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利拉鲁肽

利拉鲁肽-API

利拉鲁肽 API

CAS Number: 204656-20-2

About 利拉鲁肽 API

Therapeutic Category
Anti-Diabetic

API Technology
Peptide

Dose Form
Injectable

Dr Reddy's Development Status
Available

Available Regulatory Filing
USDMF

作用机制

Liraglutide is an acylated human glucagon-like peptide-1 (GLP-1) receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). Like endogenous GLP-1, liraglutide binds to and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G-protein, Gs. Endogenous GLP-1 has a half-life of 1.5-2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once-daily administration, is a result of self-association that delays absorption, plasma protein binding, and stability against metabolic degradation by DPP-4 and NEP.

GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. In animal studies, peripheral administration of liraglutide resulted in the presence of liraglutide in specific brain regions regulating appetite, including the hypothalamus. Although liraglutide activated neurons in brain regions known to regulate appetite, specific brain regions mediating the effects of liraglutide on appetite were not identified in rats.

适应症

Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of

  • 30 kg/m2 or greater (obese) or
  • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia)

Limitations of Use:

  • Saxenda is not indicated for the treatment of type 2 diabetes
  • Saxenda should not be used in combination with any other GLP-1 receptor agonist
  • Saxenda should not be used with insulin
  • The effects of Saxenda on cardiovascular morbidity and mortality have not been established
  • The safety and efficacy of coadministration with other products for weight loss have not been established
  • Saxenda has not been studied in patients with a history of pancreatitis

Dr. Reddy's的专长

Dr. Reddy's总部位于印度海得拉巴,是全球领先的活性药物成分(API)供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。

Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API(如类固醇,多肽,复杂长链分子和高效API(HPAPI /肿瘤药物))方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准,从而为这一专业知识提供补充。 Dr. Reddy's博士 利拉鲁肽 API是研发,知识产权和监管方面广泛专业知识的结果。

帮助我们的客户率先进入市场的关键组成部分是响应式供应链。 我们通过确保所有设施都高效运行并达到最新的质量,安全和生产率标准来实现这一目标。 业务和工厂之间的强大互联可以快速响应动态的市场变化,从而避免短缺并满足需求的突然激增。

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免责声明

本目錄中的任何信息(包括對任何產品或服務的任何引用)均不構成銷售要約,或被解釋為代表銷售要約。受有效專利保護的產品不提供或供應用於商業用途。但是,只要存在此類監管豁免,就可以出於監管提交的目的提供此類產品的研究數量。買方應對各自市場的專利方案進行獨立評估,並承擔所有與專利相關的責任。在印度受有效專利保護的產品不可用於商業用途,但可用於第 107A 節。

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免责声明

本目錄中的任何信息(包括對任何產品或服務的任何引用)均不構成銷售要約,或被解釋為代表銷售要約。受有效專利保護的產品不提供或供應用於商業用途。但是,只要存在此類監管豁免,就可以出於監管提交的目的提供此類產品的研究數量。買方應對各自市場的專利方案進行獨立評估,並承擔所有與專利相關的責任。在印度受有效專利保護的產品不可用於商業用途,但可用於第 107A 節。