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:2/5/2016)... ... February 05, 2016 , ... In the fourth quarter ... gathered at the La Valencia Hotel in San Diego, California to discuss changes ... the year’s most outstanding franchise, walking away with the coveted David Wright Award ...
(Date:2/5/2016)... ... 2016 , ... Pivot Point Consulting, a leading national Healthcare ... Services for HIT Implementation Support & Staffing report with an outstanding score of ... healthcare executives, managers and clinicians representing over 4,500 hospitals and 2,500 clinics. , ...
(Date:2/5/2016)... Aliso Viejo, CA (PRWEB) , ... February 05, 2016 , ... ... Pro X. Move from on one drop zone to the next using Colorize's dynamic ... design complements any project. This package includes a 3D slideshow environment with 1 to ...
(Date:2/5/2016)... ... February 05, 2016 , ... Calls Blacklist has just ... new user interface design and the developer has fixed known bugs within the app. ... to on their phone while not consuming any of their device’s battery power or ...
(Date:2/4/2016)... ... February 04, 2016 , ... Dr. Carol Francis and ... February 19-21, 2016, in Southern California . The International Hypnosis Federation 2016 Conference ... professional speakers, including Clinical Psychologist and Hypnotherapist Dr. Carol Francis (topics ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... , Feb. 4, 2016 Global Immunology ... market to drive long-term market growth Summary ... set of chronic disorders that affect 5–7% of ... terms of their symptoms and key patient demographics, ... of immune pathways and an inappropriate immune response. ...
(Date:2/4/2016)... VIEW, Calif., Feb. 4, 2016  Omnicell, Inc. (NASDAQ: ... management solutions to healthcare systems, today announced results for ... --> --> GAAP ... $130.3 million, up $5.1 million or 4.1% from the ... 7.2% from the fourth quarter of 2014. Revenue for ...
(Date:2/4/2016)... SAN DIEGO, Feb. 4, 2016  Aethlon Medical, ... creating affinity biofiltration devices to treat life-threatening diseases, ... fiscal 2016 ended December 31, 2015. ... short-term objectives set forth in our last quarterly ... that reinforce our long-term objective to establish the ...
Breaking Medicine Technology: