX1001, TB006, Pepinemab, Posiphen, E2814, RO7126209, IONIS MAPTRx, Brexpiprazole, CT1812, MK-1942, IBC Ab002, ABBV-916, AR1001, ORY-2001, LY3372689, MW150, EX039, SLS-005, Seltorexant, Donanemab, SHR-1707, REM0046127, ALZ-101, VT301, NE3107, PRX005, MK-6240, and others. In February 2023, Lantheus Holdings, Inc. announced it had acquired Knoxville-based Cerveau Technologies, Inc. ("Cerveau"). Cerveau's asset is MK-6240, a second-generation F 18-labeled positron emission tomography ("PET") imaging agent that targets Tau tangles in Alzheimer's disease.Under the terms of the agreement, Lantheus will pay an upfront payment and potential additional development and commercial milestone payments. Additionally, Lantheus will pay double-digit royalty payments for research revenue and commercial sales. In January 2023, Prothena Corporation plc announced positive topline Phase I single ascending dose (SAD) study results for PRX005, a potentially best-in-class investigational tri-epitopic antibody for the treatment of Alzheimer's disease that specifically binds with high affinity to the R1, R2, and R3 repeats within the microtubule binding region (MTBR) of tau and targets both 3R and 4R tau isoforms. The results of the study found all three dose level cohorts of PRX005 to be generally safe and well tolerated, meeting the Phase 1 SAD study primary objective. None of the treatment emergent adverse events (TEAE) were serious. No clinically relevant changes were observed in other safety parameters. PRX005 also met key pharmacokinetic (PK) and immunogenicity secondary endpoints. In January 2023, Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. No other deficiencies in the application were noted.The confirmatory Phase 3 TRAILBLAZER-ALZ 2 trial remains ongoing, with topline data read-out expected in Q2 2023, and will form the basis of donanemab's application for traditional approval shortly thereafter. Lilly will continue to work with the FDA to evaluate the fastest pathway to make this potential treatment option widely available to patients. In January 2023, Coya Therapeutics, Inc. announced the recent publication of an article entitled "Ex vivo expanded human regulatory T cells modify neuroinflammation in a preclinical model of Alzheimer's Disease" in the peer-reviewed journal Acta Neuropathologica Communications.Furthermore, Treg-treated mice showed a significant reduction in total and plaque-associated microglia as well as reactive astrocytes in the dentate gyrus and frontal cortex versus untreated mice. The reduction in the number of plaque-associated glial cells and suppression of pro-inflammatory signaling pathways within these cells following Treg therapy may attenuate the contribution of these toxic glial cells in AD pathology resulting in mitigation of amyloid burden. In November 2022, Eli Lilly and Company announced that donanemab met all primary and secondary endpoints for the 6-month primary outcome analysis in the Phase III TRAILBLAZER-ALZ 4 study, providing the first active comparator data on amyloid plaque clearance in patients with early symptomatic Alzheimer's disease treated with amyloid-targeting therapies. Donanemab is an investigational antibody that targets a modified form of beta-amyloid plaque called N3pG. Request a sample and discover the recent advances in Alzheimer's disease drug treatment @ Alzheimer's Disease Pipeline Report The Alzheimer's disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Alzheimer's disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Alzheimer's disease clinical trial landscape. Alzheimer's Disease Overview Alzheimer's disease (AD) is a slowly progressive brain disease that manifests itself many years before symptoms appear. It is the leading cause of dementia, accounting for 60% to 80% of cases. The accumulation of the protein fragment beta-amyloid (plaques) outside neurons in the brain and twisted strands of the protein tau (tangles) inside neurons are the hallmark pathologies of Alzheimer's disease. Alzheimer's disease is a progressive disease, so the symptoms worsen over time. Memory loss is a key feature, and it is often one of the first Alzheimer's disease symptoms to appear. The other Alzheimer's disease symptoms include cognitive deficits, problems with recognition, problems with spatial awareness, and others. A thorough clinical evaluation, a detailed patient history, and various specialized tests are used to make an Alzheimer's disease diagnosis. Clinical diagnosis, which is usually made during the early stages of the disease, lumbar puncture, and imaging studies are all methods of diagnosing Alzheimer's disease. Treatment for Alzheimer's disease includes options that may alleviate symptoms and improve quality of life. To treat cognitive symptoms, the FDA has approved two types of medications to treat cognitive symptoms: cholinesterase inhibitors (Aricept, Exelon, Razadyne) and memantine (Namenda). Other non-pharmacological therapies are also used to maintain or improve cognitive function, daily living ability, or overall quality of life. Find out more about drugs for Alzheimer's disease @ New Alzheimer's Disease Drugs A snapshot of the Alzheimer's Disease Pipeline Drugs mentioned in the report: Learn more about the emerging Alzheimer's disease pipeline therapies @ Alzheimer's Disease Clinical Trials Alzheimer's Disease Therapeutics Assessment The Alzheimer's disease pipeline report proffers an integral view of Alzheimer's disease emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Alzheimer's Disease Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Amyloid beta-protein inhibitors, Inflammation mediator inhibitors, Immunostimulants, Tumour necrosis factor alpha inhibitors, Microfilament protein modulators, Angiogenesis inhibitors, Colony stimulating factor inhibitors, Coronavirus-3C-like-proteinase inhibitors, Endopeptidase Clp inhibitors, Focal adhesion protein-tyrosine kinase inhibitors, Lyn protein-tyrosine kinase inhibitors, Macrophage colony-stimulating factor receptor modulators, Mast cell inhibitors, Platelet-derived growth factor receptor antagonists, Protein tyrosine kinase inhibitors, Proto oncogene protein c-kit inhibitors, Proto-oncogene protein c-fyn modulators, Type 3 fibroblast growth factor receptor antagonists Key Alzheimer's Disease Companies: Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., and others. Key Alzheimer's Disease Pipeline Therapies: ALZT-OP1, Tricaprilin, Bryostatin-1, INB03, Sumifilam, Neflamapimod, Pegylated exenatide, NLY-02, Masitinib, Atuzaginstat, COR588, Blarcamesine, NDX-1017, Bromocriptine, DNL788, AL002,CMS121, LX1001, TB006, Pepinemab, Posiphen, E2814, RO7126209, IONIS MAPTRx, Brexpiprazole, CT1812, MK-1942, IBC Ab002, ABBV-916, AR1001, ORY-2001, LY3372689, MW150, EX039, SLS-005, Seltorexant, Donanemab, SHR-1707, REM0046127, ALZ-101, VT301, NE3107, PRX005, MK-6240, and others. Dive deep into rich insights for new drugs for Alzheimer's disease treatment; visit @ Alzheimer's Disease Medications Table of Contents For further information on the Alzheimer's disease pipeline therapeutics, reach out @ Alzheimer's Disease Drug Treatment Related Reports Alzheimer's Disease Epidemiology Alzheimer's Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted Alzheimer's disease epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies including AZTherapies, Cerecin, Neurotrope, Lyndra, AC Immune, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, among others. Neurostimulation Devices Market Neurostimulation Devices Market Insight, Competitive Landscape, and Market Forecast – 2027 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key neurostimulation devices companies, including Medtronic PLC, Cyberonics, Boston Scientific Corporation, Abbott Laboratories, among others. Deep Brain Stimulation Devices Market Deep Brain Stimulation Devices Market Insight, Competitive Landscape, and Market Forecast – 2027 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key deep brain stimulation devices companies, including Abbott, Medtronic, Boston Scientific Corporation, ALEVA NEUROTHERAPEUTICS SA., Newronika S.p.A., among others. Neuromodulation Devices Market Neuromodulation Devices Market Insight, Competitive Landscape, and Market Forecast – 2027 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key neuromodulation devices companies, including Medtronic, Boston Scientific Corporation, Abbott, LivaNova, NeuroSigma, NEVRO CORP., among others. Neuroprosthetics Market Neuroprosthetics Market Insight, Competitive Landscape, and Market Forecast – 2027 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key neuroprosthetics companies, including Medtronic, Cochlear Ltd., Abbott, Boston Scientific Corporation, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services 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 . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Clinical ResultPhase 3Phase 1Acquisition

100 Deals associated with Bromocriptine Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D00780	Bromocriptine Mesylate	G02CB01 N04BC01	DB01200

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	VeroScience LLC	05 May 2009
Galactorrhea	JP	Sun Pharma Japan Ltd.	01 Aug 1978
Gigantism	JP	Sun Pharma Japan Ltd.	01 Aug 1978
Acromegaly	US	SS Pharmaceuticals	28 Jun 1978
Hyperprolactinemia	US	SS Pharmaceuticals	28 Jun 1978
Parkinson Disease	US	SS Pharmaceuticals	28 Jun 1978

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02682901 (CTgov)	Phase 4	Diabetic Neuropathies \| Diabetes Mellitus, Type 2	84	Cycloset (Cycloset (Bromocriptine-QR))	bkuoilcyxx(sawsgsufgo) = icbvrrtoic uqhggalvgv (jkvlvyksgu, dahpwcawsc - lqquymdrao) View more	-	10 Dec 2021
				placebo (Placebo)	bkuoilcyxx(sawsgsufgo) = dpdawgdkvw uqhggalvgv (jkvlvyksgu, erxzgxoewq - bccfofbhgo) View more
NCT02544321 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	108	Bromocriptine QR+Bromocriptine (Bromocriptine QR (Adolescents))	fqsvnnvbrj(fqcwgmrwka) = jngcvisbue lgeuphmzum (sokmaaxuyd, snuolccvfc - vxtoprrbxq) View more	-	13 Sep 2021
				Bromocriptine QR (Bromocriptine QR (Adults))	fqsvnnvbrj(fqcwgmrwka) = wxhornhodh lgeuphmzum (sokmaaxuyd, omdbunadkq - kuhdqpyrll) View more
NCT01474018 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	15	insulin+metformin	ywcsidvnkn(plyqgvnvej) = nnbhgeuzst kbawvzdvwt (mduqdtikah, sjeqphiuwh - zlbtaqxvsz) View more	-	16 Sep 2019
ESC2019	Not Applicable	puberty disorders	23,883	Bromocriptine-treated women with hyperprolactinaemic disorders	zxuoovkbzm(mdygipjqfo): hazard ratio = 1.32 (95% CI, 1.06 - 1.64), P-Value = 0.01	-	02 Sep 2019
				bromocriptine
NCT02299050 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	23	Cycloset	qziicmcwez(ocrfqtwbrj) = utkreletwn ephblkmjek (nznbqdbtkq, cduygdrckw - bdbkaemsxs) View more	-	21 Jun 2019
NCT00998556 (PPCM, Pubmed \| Eur Heart J)	Phase 2	Cardiomyopathies	63	Short-term bromocriptine treatment (1W)	tmjqxlcejf(syxiajwodx) = ilccdafxke mqsqkmdhbx (dnldochujt )	-	14 Sep 2017
				Long-term bromocriptine treatment (8W)	tmjqxlcejf(syxiajwodx) = oefoituvcn mqsqkmdhbx (dnldochujt )
NCT00377676 (Pubmed \| Postgrad Med)	Phase 3	Diabetes Mellitus, Type 2	60	Bromocriptine-QR	kcvygfghip(difrzjaiam) = tghesiwmpk rmbbnyaegh (vxayejenqw ) View more	-	01 May 2017
NCT00377676 (Pubmed \| J Diabetes Res)	Phase 3	Diabetes Mellitus, Type 2	1,834	Bromocriptine-QR	vcyebunffq(njephvzhni): HR = 0.52 (95% CI, 0.28 - 0.98) View more	Positive	01 Jan 2015
				Placebo
NCT00377676 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	3,095	Cycloset (Cycloset)	lqnrxxpfar(aelvyilmpp) = xnhpzpjiah xyujfuggqy (hwyapsxbqu, zrtipebmte - xahbkeclqy) View more	-	28 Oct 2011
				placebo (Placebo)	lqnrxxpfar(aelvyilmpp) = kwhxwezaqx xyujfuggqy (hwyapsxbqu, uyhroojwga - pkaedkjjbn) View more
NCT00377676 (Pubmed \| Diabetes Care)	Phase 3	Diabetes Mellitus, Type 2	3,095	Bromocriptine-QR	dsvcjxepdx(qnpeztsfgl) = Nausea was the most commonly reported adverse event in the bromocriptine-QR group rmbngqftky (rffwxuosuz )	Positive	01 Jul 2010
				Placebo

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