Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Akesis Pharmaceuticals has filed its first investigational new drug application with the FDA to start Phase IIa open-label, single arm US clinical trial for its type 2 diabetes treatment.
Subscribe to our email newsletter
Akesis will initiate the trial after FDA approval. The trial will be performed by dgd Research of San Antonio and will be designed to measure efficacy (using the gold-standard euglycemic-hyperinsulinemic clamping test), pharmacokinetic parameters, safety and tolerability of AKP-020 in diabetics. The company is currently projecting the trial to begin in the fourth quarter of 2007.
Jay Lichter, president and CEO of Akesis, said: “The IND filing is an important milestone for the company, and we continue to stay on track with our development timeline.”