Navigation Links
Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
Date:1/3/2008

DEERFIELD, Ill., Jan. 3 /PRNewswire/ -- 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. "Takeda's 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 treat
'/>"/>

SOURCE Takeda Global Research & Development Center, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
2. Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
3. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
4. Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer
5. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
6. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
7. ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
8. Quark Pharmaceuticals Files Patent Application Covering Novel Chemical Modifications to its RNAi Molecules
9. Indevus Announces Submission of New Drug Application
10. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
11. Lexicon Files Investigational New Drug Application for LX2931 as a Potential Treatment for Rheumatoid Arthritis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... ORLANDO, Fla. and DUBLIN , ... of the agreement with KRS Global Biotechnology, Inc. for the ... will be compounded for shipment in the United ... 503B FDA approved Outsourcing Facility capable of compounding naltrexone tablets ...
(Date:1/23/2015)... 23, 2015  Now available for sale, The Armor1 Ankle ... prevents ankle sprains by cushioning the ankle from an ... around the outside of any shoe type and allows ... still offering protection against sprains. With customers in physical ...
(Date:1/23/2015)... , Jan. 23, 2015   Leatt Corporation  (OTCQB: ... protective equipment for all forms of sports, including extreme ... neck brace, announced today that the UISP Lega Motociclismo ... requires all riders to wear a neck brace during ...
Breaking Medicine Technology:Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 2Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 3Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 4The Armor1 Ankle Roll Guard is the New Breakthrough Solution for Ankle Sprain Prevention! 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 3
... Response Rates Recognized as Marker of,Treatment Success -, ... new,independently-conducted study being presented at the 59th Annual ... Liver Diseases (AASLD) shows that,PEGASYS(R) (peginterferon alfa-2a) treatment ... for hepatitis C patients as,compared to regimens with ...
... complications; they are also more likely,to become overweight or ... A study by the Kaiser,Permanente Center for Health ... that women who gained more than 40 pounds during ... heavy baby. Published in,the November issue of Obstetrics & ...
Cached Medicine Technology:New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients 2New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients 3New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients 4New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients 5New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients 6New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients 7Gaining Too Much Weight During Pregnancy Nearly Doubles Risk of Having a Heavy Baby 2Gaining Too Much Weight During Pregnancy Nearly Doubles Risk of Having a Heavy Baby 3
(Date:1/22/2015)... January 22, 2015 Blue Cross and Blue ... who exemplify what it means to “Live Fearless.” ... people to share their stories about how they or someone ... inspired others by living in the moment. By telling these ...
(Date:1/22/2015)... 22, 2015 Thousand of GranuFlo lawsuits ... recalled its GranuFlo and NaturaLyte dialysis concentrates continue to ... U.S. District Court, District of Massachusetts, Bernstein Liebhard LLP ... Court has remanded a case filed by the state ...
(Date:1/22/2015)... 2015 A study recently published ... journal Medicine & Science in Sports & Exercise ... help reduce gastrointestinal (GI) problems associated with physical ... in the double-blind, placebo-controlled study took 10 grams ...
(Date:1/22/2015)... 22, 2015 Payday lending practices in ... and cause financial distress to the states that permit ... Howard University’s Center on Race and Wealth. , While ... activity, payday loans at the same time substantially depress ...
(Date:1/22/2015)... Lower-Auto-Insurance.com has released a new blog post explaining the importance ... reducing the costs of an auto insurance policy . , ... lower prices for their vehicle insurance policies. The safety a vehicle ... costs. Because of this, drivers should always carry a first ...
Breaking Medicine News(10 mins):Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:Driving Safe And Other Factors That Make Auto Insurance Affordable! 2
... HealthDay Reporter , THURSDAY, March 15 (HealthDay News) -- ... appeared linked to symptoms in offspring that resemble attention-deficit ... Moreover, these problems with attention, hyperactivity and memory ... the longer they were exposed to cellphone radiation in ...
... Marcus HealthDay Reporter , THURSDAY, March 15 ... trying to become pregnant, but overdoing workouts might make ... report. Usually a risk factor for most health ... heavy women who logged vigorous workouts -- running, fast ...
... DENVER A panel of serum biomarkers could help ... patients, offering doctors an option before proceeding with a ... the International Association for the Study of Lung Cancer,s ... a panel of 10 serum protein biomarkers could help ...
... by others, pounding to the beat in group exercise class has ... the experience of changing in the locker room, the acts of ... be very discomfiting. It,s a complex experience as women are faced ... space. "I walk into the change room and pace anxiously ...
... HealthDay Reporter , WEDNESDAY, March 14 (HealthDay News) ... and confounding issues in medicine, a new European study reports ... check for signs of prostate cancer were 30 percent less ... big picture isn,t simple enough for the new research to ...
... 15, 2012) As the supply of life-saving ... healthcare systems and policymakers to step up efforts ... available antibiotics through antimicrobial stewardship initiatives. ... Healthcare Epidemiology of America (SHEA), Infectious Diseases Society ...
Cached Medicine News:Health News:Fetal Exposure to Cellphone Radiation Tied to ADHD-Like Symptoms in Mice 2Health News:Fetal Exposure to Cellphone Radiation Tied to ADHD-Like Symptoms in Mice 3Health News:Too Much Exercise Delays Pregnancy in Normal-Weight Women: Study 2Health News:Too Much Exercise Delays Pregnancy in Normal-Weight Women: Study 3Health News:Too Much Exercise Delays Pregnancy in Normal-Weight Women: Study 4Health News:The stress of undress 2Health News:The stress of undress 3Health News:Study Finds PSA Testing Cuts Prostate Cancer Death Risk 2Health News:Leading infectious diseases experts call for increased focus on protecting antibiotics 2
... Enhanced Durability for Excellent ... working with challenging cases. PT² ... of a linear elastic nitinol ... resilient polymer tip. This provides ...
... Separation System is an enabling ... separate cell populations into multiple ... and density. This flexible laboratory ... depletion, concentration, and washing ...
... is a positive-displacement, continuously ... designed to simplify multiple ... Gilson DistriTip syringes. DistriTips ... with level indicators. Three ...
... are lightweight and balanced for smooth, one-handed ... and comfort, reducing fatigue in even the ... a physician to easily steer the catheter ... just one finger. Reflexion's auto-lock technology keeps ...
Medicine Products: