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Disease

Fibrosis

Late-stage therapeutic developmentActively researchedCooling momentum
31
Publications
24
Clinical trials
10
Related conditions
2
Related proteins
2025
Latest publication
Current focus
Therapeutic developmentInflammation & immunityMetabolic & lifestyle factorsDisease mechanisms & pathology
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

The immunology of diabetic cardiomyopathy.

Research2025-04-07Frontiers in endocrinology

TGF-β signaling: critical nexus of fibrogenesis and cancer.

Research2024-06-26Journal of translational medicine

Macrophages in cardiovascular diseases: molecular mechanisms and therapeutic targets.

Research2024-05-31Signal transduction and targeted therapy

Myocardial Fibrosis: Emerging Target for Cardiac Molecular Imaging and Opportunity for Image-Guided Therapy.

Research2023-11-01Journal of nuclear medicine : official publication, Society of Nuclear Medicine

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Major developments
Important regulatory approvalHigh impact
Kayshild 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).2026-03-26
Clinical Milestones11View all 11
+3 more in the activity timeline below
Industry & Market2View
Regulatory Updates4View
  • 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.
  • 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).
  • 2025-08-18Approval — ResmetiromRezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
Activity timeline17

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Semaglutideapproved

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)

Nintedanibapproved

Approval — Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibro… (2025)

Resmetiromapproved

Approval — Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults… (2025)

Pirfenidoneapproved

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

17 sponsors · 1 new · 6 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies
Recently completed

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2026emaApprovalSemaglutide· Kayshild 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). source ↗
2025emaApprovalBrensocatib Monohydrate· Brinsupri 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. source ↗
2025emaApprovalNintedanib· Nintedanib 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). source ↗
2025emaApprovalResmetirom· Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3). source ↗
2024emaApprovalNintedanib· Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1). Nintedanib Accord is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD). Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Accord 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 Accord is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD). source ↗
2023emaApprovalPirfenidone· Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). source ↗
2022emaApprovalPirfenidone· Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). source ↗
2020emaApprovalAmikacin sulfate· Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. source ↗

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

31 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20102025
Most influential

The basics of epithelial-mesenchymal transition.

The Journal of clinical investigation · 2009 · 7,732 cites

Inflammatory links between obesity and metabolic disease.

The Journal of clinical investigation · 2011 · 1,680 cites

Inflammation and wound healing: the role of the macrophage.

Expert reviews in molecular medicine · 2011 · 1,116 cites

TGF-β and the TGF-β Family: Context-Dependent Roles in Cell and Tissue Physiology.

Cold Spring Harbor perspectives in biology · 2016 · 1,006 cites

Systemic sclerosis: a prototypic multisystem fibrotic disorder.

The Journal of clinical investigation · 2007 · 843 cites
Recent publications
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

Disease biology

2 matches

Key proteins & gene products studied in this disease. Number shows shared papers.

Related conditions

10 matches

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.

Overview

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.

Causes

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.

Pathophysiology

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.

Risk factors

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.

Current standard of care

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.

Defined in MeSH

Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.

Identifiers
References & data sources
  • 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.