Fibrosis
Recent clinical, regulatory, research and industry developments relating to this disease.
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What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 2 regulatory approvals from EMA on record.
- 5 clinical trials expected to report results, the earliest in Q4 2026.
- 12 industry developments reported.
- Q4 2026SECOVID: A Multi-center, Randomized, Dose-ranging Parallel-group Trial Assessing the Efficacy of Sirolimus in Hospitalized Patients With COVID-19 Pneumonia for the Prevention of Post-COVID Fibrosis
- Q4 2027A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
- Q4 2027Effects of Empagliflozin on Preventing Fibrosis and Cirrhosis Progression in Nucleos(t)Ide Analogue-treated Chronic Hepatitis B Patients With F2-F4 Fibrosis: a Randomized, Double-blind Placebo-controlled Trial
- 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
- Q2 2030A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of Age
Clinical MilestonesView all 11Hide
- 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
- 2026-05-28A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of AgeResults expected Q2 2030
- 2026-04-23A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary FibrosisResults expected Q4 2027
- 2026-01-30Effects of Empagliflozin on Preventing Fibrosis and Cirrhosis Progression in Nucleos(t)Ide Analogue-treated Chronic Hepatitis B Patients With F2-F4 Fibrosis: a Randomized, Double-blind Placebo-controlled TrialResults expected Q4 2027
- 2025-12-15SECOVID: A Multi-center, Randomized, Dose-ranging Parallel-group Trial Assessing the Efficacy of Sirolimus in Hospitalized Patients With COVID-19 Pneumonia for the Prevention of Post-COVID FibrosisResults expected Q4 2026
- 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
- 2026-01-29A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and OlderCompleted
- 2026-01-21The Return of the Pancreas: Evaluating Impact of CFTR Modulators on Pancreatic FunctionCompleted
- 2026-01-09Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized TrialCompleted
Industry & MarketView all 12Hide
- 2026-09-17SpliSense begins Phase IIb SPL84 trial for cystic fibrosisTrial news · Clinical Trials Arena
- 2026-09-15Sionna lays off 46% of workforce in strategic shift after cystic fibrosis trial failTrial news · Fierce Biotech
- 2026-08-10STAT+: Sionna’s experimental cystic fibrosis pill falls flat in mid-stage trialTrial news · STAT News
- 2026-09-17Experts Debate Combination Therapy for Pulmonary FibrosisIndustry · Medscape Medical News
- 2026-09-15Sionna cuts nearly half of staff as it lines up second attempt at cystic fibrosisIndustry · Endpoints News
Regulatory UpdatesViewHide
- 2026-03-26Approval — SemaglutideKayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
- 2025-11-18Approval — Brensocatib MonohydrateBrinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
- 2026-09-18IndustryPodcast: What’s new in pulmonary fibrosis: Insights from ERS 2026Industry · Clinical Trials Arena
- 2026-09-17IndustryExperts Debate Combination Therapy for Pulmonary FibrosisIndustry · Medscape Medical News
- 2026-09-17IndustrySpliSense begins Phase IIb SPL84 trial for cystic fibrosisTrial news · Clinical Trials Arena
- 2026-09-15IndustrySionna cuts nearly half of staff as it lines up second attempt at cystic fibrosisIndustry · Endpoints News
- 2026-09-15IndustrySionna lays off 46% of workforce in strategic shift after cystic fibrosis trial failTrial news · Fierce Biotech
- 2026-09-10IndustryPreschoolers With Cystic Fibrosis Get Close to Normal on AlyftrekIndustry · MedPage Today
- 2026-09-07IndustryAptar Pharma to support Aceso’s inhaled cystic fibrosis candidate’s advanceIndustry · Pharmaceutical Technology
- 2026-08-27IndustryInhaled Suppressor tRNA Restores Gene Function in Cystic Fibrosis ModelsIndustry · GEN News
- 2026-08-21IndustryA self-sustaining hypoxia inducible factor-1α–creatine kinase B feedforward circuit drives macrophage-mediated kidney fibrosisIndustry · Kidney International
- 2026-08-18IndustryNoninvasive testing for fibrosis and cirrhosis in MASLDIndustry · Nature Reviews Gastroenterology & Hepatology
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Kayshild is indicated in conjunction with diet and exercise for the treatment of adults w… (2026)
Approval — Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in… (2025)
Approval — Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibro… (2025)
Approval — Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults… (2025)
Approval — Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopath… (2023)
Approval — Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM)… (2020)
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
- Fibrosis4
- Heart Failure3
- Neoplasms3
- Renal Insufficiency, Chronic3
- Diabetic Cardiomyopathies2
- Endothelial Cells2
- Inflammation2
- Macrophages2
Leading journals6
- The Journal of clinical investigation3
- Cells2
- Frontiers in immunology2
- Signal transduction and targeted therapy2
- Cardiovascular research1
- Cellular and molecular life sciences : CMLS1
Leading researchers8
- Luo Y2
- Newsome PN2
- Abplanalp WT1
- Abraham D1
- Ahmadian MR1
- Akoum N1
- Amano MT1
- Ambery P1
Affiliations (unnormalised)6
- "Ss. Annunziata" Hospital1
- Academic Medical Center1
- Adelaide Medical School1
- AHEPA Hospital1
- Ambroise Paré University Hospital1
- Anhui Women and Children's Medical Center1
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Disease biology
Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.
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.
Fibrosis is a pathological condition in which fibrous connective tissue invades an organ, typically after inflammation or other injury. It can affect many organs and is a major driver of morbidity in multisystem fibrotic disorders. The literature also treats fibrosis as a process linked to tissue repair that becomes excessive or dysregulated.
Fibrosis is commonly described as arising as a consequence of inflammation or other injury. In the supplied grounding, chronic inflammation and wound-healing responses are repeatedly associated with fibrotic change. The grounding also links fibrosis to autoimmune and vasculopathic disease in systemic sclerosis, but does not support broader causal claims beyond that context.
The grounding supports a mechanism in which injury- or inflammation-driven signaling promotes abnormal wound healing, cell proliferation and differentiation, and deposition of extracellular matrix and fibrous connective tissue. Transforming growth factor beta is highlighted as a key mediator, with overexpression associated with epithelial-mesenchymal transition and fibrotic tissue remodeling. Oxidative stress, innate immunity, and cytokine signaling are also co-studied as part of the biological network underlying fibrosis.
Chronic inflammation and prior tissue injury are supported risk factors in the supplied material. In systemic sclerosis, autoimmunity and vasculopathy precede fibrosis and are therefore associated with fibrotic disease development. The grounding does not support additional general risk factors.
The supplied grounding supports management at the modality level rather than specific regimens. Diagnostic imaging and surgery are listed as covered aspects, and immunomodulatory drugs are noted in systemic sclerosis, although no therapy is described as reversing or slowing fibrosis in that disease. The literature also points to targeting TGF-beta signaling as a therapeutic strategy under investigation.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.
- 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.