Diabetes Pipeline: 200+ Companies Driving Innovation in Glucose Control, Disease Modification, and Next-Gen Therapeutics | DelveInsight

The treatment landscape for diabetes is undergoing a significant transformation as the global burden of the disease continues to rise. With over 200 companies advancing cutting-edge therapies, the focus is shifting from traditional glucose-lowering strategies to disease-modifying approaches, beta-cell preservation, and precision-based therapeutics. As the limitations of current insulin-based and oral antidiabetic therapies become more evident, biopharma innovators are exploring novel pathways, including incretin-based therapies, SGLT2 inhibitors, GLP-1/glucagon dual and triple agonists, GABA receptor modulators, and stem cell-based regenerative therapies.

DelveInsight's "Diabetes - Pipeline Insight, 2025" provides a comprehensive overview of the global diabetes R&D landscape, encompassing both type 1 and type 2 diabetes. The report highlights promising clinical and preclinical candidates aimed at improving glycemic control, reducing insulin dependency, preserving pancreatic beta-cell function, and managing diabetes-related complications. It offers detailed profiles of emerging therapies, including oral GLP-1 receptor agonists, gene therapies, microbiome modulators, and combination regimens targeting metabolic dysfunction.

In addition to therapeutic advancements, the report explores novel drug delivery technologies, biomarker-guided development strategies, regulatory incentives, and strategic collaborations shaping the diabetes pipeline. As the need for more effective and durable treatments becomes critical, this report showcases the next generation of therapies set to redefine diabetes care and improve patient outcomes worldwide.

Interested in learning more about the current treatment landscape and the key drivers shaping the diabetes pipeline? Click here: https://www.delveinsight.com/report-store/diabetes-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Diabetes Pipeline Report
• DelveInsight's diabetes pipeline analysis depicts a strong space with 200+ active players working to develop 200+ pipeline drugs for diabetes treatment.
• The leading diabetes companies include vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical, and others are evaluating their lead assets to improve the diabetes treatment landscape.
• Key diabetes pipeline therapies in various stages of development include Cadisegliatin, THDB0206, LY-3209590, CPL207280, XW014, ECC5004, KN056, RGT001-075, NRDN-101, Research programme: Diabetes mellitus therapeutics, CKD-383, and others.
• In February 2025, Tandem Diabetes Care announced FDA clearance of its Control-IQ+ automated insulin delivery algorithm for type 2 diabetes patients.
• In February 2025, Sotagliflozin, FDA-approved for type 2 diabetes and kidney disease, was shown to significantly reduce heart attack and stroke risk in high-risk patients, offering a new treatment for cardiovascular protection.
• In February 2025, the FDA approved MERILOG (insulin-aspart-szjj), the first rapid-acting insulin biosimilar to NovoLog, marking a significant milestone in diabetes care. This approval is expected to improve patient access to insulin and increase market competition, potentially lowering costs.
• In February 2025, NLS Pharmaceutics, Kadimastem, and iTolerance announced the results of a Type B pre-IND meeting with the FDA on iTOL-102, a potential Type 1 Diabetes cure. The treatment combines Kadimastem's stem cell-derived pancreatic islets with iTolerance's immunomodulator, without requiring lifelong immune suppression.
• In February 2025, the FDA issued a safety alert about diabetes devices, including CGMs, insulin pumps, and automated insulin dosing systems, that rely on smartphones for critical safety alerts. Users can customize alert settings (e.g., type, frequency, and delivery method) through the app on their phone.
• In February 2025, COUR Pharmaceuticals announced that the FDA cleared its Investigational New Drug (IND) application for CNP-103, a nanoparticle therapy in development to target the underlying autoimmunity of Type 1 diabetes (T1D). COUR is a clinical-stage biotechnology company focused on disease-modifying therapies that induce antigen-specific tolerance for immune-mediated diseases.
• In January 2025, Rise Therapeutics announced that the FDA had accepted its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of R-5780 for cancer, marking the company's fourth clinical program. The company is also conducting ongoing studies in ulcerative colitis, rheumatoid arthritis, and type 1 diabetes.
• In January 2025, the FDA approved a new indication for semaglutide to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, according to Novo Nordisk.
• In December 2024, Novo Nordisk submitted a Citizen Petition to the FDA requesting the removal of liraglutide from the 503B Bulks List, arguing that its approved products, VICTOZA, SAXENDA, and XULTOPHY, adequately meet patient needs and that compounded versions could pose safety and efficacy risks.

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Diabetes Overview
Diabetes is a chronic metabolic disorder characterized by elevated blood glucose levels resulting from the body's inability to produce or effectively use insulin. It primarily includes Type 1 diabetes, an autoimmune condition where the immune system destroys insulin-producing cells, and Type 2 diabetes, which is more prevalent and associated with insulin resistance and factors like obesity and poor lifestyle choices. Other forms include gestational diabetes, occurring during pregnancy, and rarer types such as MODY and LADA.

Typical symptoms of diabetes include increased thirst, frequent urination, fatigue, unexplained weight loss, blurred vision, and slow-healing wounds. In Type 1 diabetes, insulin deficiency leads to uncontrolled blood sugar, while in Type 2, the body's cells become resistant to insulin, and the pancreas cannot compensate. Prolonged high blood sugar can damage blood vessels, nerves, and organs, increasing the risk of cardiovascular disease, neuropathy, retinopathy, and kidney complications. Both genetic and environmental factors influence disease development and progression.

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Diabetes Treatment Analysis: Drug Profile
Cadisegliatin: vTv Therapeutics
Cadisegliatin, also known as TTP399, is an innovative oral liver-selective glucokinase activator developed by vTv Therapeutics. It is designed as an adjunct therapy to insulin for patients with type 1 diabetes (T1D). By enhancing hepatic glucose uptake and glycogen storage independently of insulin, Cadisegliatin aims to improve glycemic control and address an important gap in diabetes management. The drug is currently in Phase III clinical trials for diabetes treatment.

LY-3209590: Eli Lilly and Company
Insulin efsitora alfa (LY-3209590) is a once-weekly basal insulin developed by Eli Lilly, consisting of a novel single-chain insulin variant fused with a human IgG2 Fc domain. Its design allows for subcutaneous administration once weekly and provides a low peak-to-trough ratio, potentially resulting in more stable glucose levels and reduced variability over the week. LY-3209590 is in Phase III development for both type 1 and type 2 diabetes.

CT-388: Roche
CT-388 is a once-weekly injectable dual GLP-1/GIP receptor agonist under development by Roche for obesity and type 2 diabetes (T2D). It is engineered to activate both GLP-1 and GIP receptors with minimal ß-arrestin recruitment, which reduces receptor internalization and desensitization, thereby extending its pharmacological effect. CT-388 is currently in Phase II clinical trials for type 2 diabetes.

HU6: Rivus Pharmaceuticals
HU6 is a first-in-class oral therapy developed by Rivus Pharmaceuticals, belonging to a novel class known as Controlled Metabolic Accelerators (CMAs). It selectively enhances fat metabolism to promote fat loss while preserving muscle mass by activating mitochondrial uncoupling-a process that increases oxidation of sugars and fats without decreasing energy (ATP) production. HU6 is currently in Phase II development for diabetes treatment.

Learn more about the novel and emerging diabetes pipeline therapies at https://www.delveinsight.com/report-store/diabetes-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Diabetes Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Diabetes Pipeline Report
• Coverage: Global
• Key Diabetes Companies: vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical, and others.
• Key Diabetes Pipeline Therapies: Cadisegliatin, THDB0206, LY-3209590, CPL207280, XW014, ECC5004, KN056, RGT001-075, NRDN-101, Research programme: Diabetes mellitus therapeutics, CKD-383, and others.

Dive deep into rich insights for drugs used for diabetes treatment, visit: https://www.delveinsight.com/report-store/diabetes-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Diabetes Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Diabetes Pipeline Therapeutics
6. Diabetes Pipeline: Late-Stage Products (Phase III)
7. Diabetes Pipeline: Mid-Stage Products (Phase II)
8. Diabetes Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
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About DelveInsight
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This release was published on openPR.