Lung Fibrosis Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | Bristol-Myers Squibb, Boehringer Ingelheim, Pfizer, Zambon SpA, Centocor

June 30 10:00 2025
Lung Fibrosis Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | Bristol-Myers Squibb, Boehringer Ingelheim, Pfizer, Zambon SpA, Centocor
(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Lung Fibrosis pipeline constitutes key companies continuously working towards developing Lung Fibrosis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

Lung Fibrosis Pipeline Insight, 2025” report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Lung Fibrosis Market.

 

The Lung Fibrosis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Some of the key takeaways from the Lung Fibrosis Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Lung Fibrosis treatment therapies with a considerable amount of success over the years.

  • Lung Fibrosis companies working in the treatment market are Genentech, Inc., Bristol-Myers Squibb, Boehringer Ingelheim, Assistance Publique – Hôpitaux de Paris, Pfizer, Zambon SpA, Centocor, Inc., Tvardi Therapeutics, Bristol-Myers Squibb, PureTech, Endeavor Biomedicines, Syndax Pharmaceuticals, SPARK Biopharma, CSL Behring, and others, are developing therapies for the Lung Fibrosis treatment

  • Emerging Lung Fibrosis therapies in the different phases of clinical trials are- Pirfenidone, BMS-986278, BI 1839100, Pirfenidone, Etanercept, n-acetylcysteine, CNTO 888, TTI-101, BMS-986278, Pirfenidone, taladegib, Axatilimab, SB17170, Garadacimab, and others are expected to have a significant impact on the Lung Fibrosis market in the coming years.

  • In April 2025, Endeavor BioMedicines (“Endeavor”), a clinical-stage biotech company focused on developing treatments for life-threatening diseases, has shared a post hoc analysis from its completed Phase 2a trial of ENV-101 (taladegib), its lead investigational therapy. The findings showed a notable decrease in pulmonary vessel volume, a significant increase in lung volume, and a trend toward reduced lung fibrosis in patients with idiopathic pulmonary fibrosis (IPF) who received ENV-101 for 12 weeks compared to placebo. The analysis leveraged Qureight’s AI-powered CT imaging technology and was presented as a poster at the American Thoracic Society (ATS) 2025 International Conference.

  • In April 2025, Avalyn Pharma Inc., a clinical-stage biopharma company focused on inhaled treatments for severe pulmonary conditions, announced that its investigational therapy AP02 (inhaled nintedanib) demonstrated a favorable safety and tolerability profile in multiple Phase 1 clinical trials. These included both single-ascending dose (SAD) and multiple-ascending dose (MAD) studies conducted in healthy adults and patients with idiopathic pulmonary fibrosis (IPF).

  • In January 2025, Mediar Therapeutics entered into a global licensing agreement with Eli Lilly and Company to progress MTX-463 into a Phase II clinical trial for idiopathic pulmonary fibrosis (IPF). MTX-463 is a pioneering human IgG1 antibody aimed at inhibiting WISP1-driven fibrotic signaling in various severe diseases.

  • In October 2024, Trevi Therapeutics, a company focused on developing the investigational therapy Haduvio (oral nalbuphine ER) for treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), has shared updates on its clinical development program.

  • In September 2024, Aileron Therapeutics announced that enrollment for Cohort 2 in the ongoing Phase Ib clinical trial of LTI-03 for IPF patients has been successfully completed.

  • In July 2024, Bridge Biotherapeutics announced the completion of patient enrollment in the Phase II clinical trial of BBT-877, a novel autotaxin (ATX) inhibitor developed for the treatment of idiopathic pulmonary fibrosis (IPF).

  • In July 2024, Huitai BioMedicine (HUITAI) announced that its first independently developed and globally patented innovative drug, inhaled HTPEP-001 for pulmonary fibrosis treatment, has successfully administered the first dose to a healthy subject in a Phase I clinical trial at Beijing Chaoyang Hospital.

 

Lung Fibrosis Overview

Lung fibrosis, also known as pulmonary fibrosis, is a chronic lung disease characterized by scarring (fibrosis) of lung tissue, leading to stiffness and reduced oxygen exchange. This progressive condition makes breathing difficult and can result from idiopathic pulmonary fibrosis (IPF), autoimmune diseases, infections, environmental exposures, or certain medications. Symptoms include persistent dry cough, shortness of breath, fatigue, and chest discomfort. There is no cure, but treatments such as antifibrotic drugs (pirfenidone, nintedanib), oxygen therapy, and pulmonary rehabilitation can help slow disease progression and improve quality of life. In severe cases, lung transplantation may be considered.

 

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https://www.delveinsight.com/report-store/lung-fibrosis-pipeline-insight

 

Emerging Lung Fibrosis Drugs Under Different Phases of Clinical Development Include:

  • Pirfenidone: Genentech, Inc.

  • BMS-986278: Bristol-Myers Squibb

  • BI 1839100: Boehringer Ingelheim

  • Pirfenidone: Assistance Publique – Hôpitaux de Paris

  • Etanercept: Pfizer

  • n-acetylcysteine: Zambon SpA

  • CNTO 888: Centocor, Inc.

  • TTI-101: Tvardi Therapeutics

  • BMS-986278: Bristol-Myers Squibb

  • Pirfenidone: PureTech

  • taladegib: Endeavor Biomedicines

  • Axatilimab: Syndax Pharmaceuticals

  • SB17170: SPARK Biopharma

  • Garadacimab: CSL Behring

 

Lung Fibrosis Route of Administration

Lung Fibrosis 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

  • Parenteral

  • Intravenous

  • Subcutaneous

  • Topical

 

Lung Fibrosis Molecule Type

Lung Fibrosis Products have been categorized under various Molecule types, such as

  • Monoclonal Antibody

  • Peptides

  • Polymer

  • Small molecule

  • Gene therapy

 

Lung Fibrosis Pipeline Therapeutics Assessment

  • Lung Fibrosis Assessment by Product Type

  • Lung Fibrosis By Stage and Product Type

  • Lung Fibrosis Assessment by Route of Administration

  • Lung Fibrosis By Stage and Route of Administration

  • Lung Fibrosis Assessment by Molecule Type

  • Lung Fibrosis by Stage and Molecule Type

 

DelveInsight’s Lung Fibrosis Report covers around products under different phases of clinical development like

  • Late-stage products (Phase III)

  • Mid-stage products (Phase II)

  • Early-stage product (Phase I)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further Lung Fibrosis product details are provided in the report. Download the Lung Fibrosis pipeline report to learn more about the emerging Lung Fibrosis therapies

 

Some of the key companies in the Lung Fibrosis Therapeutics Market include:

Key companies developing therapies for Lung Fibrosis are – Endeavor BioMedicines, Humanetics Corporation, Melius Pharma AB, Tvardi Therapeutics, GRI Bio Operations, Daewoong Pharmaceutical, Regend Therapeutics, Boehringer Ingelheim, Avalyn Pharmaceuticals, Syndax Pharmaceuticals, PureTech Health, Otsuka Holdings, Vicore Pharma, Sunshine Lake Pharma, and others.

 

Lung Fibrosis Pipeline Analysis:

The Lung Fibrosis pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Lung Fibrosis with aggregate therapies developed by each company for the same.

  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Lung Fibrosis Treatment.

  • Lung Fibrosis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

  • Lung Fibrosis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Lung Fibrosis market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Lung Fibrosis drugs and therapies

 

Lung Fibrosis Pipeline Market Drivers

  • Rising Disease Prevalence, Advancements in Drug Development, Growing Research & Clinical Trials, Regulatory Support, Improved Diagnostic Techniques, are some of the important factors that are fueling the Lung Fibrosis Market.

 

Lung Fibrosis Pipeline Market Barriers

  • However, High Drug Development Costs, Limited Treatment Options, Stringent Regulatory Approvals, Side Effects & Safety Concerns, Low Awareness & Late Diagnosis, and other factors are creating obstacles in the Lung Fibrosis Market growth.

 

Scope of Lung Fibrosis Pipeline Drug Insight

  • Coverage: Global

  • Key Lung Fibrosis Companies: Genentech, Inc., Bristol-Myers Squibb, Boehringer Ingelheim, Assistance Publique – Hôpitaux de Paris, Pfizer, Zambon SpA, Centocor, Inc., Tvardi Therapeutics, Bristol-Myers Squibb, PureTech, Endeavor Biomedicines, Syndax Pharmaceuticals, SPARK Biopharma, CSL Behring, and others

  • Key Lung Fibrosis Therapies: Pirfenidone, BMS-986278, BI 1839100, Pirfenidone, Etanercept, n-acetylcysteine, CNTO 888, TTI-101, BMS-986278, Pirfenidone, taladegib, Axatilimab, SB17170, Garadacimab, and others

  • Lung Fibrosis Therapeutic Assessment: Lung Fibrosis current marketed and Lung Fibrosis emerging therapies

  • Lung Fibrosis Market Dynamics: Lung Fibrosis market drivers and Lung Fibrosis market barriers

 

Request for Sample PDF Report for Lung Fibrosis Pipeline Assessment and clinical trials

 

Table of Contents

1. Lung Fibrosis Report Introduction

2. Lung Fibrosis Executive Summary

3. Lung Fibrosis Overview

4. Lung Fibrosis- Analytical Perspective In-depth Commercial Assessment

5. Lung Fibrosis Pipeline Therapeutics

6. Lung Fibrosis Late Stage Products (Phase II/III)

7. Lung Fibrosis Mid Stage Products (Phase II)

8. Lung Fibrosis Early Stage Products (Phase I)

9. Lung Fibrosis Preclinical Stage Products

10. Lung Fibrosis Therapeutics Assessment

11. Lung Fibrosis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Lung Fibrosis Key Companies

14. Lung Fibrosis Key Products

15. Lung Fibrosis Unmet Needs

16 . Lung Fibrosis Market Drivers and Barriers

17. Lung Fibrosis Future Perspectives and Conclusion

18. Lung Fibrosis Analyst Views

19. Appendix

20. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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