Bronchiolitis Obliterans Syndrome Pipeline

DelveInsight’s, “Bronchiolitis Obliterans Syndrome - Pipeline Insight, 2025” report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Bronchiolitis Obliterans Syndrome 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

 

Bronchiolitis Obliterans Syndrome: Understanding

Bronchiolitis Obliterans Syndrome: Overview

Bronchiolitis obliterans, also called obliterative or constrictive bronchiolitis, is a rare obstructive lung disease affecting the small airways, characterized by fibrosis of the terminal and distal bronchioles and spirometry findings of airflow obstruction. When it develops after lung transplantation or hematopoietic stem cell transplantation, it is termed bronchiolitis obliterans syndrome. The condition often leads to progressive and sometimes irreversible decline in lung function, with variable clinical outcomes. Causes can include inhalation of toxic fumes, severe respiratory infections, autoimmune diseases, and chronic graft-versus-host disease. Early detection is crucial, as timely intervention may slow progression, though curative treatments are limited.

Bronchiolitis obliterans commonly presents with progressive shortness of breath, especially on exertion, a persistent dry cough, wheezing during exhalation, fatigue, and occasionally a skin rash. Some patients may also experience fever, night sweats, or produce mucus with coughing, while infants can show increased irritability. Symptoms often worsen gradually over time as lung function declines, and in advanced cases, even minimal activity can trigger breathlessness. The condition may mimic asthma or chronic bronchitis, which can delay diagnosis. Over time, the narrowing and scarring of the small airways make breathing increasingly difficult, underscoring the importance of early recognition and management to slow progression and improve quality of life.

Bronchiolitis obliterans involves inflammation of sub-epithelial airway structures and dysregulated repair following injury from inhalational toxins, autoimmune reactions, or other insults, leading to fibroproliferation and abnormal regeneration of the small airway epithelium. Histologically, it affects terminal and respiratory bronchioles without significant changes in alveolar spaces, showing smooth muscle hypertrophy, peribronchiolar inflammation, mucus accumulation, scarring, and concentric fibrotic narrowing that can progress to complete lumen occlusion. In lung transplant recipients, microvascular insufficiency and alloimmune responses, along with risk factors such as acute cellular rejection, HLA antibodies, and gastroesophageal reflux with microaspiration, contribute to the development of bronchiolitis obliterans syndrome. In cases linked to paraneoplastic pemphigus, autoantibodies against desmoglein and plakin proteins target both skin and respiratory epithelium.

Treatment of bronchiolitis obliterans syndrome after lung transplant focuses on augmenting immunosuppression, as it is considered a form of chronic rejection, using agents such as tacrolimus, cyclosporine, mycophenolate mofetil, and prednisone. Azithromycin has been shown to reduce incidence and improve lung function, and a triple regimen of inhaled fluticasone, oral montelukast, and azithromycin can slow lung function decline post-HSCT. Managing gastroesophageal reflux is recommended, and severe progressive cases may require lung retransplantation. Extracorporeal photopheresis can also help slow disease progression. For non-transplant-related cases, eliminating exposure to causative agents is key, with immunosuppression using corticosteroids or cytotoxic drugs like cyclophosphamide offering benefit in autoimmune-related disease but limited value for toxic inhalation or post-infectious causes. Supportive care includes cough suppressants, inhaled bronchodilators, and supplemental oxygen as needed.

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

 

Bronchiolitis Obliterans Syndrome Emerging Drugs Chapters

This segment of the Bronchiolitis Obliterans Syndrome 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.

 

Bronchiolitis Obliterans Syndrome Emerging Drugs

• Liposomal Cyclosporine A: ZAMBON

Liposomal Cyclosporine A for Inhalation (L-CsA-i) is a novel liposomal formulation of cyclosporine A developed for inhaled delivery to the lungs. Calcineurin inhibitors (CNIs), like cyclosporine A, are highly potent immunosuppressive drugs and a cornerstone of lung transplant medicine. L-CsA-i is administered via a drug-specific Investigational eFlow® Technology nebulizer system (PARI Pharma GmbH). The investigational drug-device combination is designed to deliver L-CsA-i to the site of disease in the lung. The FDA has granted fast track designation to liposomal cyclosporine A for inhalation for treatment of bronchiolitis obliterans syndrome. Currently, the drug is in Phase III stage of its development for the treatment of Bronchiolitis Obliterans Syndrome.

 

• LAM 001: OrphAI Therapeutics

The potential for rapamycin to treat BOS is supported by both human and animal data.  Retrospective data in humans administered oral rapamycin post lung transplant has demonstrated improvement in both lung function, as measured by FEV16, and survival in the treatment7 of BOS.  These data are further bolstered by data in a mouse model of BOS which demonstrated that rapamycin prevented occlusion of airways via several mechanisms, including reduction in recruitment of fibrocytes, protection against airway epithelial loss and increased infiltration of immune inhibitory Treg and Breg cells. LAM-001, an inhaled formulation of rapamycin that achieves superior lung exposure with reduced systemic exposure, holds promise as a potential treatment for BOS. OrphAI Therapeutics has been granted orphan status in the US and EU for the treatment of BOS with LAM-001. Currently, the drug is in Phase II stage of its development for the treatment of Bronchiolitis Obliterans Syndrome.

Further product details are provided in the report……..

 

Bronchiolitis Obliterans Syndrome: Therapeutic Assessment

This segment of the report provides insights about the different Bronchiolitis Obliterans Syndrome drugs segregated based on following parameters that define the scope of the report, such as:

 

Major  Players in Bronchiolitis Obliterans Syndrome

• There are approx. 3+ key companies which are developing the therapies for Bronchiolitis Obliterans Syndrome. The companies which have their Bronchiolitis Obliterans Syndrome drug candidates in the most advanced stage, i.e. Phase III include, ZAMBON.

 

Phases

DelveInsight’s report covers around 3+ 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

Bronchiolitis Obliterans Syndrome 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.

 

Bronchiolitis Obliterans Syndrome: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Bronchiolitis Obliterans Syndrome 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 Bronchiolitis Obliterans Syndrome drugs.

 

Bronchiolitis Obliterans Syndrome Report Insights

• Bronchiolitis Obliterans Syndrome Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Bronchiolitis Obliterans Syndrome 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 Bronchiolitis Obliterans Syndrome drugs?
• How many Bronchiolitis Obliterans Syndrome drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Bronchiolitis Obliterans Syndrome?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Bronchiolitis Obliterans Syndrome 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 Bronchiolitis Obliterans Syndrome and their status?
• What are the key designations that have been granted to the emerging drugs?