Pulmonary Fibrosis Clinical Trial Analysis 2026: 110+ Companies Advancing 140+ Therapies with Breakthrough Clinical Progress, analyses DelveInsight

Pulmonary Fibrosis Pipeline

According to DelveInsight’s latest evaluation, the global Pulmonary Fibrosis pipeline includes the active participation of more than 110 pharmaceutical and biotech companies developing over 140 therapeutic candidates. The analysis highlights ongoing clinical trials, therapeutic approaches, mechanisms of action, routes of administration, and key developments shaping the treatment landscape.

DelveInsight’s report, “Pulmonary Fibrosis Pipeline Insight, 2026” delivers a comprehensive overview of the current clinical development scenario while exploring future growth opportunities within the Pulmonary Fibrosis market.

The report offers a detailed clinical and commercial evaluation of pipeline candidates, spanning early discovery stages to marketed products. It provides in-depth drug profiles, including mechanisms of action, clinical trial data, regulatory milestones such as NDA approvals (where applicable), and development activities such as technological advancements, partnerships, mergers and acquisitions, funding trends, and special designations.

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Key Highlights from the Pulmonary Fibrosis Pipeline Report

• Pulmonary Fibrosis Companies worldwide are actively pursuing innovative therapies for Pulmonary Fibrosis, with notable progress achieved in recent years.
• Major industry players involved in this space include Boehringer Ingelheim, PureTech, Guangzhou JOYO Pharma, Tvardi Therapeutics, Pliant Therapeutics, GlaxoSmithKline, Amgen, Bristol-Myers Squibb, Endeavor Biomedicines, Syndax Pharmaceuticals, Regend Therapeutics, among others.
• Promising pipeline candidates such as BI 1015550, OFEV (Nintedanib), Pirfenidone, SC1011, TTI-101, PLN-74809, GSK3915393, HZN-825, BMS-986278, taladegib, BI 181947, Axatilimab, and REGEND001 are expected to significantly influence the future treatment landscape.

Recent Developments in the Pipeline

• February 2026: PureTech Health announced that deupirfenidone (LYT-100) received Orphan Drug Designation from both the U.S. FDA and the European Commission for treating idiopathic pulmonary fibrosis (IPF). The drug is being advanced by its subsidiary, Celea Therapeutics, for late-stage development and potential commercialization.
• February 2025: Shanghai Ark Biopharmaceutical secured FDA approval for its Investigational New Drug (IND) application for AK3280. This enables the initiation of a Phase II clinical trial in the United States to evaluate its safety, efficacy, and pharmacokinetics in IPF patients.
• November 2025: Reviva Pharmaceuticals obtained a European patent for brilaroxazine for treating pulmonary fibrosis, strengthening its global intellectual property portfolio. The drug has also received Orphan Drug Designation from the FDA.
• September 2025: Updated results from PureTech’s Phase IIb ELEVATE IPF trial showed that deupirfenidone helped stabilize lung function in patients, reinforcing its potential as a future standard-of-care treatment.
• September 2025: United Therapeutics reported positive Phase III results for Tyvaso (treprostinil), demonstrating improved forced vital capacity (FVC) and delayed disease progression in IPF patients.
• May 2025: Endeavor BioMedicines presented encouraging Phase IIa results for ENV-101 (taladegib), highlighting improvements in lung volume and reductions in fibrosis.
• February 2025: Pliant Therapeutics paused enrollment in its BEACON-IPF Phase IIb trial of bexotegrast following safety review recommendations, although existing participants continue in the study.
• January 2025: Mediar Therapeutics partnered with Eli Lilly to advance MTX-463, a novel antibody therapy targeting fibrotic signaling pathways, into Phase II trials.
• December 2024: PureTech announced successful Phase IIb results for deupirfenidone, demonstrating reduced lung function decline and positioning the therapy as a potential new standard of care.

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Pulmonary Fibrosis Overview

Pulmonary fibrosis is a progressive lung disorder characterized by scarring and thickening of lung tissue, which impairs oxygen transfer into the bloodstream. Common symptoms include persistent dry cough, shortness of breath, fatigue, and reduced physical endurance. The disease may result from environmental exposure, autoimmune conditions, infections, medications, or may occur without a known cause, as in idiopathic pulmonary fibrosis (IPF).

Emerging Therapies in Development

Key drugs under investigation across different development stages include:

• BI 1015550
• OFEV (Nintedanib)
• Pirfenidone
• SC1011
• TTI-101
• PLN-74809
• GSK3915393
• HZN-825
• BMS-986278
• taladegib
• BI 181947
• Axatilimab
• REGEND001

Route of Administration

Pipeline therapies are being developed across multiple delivery methods, including:

• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Molecule Types

The report categorizes therapies based on molecular composition, such as:

• Monoclonal antibodies
• Peptides
• Polymers
• Small molecules
• Gene therapies

Therapeutic Assessment Coverage

The report evaluates Pulmonary Fibrosis therapies based on:

• Product type and development stage
• Route of administration
• Molecular classification
• Clinical and commercial positioning

It includes analysis of:

• Late-stage (Phase III) candidates
• Mid-stage (Phase II) therapies
• Early-stage (Phase I) assets
• Preclinical and discovery-stage programs
• Discontinued or inactive candidates

Competitive Landscape and Pipeline Insights

The study provides:

• Company-wise pipeline analysis
• Segmentation of therapies by development phase
• Evaluation of active and dormant projects
• Insights into mechanisms of action, combination strategies, and therapeutic targets
• Detailed review of partnerships, licensing agreements, and funding activities

The findings are derived from proprietary databases, clinical trial registries, company disclosures, investor presentations, scientific conferences, and industry publications.

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Market Drivers

• Increasing global prevalence of IPF, particularly among aging populations
• Improved diagnostic tools enabling earlier detection
• Strong R&D investments targeting novel antifibrotic pathways
• Regulatory incentives such as orphan drug designations

Market Challenges

• Complex and poorly understood disease biology
• High clinical trial failure rates
• Significant development costs
• Limited patient pool for large-scale studies
• Side effects impacting treatment adherence
• Regulatory hurdles in demonstrating long-term benefits

Report Scope

• Coverage: Global
• Key Companies: Boehringer Ingelheim, PureTech, Guangzhou JOYO Pharma, Tvardi Therapeutics, Pliant Therapeutics, GlaxoSmithKline, Amgen, Bristol-Myers Squibb, Endeavor Biomedicines, Syndax Pharmaceuticals, Regend Therapeutics, among others
• Key Therapies: BI 1015550, OFEV, Pirfenidone, SC1011, TTI-101, PLN-74809, GSK3915393, HZN-825, BMS-986278, taladegib, BI 181947, Axatilimab, REGEND001
• Analysis Includes: Market dynamics, emerging therapies, and current treatment landscape

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Table of Contents

1. Introduction
2. Executive Summary
3. Disease Overview
4. Analytical Perspective
5. Pipeline Therapeutics
6. Late-Stage Products
7. Mid-Stage Products
8. Early-Stage Products
9. Preclinical Candidates
10. Therapeutic Assessment
11. Inactive Programs
12. Collaboration Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Outlook
18. Analyst Insights
19. Appendix
20. About DelveInsight

About DelveInsight

DelveInsight is a specialized market research and business consulting firm focused on the life sciences sector. The company supports pharmaceutical organizations with end-to-end solutions, including market intelligence, competitive analysis, and strategic consulting services, enabling informed decision-making and sustainable growth.

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