Publication Date: 1/6/2010
This webpage mentions a number of diabetes products in development since 1995, including some that have been approved by the US FDA and some that have failed in trials.
Those that have been approved by the FDA no longer appear in the Table of Contents on this page, but are listed alphabetically below, with links to separate webpages.
For information about the FDA's drug approval process in the USA, see Drug-Development and Drug-Approval Process, "a table that provides readers with information about the investigational-drug and the drug-approval processes in the United States. An understanding of these terms will aid readers in understanding later descriptions of the status of investigational drugs as they move through the research and development pipeline." By L. Michael Posey and Jennifer T. Chang, PharmD; at the American Society of Consultant Pharmacists website.
acarbose (Precose™)
acetyl-l-carnitine
[Top]
- Class: not stated
- For: diabetic neuropathy
- Route of Administration: not stated
- Action: acts as a precursor of a neurotransmitter, acetylcholine
- Manufacturer: Sigma-Tau, together with Hoffmann-La Roche
- Status: Phase II testing for diabetic neuropathy in US; currently marketed in Italy (as of April 1994)
- Source of Information: British J Clinical
Pharmacology , Mar/Apr, 1994, Vol. 48 #2, page 94CS-011/CI-1037
[Top]
- Brand name in US: unstated
- Class: thiazolidinedione
- For: Type 2 diabetes
- Route of Administration: unstated
- Action: insulin sensitizer.
- Manufacturer: Sankyo Co Ltd and Abbott Laboratories
- Status: phase I trials in the US, and phase I trials are planned in Japan.
- Source of Information: Sankyo; Current Drugs
dexfenfluramine (Redux™)
DiaPep 277
[Top]
- For: treatment of type 1 diabetes and Latent Auto-immune Diabetes of the Adult (LADA)
- Route of Administration: not stated
- Manufacturer: Aventis, together with Peptor
- Status: Phase I/II
- Source of Information: Aventis Press Release (2002)
encapsulated porcine islets
[Top]
- Brand name in US: BetaRx-P
- Class: pig islet cells
- For: Type 1 diabetic patients with kidney transplants; perhaps for Type 1 patients with no immunosuppression.
- Route of Administration: transplant
- Action: same as human insulin
- manufacturer: VivoRx, Inc.
- Status: Has FDA approval for Phase I/II clinical trials
- Source of Information: Press Release, July 22, 1996, VivoRx,Inc (310) 264-7768
englitazone
[Top]
- Brand name in US: unstated
- Class: unstated (thiazolidinedione?)
- For: Type 2 diabetes
- Route of Administration: unstated
- Action: insulin sensitizer.
- Manufacturer: Pfizer
- Status: unstated
- Source of Information: New Drugs for 1997
glucagon, recombinant origin
[Top]
- Brand name in US: unstated
- Class: hyperglycemic hormone
- For: diabetes
- Route of Administration: unstated; presumably injected
- Action: presumably the same as glucagon
- Manufacturer: Eli Lilly
- Status: Phase III trials
- Source of Information: Products in Development (at Eli Lilly's website, as of Mar 20, 1998)
glimeprimide (Amaryl™)
glucagon-like peptide I (GLP-I)
[Top]
- Class: endogenous incretin
- For: Type 2 diabetes
- Route of Administration: buccal tablet (transmucosal absorption)
- Action: lowers blood sugar by suppressing glucagon secretion, prolonging stomach emptying after meals, and stimulating insulin release; might also decrease insulin resistance.
- Manufacturer:TheraTech
- Status: Human feasibility trial reported in Diabetes
Care .- Sources of Information: Diabetes
Care , Vol 19, #8, August 1996; Diabetes WellnessLetter , Vol 2, #9, 1996.iamin
[Top]
- Class: copper-based agent
- For: diabetic foot ulcers
- Route of Administration: unstated
- Action: unstated
- Manufacturer: unstated
- Status: Phase III
- Source of Information: All About Health, Dec 19, 1996; Diabetes Management: Current Diagnostic Criteria, Drug Therapies, and State Legislation. Lyons, T, II, et al Amer J Managed Care, pp.1599-1608 10/97
IDDM-AnergiX™
[Top]
- Brand name in US: IDDM-AnergiX
- Class: T cell inactivator
- For: Type 1 diabetes
- Route of Administration: unstated
- Action: inactivates the disease-related T cells in the immune system that are responsible for the disease.
- Manufacturer: Anergen
- Status: preliminary data presented in an animal model of IDDM at the International Immunology and Diabetes Workshop, Rome Italy, November, 1995
- Source of Information: First! For the WEB, April 2, 1996
Islet NeoGenesis Associated Protein (INGAP)
[Top]
- A hamster protein which has been shown to increase islet cell mass in both normal animals and young animals with diabetes.
- Proctor and Gamble
- Phase I/II clinical trials are under way (2003)
Insulin aspart (NovoLog, NovoRapid)
Now approved, and available in Europe and in the USA: See separate page
Insulin detemir (Levemir)
[Top]Insulin glulisine (Apidra)
[Top]Now approved, and soon available in Europe and in the USA: See separate page
Insulin glargine (Lantus)
insulin: inhaled
insulin: oral
[Top]
- Brand name in US: unstated
- Class: synthetic "mini-protein" analogue of insulin
- For: insulin-treated diabetes
- Route of Administration: oral
- Action: same as insulin
- manufacturer: Johnson & Johnson
- Status: speculation based on success of other protein analogues
- Source of Information: Jerry Bishop, Staff Reporter, Wall Street
Journal , July 1996insulin-like growth factor (IGF)
[Top]
- Brand name in US: unstated
- Class: peptide hormone
- For: diabetic neuropathy.
- Route of Administration: subcutaneous
- Action: Acute lowering of blood glucose and long-term improvement in insulin sensitivity. Also, "subcutaneous administration of IGFs can increase the rate of nerve regeneration, whereas regeneration is retarded by an antiserum that blocks the IGFs produced in nerves. IGF treatment can prevent the death of 80% of brain neurons which otherwise die following hypoxic-ischemic injury, a model of stroke. It also prevents memory loss which occurs in aging rats. IGFs are particularly high in the brain, spinal cord, nerves and circulation. " (per Aurogen information).
- Manufacturers: Genentech, Aurogen
- Status: Genentech's Phase III diabetes trials to lower blood glucose levels were suspended in 1997: Genentech Discontinues IGF-I Drug Development Effort In Type I and Type II Diabetes; they intend to continue exploring other applications.
Randomized, placebo-controlled, multicenter phase I and phase II clinical trials for IGF-II treatment of diabetic neuropathy has been drafted (Aurogen).- Sources of Information: Drug
Topics , June 12, 1995; Aurogen website; Genentech website; personal communication.LGD1069
[Top]
- Brand name in US: Targretin
- Class: RXR (retinoid X receptor) stimulator; insulin sensitizer
- For: Type 2 diabetes
- Route of Administration: unstated
- Manufacturers: Ligand Pharmaceuticals
- Status: Phase II clinical trials in diabetic patients in Belgium and Netherlands.
- Source: Press release, March 26, 1997, Ligand Pharmaceuticals Inc
- See also: RXR-selective retinoids
lispro insulin (Humalog®)
lispro mixtures (Humalog Mix25®)
metformin/glyburide combination (Glucovance®)
miglitol (Glyset)
MK-767
[Top]
- Class: dual peroxisome proliferator-activated receptor (PPAR) agonist (targets both gamma and alpha receptors)
- For: Type 2 Diabetes hyperglycemia and dyslipidemia
- Route of Administration: not stated
- Action: decreases blood sugar and triglyceride and increases HDL
- Manufacturer: Merck, together with Kyorin
- Status: Phase III development stopped in 2003, citing cases of a rare form of malignant tumor in long-term safety trials in mice.
- Source of Information: Merck, others, 2003; BioCentury Report (2004)
muraglitazar
[Top]
- Brand name in US: Paragluva
- Class: dual peroxisome proliferator activated receptor (PPAR) agonist
- For: Type 2 Diabetes
- Route of Administration: oral (2.5 mg and 5 mg tablets)
- Action: not stated
- Manufacturer: Bristol-Myers Squibb, together with Merck & Co., Inc
- Status: NDA submitted Dec2004; development discontinued May 2006.
- Sources of Information: FDA website; Press release: Bristol-Myers Squibb Announces Discontinuation of Development of Muraglitazar, an Investigational Oral Treatment for Type 2 Diabetes.
nateglinide (Starlix)
orlistat (Xenical)
Now available: See www.xenical.com
pimagedine
[Top]
- Brand name in US: unstated
- Class: aminoguanidine
- For: Prevention of complications in Type 1 and Type 2 patients
- Route of Administration: unstated
- Action: in diabetic rats, and in in vitro studies, pimagedine inhibits the formation of advanced glycosylation end-products (AGE's) which occur when glucose attaches itself to proteins without the aid of enzymes. The resulting cross-links between proteins may contribute to the development of atherosclerosis, nerve damage, kidney failure, and blindness.
- manufacturer: Alteon, Inc.
- Status: Phase III
- Sources of Information: Clinical
Diabetes , July/August, 1995; DrugTopics , June 12, 1995; ClinicalDiabetes , March/April, 1996; New Drugs for 1997pioglitazone (Actos®)
pramlintide
[Top]rosiglitazone/glimepiride combination
[Top]
- Brand name in US: Avandaryl
- Class: combination pill with rosiglitazone (Avandia) and glimepiride (Amaryl)
- For: Type 2 diabetes
- Route of Administration: oral
- Action: lowers blood sugar through two different mechanisms
- manufacturer: GlaxoSmithKline and Aventis
- Status: Application submitted to FDA
- Sources of Information: Presentation at GlaxoSmithKline website; PhPRMA website
repaglinide (Prandin™)
RXR-selective retinoids
[Top]
- Brand name in US: Unstated
- Class: RXR (retinoid X receptor) stimulator
- For: Type 2 diabetes, insulin resistant syndromes and dyslipidemias
- Route of Administration: unstated
- Action: lowers blood sugar
- Manufacturer: Allergan and Parke-Davis
- Status: uncertain
- Source: Press release, July 22, 1998
- See also: LGD1069
SGLT-2 inhibitors
rosiglitazone maleate (Avandia®)
exenatide (Byetta)
[Top]tolrestat
[Top]
- Brand name in US: Alredase
- Class: aldose reductase inhibitor
- For: prevention/controlling diabetic complications
- Route of Administration: unstated
- Action: enzyme inhibition
- Manufacturer: Wyeth-Ayerst Laboratories
- Status: Withdrawn by manufacturer in October, 1996 as being ineffective
- Other drugs in same class: zenarestat, zopolrestat
- Source of Information: Drug
Topics , June 12, 1995; local researcher, October, 1996troglitazone (Rezulin™)
vildagliptin
[Top]
- Now available (in Europe): See separate page vildagliptin (Galvus)
voglibose
[Top]
- Brand name in US: unstated
- Class: alpha glucosidase inhibitor
- For: Type 2 diabetes
- Route of Administration: unstated
- Action: unstated
- Other drugs in same class: acarbose, miglitol
- Manufacturer: Takeda
- Status: Available in some countries
- Source of Information: New Drugs for 1997
zenarestat
- Brand name in US: unstated
- Class: aldose reductase inhibitor
- For: prevention/controlling diabetic complications
- Route of Administration: unstated
- Action: enzyme inhibition
- Manufacturer: Pfizer
- Status: Withdrawn from development for the treatment of peripheral diabetic neuropathy, 2000
- Other drugs in same class: tolrestat, zopolrestat
- Source of Information: Pfizer press release: "Pfizer suspends development of compound for the treatment of diabetic neuropathy."
zopolrestat
- Brand name in US: Alond
- Class: aldose reductase inhibitor
- For: prevention/controlling diabetic complications
- Route of Administration: unstated
- Action: enzyme inhibition
- Manufacturer: Pfizer
- Status: Withdrawn from development for the treatment of peripheral diabetic neuropathy, 1999
- Other drugs in same class: tolrestat, zenarestat
- Source of Information: Doctor's Guide to the Internet: "Pfizer Halts Development Of Alond For Diabetic Neuropathy"
ZP10
[Top]
- Class: GLP-1 (glucagon-like peptide-1) receptor agonist of the exendin class
- For: type 2 diabetes.
- Route of Administration: not stated
- Action:
- Manufacturer: Aventis, together with Zealand Pharma A/S
- Status: phase I/II clinical trials
- Source of Information: Aventis Press Release, 2003
Also see
Research: What's Coming? for information about other concepts that are under development for the treatment of diabetes, and
