M3 receptor

NBI-1117568 is an oral, selective muscarinic M4 receptor agonist advancing through Phase 2 clinical development under a multi-program collaboration with Neurocrine Biosciences Successful completion of a long-term preclinical toxicity program to support safe, chronic dosing of NBI-1117568 in future clinical trials triggers a $15 million payment to Nxera from Neurocrine Biosciences 16 April 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – has been notified by its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX) that NBI-1117568, an oral selective muscarinic M4 receptor agonist being advanced in Phase 2 clinical trials by Neurocrine for the treatment of schizophrenia and other neuropsychiatric disorders, has successfully completed a long-term preclinical toxicity program that meets US FDA requirements to allow for safe, chronic (i.e. long-term) dosing in future clinical trials. The achievement of this important safety development milestone triggers a $15 million payment to Nxera from Neurocrine. NBI-1117568 is the most advanced candidate from a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera and advancing under the 2021 global collaboration with Neurocrine for the treatment of major neurological disorders. These candidates have potential to address a range of neurological and neuropsychiatric conditions and include: NBI-1117568 (an M4 selective agonist) in Phase 2 trials with top-line data expected in H2 2024 NBI-1117570 (an M1/M4 selective dual agonist) in Phase 1 NBI-1117569 (an M4-preferring agonist) in Phase 1 NBI-1117567* (an M1-preferring agonist) expected to enter Phase 1 in 2024 Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented: “We are delighted that NBI-1117568 has successfully achieved this important safety development milestone. These results will support the safe, long-term use of this novel clinical candidate, which is consistent with a desired product profile for schizophrenia and other neurological diseases where patients often need therapy over many years. We are extremely pleased at the progress being made under our highly productive partnership with Neurocrine and look forward to reporting further progress and upcoming clinical data readouts, including the top-line Phase 2 data on NBI-1117568, which is expected in the second half of 2024.” *Nxera retains rights to develop M1 agonists advancing under this collaboration in Japan in all indications. Muscarinic receptors are G protein-coupled receptors (GPCRs) found in multiple tissues including the brain, cardiovascular system, and gastrointestinal tract. Selective activation of M4 and M1 receptors in the brain is a clinically validated approach to treating cognitive and neuropsychological symptoms of neurological diseases, including Schizophrenia, dementia associated with Alzheimer’s disease, Parkinson’s disease, and others. Until now, attempts to develop medicines that selectively target M4 and M1 receptors have been unsuccessful because of side effects caused by the activation of M2 and M3 receptors. Highly selective M4 or M1 agonists that do not activate M2 or M3 therefore are highly sought after and expected to have the potential to address major unmet medical needs with blockbuster potential. NBI-1117568 is an oral, selective muscarinic M4 receptor agonist discovered by Nxera Pharma and being developed in Phase 2 clinical trials by Neurocrine for the treatment of schizophrenia and other neuropsychiatric disorders. As a selective M4 orthosteric agonist, NBI-1117568 offers the potential to deliver therapeutic effects without the need of combination therapy to minimize side effects, as required with non-selective muscarinic agonists, whilst also avoiding the requirement for cooperativity with acetylcholine (ACh) when compared to positive allosteric modulators. Clinical studies completed to date have shown NBI-1117568 to be generally well tolerated. Nxera Pharma and Neurocrine BioSciences entered a collaboration and licensing agreement in November 2021 to develop novel muscarinic receptor agonists for the treatment of schizophrenia, dementia and other neuropsychiatric disorders. Under the terms of the agreement, Neurocrine gains development and commercialization rights to a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera. Neurocrine is responsible for development costs associated with the programs globally, except for M1 agonists being developed in Japan. Nxera retains rights to develop M1 agonists in Japan for any indication, with Neurocrine receiving co-development and profit share options. Nxera is eligible to receive R&D funding plus development, regulatory and commercial milestones of up to US$2.6 billion, with further product royalties, provided the criteria under the agreement are satisfied. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter), and Facebook. NEUROCRINE BIOSCIENCES, NEUROCRINE, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc. Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery “NxWaveTM” platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). The content above comes from the network. if any infringement, please contact us to modify.

Trelegy Ellipta is approved as a maintenance treatment for COPD and asthma in the US. Image Credit: MAXSHOT.PL / Shutterstock. Singapore’s Health Sciences Authority (HSA) has expanded the label of GlaxoSmithKline (GSK)’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include its use as a maintenance therapy for adults with asthma. The Singapore agency also approved a new dosage strength for the inhaled therapy in asthma. In 2019, HSA approved Trelegy Ellipta as a maintenance therapy for relieving moderate to severe exacerbations in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is approved as a maintenance treatment for COPD in multiple regions including the US, Europe and China. However, the drug has also been approved for treating asthma in a few countries such as the US. Trelegy Ellipta pulled in £2.2bn ($2.8bn) in global sales for GSK in 2023, as per the company’s financials. The drug sales are expected to rise, with Trelegy Ellipta expected to generate approximately $3.8bn in global sales in 2027, according to a GlobalData analysis. GlobalData is the parent company of Pharmaceutical Technology . Last month, GSK announced plans to cap out-of-pocket costs for eligible patients at $35 per month for its COPD and asthma medications in light of the rising drug prices in the US. Trelegy Ellipta is one of the drugs included in GSK’s programme, which will be implemented across the country no later than 1 January 2025. See Also: UK MHRA approves Advanz Pharma antibiotic for complex infections Japan’s PMDA approves Partner’s inhaled Leukine for aPAP Another therapy looking to target both asthma and COPD populations is Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko). The monoclonal antibody has been approved for treating severe asthma in multiple countries including the US. The companies are evaluating the therapy in patients with moderate to severe COPD in a placebo-controlled Phase II trial (NCT04039113). Data from the trial is expected in H1 this year. Regeneron Pharmaceuticals and Sanofi are also seeking approval for their monoclonal antibody , Dupixent (dupilumab) as a maintenance therapy for COPD. The US Food and Drug Administration (FDA) has set a target action date of 27 June for an approval decision. Dupixent is approved for treating atopic dermatitis , asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.

QUEBEC CITY, July 11, 2023 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) announced on May 26, 2023, that its Canada subsidiary, Lupin Pharma Canada Ltd., has received approval from Health Canada to market a generic version of Spiriva® (tiotropium bromide inhalation powder) for the treatment of chronic obstructive pulmonary disease (COPD), in Canada. Lupin wishes to clarify that Tiotropium Bromide Inhalation Powder is indicated in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. "This approval of the first generic for Tiotropium Bromide Inhalation Powder by Health Canada underscores our commitment to bring affordable options of complex products for patients in Canada, particularly in the respiratory therapeutic area," said, Dr. Sofia Mumtaz, President – Legal, Canada, Australia, and Japan, Lupin. Tiotropium Bromide Inhalation Powder (RLD Spiriva®) had estimated annual sales of USD 42 million in Canada (IQVIA MAT Q4 of 2022). About Lupin Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector. Please visit for more information. Follow us on - Twitter: LinkedIn: Facebook: Spiriva® is registered trademark of Boehringer Ingelheim International GmbH. Logo: SOURCE Lupin Pharma Canada Ltd.