nintedanib

A small increase in C3A (collagen 3 degraded by ADAMTS-1/4/8) and a small decrease in C3M (collagen 3 degraded by matrix metalloproteinase-9), markers of extracellular matrix turnover, were observed in subjects treated with nintedanib versus placebo. Effects of nintedanib on circulating markers of epithelial dysfunction and collagen degradation, most notably CA-125, were observed in patients with IPF.

P4, N=70, Active, not recruiting, Rohit Aggarwal, MD | Recruiting --> Active, not recruiting | N=134 --> 70 | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jan 2025 --> Jul 2025

P1, N=30, Not yet recruiting, PureTech

P=N/A, N=100, Active, not recruiting, IRCCS Azienda Ospedaliero-Universitaria di Bologna

P4, N=10, Not yet recruiting, Dematology Hospital of Southern Medical University; Dematology Hospital of Southern Medical University

P1, N=73, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting

P4, N=120, Recruiting, Post Graduate Institute of Medical Education and Research, Chandigarh | Active, not recruiting --> Recruiting

P=N/A, N=800, Active, not recruiting, Boehringer Ingelheim | Not yet recruiting --> Active, not recruiting

Coadministration of PD and nintedanib, known to upregulate MHC-I expression, enhanced tumor recognition and killing by T cells. This study provides new insights into PD applications and mechanisms.

P=N/A, N=152, Completed, Karadeniz Technical University

P=N/A, N=425, Active, not recruiting, Boehringer Ingelheim | Trial primary completion date: Sep 2024 --> Dec 2024

P2, N=13, Not yet recruiting, Assistance Publique - Hôpitaux de Paris

Herein, a hydrogelator, Nap-Phe-Phe-Phe-Glu-Thr-Glu-Leu-Tyr-OH (Nap-Y), was rationally designed to coassemble with an FGFR1 inhibitor nintedanib (Nin) to form a peptide hydrogel Gel Y/Nin for localized administration and FGFR1-triggered release of Nin...Nude mouse studies show that Gel Y/Nin exhibits enhanced therapeutic efficacy on lung tumor than free Nin. We anticipate that Gel Y/Nin will be utilized for lung cancer treatment in clinical settings in the near future.

P1, N=38, Not yet recruiting, GlaxoSmithKline

In vitro, MSC-CM promote fibrosis resolution, an effect enhanced following MSC cytokine priming. Specifically, MSC-CM reduces fibrogenic myofibroblasts through apoptosis, senescence, and by enhancing ECM degradation. Future studies will establish the in vivo relevance of MSC priming to fibrosis resolution.

High MeCo is predictive of poor outcomes in HER2-negative early breast cancer, although this risk can be mitigated by nintedanib, which is able to specifically reduce mechanical conditioning.

P1, N=73, Not yet recruiting, Bristol-Myers Squibb

P2, N=120, Completed, Belgian Gynaecological Oncology Group | Active, not recruiting --> Completed

A hydrogel drug-delivery platform, ALG@TBP-2/Pt(0)/nintedanib (ALG@TPN), is designed to induce strong immune functions and the dual elimination of the internal and external tumor microenvironment (TME)...Overall, the study provides a self-oxygenating hydrogel with the "PDT/chemotherapy/anti-CAFs" effect, triggering the cGAS/STING pathway to reshape the TME. Both internal and external interventions increase anti-TNBC immune responses.

She was treated with mycophenolate mofetil monotherapy for her skin manifestations...He was started on nintedanib...Given her lack of respiratory symptoms and normal PFTs, she was not initiated on ILD-specific treatment. While anti-MDA5 ILD is certainly associated with RP-ILD, clinicians should maintain awareness that there may be cases of asymptomatic or slowly progressive ILD as well.

P=N/A, N=160, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting | N=123 --> 160

Tamoxifen and fulvestrant represent standard therapy options in estrogen-mediated disease but have their own limitations. Isatin-based triple angiokinase inhibitor BIBF1120 (Nintedanib) and multikinase inhibitor Sunitinib (Sutent) have been approved by the FDA...Finally, molecular dynamics (MD) simulations indicated stable behavior of the protein-ligand complex between ERα and its ligand 5i. Overall, these results suggest that the new isatin derivative 5i holds promise as a new ERα degrader.

P=N/A, N=108, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed

The most common adverse events of any grade included nausea (80%), fatigue (70%), diarrhea (60%), and anorexia (60%). In this pilot study in heavily pretreated and molecularly selected patients with metastatic NSCLC, nintedanib showed modest activity.

P=N/A, N=800, Not yet recruiting, Boehringer Ingelheim

However, none of these delivery systems are commercialised, and further research is required to ensure safety and effectiveness in clinical settings. Yet, as research progresses, these advanced delivery systems promise to revolutionise the treatment landscape for various fibrotic disorders and cancers, potentially improving patient outcomes and quality of life.

P4, N=120, Active, not recruiting, Post Graduate Institute of Medical Education and Research, Chandigarh

P1/2, N=14, Terminated, University of Texas Southwestern Medical Center | Phase classification: P1b --> P1/2 | Active, not recruiting --> Terminated; The study was terminated due to futility and lack of future funding

P3, N=81, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed

We identified a panel of serum biomarkers that showed association with nintedanib treatment and acute pulmonary exacerbations in patients with RP. A confirmatory study will be needed to validate this panel for use as a prognostic tool in patients with RP.

Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive interstitial lung disease with a high mortality rate and limited treatment efficacy. Pazopanib inhibits myofibroblast activation, migration, autophagy, apoptosis, and extracellular matrix (ECM) buildup by downregulating the TGF-β1/Smad signal route and the TGF-β1/non-Smad signal pathway. It has the same target as nintedanib and is a tyrosine kinase inhibitor.

P1, N=26, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed

P=N/A, N=100, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting

The combination of nintedanib and capecitabine is well tolerated. Clinical efficacy appears to be superior to regorafenib or tipiracil hydrochloride monotherapy. Further investigation of similar combinations is warranted.

In summary, our pioneering approach involving the silicasome carrier not only improved antitumor angiogenesis but also profoundly reshaped the desmoplastic stromal and immune landscape within PDAC. These insights hold excellent promise for the development of innovative combinatorial strategies in PDAC therapy.

P=N/A, N=585, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting

P2, N=33, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Apr 2024 | Trial primary completion date: Jul 2025 --> Apr 2024

P4, N=103, Completed, Icahn School of Medicine at Mount Sinai | Active, not recruiting --> Completed

We further pinpoint reduced SMAD3 expression and consequent limited TIMP-1 production in SCC-TAFs as key for the resistance of SCC to nintedanib. These observations strongly support the emerging role of TIMP-1 as a critical regulator of therapy response in solid tumors.

GPS and BMI were significant factors for short-term pirfenidone and nintedanib discontinuation, respectively. Initial evaluation of GPS and BMI prior to antifibrotic therapy may contribute to less interrupted IPF management, thus leading to better prognostic outcomes in patients with IPF.

Nintedanib inhibits the proliferation, invasion, and metastasis of gastric cancer cells. The crossover pathways and protein networks predicted by proteomics should provide more detailed molecular information enabling the use of nintedanib against gastric cancer.

P2, N=20, Recruiting, University Hospital, Basel, Switzerland | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025