| 查看: 709 | 回复: 2 | |||
狼行拂晓荣誉版主 (著名写手)
~~~~
|
[交流]
Novo Nordisk to Initiate Phase 3a Development of Oral Semaglutide 已有2人参与
|
|
Novo Nordisk to Initiate Phase 3a Development of Oral Semaglutide, a Once-Daily Oral GLP-1 Analogue Bagsværd, Denmark, 26 August 2015 - Novo Nordisk today announced the decision to initiate a phase 3a programme with oral semaglutide; a once-daily oral formulation of the long-acting GLP-1 analogue semaglutide. The decision follows the encouraging results of the proof-of-concept phase 2 trial announced on 20 February 2015 and the subsequent consultations with regulatory authorities. Novo Nordisk intends to initiate a global phase 3a programme, named PIONEER, comprising seven trials with approximately 8,000 people with type 2 diabetes. The PIONEER programme will include six safety and efficacy trials and one trial for evaluating the cardio-vascular safety of oral semaglutide. The first trial in the programme is planned for initiation in first quarter of 2016 and will investigate the efficacy and safety of once-daily oral semaglutide doses of 3 mg, 7 mg and 14 mg, compared to once-daily oral anti-diabetic sitagliptin dose of 100 mg. The remaining six trials of the PIONEER programme are all expected to be initiated during 2016. In order to meet capacity requirements for current and future diabetes care products, including oral semaglutide, Novo Nordisk expects to invest an estimated 2 billion US dollars over the coming five years in two new production facilities; a new production facility for a range of active pharmaceutical ingredients in Clayton, North Carolina, US and a new drug-product facility in Måløv, Denmark. The final design and cost of the new production facilities will be presented for approval by the company's board of directors in 2016. "Delivering protein-based medicine like semaglutide in the form of a tablet and producing it on a large scale is a major challenge, and with the announcement today we have reached a significant milestone towards achieving that goal", said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We are excited about the opportunities oral semaglutide represents as a new oral anti-diabetic agent to further improve type 2 diabetes treatment". About Semaglutide Semaglutide (NN9924) is a new glucagon-like peptide-1 (GLP-1) analogue that can help people with type 2 diabetes achieve substantial lowering of blood glucose with a low risk of hypoglycaemia. In addition, semaglutide induces weight loss by decreasing appetite and food intake. The oral formulation of semaglutide is provided in a tablet formulation with SNAC, an absorption-enhancing excipient included in the Eligen® Carrier Concept. The Eligen® technology is licenced from Emisphere Technologies, Inc. Source: Novo Nordisk Posted: August 2015 |
回复此楼» 猜你喜欢
巴黎萨克雷大学与国家留学基金委合作博士研究生项目-脂质纳米药物/生物材料/多酚递送
已经有10人回复
-
广西医科大学基础医学院自身免疫病课题组招收基础医学相关专业的调剂研究生
已经有2人回复
-
药物学论文润色/翻译怎么收费?
已经有56人回复
-
锦州医科大学药用生物材料（专业代码1007Z1）招收调剂考生
已经有0人回复
-
锦州医科大学药用生物材料（专业代码1007Z1）招收调剂考生
已经有2人回复
-
26申博自荐
已经有12人回复
-
SUES&NERCN课题组接受硕士生调剂 (学硕1名+专硕1名)
已经有0人回复
-
SUES&NERCN课题组接受硕士生调剂 (学硕1名+专硕1名)
已经有0人回复
-
SUES&NERCN课题组接受硕士生调剂 (学硕1名+专硕1名)
已经有0人回复
-
广西医科大学基础医学院招收基础医学、药学、生物检验相关专业的研究生
已经有1人回复
-
求大佬收留
已经有0人回复
voyager88
金虫 (著名写手)
- DRDEPI: 11
- 应助: 584 (博士)
- 金币: 2387.8
- 散金: 4182
- 红花: 338
- 帖子: 1994
- 在线: 551.7小时
- 虫号: 1259270
- 注册: 2011-04-08
- 专业: 药剂学
2楼2015-09-01 13:52:11
3楼2015-09-10 22:43:50
