Navigation Links
Takeda submits new drug application for alogliptin (syr-322) in the US
Date:1/4/2008

Deerfield, IL, January 3, 2008 --- Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc. submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for alogliptin (development code: SYR-322), a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes. Discovered by Takeda San Diego, Inc., alogliptin was designed to selectively inhibit DPP-4 taken orally once daily.

DPP-4 inhibitors are a new class of oral agents for the treatment of type 2 diabetes, which slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). The incretins play a major role in regulating blood glucose levels and may have the potential to improve pancreatic beta-cell function.

The NDA submission was supported by six Phase 3 clinical trials involving over 2,000 patients conducted in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones (TZDs), and insulin. In the studies, alogliptin was associated with statistically significant reductions in hemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. Alogliptin was generally well-tolerated and weight neutral. There was no increase in hypoglycemia compared to placebo.

The NDA submission for alogliptin is a significant milestone for Takeda, as it has the potential to position us as one of the global leaders in diabetes treatment, said Yasuchika Hasegawa, president of Takeda. Takedas continued growth, now and in the future, will be based on our ability to focus and have success in this therapeutic area. Our hope is that alogliptin will become an important treatment option for patients with type 2 diabetes and the healthcare providers who treat them.

GLP-1 and GIP are produced by the digestive tract in response to food, and regulate glucose balance, primarily by stimulating glucose-dependent insulin secretion. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness.


'/>"/>

Contact: Carrie Rose
carrie.rose@ketchum.com
646-935-3938
Takeda Pharmaceuticals North America
Source:Eurekalert

Related medicine news :

1. Chemizon Announces Research Collaboration Expansion With Takeda
2. Takeda Statement on ACTOS(R) (Pioglitazone HCl) Meta-Analysis Published in the Journal of the American Medical Association
3. Takeda statement on ACTOS meta-analysis published in the Journal of the American Medical Association
4. XTENT Submits CE Mark Registration to Market Custom NX(R) Drug-Eluting Stent System in Europe
5. ImaRx Therapeutics Submits Urokinase Data to FDA Supporting Extended Expiration Dating
6. Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma
7. ISTA Pharmaceuticals Submits New Drug Application for Xibrom(TM) QD (once-daily)
8. SGX Pharmaceuticals Submits Investigational New Drug Application for SGX523, a Highly Potent, Selective, Orally Bioavailable cMET Inhibitor
9. Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application for Paliperidone Palmitate
10. Global Med Technologies(R), Inc. Submits ElDorado Donor(TM) to FDA
11. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... ... ... The Waismann Method® is providing a faster, safer, and more ... to America’s opioid epidemic. Now, opiate dependent individuals can be treated in a ... shame, stigma, and harmful labeling believed to prevent many of these victims ...
(Date:2/22/2017)... ... ... South Bend’s Lunkerville, the award-winning TV series that catches real people with real ... non-profit organization dedicated to helping military veterans relax, rehabilitate, and reintegrate through kayak fishing. ... Denmark, New Jersey, to fish with war veteran Justin Vail from the New Jersey ...
(Date:2/22/2017)... (PRWEB) , ... February 22, 2017 , ... ... adults with chronic conditions reported skipping doses or not filling a prescription because ... or under-insured, rates of cost-related problems getting medications were 30-60%*. At ...
(Date:2/22/2017)... ... 22, 2017 , ... Sideline Products participated in the World Horse Expo held ... Seay and his production crew. Tom Seay’s program “Best of America by Horseback” ... Saddle Sidekicks will be featured on April 6, 2017. After the broadcast, the clip ...
(Date:2/22/2017)... ... February 22, 2017 , ... The first-ever National Heart ... advocates, and individuals join together to increase recognition about the risks of heart ... , “Today we mark a nationwide movement to raise awareness about a disease ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) ... quarter and full year 2016 financial results on Thursday, March ... markets. Following the announcement, members of the management team ... results and provide a general corporate update at 4:30 p.m. ... obtained as follows: Thursday, March 2 1:30 ...
(Date:2/22/2017)... 2017  Andre, DiMino, CEO of ADM Tronics Unlimited, ... innovative technologies and products, commented on ADMT,s third quarter ... 2017 in the Company,s quarterly report on Form 10Q ... Andre, DiMino stated "During the quarter ended December 31, ... a larger portion of our engineering efforts into the ...
(Date:2/22/2017)... Clean Holdings, Inc. (Nasdaq: UCTT), a leading developer ... the semiconductor capital equipment, flat panel, medical, energy ... for the fourth quarter and fiscal year ended ... year of extraordinary growth for UCT. Total revenue ... with continued focus on operational excellence resulted in ...
Breaking Medicine Technology: