Idiopathic Pulmonary Fibrosis
Recent clinical, regulatory, research and industry developments relating to this disease.
Approval: Nintedanib Viatris (EMA)
Single-Cell Analysis Reveals Novel Immune Perturbations in Fibrotic Hypersensitivity Pneumonitis.
Macrophage polarization and its impact on idiopathic pulmonary fibrosis.
Approval: Nintedanib Accord (EMA)
The Role of Immune Cells in the Pathogenesis of Idiopathic Pulmonary Fibrosis.
Approval: Pirfenidone Viatris (EMA)
Approval: Pirfenidone axunio (previously Pirfenidone AET) (EMA)
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 1 regulatory approval from EMA on record.
- 5 clinical trials expected to report results, the earliest in Q2 2028.
- Q2 2028A Prospective, Multicenter, Randomized, Open-Label Clinical Trial Evaluating the Efficacy of Intravenous Immunoglobulin in Patients Hospitalized for Acute Exacerbations of Idiopathic Pulmonary Fibrosis.
- Q2 2028A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis
- Q4 2028Senicapoc in Patients With Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to Prevent Progression.
- Q3 2029A Multicentre, Randomised, Double-blind, Placebo-controlled, Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
- Q1 2031A Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Clinical MilestonesView all 11Hide
- 2026-05-07PAciFy Cough: A Multicentre, Double Blind, Placebo Controlled, Crossover Trial of Morphine Sulfate for the Treatment of PulmonAry Fibrosis CoughResults posted
- 2025-10-20A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)Results posted
- 2026-07-10A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary FibrosisResults expected Q2 2028
- 2026-05-07Senicapoc in Patients With Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to Prevent Progression.Results expected Q4 2028
- 2026-04-21A Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)Results expected Q1 2031
- 2026-03-16A Prospective, Multicenter, Randomized, Open-Label Clinical Trial Evaluating the Efficacy of Intravenous Immunoglobulin in Patients Hospitalized for Acute Exacerbations of Idiopathic Pulmonary Fibrosis.Results expected Q2 2028
- 2026-03-11A Multicentre, Randomised, Double-blind, Placebo-controlled, Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)Results expected Q3 2029
- 2026-03-30Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled TrialPrimary completion
- 2026-03-02Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) TrialCompleted
- 2026-02-02A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-1)Completed
- 2026-01-09Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized TrialCompleted
Regulatory UpdatesViewHide
- 2025-08-22Approval — NintedanibNintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Viatris is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Viatris is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
- 2026-07-10ClinicalA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary FibrosisResults expected Q2 2028
- 2026-05-07ClinicalPAciFy Cough: A Multicentre, Double Blind, Placebo Controlled, Crossover Trial of Morphine Sulfate for the Treatment of PulmonAry Fibrosis CoughResults posted
- 2026-05-07ClinicalSenicapoc in Patients With Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to Prevent Progression.Results expected Q4 2028
- 2026-04-21ClinicalA Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)Results expected Q1 2031
- 2026-03-30ClinicalGlucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled TrialPrimary completion
- 2026-03-16ClinicalA Prospective, Multicenter, Randomized, Open-Label Clinical Trial Evaluating the Efficacy of Intravenous Immunoglobulin in Patients Hospitalized for Acute Exacerbations of Idiopathic Pulmonary Fibrosis.Results expected Q2 2028
- 2026-03-11ClinicalA Multicentre, Randomised, Double-blind, Placebo-controlled, Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)Results expected Q3 2029
- 2026-03-02ClinicalProspective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) TrialCompleted
- 2026-02-02ClinicalA Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-1)Completed
- 2026-01-09ClinicalPragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized TrialCompleted
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibro… (2025)
Approval — Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopath… (2023)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Idiopathic Pulmonary Fibrosis4
- Alveolitis, Extrinsic Allergic1
- Genome-Wide Association Study1
- Genomics1
- Macrophage Activation1
- Macrophages1
- Mucin-5B1
- Precision Medicine1
Leading journals6
- American journal of respiratory and critical care medicine2
- EBioMedicine1
- Frontiers in endocrinology1
- Frontiers in immunology1
- Medicina (Kaunas, Lithuania)1
- Nature communications1
Leading researchers8
- Adams TS2
- Adegunsoye A2
- Kaminski N2
- Rosas IO2
- Schupp JC2
- Abu Hussein NS1
- Ahangari F1
- Bao M1
Affiliations (unnormalised)6
- Brigham and Women's Hospital2
- University of Virginia2
- Yale School of Medicine2
- Barshop Institute for Longevity and Aging Studies1
- Baylor College of Medicine1
- Burnett School of Biomedical Sciences1
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Idiopathic pulmonary fibrosis is a common interstitial lung disease of unknown cause that usually presents in adults between 50 and 70 years of age. It is marked by an insidious onset of exertional breathlessness and a nonproductive cough, with progressive worsening dyspnea over time. Pathology shows scant interstitial inflammation, patchy collagen fibrosis, prominent fibroblast foci, and microscopic honeycombing.
The disease is idiopathic, so no definite cause is established in the supplied grounding. The literature grounding indicates that its etiology is complex and includes heritable factors, with both rare genetic variants and common SNPs contributing to pulmonary fibrosis risk. The MUC5B promoter variant is specifically highlighted as a genetic contributor associated with increased risk.
The disease is characterized by progressive fibrotic remodeling of the lung interstitium, with patchy collagen deposition and fibroblast proliferation. Immune dysregulation is implicated, including uncontrolled immune responses and the activity of innate and adaptive immune cells in driving onset and progression. Macrophage polarization is also described as important, with M1 macrophages contributing to early inflammatory injury and M2 macrophages supporting tissue repair and fibrosis.
Older adult age is part of the typical clinical profile, with onset usually between 50 and 70 years of age. Genetic susceptibility increases risk, including rare genetic variants, common SNPs, and the MUC5B promoter variant. The supplied grounding also indicates that heritable factors contribute to disease risk, but does not support additional specific environmental or clinical risk factors.
The supplied grounding supports pharmacological treatment for IPF but does not provide specific drug names or regimens. It indicates that current management includes pharmacological therapies and emerging immunotherapy, with interest in targeted immunomodulatory approaches. At the modality level, treatment is described as disease-directed therapy aimed at slowing progression rather than reversing established fibrosis.
AI-generated summary grounded in MeSH and 3 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
A common interstitial lung disease of unknown etiology, usually occurring between 50-70 years of age. Clinically, it is characterized by an insidious onset of breathlessness with exertion and a nonproductive cough, leading to progressive DYSPNEA. Pathological features show scant interstitial inflammation, patchy collagen fibrosis, prominent fibroblast proliferation foci, and microscopic honeycomb change.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.