Type 2 Diabetes - Pipeline Insight, 2024

This “Type 2 Diabetes - Pipeline Insight, 2024” report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Type 2 Diabetes pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Type 2 Diabetes: Understanding

Type 2 Diabetes: Overview

Type 2 diabetes mellitus (T2DM) is a chronic condition that affects the way the body processes blood sugar (glucose). In T2DM, the response to insulin is diminished, and this is defined as insulin resistance. During this state, insulin is ineffective and is initially countered by an increase in insulin production to maintain glucose homeostasis, but over time, insulin production decreases, resulting in T2DM. T2DM is most commonly seen in persons older than 45 years. Still, it is increasingly seen in children, adolescents, and younger adults due to rising levels of obesity, physical inactivity, and energy-dense diets.

T2DM is an insulin-resistance condition with associated beta-cell dysfunction. Initially, there is a compensatory increase in insulin secretion, which maintains glucose levels in the normal range. As the disease progresses, beta cells change, and insulin secretion is unable to maintain glucose homeostasis, producing hyperglycemia. Most of the patients with T2DM are obese or have a higher body fat percentage, distributed predominantly in the abdominal region. This adipose tissue itself promotes insulin resistance through various inflammatory mechanisms, including increased FFA release and adipokine dysregulation.

Lack of physical activity, prior GDM in those with hypertension or dyslipidemia also increases the risk of developing T2DM. Evolving data suggest a role for adipokine dysregulation, inflammation, abnormal incretin biology with decreased incretins such as glucagon-like peptide-1 (GLP-I) or incretin resistance, hyperglucagonemia, increased renal glucose reabsorption, and abnormalities in gut microbiota.

The diagnostic procedure to confirm type 2 diabetes fasting plasma glucose (FPG) test, A1C test, random plasma glucose (RPG), and oral glucose tolerance test are carried out. For A1C, the normal range should be below 5.7%, fasting plasma glucose should be 99 mg/dL or below, and oral glucose tolerance should be 139 mg/dL or below. Diabetes can be treated and its consequences avoided or delayed with diet, physical activity, medication and regular screening and treatment for complications.

Medications include metformin, meglitinides and sulfonylureas, DPP-4 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, SGLT2 inhibitors, bile acid sequestrants etc. In September 2019, the US Food and Drug Administration approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.

"Type 2 Diabetes- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Type 2 Diabetes pipeline landscape is provided which includes the disease overview and Type 2 Diabetes treatment guidelines. The assessment part of the report embraces, in depth Type 2 Diabetes commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Type 2 Diabetes collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Type 2 Diabetes R&D. The therapies under development are focused on novel approaches to treat/improve Type 2 Diabetes.

Type 2 Diabetes Emerging Drugs Chapters

This segment of the Type 2 Diabetes report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Type 2 Diabetes Emerging Drugs

LY-3209590: Eli Lilly and Company

Insulin efsitora alfa (LY3209590) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in phase III development for adults with type 1 and 2 diabetes.

THDB0206: Tonghua Dongbao Pharmaceutical

BC Lispro (THDB0206) is an ultra-rapid-acting insulin analog developed by Tonghua Dongbao Pharmaceutical Co., Ltd. for the treatment of type 2 diabetes. BC Lispro is designed to restore early-phase insulin secretion, which is often impaired in diabetic patients. This insulin analog utilizes a new formulation technology that allows for rapid absorption and action, mimicking the physiological pattern of insulin secretion after meals. Such characteristics are expected to reduce the risk of late postprandial hypoglycemia, providing patients with greater flexibility in managing their insulin injections. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Type 2 Diabetes.

HU6: Rivus Pharmaceuticals

Rivus Pharmaceuticals is developing HU6, a novel oral medication classified as a Controlled Metabolic Accelerator (CMA), aimed at treating various metabolic diseases, including type 2 diabetes. HU6 works by leveraging mitochondrial uncoupling to increase the body's resting metabolic rate, promoting fat loss while preserving lean muscle mass. Currently, the drug is in the Phase II stage of development to treat Type 2 Diabetes.

AZD5004: AstraZeneca

AZD-5004, also known as ECC5004, is an investigational small molecule glucagon-like peptide-1 receptor agonist (GLP-1RA) developed by AstraZeneca in collaboration with Eccogene. It is primarily aimed at treating obesity, type 2 diabetes, and related cardiometabolic conditions. AZD-5004 works by mimicking the effects of GLP-1, a hormone that regulates appetite and insulin secretion. This mechanism is crucial for managing weight and improving glucose metabolism, making it a potential therapeutic option for individuals with obesity and type 2 diabetes. Currently, the drug is in the Phase II stage of development to treat Type 2 Diabetes.

XW014: Sciwind Biosciences

XW014 is an oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist developed by Sciwind Biosciences for the treatment of obesity and type 2 diabetes (T2D). XW014 functions as a GLP-1 receptor agonist, which means it mimics the action of the GLP-1 hormone that is released after meals. This hormone plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. As an oral small molecule, XW014 offers advantages over traditional peptide-based GLP-1 therapies, such as ease of administration and the potential for combination therapies with other oral medications. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Type 2 Diabetes.

KN056: Suzhou Alphamab Co., Ltd.

KN-056 is a glucagon-like peptide-1 receptor (GLP-1R) modulator developed by Suzhou Alphamab Co., Ltd. for the treatment of type 2 diabetes. KN-056 functions as a GLP-1R modulator, which means it targets the glucagon-like peptide-1 receptor. GLP-1 is a hormone that plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. By modulating the GLP-1 receptor, KN-056 aims to improve glycemic control in patients with type 2 diabetes. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Type 2 Diabetes.

Type 2 Diabetes: Therapeutic Assessment

This segment of the report provides insights about the different Type 2 Diabetes drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Type 2 Diabetes

• There are approx. 75+ key companies which are developing the therapies for Type 2 Diabetes. The companies which have their Type 2 Diabetes drug candidates in the most advanced stage, i.e. Phase III include, Eli Lilly and Company and Tonghua Dongbao Pharmaceutical.

Phases

The report covers around 80+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Type 2 Diabetes pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Type 2 Diabetes: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Type 2 Diabetes therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Type 2 Diabetes drugs.

Type 2 Diabetes Report Insights

• Type 2 Diabetes Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Type 2 Diabetes Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Type 2 Diabetes drugs?
• How many Type 2 Diabetes drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Type 2 Diabetes?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Type 2 Diabetes therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Type 2 Diabetes and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Tonghua Dongbao Pharmaceutical
• Eli Lilly and Company
• Rivus Pharmaceuticals
• Celon Pharma
• Sciwind Biosciences
• AstraZeneca
• Suzhou Alphamab Co., Ltd.
• Neurodon
• Abarceo Pharma
• Chong Kun Dang Pharmaceutical

Key Products

• THDB0206
• LY-3209590
• HU6
• CPL207280
• XW014
• AZD5004
• KN056
• RGT001-075
• NRDN-101

Research programme: type 2 diabetes mellitus therapeutics

• CKD-383

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