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. Author manuscript; available in PMC: 2026 Jun 15.
Published in final edited form as: Nat Rev Drug Discov. 2025 Mar 18;24(7):543–569. doi: 10.1038/s41573-025-01158-9

Table 3 |.

Selected treatments approved or in development for fibrosis affecting various organs

Treatment type Drug or procedure Ref. or trial identifier
Lung
Immunosuppression Approved: oral mycophenoLate mofetiL, oral or intravenous cyclophosphamide, rituximab (CD20 inhibitor), tociiizumab (IL-6 inhibitor) 301303,349
NCT01933334, NCT03068234, NCT03856853, NCT03221257
Antifibrotic therapy Approved: nintedanib, pirfenidone
In development: nerandomiLast (PDE4B inhibitor), bexotegrast (avβ6 and avβ1 integrin inhibitor), admiLparant (LPA1 receptor inhibitor), treprostiniL (prostacyclin analogue)
139,140,142
NCT06806592, NCT04396756136, NCT06003426, NCT04905693
Other interventions Lung transplantation, oxygen, inhaled treprostiniL (as treatment for pulmonary hypertension related to fibrotic interstitial Lung disease) 205,209,350
Gut
Immunosuppression None NA
Antifibrotic therapy In development: AGMB-129 (topical ALK5 inhibitor) NCT05843578
Other interventions Approved: surgical resection, surgical strictureplasty, endoscopic baLLoon dilation 351,352
Kidney
Immunosuppression None NA
Antifibrotic therapy In development: pirfenidone, nintedanib, runcaciguat (sGC activator) 280,281
Other interventions Approved: dapagLifLozin, empagLifLozin (both SGLT2 inhibitors), finerenone (mineraLocorticoid receptor antagonist); muLtipLe RAAS inhibitors (angiotensin II receptor bLockers or angiotensin-converting enzyme inhibitors) have shown positive effects on end points of kidney function but Lack direct antifibrotic effects
In deveLopment: zibotentan, atrasentan (both endotheLin receptor antagonists), pentoxyfiLLine, diaLysis and kidney transpLantation
353358
Skin (SSc)
Immunosuppression Approved: oraL mycophenoLate mofetiL; intravenous or oraL cycLophosphamide, rituximab (CD20 inhibitor); high-dose chemotherapy with haematopoietic stem cell transpLantation In deveLopment: tociLizumab (IL-6 inhibitor), Lenabasum (CB2 receptor agonist), CAR-T ceLL therapy 301304,359362
151,363368
Antifibrotic therapy In deveLopment: fasudiL, reLaxin, pravastatin (aLL three targeting Rho–ROCK fibrobLast mechanosignaLLing); QAX576 (IL-13 inhibitor), SAR156597 (IL-4/IL-13 inhibitor) 110
NCT00704665
NCT01268202
NCT00581997
NCT02921971
Other interventions None NA
Liver
Immunosuppression None NA
Antifibrotic therapy In deveLopment: simtuzumab (LOXL2 inhibitor), QAX576 (IL-4/IL-13 inhibitor) 369
NCT01266135
Other interventionsa Approved: resmetirom (thyroid hormone receptor β agonist)
In deveLopment: GSK-233072 (ASBT inhibitor); cenicriviroc (CCR2/5 receptor antagonist); semagLutide (GLP1 receptor agonist), tirzepatide (GLP1/GIP receptor agonist); obetichoLic acid (FXR agonist); Lanifibranor (pan-PPAR agonist); efruxifermin (Long-acting FGF21 anaLogue)
333,369,331,332
NCT03900429

ALK5, activin receptor-like kinase 5; ASBT, apical sodium-bile acid transporter; CAR, chimeric antigen receptor; CB2 receptor, cannabinoid receptor type 2; CCR2; CC chemokine receptor 2; FGF21; fibroblast growth factor 21; FXR, farnesoid X receptor; GLP1, glucagon-like peptide 1; GIP, gastric inhibitory polypeptide; LPA, lysophosphatidic acid; LOXL2, lysyl oxidase-like 2; NA, not applicable; PDE4B, phosphodiesterase 4B; PPAR, peroxisome proliferator-activated receptor; RAAS, renin-angiotensin-aldosterone system; ROCK, Rho-associated protein kinase; sGC, soluble guanylate cyclase; SGLT2, sodium-glucose transporter 2; SSc, systemic sclerosis.

a

Most drugs in clinical trials for fibrotic liver diseases (in particular, metabolic dysfunction-associated steatohepatitis (MASH)) aim to reduce the metabolic and/or inflammatory impact of the disease and are not direct antifibrotics.