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On December 16th Novo Nordisk announced that it would launch a Phase III research project on the treatment of Alzheimer's disease with oral smeglutide (Somaglutide).
's decision was made after assessing preclinical animal model data, real-world research data, and post-mortem results from large cardiovascular outcome studies, and was discussed with regulators.
animal model study data suggest that GLP-1 plays a key role in Alzheimer's treatment, including improving memory function and reducing the accumulation of phosphate tau protein, and Smeglutide has been shown to reduce neuroinstration that has a potentially significant impact on cognitive and physical function.
based on real-world research evidence from the Danish-registered U.S. Truven Claims Database and the FDA FAERS Database, there is also a potential link between GLP-1 treatment and reduced risk of dementia.
In addition, Novartis conducted an after-the-fact analysis of trial data from three large cardiovascular outcome studies, LEADER, SUSTAIN 6 and PINEER 6, in which 15,820 patients with type 2 diabetes had a moderate follow-up time of 3.6 years and found that 47 people had dementia (early mild Alzheimer's disease), 32 of whom used placebo and 15 with GLP-1 drugs (lilaruptide or Smaglu.
, the risk of dementia was statistically significantly reduced by 53%, providing evidence for the GLP-1 treatment of dementia.
According to the plan, Novo Nordisk will directly launch a critical Phase IIIa study involving approximately 3,700 patients with early-onset Alzheimer's disease, which will begin patient recruitment in 2021H1, primarily to assess differences in the efficacy and safety of oral smegruptides (14 mg, 1 time per day) compared to placebos, and the duration of the drug is expected to last approximately 2 years. Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of
no and Nord, said, "We are eager to address the highly unsealed medical needs of severe chronic diseases, so we are pleased to be able to launch the Phase 3 project to develop Smegropeptide for the treatment of Alzheimer's disease.
alzheimer's disease has been a subject of widespread research for decades, but unfortunately there have been no major medical breakthroughs in this field.
With growing evidence of the potential role of GLP-1 in Alzheimer's treatment, we will explore the therapeutic benefits of oral meglupeptides for early Alzheimer's disease.
" Alzheimer's disease is one of the increasingly prominent public health problems, with serious adverse effects on patients and their families and increasing the global socio-economic burden.
an estimated 70 to 100 million people worldwide currently suffer from early-stage Alzheimer's disease (mild cognitive impairment and mild dementia).
oral meglupeptides (7mg and 14mg) have been approved in the United States, Europe and Japan to aid diet and exercise to improve blood sugar control in people with type 2 diabetes.
it showed excellent safety and tolerance in 10 clinical trials in 9,543 patients, with the most common adverse events being mild nausea.
December 4, Noor and Nord just submitted to the FDA a 2.4mg listing application for subsurfed injections of smelutide once a week to assist in the management of chronic weight in adult patients with low-fat diets and enhanced exercise associated with at least one weight-related combination (BMI≥30kg/m2) or overweight (BMI≥27kg/m2).
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