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benzydamine flufenamate (Agilona)

✓ Approved

Vinas · PTGS1 · Small Molecule

What is benzydamine flufenamate?

benzydamine flufenamate is a small molecule developed by Vinas. It is approved for therapeutic indications via topical.

Drug Profile

Brand NamesAgilona
CompanyVinas
Drug ClassSmall Molecule
Molecular TargetPTGS1, PTGS2
RouteTopical
StatusApproved
Sources: ClinicalTrials.gov, Vinas

Mechanism of Action

Molecular Targets

benzydamine flufenamate acts on 2 molecular targets:

PTGS1prostaglandin-endoperoxide synthase 1 (COX3, PCOX1)
PTGS2prostaglandin-endoperoxide synthase 2 (GRIPGHS, hCox-2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

benzydamine flufenamate is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Gastrointestinal disordersAbdominal pain✓ Approved
Hepatobiliary disordersHepatitis✓ Approved

Related Research Articles

PubMedRSC advances2026-05-13

Eco-friendly differential pulse voltammetric determination of benzydamine hydrochloride using a gold nanoparticles-modified carbon paste electrode.

Bakr Maryam A MA, Abbas Samah S SS, Hegazy Maha A MA, Badawey Amr M AM et al.

A differential pulse voltammetric (DPV) method is presented for the determination of benzydamine hydrochloride (BZ) in bulk powder, mouthwash, and artificial saliva matrices. This work represents the first application of DPV for the electrochemical determination of BZ. The method employs a carbon paste electrode (CPE) modified with electrodeposited gold nanoparticles (Au-NPs) through a chronoamperometric step, which significantly enhances the oxidation peak current for BZ within the potential window of 0.0 to 1.6 V. The variables, most significantly the pH and scan rate, affecting the voltammetric response were systematically optimized. Under the optimized conditions, the proposed sensor exhibited a linear response over the concentration range of 1.00-10.00 µM with a limit of detection (LOD) of 0.1024 µM. Validation in accordance with the ICH guidelines confirmed satisfactory accuracy and precision. The applicability of the developed method was further verified through the successful quantification of BZ in mouthwash formulations and artificial saliva samples. The proposed DPV approach provides a complementary analytical alternative rather than a replacement, which was evidenced by comparison with the reported electrochemical methods. In addition, the environmental and practical performance of the method was assessed using established greenness and applicability metrics, confirming that the proposed approach combines analytical effectiveness with a low environmental burden and favorable practical characteristics.

PMID 42124840
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PubMedACS omega2026-04-27

Synthesis and Structure Elucidation of New NSAID Diphosphine Ruthenium(II) Complexes as Potential Anticancer Agents: DNA/BSA Binding and Cytotoxicity Assays.

Carvalho Diogo E L DEL, Teixeira Tamara T, de Araujo-Neto João Honorato JH, Batista Alzir A AA et al.

New diphosphine ruthenium-(II) complexes with nonsteroidal anti-inflammatory drugs (NSAID) derivatives with general formula [Ru-(L)-(dppe)2]-PF6 [dppe = 1,2-bis(diphenylphosphine)-ethane and (L) corresponds to fenamate (fe-) (Complex 1), mefenamate (me-) (Complex 2), tolfenamate (tol-) (Complex 3) or flufenamate (flu-) (Complex 4)] were synthesized. All compounds were characterized by several techniques, including 1H, 13C-{1H} and 31P-{1H} NMR, cyclic voltammetry, conductivity, elemental analysis, ultraviolet/visible absorption spectroscopy, infrared absorption spectroscopy and single crystal X-ray diffraction. ct-DNA (Calf-Thymus DNA) interaction studies by spectroscopic titrations and viscosity measurements demonstrated that the complexes may interact weakly with ct-DNA, considering that the complexes are cationic and that DNA carries a negative charge due to its phosphate groups, electrostatic interactions could occur. The complexes showed a moderate interaction with Bovine Serum Albumin (BSA) mediated by both dynamic and static quenching mechanisms. Also, the cytotoxic activity of the complexes was evaluated against breast (MDA-MB-231) and lung (A549) tumor cell lines and nontumor lung (MRC-5) cell lines. All complexes showed cytotoxicity against the cell lines investigated, with IC50 values in the range of 0.94-17.71 μM. [Ru-(me)-(dppe)2]-PF6 showed a high selectivity index against the A549 cell line. For MDA-MB-231 cell line, the most selective complex was [Ru-(fe)-(dppe)2]-PF6. Except for [Ru-(tol)-(dppe)2]-PF6, all other complexes were more cytotoxic than cisplatin, making them promising compounds.

PMID 42040486
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PubMedInternational journal of biological macromolecules2026-04-25

Direct powder extrusion 3D printing of a polyhydroxybutyrate-based dual-release drug delivery device for dental therapy.

Fratini Costanza C, Grandoni Matteo M, Vanzolini Tania T, Aluigi Annalisa A et al.

This study investigates the processability of polyhydroxybutyrate (PHB) in different physical forms (i.e., powder, pellets, and granules) using direct powder extrusion (DPE) 3D printing (3DP), a technique that enables the direct use of raw materials without prior filament fabrication. The raw materials were thoroughly characterized with respect to their thermal properties to evaluate their suitability for additive manufacturing application. Two DPE 3D printers employing distinct extrusion-driven mechanisms were used to enable a comparative evaluation under identical material conditions. Following printing, the resulting scaffolds were assessed in terms of their thermal, chemical and morphological characteristics to determine the feasibility and performance of each material form within the DPE 3D-printing process. In the second phase of the work, the potential of DPE to fabricate a functional PHB-based dental device enabling dual drug release (i.e., immediate and extended) was investigated. This was achieved by optimizing the printed geometry to incorporate a hydrophilic gel reservoir for burst release. Benzydamine hydrochloride, a non-steroidal anti-inflammatory drug with anti-inflammatory and antimicrobial properties, was selected as the model drug due to its compatibility with PHB processing temperatures (∼160 °C). The drug-loaded devices were successfully printed and evaluated through in vitro release studies and antimicrobial testing, confirming both controlled release and biological activity. The findings support the use of PHB and DPE 3DP for the development of customizable, biodegradable drug delivery systems, with promising applications in oral and dental care.

PMID 42031248
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PubMedInternational journal of molecular sciences2026-04-14

Prenatal Benzydamine Exposure Induces Fetal Growth Restriction and Maternal Oxidative Stress in Rats.

Ősz Bianca-Eugenia BE, Ștefănescu Ruxandra R, Tero-Vescan Amelia A, Vari Camil-Eugen CE et al.

Benzydamine is a nonsteroidal anti-inflammatory drug widely used in topical formulations but occasionally misused orally at high doses for psychoactive effects. Data regarding the safety of benzydamine at supratherapeutic doses are limited and mainly focus on central nervous system effects. Even less information is available concerning its safety during pregnancy, despite the increased risk of unplanned pregnancies among users of psychoactive substances. In this preliminary study, we aimed to evaluate the maternal and fetotoxic potential of benzydamine to support future targeted reproductive toxicity investigations. Pregnant Wistar rats received benzydamine throughout gestation, followed by cesarean section and evaluation of fetal viability, fetal body weight at term, and macroscopic abnormalities. Maternal biochemical parameters related to hepatic, renal, and metabolic function, and oxidative stress markers, were also assessed. Results were compared with those of a control group. No significant differences in routine biochemical parameters were observed between groups; however, benzydamine exposure was associated with reduced fetal body weight and increased maternal plasma malondialdehyde levels. These findings suggest that benzydamine may impair fetal growth through indirect maternal toxicity and oxidative stress rather than direct teratogenic effects.

PMID 41977194
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PubMedBioinformation2026-03-30

Novel herbal-antioxidant topical gel for managing chemotherapy-induced oral mucositis in oral cancer patients: A randomized controlled trial.

Sahoo Sushil Kumar SK, Saluja Pulin P, Panda Ashutosh A, Makwani Disha D et al.

Oral mucositis is a side effect of oral cancer chemotherapy, which is painful and frequent, usually interfering with the continuity and quality of life. This was a randomized controlled trial of a topical gel comprising of novel herbal-antioxidants when compared to standard benzydamine mouthwash in 60 subjects. WHO and VAS scales were used to evaluate the severity of the mucositis and its pain in 21 days. The novel gel exhibited much less decrease in the degree of mucositis (1.2 ± 0.4 vs 2.6 ± 0.6; p < 0.001) and pain levels (2.1 ± 0.9 vs 4.8 ± 1.3) and quicker recovery of the mucosal wound and no side effects. The new topical agent was more used to reduce the severity and duration of oral mucositis, benefiting the patients and enhancing their recovery.

PMID 41907896
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PubMedRevue medicale suisse2026-03-11

Terrat Jeremy J, Joly Ophelie O, Marcot Dominique D

Recreational misuse of over-the-counter medications in Switzerland poses risks of severe toxicity, dependence, and dangerous drug interactions. Fourteen molecules have been identified as the most frequently diverted for their psychoactive effects: first-generation antihistamines, dextromethorphan, codeine, benzydamine, loperamide, butylscopolamine, and certain nasal decongestants. Prevention requires stricter regulation of distribution, increased awareness among healthcare professionals, and enhanced monitoring. Further research is essential to assess the magnitude of the phenomenon and to develop tailored strategies.

PMID 41811742
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