Type 1 Diabetes - Pipeline Insight, 2025

This “Type 1 Diabetes - Pipeline Insight, 2025” report provides comprehensive insights about 85+ companies and 100+ pipeline drugs in Type 1 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

Type 1 Diabetes: Understanding

Type 1 Diabetes: Overview

Type 1 diabetes is an autoimmune disease where the body's immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. This results in a complete lack of insulin production, which is required for the body to regulate blood sugar levels. The exact cause of this autoimmune destruction is unknown, but it is believed to involve a combination of genetic and environmental factors.

Genetic factors play a significant role, as having a first-degree relative (parent or sibling) with type 1 diabetes increases the risk of developing the disease. Certain genes have also been linked to an increased susceptibility. Environmental triggers, such as viral infections, exposure to certain chemicals, or dietary factors like cow's milk, may also contribute to the autoimmune response that leads to beta cell destruction. However, the specific trigger that initiates this process remains unclear. The 10-30% of cases where no autoimmunity is detected are classified as idiopathic type 1 diabetes, and the cause in these instances is unknown.

The most common symptoms of type 1 diabetes include increased thirst, frequent urination (especially at night), extreme hunger, unintended weight loss, fatigue and weakness, blurred vision, irritability, and other mood changes. Additional signs may include genital itching or thrush, cuts and wounds that take longer to heal, and fruity-smelling breath. In children, symptoms can also manifest as heavier diapers, bed-wetting in previously potty-trained kids, fast breathing, belly pain, vomiting, and behavior changes. The symptoms often appear suddenly, especially in children, and can progress rapidly over days or weeks as the pancreas produces less and less insulin. Prompt diagnosis and treatment are crucial, as untreated type 1 diabetes can lead to life-threatening diabetic ketoacidosis.

The primary treatment for type 1 diabetes is insulin therapy, which involves administering insulin via injections or an insulin pump to regulate blood sugar levels. Insulin is essential for people with type 1 diabetes as their pancreas is unable to produce it. Carbohydrate counting is also crucial to match insulin doses with the amount of carbs consumed. Continuous glucose monitoring (CGM) or flash glucose monitoring can help track blood sugar levels without frequent finger prick tests. Other medications like metformin may sometimes be prescribed in addition to insulin. Maintaining a healthy diet, regular physical activity, and achieving a healthy weight are important lifestyle factors that help manage type 1 diabetes. Regular check-ups with the diabetes care team, including an endocrinologist, certified diabetes educator, and registered dietitian, are necessary to monitor the condition and adjust treatment as needed.

"Type 1 Diabetes - Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Type 1 Diabetes pipeline landscape is provided which includes the disease overview and Type 1 Diabetes treatment guidelines. The assessment part of the report embraces, in depth Type 1 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 1 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 1 Diabetes R&D. The therapies under development are focused on novel approaches to treat/improve Type 1 Diabetes.

Type 1 Diabetes Emerging Drugs Chapters

This segment of the Type 1 Diabetes report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II/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 1 Diabetes Emerging Drugs

Insulin Efsitora Alfa: Eli Lilly and Company

LY3209590 "Insulin Efsitora Alfa" is a biologic entity comprised of an engineered insulin fused to an Fc domain designed to provide a long-acting basal profile. LY3209590 is being studied for the treatment of diabetes. The drug is currently being evaluated under Phase III clinical trial for the treatment of patients with Type 1 Diabetes.

• Stem Cell Educator therapy: Throne Biotechnologies

Throne’s Stem Cell Educator Therapy is designed to reverse the root causes of autoimmune diseases, such as diabetes and alopecia, by fundamentally “resetting” the immune system through a one-time dialysis-like treatment using CB-SC stem cells. The drug is currently being evaluated under Phase II/III clinical trial for the treatment of patients with Type 1 Diabetes.

Frexalimab: Sanofi

Frexalimab (SAR441344) is a potentially first-in-class second generation investigational anti-CD40L antibody that blocks the costimulatory CD40/CD40L pathway which is important for activation and function of adaptive (T and B cells) and innate (macrophages/microglia and dendritic cells) immunity. Through this unique upstream mechanism of action, frexalimab has the potential to address both acute and chronic neuroinflammation in MS, without causing lymphocyte depletion. Sanofi is developing frexalimab under an exclusive license from ImmuNext. The drug is currently being evaluated under Phase II clinical trial for the treatment of patients with Type 1 Diabetes.

• VX-880: Vertex Pharmaceuticals

VX-880 is an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy manufactured using proprietary technology. It is being evaluated for patients who have type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. VX-880 is being investigated as an infusion into the hepatic portal vein and requires immunosuppressive therapy to protect the islet cells from immune rejection. The drug is currently being evaluated under Phase I/II clinical trial for the treatment of patients with Type 1 Diabetes.

MTX-101: Mozart Therapeutics

MTX-101 is a bispecific autoimmune checkpoint inhibitor. Its dual configuration binds the CD8 Treg receptors, KIR and CD8, to selectively activate CD8 Treg and enhance MTX-101’s specificity, respectively. MTX-101 is designed to restore CD8 Treg functionality and the cytolytic elimination of pathogenic CD4 T cells. The drug is currently being evaluated under Phase I clinical trial for the treatment of patients with Type 1 Diabetes.

Type 1 Diabetes: Therapeutic Assessment

This segment of the report provides insights about the different Type 1 Diabetes drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Type 1 Diabetes

There are approx. 85+ key companies which are developing the therapies for Type 1 Diabetes. The companies which have their Type 1 Diabetes drug candidates in the most advanced stage, i.e. Phase III include, Eli Lilly and Company.

Phases

The report covers around 100+ 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 1 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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

Product Type

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

Type 1 Diabetes: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Type 1 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 1 Diabetes drugs.

Type 1 Diabetes Report Insights

• Type 1 Diabetes Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Type 1 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 1 Diabetes drugs?
• How many Type 1 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 1 Diabetes?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Type 1 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 1 Diabetes and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Eli Lilly and Company
• Throne Biotechnologies
• Sanofi
• Vertex Pharmaceuticals
• Mozart Therapeutics
• Zealand Pharma
• Adocia
• Creative Medical Technology Holdings
• Sernova
• Boehringer Ingelheim
• Bayer
• Tiziana Life Sciences
• Amarna Therapeutics
• PolTREG
• Surrozen
• Biomea Fusion
• ITBMed Biopharmaceuticals
• Panbela Therapeutics
• Diamyd Medical

Key Products

• Insulin Efsitora Alfa
• Stem Cell Educator Therapy
• Frexalimab
• VX-880
• MTX-101
• Dasiglucagon
• BioChaperone Lispro
• CELZ-201
• Islet cell replacement therapy
• Empagliflozin
• Finerenone
• Foralumab
• AM-510
• PTG-020
• Research programme
• BMF-219
• Siplizumab
• Eflornithine
• Diamyd

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