Type 1 Diabetes Pipeline Insight 2025: 100+ Pipeline Drugs, Cell Therapies, and Closed-Loop Systems Redefining Care | DelveInsight

DelveInsight's "Type 1 Diabetes - Pipeline Insight, 2025" explores the fast-evolving pipeline of more than 100+ therapies in development for type 1 diabetes (T1D), an autoimmune condition driven by the destruction of insulin-producing β-cells. Despite insulin remaining the backbone of treatment, the persistent unmet need to prevent, delay, or modify disease progression continues to shape the Type 1 diabetes treatment market.

The Type 1 diabetes pipeline is diversifying across multiple fronts. Cell-based therapies, including stem-cell-derived and gene-edited islet replacements, aim to restore endogenous insulin production. Immunomodulators, such as teplizumab and next-generation checkpoint therapies, are being investigated to preserve residual β-cell function in newly diagnosed and at-risk individuals. In parallel, advances in automated insulin delivery, including FDA-cleared hybrid closed-loop systems like Medtronic's MiniMed 780G, are improving real-time glucose management and patient quality of life, redefining the Type 1 diabetes treatment landscape.

With Type 1 diabetes clinical trials advancing across biologics, small molecules, and intelligent devices, the therapeutic focus is shifting from symptom control to disease modification. As these innovations move closer to market, the Type 1 diabetes market is expected to transition toward integrated solutions that combine cutting-edge pharmacology, regenerative medicine, and digital health-paving the way for a future where T1D care is not just managed, but fundamentally transformed.

Interested in learning more about the current treatment landscape and the key drivers shaping the Type 1 Diabetes pipeline? Click here: https://www.delveinsight.com/report-store/type-1-diabetes-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Type 1 Diabetes Pipeline Report
• DelveInsight's Type 1 Diabetes pipeline analysis depicts a strong space with 85+ active players working to develop 100+ pipeline drugs for Type 1 Diabetes treatment.
• The leading Type 1 Diabetes companies include AstraZeneca, Eli Lilly and Company, Shandong Suncadia Medicine, Boehringer Ingelheim, AdAlta, Lisata Therapeutics, Alebund Pharmaceuticals, SCOHIA PHARMA, DiaMedica Therapeutics, Roche, MC2 Therapeutics, Allena Pharmaceuticals, Regulus Therapeutics, UnicoCell Biomed, Regeneron Pharmaceuticals, and others are evaluating their lead assets to improve the Type 1 Diabetes treatment landscape.
• Key Type 1 Diabetes pipeline therapies in various stages of development include 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, and others.
• In Sept 2025, Lexicon Pharmaceuticals submitted new clinical data to the FDA supporting a potential resubmission of Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor for type 1 diabetes. This follows FDA concerns about diabetic k3toacidosis risk raised in a 2024 complete response letter. The data comes from three investigator-initiated studies aimed at addressing the benefit-risk profile.
• In September 2025, Medtronic announced two FDA regulatory milestones for its MiniMedTM 780G system: clearance of the SmartGuardTM algorithm as an interoperable automated glycemic controller (iAGC) allowing integration with Abbott's Instinct sensor for type 1 diabetes, and approval of the MiniMedTM 780G system for adults (18+) with insulin-requiring type 2 diabetes.
• In July 2025, PolTREG and its U.S. subsidiary Immuthera announced that the FDA issued a formal meeting protocol following their pre-IND meeting on the adaptive Phase II/III trial of PTG-007 for children with presymptomatic Type 1 diabetes. The protocol confirmed that the submitted clinical data support an IND application and outlined regulatory pathways to accelerate development in the U.S.
• In July 2025, Takeda announced that its Phase III trials for oveporexton (TAK-861), an oral orexin receptor 2 agonist, met all primary and secondary endpoints in treating narcolepsy type 1 (NT1). NT1 is caused by loss of orexin neurons, and oveporexton targets this underlying deficiency. The trials showed significant symptom improvement and good tolerability, marking a major step toward a new standard of care for NT1.
• 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, SpringWorks Therapeutics received FDA approval for a new treatment for neurofibromatosis type 1 (NF1), a genetic disease that causes tumors to form on nerves. This drug is able to treat a broader range of patients compared to the AstraZeneca product, which was the first to address this rare disorder.

Request a sample and discover the recent breakthroughs happening in the Type 1 Diabetes pipeline landscape at https://www.delveinsight.com/report-store/type-1-diabetes-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Type 1 Diabetes Overview
Type 1 Diabetes (T1D) is a chronic autoimmune condition where the body's immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. Without insulin, the body cannot regulate blood sugar levels, leading to serious health complications. T1D is most commonly diagnosed in children and young adults, though it can develop at any age. Its exact cause remains unclear, but genetic and environmental factors are believed to play a role.

Management of T1D requires lifelong insulin therapy, either through injections or insulin pumps, along with regular blood glucose monitoring. In recent years, advancements in technology (like continuous glucose monitors and automated insulin delivery systems) and research into beta cell replacement, immunotherapies, and other novel treatments offer hope for better disease control and, eventually, a cure.

Find out more about Type 1 Diabetes medication at https://www.delveinsight.com/report-store/type-1-diabetes-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Type 1 Diabetes Treatment Analysis: Drug Profile
Insulin Efsitora Alfa: Eli Lilly and Company
LY3209590, known as Insulin Efsitora Alfa, is a biologic drug composed of engineered insulin linked to an Fc domain, designed to provide a long-lasting basal insulin effect. It is currently in Phase III clinical trials for treating patients with Type 1 Diabetes.

Stem Cell Educator Therapy: Throne Biotechnologies
Throne Biotechnologies' Stem Cell Educator Therapy aims to address the root causes of autoimmune diseases, including diabetes and alopecia, by "resetting" the immune system through a one-time dialysis-like procedure using cord blood-derived stem cells (CB-SC). This therapy is in Phase II/III clinical trials for Type 1 Diabetes.

Frexalimab: Sanofi
Frexalimab (SAR441344) is a novel, second-generation anti-CD40L antibody that blocks the CD40/CD40L pathway, which is crucial for activating both adaptive (T and B cells) and innate (macrophages, microglia, dendritic cells) immune responses. This unique mechanism could target both acute and chronic neuroinflammation in multiple sclerosis without depleting lymphocytes. Sanofi is developing frexalimab under an exclusive license from ImmuNext, and it is currently in Phase II trials for Type 1 Diabetes.

VX-880: Vertex Pharmaceuticals
VX-880 is an investigational allogeneic stem cell-derived therapy consisting of fully differentiated insulin-producing islet cells created with proprietary technology. It targets patients with Type 1 Diabetes who experience impaired hypoglycemic awareness and severe hypoglycemia. Administered via infusion into the hepatic portal vein, the treatment requires immunosuppressive drugs to prevent rejection of the transplanted cells. VX-880 is currently in Phase I/II clinical trials.

Learn more about the novel and emerging Type 1 Diabetes pipeline therapies at https://www.delveinsight.com/report-store/type-1-diabetes-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Type 1 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
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the Type 1 Diabetes Pipeline Report
• Coverage: Global
• Key Type 1 Diabetes Companies: AstraZeneca, Eli Lilly and Company, Shandong Suncadia Medicine, Boehringer Ingelheim, AdAlta, Lisata Therapeutics, Alebund Pharmaceuticals, SCOHIA PHARMA, DiaMedica Therapeutics, Roche, MC2 Therapeutics, Allena Pharmaceuticals, Regulus Therapeutics, UnicoCell Biomed, Regeneron Pharmaceuticals, and others.
• Key Type 1 Diabetes Pipeline Therapies: 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, and others.

To dive deep into rich insights for drugs used for Type 1 Diabetes treatment, visit: https://www.delveinsight.com/report-store/type-1-diabetes-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Type 1 Diabetes Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Type 1 Diabetes Pipeline Therapeutics
6. Type 1 Diabetes Pipeline: Late-Stage Products (Phase III)
7. Type 1 Diabetes Pipeline: Mid-Stage Products (Phase II)
8. Type 1 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

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jvimal@delveinsight.com
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Healthcare Consulting
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