美国2012年开发中的糖尿病新药

America’s biopharmaceutical research com- panies are developing 221 medicines to treat diabetes and related conditions. All of the medicines in this report are either in clinical trials or awaiting approval by the U.S. Food and Drug Administration. Diabetes affects nearly 26 million Americans —8.3 percent of the U.S. population—and about one-quarter are unaware they have the disease. Unfortunately, while the death rate due to diabetes is declining, the rate of new cases has been rising. The number of Americans diagnosed with diabetes has more than tripled since 1980, according to the U.S. Centers for Disease Control and Prevention (CDC). Lifestyle choices can affect this increase. The CDC-led National Diabetes Prevention Program found that weight loss and increased physical activity in people at high risk for diabetes reduced the development of type 2 diabetes by 58 percent in a 3-year period. Medicines can also help reduce the risk of type 2 diabetes. For example, one medicine was found in studies to lower the risk by 31 percent. According to the American Diabetes Asso- ciation, most Americans with diabetes have type 2, in which relative insulin deficiency combines with the body failing to properly use insulin. Between 5 percent and 10 percent of Americans with diabetes have type 1, in which the body fails to produce insulin. The medicines in the pipeline today offer hope of reducing the human toll and eco- nomic costs of diabetes. Examples of some medicines now being tested include: • A medicine that improves glucose-dependent insulin secretion. • A medicine designed to inhibit an enzyme linked to diabetic neuropathy. • A medicine to treat type 2 diabetes that may allow for once-weekly dosing. While diabetes remains a formidable foe, America’s biopharmaceutical research com- panies are continuing their efforts to develop novel and more effective therapies to treat the disease and increase patients’ quality of life. Biopharmaceutical Research Companies Are Developing More Than 220 Medicines to Treat Diabetes and Related Conditions Medicines in Development Diabetes presented by america’s biopharmaceutical research companies 2012 RepoRt 32 130 64 D ia be te s- R el at ed C on di tio ns Ty pe 1 D ia be te s Ty pe 2 D ia be te s U ns pe ci fie d D ia be te s 14 Medicines in Development For Diabetes* * Some medicines are listed in more than one category 79 million American adults have prediabetes 18.8 million Americans have been diagnosed with diabetes Each day more than 5,000 American adults are diagnosed with diabetes 7million Americans are undiagnosed Medicines in Development for Diabetes Medicines in Development Diabetes 20122 *For more information about a specific medicine in this report, please call the telephone number listed. Medicines in Development for Diabetes Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status* 11ß-HSD inhibitor Bristol-Myers Squibb Princeton, NJ diabetes Phase II (800) 332-2056 AC 201 (interleukin-1ß inhibitor) Twi Pharmaceuticals Taipei, Taiwan type 2 diabetes Phase II www.twipharma.com AC 165198 (fusion protein) Amylin Pharmaceuticals San Diego, CA Biocon Bangalore, India diabetes Phase I (858) 552-2200 Afrezza® insulin inhalation MannKind Valencia, CA type 1 diabetes, type 2 diabetes application submitted (661) 775-5300 aleglitazar (PPAR a/g agonist) Roche Nutley, NJ type 2 diabetes -------------------------------------------------- type 2 diabetes (combination therapy) Phase III (973) 235-5000 ------------------------------------------- Phase I (973) 235-5000 alogliptin (DPP-IV inhibitor) Takeda Pharmaceuticals U.S.A. Deerfield, IL type 2 diabetes -------------------------------------------------- type 2 diabetes in adolescents and children application submitted (877) 825-3327 ------------------------------------------- Phase I (877) 825-3327 alogliptin/metformin (fixed-dose combination) Takeda Pharmaceuticals U.S.A. Deerfield, IL type 2 diabetes application submitted (877) 825-3327 alogliptin/pioglitazone (fixed-dose combination) Takeda Pharmaceuticals U.S.A. Deerfield, IL type 2 diabetes application submitted (877) 825-3327 alogliptin/roflumilast Takeda Pharmaceuticals U.S.A Deerfield, IL type 2 diabetes Phase I (877) 825-3327 alpha-1 antitrypsin Omni Bio Pharmaceutical Greenwood Village, CO type 1 diabetes Phase I/II www.omnibiopharma.com AMG 151 (glucokinase stimulant) Amgen Thousand Oaks, CA type 2 diabetes Phase II (800) 772-6436 AMG 876 (fusion protein) Amgen Thousand Oaks, CA type 2 diabetes Phase I (800) 772-6436 Medicines in Development Diabetes 2012 3 Medicines in Development for Diabetes Medicines in Development for Diabetes Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status anagliptin (DPP-IV antagonist) Kowa Research Institute Morrisville, NC type 2 diabetes Phase II (919) 433-1600 analog insulin-PH20 Halozyme Therapeutics San Diego, CA type 1 diabetes, type 2 diabetes Phase II (858) 794-8889 ARI-2243 (DPP-IV antagonist) Arisaph Pharmaceuticals Boston, MA type 2 diabetes Phase I (617) 986-4500 ASP-1941 (SGLT2 inhibitor) Astellas Pharma US Deerfield, IL type 2 diabetes Phase II (800) 695-4321 AV 133 (imaging agent) Avid Radiopharmaceuticals Philadelphia, PA diabetes (diagnosis) Phase I (215) 298-0700 BGP-15 (JNK inhibitor/insulin sensitiser) N-Gene Research Laboratories New York, NY type 2 diabetes Phase II (212) 605-0225 BI-135585 (11ß-HSD1 inhibitor) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT type 2 diabetes Phase I (800) 243-0127 BIOD-123 (ultra-rapid-acting recombinant human insulin) Biodel Danbury, CT type 1 diabetes Phase II (203) 796-5000 BIOD-125 (ultra-rapid-acting recombinant human insulin) Biodel Danbury, CT type 1 diabetes Phase I completed (203) 796-5000 Byetta® exenatide Amylin Pharmaceuticals San Diego, CA type 2 diabetes in adolescents Phase III (858) 552-2200 CA-18C3 XBiotech Austin, TX type 2 diabetes Phase II (512) 386-2900 canagliflozin (SGLT2 inhibitor) Janssen Research & Development Raritan, NJ type 2 diabetes application submitted www.janssenrnd.com canagliflozin/metformin extended-release (fixed-dose combination) Depomed Menlo Park, CA Janssen Research & Development Raritan, NJ type 2 diabetes Phase III (650) 462-5900 www.janssenrnd.com canagliflozin/metformin immediate-release (fixed-dose combination) Janssen Research & Development Raritan, NJ type 2 diabetes Phase III www.janssenrnd.com Medicines in Development for Diabetes Medicines in Development Diabetes 20124 Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status CAT 1004 Catabasis Pharmaceuticals Cambridge, MA type 2 diabetes Phase I (617) 349-1971 CCX140 ChemoCentryx Mountain View, CA type 2 diabetes (see also diabetes-related) Phase II (650) 210-2900 cetilistat (lipase inhibitor) Norgine Amsterdam, Netherlands type 2 diabetes in clinically obese patients Phase II www.norgine.com CJC-1134-PC (GLP-1 stimulant) ConjuChem Los Angeles, CA type 2 diabetes Phase II www.conjuchem.com CVX 096 (PF-04856883) (GLP-1 receptor agonist) Pfizer New York, NY type 2 diabetes Phase I (800) 879-3477 dapagliflozin (SGLT2 inhibitor) AstraZeneca Wilmington, DE Bristol-Myers Squibb Princeton, NJ type 2 diabetes ----------------------------------------------- type 2 diabetes (combination therapy), type 2 diabetes (second-line therapy) application submitted (800) 236-9933 (800) 332-2056 ---------------------------------------- Phase III (800) 236-9933 (800) 332-2056 dapagliflozin/metformin (fixed-dose combination) AstraZeneca Wilmington, DE Bristol-Myers Squibb Princeton, NJ type 2 diabetes ------------------------------------------------ type 2 diabetes (with extended-release metformin) Phase III (800) 236-9933 (800) 332-2056 --------------------------------- Phase I (800) 236-9933 (800) 332-2056 DB 959 (PPAR d/g agonist) DARA BioSciences Raleigh, NC type 2 diabetes Phase I (919) 872-5578 DC9703 Obio Pharmaceutical (Omega Bio-Pharma) Wilmington, DE type 2 diabetes Phase I www.obiopharma.com diabetes compound Eli Lilly Indianapolis, IN diabetes Phase I (800) 545-5979 diabetes compound Eli Lilly Indianapolis, IN diabetes Phase I (800) 545-5979 diabetes compound Eli Lilly Indianapolis, IN diabetes Phase I (800) 545-5979 Medicines in Development for Diabetes Medicines in Development Diabetes 2012 5 Medicines in Development for Diabetes Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status diabetes compound Eli Lilly Indianapolis, IN diabetes Phase I (800) 545-5979 DSP-8658 (PPAR a/g agonist) Sunovion Pharmaceuticals Marlborough, MA type 2 diabetes Phase I (508) 481-6700 dulaglutide (GLP-1 analog) Eli Lilly Indianapolis, IN type 2 diabetes Phase III (800) 545-5979 EGT-0001442 (SGLT2 inhibitor) Theracos Marlborough, MA type 2 diabetes Phase II (508) 688-4221 EGT-0001474 (SGLT2 inhibitor) Theracos Marlborough, MA type 2 diabetes Phase I completed (508) 688-4221 empagliflozin (SGLT2 inhibitor) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT Eli Lilly Indianapolis, IN type 2 diabetes Phase III (800) 243-0127 (800) 545-5979 empagliflozin/linagliptin (fixed-dose combination) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT type 2 diabetes Phase III (800) 243-0127 empagliflozin/metformin (fixed-dose combination) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT type 2 diabetes Phase I (800) 243-0127 emricasan Conatus Pharmaceuticals San Diego, CA type 1 diabetes after islet cell transplantation Phase I/II www.conatuspharma.com encapsulated islet cell transplantation therapy ViaCyte San Diego, CA type 1 diabetes Phase I/II (858) 455-3708 enclomifene Repros Therapeutics The Woodlands, TX type 2 diabetes in men with second- ary hypogonadism or adult-onset idiopathic hypogonadotropic hypogonadism Phase II (281) 719-3400 ertugliflozin/PF-04971729 (SGLT2 inhibitor) Pfizer New York, NY type 2 diabetes Phase II (800) 879-3477 exenatide long-acting Hanmi Pharmaceutical Seoul, South Korea type 2 diabetes Phase II www.hanmipharm.com exenatide suspension Amylin Pharmaceuticals San Diego, CA type 2 diabetes Phase II (858) 552-2200 Medicines in Development for Diabetes Medicines in Development for Diabetes Medicines in Development Diabetes 20126 Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status gevokizumab (IL-1B inhibitor mAb) XOMA Berkeley, CA type 1 diabetes, type 2 diabetes Phase II (510) 204-7200 GK1-399 (TTP-399) (glucokinase activator) Forest Laboratories New York, NY TransTech Pharma High Point, NC type 2 diabetes Phase I/II (800) 947-5227 (336) 841-0300 GPR 119 agonist Bristol-Myers Squibb Princeton, NJ diabetes Phase I (800) 332-2056 GSK256073 (HM74A agonist) GlaxoSmithKline Rsch. Triangle Park, NC type 2 diabetes Phase II (888) 825-5249 GSK1070806 (IL-18 mAb) GlaxoSmithKline Rsch. Triangle Park, NC type 2 diabetes Phase I (888) 825-5249 GSK1614235 (SGLT1 inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC type 2 diabetes Phase I (888) 825-5249 GSK2330672 (ileal bile acid transfer inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC type 2 diabetes Phase I (888) 825-5249 HDV-insulin Diasome Pharmaceuticals Conshohocken, PA type 2 diabetes Phase II (609) 923-9443 HE3286 Harbor BioSciences San Diego, CA type 2 diabetes Phase II (858) 587-9333 HIP-2B (human pro-islet peptide) CureDM Wilmington, DE type 1 diabetes, type 2 diabetes Phase I (302) 288-0620 HPP-404 (histamine H3 receptor antagonist) High Point Pharmaceuticals High Point, NC diabetes Phase I www.highpointpharma.com HPP-593 (PPAR d agonist) High Point Pharmaceuticals High Point, NC diabetes Phase I www.highpointpharma.com Humalog® insulin lispro Eli Lilly Indianapolis, IN type 1 diabetes, type 2 diabetes Phase III (800) 545-5979 IBC-VS01 (insulin B-chain vaccine) Orban Biotech Brookline, MA type 1 diabetes Phase I (774) 571-2626 Medicines in Development for Diabetes Medicines in Development Diabetes 2012 7 Medicines in Development for Diabetes Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status Ilaris® canakinumab Novartis East Hanover, NJ type 2 diabetes ------------------------------------------------ type 1 diabetes Phase II/III (888) 669-6682 --------------------------------- Phase II (888) 669-6682 indeglitazar (PLX-204) Plexxikon Berkeley, CA type 2 diabetes Phase II (510) 647-4000 INGAP peptide Exsulin Minneapolis, MN type 1 diabetes, type 2 diabetes Phase II www.exsulin.com insulin adjustable basal Biodel Danbury, CT diabetes Phase I (203) 796-5000 insulin glargine (new formulation) Sanofi US Bridgewater, NJ type 1 diabetes, type 2 diabetes Phase III (800) 981-2491 insulin oral sublingual Biodel Danbury, CT type 1 diabetes Phase I (203) 796-5000 insulin transdermal Transdermal Global Broomall, PA type 1 diabetes, type 2 diabetes Phase I www.transdermalglobal.com INT131 (PPAR g modulator) InteKrin Therapeutics Los Altos, CA type 2 diabetes Phase II (650) 941-5501 ISIS-GCCRrx (glucocorticoid receptor antagonist) Isis Pharmaceuticals Carlsbad, CA type 2 diabetes Phase I (800) 679-4747 ISIS-GCGRrx (glucagon receptor antagonist) Isis Pharmaceuticals Carlsbad, CA type 2 diabetes Phase I (800) 679-4747 ISIS-PTP1Brx (PTP-1B gene inhibitor) Isis Pharmaceuticals Carlsbad, CA type 2 diabetes Phase I (800) 679-4747 ISIS-SGLT2rx Isis Pharmaceuticals Carlsbad, CA type 2 diabetes Phase I (800) 679-4747 ITCA 650 (exenatide subcutaneous implant) Intarcia Therapeutics Hayward, CA type 2 diabetes Phase III (510) 782-7800 Janumet® sitagliptin/metformin Merck Whitehouse Station, NJ type 2 diabetes in adolescents and children Phase III (800) 672-6372 Medicines in Development for Diabetes Medicines in Development for Diabetes Medicines in Development Diabetes 20128 Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status Januvia® sitagliptin Merck Whitehouse Station, NJ type 2 diabetes in the elderly and adolescents Phase III (800) 672-6372 JNJ-16269110 (usistapide) Janssen Research & Development Raritan, NJ type 2 diabetes Phase II completed www.janssenrnd.com JNJ-41443532 Janssen Research & Development Raritan, NJ type 2 diabetes Phase II completed www.janssenrnd.com KRP-104 (CD26 antigen inhibitor) ActivX Biosciences La Jolla, CA type 2 diabetes Phase II (858) 558-5558 LCQ908 (DGAT1 inhibitor) Novartis East Hanover, NJ type 2 diabetes Phase II (888) 669-6682 LEZ763 Novartis East Hanover, NJ type 2 diabetes Phase II (888) 669-6682 LIK066 Novartis East Hanover, NJ type 2 diabetes Phase I/II (888) 669-6682 LIM-0705 Limerick Biopharma South San Francisco, CA type 2 diabetes Phase I (650) 742-0110 linagliptin/pioglitazone (fixed-dose combination) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT type 2 diabetes Phase III (800) 243-1027 lisofylline (lysophosphatidic acid transferase inhibitor) DiaKine Therapeutics Norfolk, VA type 1 diabetes Phase I (434) 981-4777 lixisenatide (AVE0010) Sanofi US Bridgewater, NJ type 2 diabetes Phase III (800) 981-2491 lixisenatide/Lantus® insulin glargine (fixed-dose combination) Sanofi US Bridgewater, NJ type 2 diabetes Phase II (800) 981-2491 LX-4211 (SLGT1/SLGT2 inhibitor) Lexicon Pharmaceuticals The Woodlands, TX type 2 diabetes Phase II (281) 863-3000 LY2409021 (glucagon-R antagonist) Eli Lilly Indianapolis, IN type 2 diabetes Phase II (800) 545-5979 Medicines in Development for Diabetes Medicines in Development Diabetes 2012 9 Medicines in Development for Diabetes Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status LY2523199 (11ß-HSD1 inhibitor) Eli Lilly Indianapolis, IN type 2 diabetes Phase II (800) 545-5979 LY2605541 novel basal insulin/insulin peglispro Boehringer Ingelheim Pharmaceuticals Ridgefield, CT Eli Lilly Indianapolis, IN type 1 diabetes, type 2 diabetes Phase III (800) 243-1027 (800) 545-5979 LY2963016 (new insulin glargine product) Boehringer Ingelheim Pharmaceuticals Ridgefield, CT Eli Lilly Indianapolis, IN type 1 diabetes, type 2 diabetes Phase III (800) 243-1027 (800) 545-5979 MBX-2982 (G-protein coupled receptor) Metabolex Hayward, CA type 2 diabetes Phase II (510) 293-8800 mesenchymal precursor cell (MPC) product (stem cell therapy) Mesoblast New York, NY type 2 diabetes Phase II (212) 880-2060 metformin delayed-release formulation (gut sensory modulator) Elcelyx Therapeutics San Diego, CA type 2 diabetes Phase I (858) 876-1814 metreleptin Amylin Pharmaceuticals San Diego, CA diabetes and/or hypertriglyceridemia in patients with inherited or acquired lipodystrophy -------------------------------------------------- type 1 diabetes application submitted (858) 552-2200 ------------------------------------------- Phase I (858) 552-2200 mitiglinide Kissei America Parsippany, NJ type 2 diabetes Phase III completed (973) 334-4400 Mitoglitazone™ MSDC-0160 (insulin sensitizer) Metabolic Solutions Development Kalamazoo, MI type 2 diabetes Phase II (269) 343-6732 MK-3102 (DPP-IV inhibitor) Merck Whitehouse Station, NJ type 2 diabetes Phase III (800) 672-6372 MK-5823 Merck Whitehouse Station, NJ type 2 diabetes Phase I (800) 672-6372 MSDC-0602 (insulin sensitizer) Metabolic Solutions Development Kalamazoo, MI type 2 diabetes Phase II (269) 343-6732 Medicines in Development for Diabetes Medicines in Development Diabetes 201210 Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status NN1218 (insulin aspart fast-acting) Novo Nordisk Princeton, NJ type 1 diabetes, type 2 diabetes Phase I (800) 727-6500 NN1953 (insulin oral) Novo Nordisk Princeton, NJ type 1 diabetes, type 2 diabetes Phase I (800) 727-6500 NN1954 (insulin oral) Novo Nordisk Princeton, NJ type 1 diabetes, type 2 diabetes Phase I (800) 727-6500 NN9068 (insulin degludec/liraglutide) Novo Nordisk Princeton, NJ type 2 diabetes Phase III (800) 727-6500 NN9924 (GLP-1 receptor agonist) Novo Nordisk Princeton, NJ type 2 diabetes Phase I (800) 727-6500 NN9926 (GLP-1 stimulant) Novo Nordisk Princeton, NJ type 2 diabetes Phase I (800) 727-6500 NP-500 Napo Pharmaceuticals San Francisco, CA type 2 diabetes (see also diabetes-related) Phase I (415) 371-8300 OAP-189 (PF-05212389) Pfizer New York, NY type 2 diabetes Phase I (800) 879-3477 onglyza™ saxagliptin AstraZeneca Wilmington, DE Bristol-Myers Squibb Princeton, NJ type 2 diabetes in adolescents and children Phase III (800) 236-9933 (800) 332-2056 oral-lyn™ insulin oral Generex Biotechnology Toronto, Canada type 1 diabetes Phase III (416) 364-2551 oxyntomodulin Merck Whitehouse Station, NJ type 2 diabetes Phase I completed (800) 672-6372 PAZ-320 Boston Therapeutics Manchester, NH type 2 diabetes Phase II (978) 886-0421 PB-1023 (GLP-1 receptor agonist) PhaseBio Pharmaceuticals Malvern, PA type 2 diabetes Phase II (610) 891-6500 PEG-FGF-21 Bristol-Myers Squibb Princeton, NJ diabetes in clinical trials (800) 332-2056 Medicines in Development Diabetes 2012 11 Medicines in Development for Diabetes Diabetes, type 1 anD type 2 product Name Sponsor Indication Development Status peptide p277 (orphan Drug) Andromeda Biotech Ness Ziona, Israel type 1 diabetes (newly diagnosed) Phase III www.andromedabio.com PF-04937319 Pfizer New York, NY type 2 diabetes Phase II (800) 879-3477 PF-05175157 Pfizer New York, NY type 2 diabetes Phase I (800) 879-3477 PF-05231023 Pfizer New York, NY type 2 diabetes Phase I (800) 879-3477 prochymal® remestemcel-L Osiris Therapeutics Columbia, MD type 1 diabetes Phase II