Upcoming Diabetes Medications - The Diabetes Monitor
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.
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acetyl-l-carnitine
CS-011/CI-1037
encapsulated porcine islets
Diapep 277
englitazone
glucagon, recombinant
glucagon-like peptide I
iamin
IDDM-AnergiX
Islet NeoGenesis Associated Protein
insulin, inhaled
insulin, oral insulin-like growth factor (IGF)
LGD1069 (Targretin)
MK-767
muraglitazar
pimagedine
rosiglitazone/glimepiride combination
RXR-selective retinoids
vildagliptin (Galvus)
voglibose
zenarestat
zopolrestat
ZP10
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acarbose (PrecoseÙ)
Now available: See separate page
acetyl-l-carnitine
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 94
CS-011/CI-1037
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 (ReduxÙ)
Previously available: Now withdrawn. See separate page
DiaPep 277
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
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
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
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 (AmarylÙ)
Now available: See separate page
glucagon-like peptide I (GLP-I)
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 Wellness Letter, Vol 2, #9, 1996.
iamin
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-AnergiXÙ
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)
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)
Now available in some countries: See separate page
Insulin glulisine (Apidra)
Now approved, and soon available in Europe and in the USA: See separate page
Insulin glargine (Lantus)
Now approved, and soon available: See separate page
insulin: inhaled
See separate page
insulin: oral
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 1996
insulin-like growth factor (IGF)
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
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?)
Now available: See separate page
lispro mixtures (Humalog Mix25?)
Now available in many countries: See separate page
metformin/glyburide combination (Glucovance?)
Now available; See separate page
miglitol (Glyset)
Now available
MK-767
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
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)
Now available: See separate page.
orlistat (Xenical)
Now available: See www.xenical.com
pimagedine
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; Drug Topics, June 12, 1995; Clinical Diabetes, March/April, 1996; New Drugs for 1997
pioglitazone (Actos?)
Now available: See separate page
pramlintide
Now available: See separate page
rosiglitazone/glimepiride combination
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 (PrandinÙ)
Now available: See separate page
RXR-selective retinoids
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
rosiglitazone maleate (Avandia?)
Now available: See separate page
exenatide (Byetta)
Now approved in USA: See separate page
tolrestat
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, 1996
troglitazone (RezulinÙ)
Previously available: Now withdrawn. See separate page
vildagliptin
Brand name in US: Galvus?
Class: DPP-4 inhibitor
For: Type 2 diabetes
Route of Administration: oral
Action: affects both pancreatic alpha and beta cells, leading to a reduction in sugar production from the liver together with an increase in production of insulin needed to keep blood sugar under control.
Manufacturer: Novartis
Status: FDA asked for additional safety data, November 2006
Source: Press release from Novartis March 2006; MarketWatch November 2006.
See also: Januvia
Information last updated: 16May2007
voglibose
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
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
Diabetes Medications Web Sites and Insulin Web Sites by David Mendosa.
