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Dec 4, 2012

25 Diabetes Drugs in the Pipeline Right Now

Meet the new weapons in the war against the chronic metabolic disease.

25 Diabetes Drugs in the Pipeline Right Now

These drugs may hit the market in the near future as potential treatments for diabetes. [Celso Pupo - Fotolia.com]

  • LY2963016

    Sponsor/Developer: Eli Lilly and Boehringer Ingelheim

    Mechanism of action: Basal insulin analog

    Indication (Phase): Type 1 diabetes, compared with Lantus and Insulin Lispro (Phase III; ELEMENT I study ongoing but not recruiting as of August 2012); Type 2 diabetes, compared with Lantus and oral antihyperglycemic medications (Phase III; ELEMENT II study completed as of September 2012); Comparison to Lantus, healthy participants (Phase I, completed September 2012); Comparison to Lantus after single dose for healthy subjects (Phase I, recruiting as of September 2012); Type 1 diabetes, comparison to Lantus (Phase I, completed July 2012); Comparison to Lantus, pharmacokinetics and pharmacodynamics (Phase I, completed July 2012); Comparison to Lantus after single dose for healthy subjects (Phase I, completed 2011)

  • Metreleptin

    Sponsor/Developer: Bristol-Myers Squibb; Developed by Amilyn Pharmaceuticals, acquired by BMS in a $7 billion deal completed Aug. 8

    Mechanism of action: Leptin analog

    Indication (Phase): Diabetes and/or hypertriglyceridemia in patients with rare forms of lipodystrophy (Registration; BLA submitted April 2012; Fast Track designation)

  • MK-3102

    Sponsor/Developer: Merck & Co.

    Mechanism of action: DPP-4 inhibitor

    Indication (Phase): Once-weekly for adults with type 2 diabetes: Comparison with Sitagliptin in Japanese participants with type 2 diabetes (Phase III; recruiting as of November 2012); Comparison with chronic kidney disease or kidney failure on dialysis (Phase III; recruiting as of November 2012); Add-on to oral antihyperglycemic agent study in Japanese participants with type 2 diabetes (Phase III; recruiting as of November 2012); Compared with glimepiride in participants with type 2 diabetes who have inadequate glycemic control on metformin (Phase III; recruiting as of November 2012); Adults with type 2 diabetes and inadequate glycemic control following combination therapy of glimepiride and metformin (Phase III; recruiting as of November 2012); Phase IIb results announced in October 2012

  • Nucynta® ER (tapentadol)

    Sponsor/Developer: Johnson & Johnson and Grunenthal

    Mechanism of action: Centrally-acting synthetic analgesic; agonist of the μ-opioid receptor and as a norepinephrine reuptake inhibitor

    Indication (Phase): Approved August 2012 for diabetic peripheral neuropathy (extended release formulation)

  • Ranolazine

    Sponsor/Developer: Gilead

    Mechanism of action: Late sodium current inhibitor

    Indication (Phase): Type 2 diabetes (Phase III)

  • RG1439 (aleglitazar)

    Sponsor/Developer: Roche

    Mechanism of action: Dual peroxisome proliferator-activated receptor (PPAR) α/γ activation

    Indication (Phase): Cardiovascular risk reduction in type 2 diabetes (Phase III; NDA filing expected 2015)

  • Ryzodeg® (insulin degludec + insulin aspart)

    Sponsor/Developer: Novo Nordisk

    Mechanism of action: Soluble fixed combination of basal insulin with bolus insulin aspart

    Indication (Phase): U.S.—Once daily for type 1 and type 2 diabetes (Registration; NDA submitted September 2011; recommended for approval Nov. 9 by FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, with commitment to a post-approval cardiovascular outcomes trial)

    EU—Type 1 and type 2 diabetes (Registration; MAA submitted September 2011; recommended for approval Oct. 18 by CHMP)

  • Semaglutide (NN9535)

    Sponsor/Developer: Novo Nordisk

    Mechanism of action: GLP-1 analog

    Indication (Phase): Once-weekly for type 2 diabetes (Phase III; SUSTAIN™ study, set to start first half of 2013)

  • Starsis (nateglinide)

    Sponsor/Developer: Ajinomoto and Astellas

    Mechanism of action: Insulin secretion enhancer

    Indication (Phase): Japan—Type 2 diabetes, with DPP-4 inhibitors (Phase III; new indication)

  • TAK-875

    Sponsor/Developer: Takeda

    Mechanism of action: G-protein-coupled receptor (GPR) 40 agonist

    Indication (Phase): Asia-Pacific adults with type 2 diabetes (Phase III; GRAND-307 study, recruiting as of November 2012); Diabetic patients, compared with Glimepiride (Phase III; recruiting as of November 2012); Adults with type 2 diabetes, with metformin, compared with Glimepiride (Phase III; GRAND-305 study, recruiting as of August 2012); Adults with type 2 diabetes (Phase III; recruiting as of August 2012); Adults with type 2 diabetes, compared to placebo and sitagliptin with metformin (Phase III; recruiting as of August 2012); Adults with type 2 diabetes and cardiovascular disease (Phase III; recruiting as of August 2012)

  • Tofogliflozin hydrate (CSG452)

    Sponsor/Developer: Roche and Chugai Pharmaceutical

    Mechanism of action: SGLT2 inhibitor

    Indication (Phase): Oral treatment for type 2 diabetes (Phase III)

  • Trelagliptin succinate (SYR-472)

    Sponsor/Developer: Takeda Pharmaceuticals and Furiex Pharmaceuticals

    Mechanism of action: DPP-4 inhibitor

    Indication (Phase): Japan—Once-weekly oral treatment for type 2 diabetes (Phase III; study expected to be completed in second half of 2013)

  • Tresiba® (Insulin degludec)

    Sponsor/Developer: Novo Nordisk

    Mechanism of action: Once-daily basal insulin

    Indication (Phase): U.S.—Type 1 and type 2 diabetes (Registration; NDA submitted September 2011; recommended for approval Nov. 9 by FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, with commitment to a post-approval cardiovascular outcomes trial)

    EU—Type 1 and type 2 diabetes (Registration; MAA submitted September 2011; recommended for approval Oct. 18 by CHMP in 100 units/mL and 200 units/mL formulations, the latter would be the first insulin in Europe to be marketed at a higher strength than 100 units/mL)

    Japan—Approved September 2012 for type 1 and type 2 diabetes


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