As Buerger's Disease increasingly affects populations worldwide and is linked to comorbidities such as diabetes, cardiovascular disorders, and certain cancers, the need for safer and more effective treatments is rising. According to DelveInsight, over 3 pharmaceutical and biotech companies are actively developing 3+ therapeutic candidates targeting Buerger's Disease. These therapies are at various stages of clinical and preclinical development, highlighting significant innovation and commitment to addressing this critical public health challenge.
DelveInsight’s “Buerger's Disease Pipeline Insight 2025” report offers a comprehensive analysis of the current R&D landscape, including clinical trial progress, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives. The report serves as an essential resource for stakeholders—researchers, healthcare investors, and decision-makers—seeking insights into the evolving Buerger's Disease therapeutics market and the innovations shaping its future.
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During the ERS Congress 2025 in September 2025, several biotechnology and pharmaceutical companies shared notable advancements in pulmonary and cardiopulmonary research:
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In September 2025, Diagonal Therapeutics presented new preclinical data highlighting the potential of its lead clustering antibody, DIAG723, as a disease-modifying therapy for pulmonary arterial hypertension (PAH).
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In September 2025, a study revealed that babies raised with dogs may have a reduced risk of developing childhood asthma.
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In September 2025, Savara shared data from the Phase 3 IMPALA-2 trial of Molgramostim Inhalation Solution for patients with autoimmune pulmonary alveolar proteinosis (aPAP).
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In September 2025, AllRock Bio, Inc. reported encouraging Phase 1 results for ROC-101, a first-in-class oral pan-ROCK inhibitor for cardiopulmonary and fibrotic diseases.
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In September 2025, Gossamer Bio, Inc., in collaboration with Chiesi Group, announced five scientific presentations on seralutinib for PAH and PH-ILD.
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In September 2025, Boehringer Ingelheim presented pooled analyses from the Phase III FIBRONEER™ program on nerandomilast, an investigational oral PDE4B inhibitor, showing a nominally significant reduction in mortality risk across IPF and PPF.
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In September 2025, Kaia Health launched a pilot program of Kaia Breathe, a digital pulmonary rehabilitation solution for COPD patients, in partnership with MedImprove.
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In September 2025, aTyr Pharma, Inc. shared additional findings from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis, a key form of interstitial lung disease.
Key Takeaways from the Buerger's Disease Pipeline Report
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DelveInsight’s Buerger's Disease pipeline report highlights a dynamic landscape with over 3 active companies developing more than 3 therapeutic candidates for Buerger's Disease.
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Leading companies such as Antidote Therapeutics, K-STEMCELL, Caladrius Biosciences, and others are actively investigating new treatments to enhance the current therapeutic options.
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Notable pipeline therapies at various stages of development include Mesenchymal stem cell therapy, ATI-1013, and additional candidates aimed at improving patient outcomes.
Buerger's Disease Overview:
Buerger’s disease, also known as Thromboangiitis obliterans, is a rare disorder characterized by inflammation and obstruction of small and medium-sized blood vessels, mainly affecting the hands and feet. Early signs typically include pain or a cold sensation in the fingers or toes, while advanced stages can result in skin discoloration (pale, red, or bluish), severe pain, ulcers, gangrene, and, in extreme cases, amputation.
Diagnosis usually involves imaging techniques to identify vascular blockages, such as plethysmography, Doppler ultrasound, or catheter-based X-ray arteriography, along with blood tests to exclude other forms of vasculitis or vascular obstruction.
The primary treatment goal is to alleviate symptoms and prevent disease progression. The most effective strategy to reduce the risk of amputation and improve outcomes is the complete cessation of all tobacco products, including smoking, secondhand smoke exposure, and nicotine replacement therapies, particularly if done before permanent tissue damage occurs. Additional treatment options may include calcium channel blockers, anticoagulants, thrombolytics, prostaglandin analogs, and, in certain cases, surgical or interventional procedures such as sympathectomy, adrenalectomy, spinal cord stimulation, or omental transfer.
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Buerger's Disease Pipeline Analysis
The Buerger's Disease pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Buerger's Disease Market.
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Categorizes Buerger's Disease therapeutic companies by development stage: early, mid, and late-stage.
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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.
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Reviews emerging Buerger's Disease drugs under development based on:
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Stage of development
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Buerger's Disease Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Buerger's Disease Mechanism of action
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Molecular type
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Offers detailed analysis of:
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Company-to-company and company-academia collaborations
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Buerger's Disease Licensing agreements
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Funding and investment activities supporting future Buerger's Disease market advancement.
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Unlock key insights into emerging Buerger's Disease therapies and market strategies here: https://www.delveinsight.com/report-store/buergers-disease-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Buerger's Disease Emerging Drugs
Mesenchymal Stem Cell Therapy – K-STEMCELL
K-STEMCELL is developing a mesenchymal stem cell-based therapy designed to treat ischemic ulcers and other complications associated with Buerger’s disease. The investigational treatment, VascoStem, facilitates blood vessel formation indirectly by stimulating vascular endothelial growth factor (VEGF) secretion and also supports direct regeneration of damaged tissues. VascoStem is currently undergoing Phase I/II clinical trials for Buerger’s disease. Recognizing its potential, the therapy was granted rare disease designation by the U.S. FDA in May 2016, based on early clinical data from Korea, and later received orphan drug designation from the European Medicines Agency (EMA) in March 2017.
ATI-1013 – Antidote Therapeutics
ATI-1013 is a fully human monoclonal antibody designed to bind to and neutralize nicotine in the bloodstream. Developed using an immune-based strategy, it is part of a larger program aimed at tackling nicotine dependence. The development of ATI-1013 has received support through an $8.5 million Strategic Alliance grant from the National Institute on Drug Abuse (NIDA) at the NIH. The therapy has also been awarded Orphan Drug Designation by the FDA, underscoring its potential in treating conditions such as Buerger’s disease, where nicotine is a key contributing factor.
Buerger's Disease Pipeline Therapeutic Assessment
Buerger's Disease Assessment by Product Type
• Mono
• Combination
• Mono/Combination
Buerger's Disease 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
Buerger's Disease Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Buerger's Disease Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
Download sample pages to get an in-depth assessment of the emerging Buerger's Disease therapies and key Buerger's Disease companies
Table of Contents
1. Report Introduction
2. Executive Summary
3. Buerger's Disease Current Treatment Patterns
4. Buerger's Disease - DelveInsight's Analytical Perspective
5. Therapeutic Assessment
6. Buerger's Disease Late-Stage Products (Phase-III)
7. Buerger's Disease Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Buerger's Disease Discontinued Products
13. Buerger's Disease Product Profiles
14. Buerger's Disease Key Companies
15. Buerger's Disease Key Products
16. Dormant and Discontinued Products
17. Buerger's Disease Unmet Needs
18. Buerger's Disease Future Perspectives
19. Buerger's Disease Analyst Review
20. Appendix
21. Report Methodology
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