Ruboxistaurin
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Ruboxistaurin
Ruboxistaurin (proposed brand name Arxxant) is an investigational drug for diabetic retinopathy being investigated by Eli Lilly and Company. It is a member of the bisindolylmaleimide family. In February 2006, Lilly submitted a New Drug Application for ruboxistaurin, and on August 18, 2006, Lilly received an approvable letter from the US FDA for ruboxistaurin, with a request for an additional clinical trial, which would take 5 years to complete. Lilly has not made any further request for approval and ruboxistaurin is not approved by the FDA for any medical use. Mechanism of action Ruboxistaurin is an inhibitor of protein kinase C In cell biology, Protein kinase C, commonly abbreviated to PKC (EC 2.7.11.13), is a family of protein kinase enzymes that are involved in controlling the function of other proteins through the phosphorylation of hydroxyl groups of serine and t ...-beta. References External linksEli Lilly and Company Product Pipeline Eli Lilly and Company bra ...
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Protein Kinase C
In cell biology, Protein kinase C, commonly abbreviated to PKC (EC 2.7.11.13), is a family of protein kinase enzymes that are involved in controlling the function of other proteins through the phosphorylation of hydroxyl groups of serine and threonine amino acid residues on these proteins, or a member of this family. PKC enzymes in turn are activated by signals such as increases in the concentration of diacylglycerol (DAG) or calcium ions (Ca2+). Hence PKC enzymes play important roles in several signal transduction cascades. In biochemistry, the PKC family consists of fifteen isozymes in humans. They are divided into three subfamilies, based on their second messenger requirements: conventional (or classical), novel, and atypical. Conventional (c)PKCs contain the isoforms α, βI, βII, and γ. These require Ca2+, DAG, and a phospholipid such as phosphatidylserine for activation. Novel (n)PKCs include the δ, ε, η, and θ isoforms, and require DAG, but do not require Ca2+ for ...
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Diabetic Retinopathy
Diabetic retinopathy (also known as diabetic eye disease), is a medical condition in which damage occurs to the retina due to diabetes mellitus. It is a leading cause of blindness in developed countries. Diabetic retinopathy affects up to 80 percent of those who have had both type 1 and type 2 diabetes for 20 years or more. In at least 90% of new cases, progression to more aggressive forms of sight threatening retinopathy and maculopathy could be reduced with proper treatment and monitoring of the eyes The longer a person has diabetes, the higher his or her chances of developing diabetic retinopathy. Each year in the United States, diabetic retinopathy accounts for 12% of all new cases of blindness. It is also the leading cause of blindness in people aged 20 to 64. Signs and symptoms Nearly all people with diabetes develop some degree of retina damage ("retinopathy") over several decades with the disease. For many, that damage can only be detected by a retinal exam, and has ...
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Eli Lilly And Company
Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War. As of 2022, Lilly is known for its clinical depression drugs Prozac ( fluoxetine) (1986) and Cymbalta (duloxetine) (2004) and its antipsychotic medication Zyprexa (olanzapine) (1996), although its primary revenue drivers are the diabetes drugs Humalog (insulin lispro) (1996) and Trulicity (dulaglutide) (2014). Lilly's achievements include being the first company to mass-produce the polio vaccine developed by Jonas Salk, and insulin. It was one of the first pharmaceutical companies to produce human insulin using recombinant DNA including Humulin ( insulin medication), Humalog (insulin lispro), and the first approved biosimilar insulin product in the US, Basaglar ( ...
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Bisindolylmaleimide
Bisindolylmaleimide is an organic compound that forms the core chemical structure of a variety of biologically active compounds. This core structure includes a central maleimide group with two indole groups attached. Examples of bisindolylmaleimide derivatives include: * Bisindolylmaleimide I * Enzastaurin * Ruboxistaurin * Tivantinib Tivantinib (ARQ197; by Arqule, Inc.) is an experimental small molecule anti-cancer drug. It is a bisindolylmaleimide that binds to the dephosphorylated MET kinase ''in vitro''. (MET is a growth factor receptor.) Tivantinib is being tested clinica ... References External links {{heterocyclic-stub ...
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Approvable Letter
Approvable letters, and the related non-approvable letters (alternately not-approvable letters), were notifications sent out by the Food and Drug Administration (FDA) to drug manufacturers alerting them to the approval prospects of their drugs under development. The letters were intended to let manufacturers know how much work is needed on their applications. Non-approval letters were rejections of a drug's application. Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (O ..., section 314.110. In 2018, the FDA replaced approvable letters with Complete Response Letters (CRL) to notify applicants when additional information is required before approval. Guidelines Approvable letters were iss ...
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US FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from h ...
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ...
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Drugs
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhalation, injection, smoking, ingestion, absorption via a patch on the skin, suppository, or dissolution under the tongue. In pharmacology, a drug is a chemical substance, typically of known structure, which, when administered to a living organism, produces a biological effect. A pharmaceutical drug, also called a medication or medicine, is a chemical substance used to treat, cure, prevent, or diagnose a disease or to promote well-being. Traditionally drugs were obtained through extraction from medicinal plants, but more recently also by organic synthesis. Pharmaceutical drugs may be used for a limited duration, or on a regular basis for chronic disorders. Pharmaceutical drugs are often classified into drug classes—groups of related ...
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Eli Lilly And Company Brands
Eli most commonly refers to: * Eli (name), a given name, nickname and surname * Eli (biblical figure) Eli or ELI may also refer to: Film * ''Eli'' (2015 film), a Tamil film * ''Eli'' (2019 film), an American horror film Music * ''Eli'' (Jan Akkerman album) (1976) * ''Eli'' (Supernaut album) (2006) Places * Alni, Ardabil Province, Iran, also known as Elī * Eli, Mateh Binyamin, an Israeli settlement in the West Bank * Éile or Éli, a medieval kingdom in Ireland * Eli, Kentucky, United States * Eli, Nebraska, United States * Eli, West Virginia, United States Other uses * ''Eli'' (opera), an opera by Walter Steffens * ELI (programming language) * Earth Learning Idea * English language institute * Environmental Law Institute, an American environmental law policy organization * European Law Institute * European Legislation Identifier * Extreme Light Infrastructure, a proposed high energy laser research facility of the European Union * Eli, someone from Yale University, after ...
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