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Latest FDA Regulations on Peptides Used as Bulk Substances for 503A or 503B Compounding Pharmacies

The FDA’s latest regulations on peptides are focused on ensuring the safety and efficacy of these drugs. In recent years, there has been a growing interest in peptides for the treatment of a variety of conditions, including cancer, diabetes, and obesity. However, peptides can also be complex and challenging to develop and manufacture. On September 29, 2023, FDA issued Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding, in which many popular peptides used in compounding pharmacies are considered not safe or

Peptide-based Gastrointestinal Disorders Therapeutics market is increasing

The Peptide-based Gastrointestinal Disorders Therapeutics market is increasing due to the rising prevalence of gastrointestinal issues, growing demand for targeted and personalized treatments, and increased research and development investments from pharmaceutical companies. North America is anticipated to lead the market due to the vast patient pool and developed healthcare infrastructure. Major players in the market include Takeda Pharmaceutical Company, GlaxoSmithKline, AstraZeneca, Eli Lilly and Company, and Novo Nordisk, as well as Shire Plc, Ironwood Pharmaceuticals, Inc., Astellas Pharma Inc., Allergan Plc, and Accredo Health Group, Inc.

FDA Approves Label Update for Semaglutide

The FDA has approved a label update for semaglutide (Rybelsus; Novo Nordisk) that allows the drug to be used in addition to diet and exercise as a first-line option to improve glycemic control in adults with type 2 diabetes. This update removes a previous limitation that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes. With its initial FDA approval in 2019, semaglutide became the first and only glucagon-like peptide-1 (GLP-1) analog in pill form. “The removal of

Israeli and Japanese researchers have identified unique peptides with potential anti-cancer properties

Unique peptides with potential anti-cancer capabilities have been found by Technion and University of Tokyo researchers. Unusual peptides have the potential to be effective anti-cancer treatments, according to a recent study published in Nature Communications. Attention has been drawn to peptides because of their possible application in the treatment of cancer. Peptides are little chains of amino acids joined together by peptide bonds. Peptides only have a few dozens of amino acids, as opposed to proteins, which typically have hundreds. The cyclic peptides were found to,

BPC 157 a possible PAH therapy

A preclinical study in a rat model of the disease suggests that a peptide known as BPC 157 may prevent or treat pulmonary arterial hypertension (PAH) and its side effects. Peptides are short chains of amino acids, which are the building blocks of proteins. The results imply that BPC 157 would be worth looking into as a possible PAH therapy. A group of scientists from Croatia published their results in the book Biomedicines under the title “Stable stomach pentadecapeptide BPC 157 therapy for monocrotaline-induced pulmonary hypertension

Compstatin used in treating severe Covid-19

Compstatin is a cyclic tridecapeptide that inhibits a key step in the activation of the human complement system[1]. It binds C3, inhibiting proteolytic cleavage by C3 convertase and activation of classical and alternative pathways[2][3]. Compstatin has been found to be highly potent and selective, with an IC50 of 28 μM[2], and has potential to prevent complement activation during and after clinical cardiac surgery[4]. Compstatins are a third-generation complement inhibitor, and AMY-101 is a selective peptidic compstatin analogue developed by AMYNDAS[1]. Clinical trials have been conducted to

Peptide-Fe complexes for Iron deficiency Anemia

Peptide-Fe complexes have been identified as promising iron-chelators[1], and peptide segments that change their conformation due to external stimuli have been used in peptide-based molecular devices[2]. Additionally, experiments modeling volcanic or hydrothermal settings have shown that amino acids can be converted into their peptides by use of coprecipitated (Ni,Fe)S and CO[3]. Finally, an Integrated Peptide and Protein prediction Framework based on Fused features and Ensemble models (IPPF-FE) has been proposed to precisely predict peptides[4]. Peptide-Fe complexes are formed mainly through the carboxyl and hydroxyl oxygen bond[1].

Ezatiostat the orphan drug granted by FDA

Ezatiostat (TER199, TLK199, Telintra)[1][2] is a peptidomimetic inhibitor of Glutathione S-transferase P1-1 (GSTP1-1)[2] and a tripeptide analog of glutathione[1]. It is being studied as a potential treatment for severe chronic neutropenia in clinical trials[3] and has been shown to stimulate the formation of bone marrow cells that are precursors to granulocytes and monocytes (white blood cells)[4][5]. It undergoes de-esterification to TLK235 and TLK236, which are its active forms[4]. Ezatiostat has a novel mechanism of action and beneficial effects on bone marrow[2][3]. It promotes maturation of hematopoietic

Exherin (ADH-1), a candidate to treat invasive carcinomas

Exherin (ADH-1) is a small, cyclic pentapeptide vascular-targeting drug developed by Adherex Technologies[1]. It is indicated for treatment of a variety of invasive carcinomas and has been shown to be synergistic with taxane-based chemotherapy[2]. It has also been evaluated in clinical and pharmacological phase I trials for its potential antineoplastic and antiangiogenic activities[3][4][5]. Invasive ductal carcinoma is one of the common types of breast cancer. It has been found to be well tolerated with a modest anti tumor effect[3]. Customer reviews suggest that it inhibits N-cadherin

Pinealon, the mood regulator

Pinealon is a synthetic peptide composed of three amino acids[1]. It has been shown to modify behavior and protect cells against the effects of aging[1]. Pinealon is available as a dietary supplement in capsule form[2] and has been found to have anabolic effects, improving the activity of the Central nervous system and other organs[3][4][5]. Pinealon is a dietary supplement with a synthesized brain peptide that normalizes the brain’s function by reducing its peptide deficiency and restoring balance[6]. It has been shown to be effective in reducing wrinkles

PT-141 the sexual function improver

PT-141 is a peptide hormone that improves sexual function in both men and women by stimulating the MC-4R[1][2]. It is used as a medication to help with low sex drive and ED[3], and has been shown to be effective in clinical trials[4]. However, it is not yet approved by the FDA[5]. The most common side effects of PT 141 are nausea, vomiting, flushing, and headaches[6][7]. Other less common side effects include dizziness, stuffy nose, and tiredness[8][9]. PT-141 is a quick acting treatment option to help improve

Can Epitalon really slow aging process?

Epitalon is a synthetic peptide, telomerase activator, and putative anti-aging drug[1][2]. It is a derivative of Epithalamin[2], which is naturally produced in the pineal gland[3]. Epitalon has the potential to modulate telomerase[2], the enzyme that maintains and protects the telomere[4][5]. Epitalon has a variety of benefits, including lengthening telomeres in human cells, promoting deeper sleep, delaying and preventing age-related diseases, and boosting energy levels[6][7]. Epitalon also helps to increase the body’s production of telomerase, an enzyme responsible for replicating DNA so that the body can repair

KPV, an antimicrobial peptide with unknown mechanism

KPV is a peptide that is naturally produced in the body and is found in the hormone alpha-MSH[1]. It is a potent anti-inflammatory peptide[2] that has shown promise in treating a number of disease conditions, with the most active research being in the area of inflammatory bowel disease[2][3].  It is a relatively newer peptide that is being researched for a number of disease conditions[4]. KPV has been shown in studies to kill Candida albicans[5] and possesses anti-inflammatory properties; however, its mechanisms of action still remain unknown[6]. It is

Lunasin's cancer treatment effects and anti-cholesterolemic and anti-diabetic properties

Lunasin is a group of amino acids, called a peptide, found in soybeans, oats, barley, and other plants[1][2][3]. Research into the properties of lunasin began in 1996[4][3], with a focus on cancer, cholesterol, and inflammation[1][3]. A Lunasin regimen consists of LunaRich X capsules (12 per day) and Reliv NOW (a mixture of vitamins, minerals, and antioxidants)[5]. Lunasin is a peptide found in soy that has been shown to have antioxidant, anti-inflammatory, anticarcinogenic, and immune-modulating properties. It is taken orally for cancer, amyotrophic lateral sclerosis (ALS), high

BPC157, the next cure-all molecule?

BPC-157 is a synthetic peptide that has been investigated for its regenerative effects, particularly in rats suffering toxic or surgical trauma[1]. It has also been studied for its potential to treat inflammatory bowel disease and improve soft tissue healing[2]. Additionally, BPC-157 is believed to help alleviate joint pain, improve joint mobility, and boost recovery from injuries[3] , as well as increase vascular flow to the muscles[3]. It is derived from a specific protein found in the stomach and is often used to treat conditions and disorders in

TAT 48-57

TAT 48-57

Introduction from Drug peptide supply about:TAT 48-57 English name TAT 48-57 Chinese name   CAS NO 253141-50-3 Peptide sequence Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg Molecular formula C55H109N31O12 Molecular weight 1396.7 storage temperature 2-8℃ purity ≥98% Package 1mg;5mg;10mg;50mg;100mg,1g or according to customer’s detail requirement. Product English synonyms         How to buy TAT 48-57 in the U. S.   Peptide supplier remetide specializes in the production and sales of It in the USA. Professional Drug peptide R&D.Professional drug peptide seller. Welcome your purchase   Hot line:+19498788363 Wechat:americhina