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:1/19/2017)... ... 20, 2017 , ... Today, the Centers for Medicare & Medicaid Services (CMS) ... Payment Models (APMs) in 2017. Clinicians who participate in APMs are paid for the ... of the Administration’s effort to build a system that delivers better care and one ...
(Date:1/19/2017)... ... January 19, 2017 , ... Wells Pharmacy Network announced ... their 503A compounding pharmacy located in Ocala, Florida. , Meeting the Needs ... throughout the United States for high-quality human anti-aging and wellness compounded medications, ...
(Date:1/19/2017)... ... 19, 2017 , ... LabRoots , the leading provider ... world, announces the launch of its newly redesigned website. The sleek new design ... and trending news, vital information on upcoming virtual events and webinars, all while ...
(Date:1/19/2017)... ... 19, 2017 , ... Cosmetic Town, an online plastic surgery community, begins 2017 ... it easier for their readers to get the information they desire. The procedures are ... the techniques used on those particular areas. , “We are excited to streamline our ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... the American Board of Dermatology and fellowship trained Mohs and cosmetic surgeon. After ... of Health, Dr. Li completed his internship in internal medicine at the Emory ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... -- The Global Therapy Partnering Terms and Agreements since ... and agreements entered into by the world,s leading healthcare ... deals by value - Deals listed by company A-Z, ... report provides understanding and access to the partnering deals ... companies. The report provides an analysis of partnering ...
(Date:1/19/2017)... 2017 The drug delivery technology market is ... USD 1,179.20 billion in 2016, at a CAGR of ... chronic diseases, increasing demand for biologics, technological advancements, and ... of this market. Whereas, self-administration & home care and ... growth opportunities for players operating in this market. On ...
(Date:1/18/2017)... , Jan. 18, 2017  EnteroMedics Inc. ... medical devices using neuroblocking technology to treat obesity, ... the pricing of an underwritten public offering of ... to deducting underwriting discounts and commissions and offering ... is comprised of Class A Units, priced at ...
Breaking Medicine Technology: