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pirfenidone (KitosCell LP)

✓ Approved

Cell Pharma · Small Molecule · Small Molecule

What is pirfenidone?

pirfenidone is a small molecule developed by Cell Pharma. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesKitosCell LP
CompanyCell Pharma
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Cell Pharma

Therapeutic Indications

pirfenidone is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Hepatobiliary disordersHepatic fibrosis✓ Approved
Respiratory, thoracic and mediastinal disordersIdiopathic pulmonary fibrosis✓ Approved

Related Research Articles

PubMedNaunyn-Schmiedeberg's archives of pharmacology2026-09-19

Gastrointestinal and skin safety evaluation of pirfenidone versus nintedanib: an analysis of real-world pharmacovigilance and randomized controlled trials.

Yang Xinping X, Wang Yuting Y, Qiaolongbatu Xijier X, Qu Han H et al.

This study compares their safety profiles using real-world pharmacovigilance data and meta-analysis to guide clinical use. The gastrointestinal disorders and skin-related ADRs listed in the latest instructions for pirfenidone and nintedanib were systematically reviewed and subsequently analyzed using the FDA Adverse Event Reporting System (FAERS) database. Adverse drug event (ADE) reports for pirfenidone (2014-Q1 2025) and nintedanib (2014-Q1 2025) were extracted from the FAERS database via OpenVigil 2.1. ADE signals were analyzed using MedDRA's system organ class (SOC) and preferred terms (PT), with reporting odds ratio (ROR) for signal detection. Randomized controlled trials (RCTs) were retrieved from Cochrane, PubMed, Embase, and ClinicalTrials.gov, and meta-analysis was performed using RevMan 5.3. Pirfenidone and nintedanib were associated with 26,352 and 9,809 ADE reports, respectively, primarily in patients aged ≥ 65. Gastrointestinal disorders were common for both, but nintedanib showed fewer skin-related ADRs. Gender-based differences were observed: nintedanib's gastrointestinal ADRs varied by gender, while pirfenidone's skin-related ADRs differed significantly. Most reports originated from the U.S. Meta-analysis of 10 RCTs (6 pirfenidone, 4 nintedanib) showed both drugs slowed forced vital capacity (FVC) decline and reduced respiratory-related mortality. Nintedanib demonstrated superior efficacy in reducing acute exacerbations (RR = 0.57, 95%CI [0.34-0.98], I2 = 47%). Both drugs primarily caused gastrointestinal ADRs (e.g., nausea, vomiting), with pirfenidone linked to more photosensitivity reactions. Integrated pharmacovigilance and RCT analyses highlight the safety profiles of pirfenidone and nintedanib, offering evidence for clinical decision-making in idiopathic pulmonary fibrosis (IPF) treatment.

PMID 42760377
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PubMedJournal of peptide science : an official publication of the European Peptide Society2026-09-19

Hydrogen Bonds Determining the Conformation of Isolated Amino Acid Residues in Proteins: Re-Examination of the Fully Extended C5 Structures.

Vijayasarathy Marimuthu M, Balaram Padmanabhan P

Hydrogen bonds contribute substantially to the stabilisation of specific three-dimensional structures of peptides. The C5 hydrogen bond is an intraresidue interaction, which appears to contribute to the stabilisation of fully extended residue conformations, with backbone torsion angles (φ, ψ) lying close to ±180°. The present study revisits the occurrence of C5 conformations in proteins, using a high-resolution, non-homologous dataset of 6924 x-ray diffraction structures (sequence identity < 30%, resolution < 1.6 Å). Gly emerges as the residue with the highest propensity to adopt C5 conformations, followed by Ser. Residues with branched sidechains Leu, Val and Ile are strongly disfavoured. Specific examples in protein structures that have contiguous residues in C5 conformations are highlighted.

PMID 42760859
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PubMedInternational journal of rheumatic diseases2026-09-19

Efficacy and Safety of Tofacitinib Versus Placebo in Patients With Early-Grade Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial.

Fasni Rini R, Tripathy Sujit Kumar SK, Mishra Archana A, Khan Shahnawaz S et al.

Knee osteoarthritis causes major pain and disability, yet disease-modifying drugs remain limited. Tofacitinib, an oral Janus kinase (JAK) inhibitor, suppresses pro-inflammatory cytokine signaling implicated in osteoarthritis but is unexplored in the knee; we evaluated it versus placebo in early-grade disease. In this single-center, randomized, double-blind, placebo-controlled trial, 100 patients with Kellgren-Lawrence Grades 1 and 2 knee osteoarthritis were randomized to tofacitinib 11 mg extended-release once daily (n = 49) or placebo (n = 51) for 12 weeks. The primary outcome was change in VAS pain to Week 12; secondary outcomes were WOMAC, Oxford Knee Score, EQ-5D-5L, and analgesic use, assessed to Week 12 and a Month-6 follow-up, and analyzed by intention-to-treat with a mixed model for repeated measures. Baseline characteristics were balanced. Both groups improved within-group during treatment (p < 0.001), but between-group differences were not significant; the Week-12 VAS effect (tofacitinib minus placebo) was +0.02 (95% CI -0.84 to 0.89), with WOMAC, Oxford Knee Score, and EQ-5D-5L likewise excluding their minimal clinically important differences. Improvements rebounded toward baseline by Month 6. Drug-related adverse events were more frequent with tofacitinib (14.3% vs. 0%, p = 0.005) but were gastrointestinal and self-limiting. Tofacitinib was not superior to placebo in early-grade knee osteoarthritis, and the large within-group improvement rebounded toward baseline by 6 months, consistent with a predominantly non-specific (contextual) response. Because participants were selected radiographically without inflammatory phenotyping, these findings do not support tofacitinib in unselected early-grade disease but cannot exclude benefit in an inflammatory phenotype; future trials should stratify accordingly, with longer follow-up and structural outcomes. Clinical Trials Registry of India: CTRI/2025/07/090567.

PMID 42760593
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PubMedFrontiers in neuroscience2026-09-19

20 Hz tACS engages striatal THINs to enhance β-band synchrony and motor drive.

Zang Honggang H, Xie Wanxia W, Tian Lei L, Kang Wanrong W et al.

Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation technique that can enhance motor function. The striatum is a central hub for motor control and β-band oscillations, and its tyrosine hydroxylase-positive interneurons (THINs) are modulated by dopamine. However, whether THINs are associated with motor changes following tACS through β-band synchrony has not been investigated. Eighteen-month-old male mice received 20 Hz tACS or sham stimulation over M1 for 7 days under sevoflurane anesthesia. Motor performance, EEG, striatal dopamine release, and THIN activation were assessed at 3 min after awakening on day 7. THINs were optogenetically manipulated during the reaching task under the same post-anesthesia testing window. Transcranial alternating current stimulation was associated with higher post-anesthesia reaching success, increased β-band power, elevated dopamine release, and enhanced THIN activation compared to sham. Optogenetic THIN activation recapitulated motor improvement and β-band enhancement. Optogenetic THIN inhibition reduced successful attempts per minute and β-band power, but no statistically significant reduction in success rate was detected. These findings suggest that 20 Hz tACS over M1 may improve post-anesthesia motor performance in aged mice, with converging evidence implicating striatal dopamine release, THIN engagement, and β-band synchrony as functionally coupled elements in the context of post-anesthesia motor recovery in aged mice.

PMID 42760921
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PubMedPrimary dental journal2026-09-19

Navigating Postgraduate Dental Qualifications and Awards in General Dental Practice.

Ellis Stuart M SM

The UK general dental practitioner is faced with a plethora of postgraduate training options, ranging from short Continuing Professional Development (CPD) courses to extended degree level qualifications. This article explores the regulatory factors that a dentist needs to be aware of when choosing a postgraduate qualification or award, including the General Dental Council's regulations on the use of postnominals. The mechanism by which the postgraduate qualifications credit system facilitates educational pathway progression within the UK and across Europe is explained.

PMID 42760854
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PubMedAdvanced healthcare materials2026-09-19

Mitochondria-Targeted Nanozyme Reprograms Dendritic-Cell Immunometabolism via Microenvironment-Responsive CO Release to Treat Periodontitis.

Shan Shangyan S, Liu Chengyu C, Ding Lina L, Zeng Weishu W et al.

Inflammatory diseases are characterized by overactivated immune responses and a disrupted metabolic equilibrium, particularly in dendritic cells (DCs), where mitochondrial reactive oxygen species (mtROS) burst and metabolic reprogramming drives pathological maturation. While modulating immunometabolism is a promising therapeutic avenue, achieving subcellular-targeted delivery of bioactive molecules remains a formidable challenge. Here, we report a mitochondria-targeted nanozyme designed to concurrently scavenge mtROS and reprogram DC metabolism for effective anti-inflammatory therapy in periodontitis. This system is constructed based on Prussian blue nanoparticles (PB NPs) loaded with manganese carbonyl, a high oxidative stress-responsive carbon monoxide (CO) donor, and further modified with triphenylphosphine for mitochondrial targeting. This nanozyme efficiently accumulates in the mitochondria of activated DCs, where it efficiently scavenges mtROS and concurrently delivers controlled CO release, synergistically modulating DC function. Metabolomics analysis reveals that CO suppresses DC maturation by reprogramming cellular metabolism, including inhibiting the tricarboxylic acid cycle, modulating glycolysis, and disrupting fatty acid synthesis. Consequently, the synergistic action of PB NPs and CO effectively reverses the pro-inflammatory phenotype of DCs, reshapes the immune microenvironment, and ultimately alleviates periodontal inflammation in vivo. This work presents a promising strategy for curing inflammatory diseases by targeting metabolic reprogramming at the subcellular level.

PMID 42760789
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