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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

PubMedFrontiers in medicine2026-09-19

An open-label randomised controlled trial protocol evaluating a Siddha add-on regimen for radiotherapy induced oral mucositis in head and neck cancer patients.

P Shanmugapriya S, T Subathra S, S Sowmiya S, R Gayatri G et al.

Radiation-induced oral mucositis (RIOM) is a common and clinically significant complication in patients undergoing radiotherapy or concurrent chemoradiotherapy for head and neck cancers. It can cause severe oral pain, dysphagia, nutritional compromise, secondary infections, and treatment interruptions, thereby affecting treatment compliance and oncological outcomes. Since the current standard of care (SOC) mainly focuses on symptomatic relief, there is a need for integrative treatment approaches that may improve overall patient outcomes. The present study is designed as a randomised controlled Phase II superiority trial involving 160 participants, with 80 participants allocated to each study arm. Participants in the control arm will receive benzydamine mouthwash six times daily as SOC, while those in the intervention arm will receive Siddha formulations such as Thiripala Chooranam mouthwash and Gungiliya Vennai topical application three times daily in addition to SOC. Weekly assessments will be carried out by oncologists using validated tools including the Radiation Therapy Oncology Group (RTOG) Oral Mucositis Scale, WHO Oral Mucositis Scale, Visual Analogue Scale (VAS) for oral pain, and WHO three-step analgesic ladder. The primary outcome of the study is the assessment of RIOM severity using RTOG grading scale. Secondary outcomes include evaluation of mucositis severity using the WHO Oral Mucositis Scale, reduction in oral pain assessed by VAS (minimum 2-point reduction), analgesic usage based on the WHO three-step analgesic ladder, safety outcomes, and treatment interruptions. This study may provide evidence on the effectiveness and safety of an integrative Siddha-based approach in reducing RIOM severity and improving supportive care in patients undergoing radiotherapy for head and neck cancers. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTQ2MTYw&Enc=&userName=, Registered in Clinical Trial Registry, India (CTRI/2025/12/098832- registered on 10-12-2025). Participant enrolment for the trial has commenced, and the study is currently ongoing.

PMID 42761039
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PubMedInternational journal of molecular sciences2026-09-15

Comparative Effects of Flurbiprofen and Benzydamine on COX-2/PGE2 and Inflammatory Cytokine Release in Polyinosinic:polycytidylic Acid-Stimulated Human Tonsil and Bronchial Epithelial Cells.

Mfotie Njoya Emmanuel E, Spears Maria M, Hallett Thomas T, Peters Philippa P et al.

Topical non-steroidal anti-inflammatory drugs (NSAIDs) such as flurbiprofen and benzydamine may be used for the symptomatic relief of pharyngitis, triggered by infections. The onset and spectrum of anti-inflammatory activity of both drugs were compared in human tonsil (HTEpiC) and bronchial epithelial (BEAS-2B) cells stimulated with poly I:C against key inflammatory mediators. Cells were stimulated with poly I:C for 24 h and treated with flurbiprofen or benzydamine for 20 s, 2 min and 5 min. Production of prostaglandin E2 (PGE2), tumour necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), interleukin-8 (IL-8), interleukin-18 (IL-18), monocyte chemotactic protein-3 (MCP-3) and C-X-C motif chemokine ligand 10 (CXCL10), as well as cyclooxygenase-2 (COX-2) protein expression, was evaluated. Flurbiprofen significantly (p < 0.05) reduced PGE2 production and COX-2 expression in both cell types within 20 s of treatment and maintained these effects at 2 and 5 min. However, benzydamine produced delayed, inconsistent inhibition. Although both drugs reduced poly I:C induced IL-6, IL-1β, IL-8 and IL-18 production, the magnitude and onset were greater with flurbiprofen. Flurbiprofen also reduced MCP-3 and CXCL10 in both cell types, alongside significant inhibition of caspase-1 activity. Benzydamine showed limited or no effect and less inhibition of caspase-1. With rapid suppression of the COX-2/PGE2 pathway, rapid onset and a broad inhibition spectrum, flurbiprofen more comprehensively modulates inflammatory processes in epithelial respiratory models.

PMID 42737602
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PubMedCancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique2026-08-08

Radiation-induced oral mucositis: Correlation between clinician-assessed WHO grades and patient-reported outcomes, an exploratory prospective observational pilot study.

Kumar Priya P, Singh Kuldeep K, Augustine Jeyaseelan J, Urs Aadithya B AB

Oral mucositis is a frequent, dose-limiting toxicity of chemoradiotherapy of head and neck cancer. Clinician-based grading such as the world health organization mucositis scale provides objective assessment of visible lesions, but patient-reported oral mucositis symptom scale capture the subjective functional impact, which may not always correspond with clinical findings. This pilot study examined the association between clinician grading and patient-reported measures and explored differences between benzydamine and bicarbonate rinses. Twenty patients with head and neck cancer receiving definitive chemoradiotherapy were enrolled; ten received benzydamine and ten bicarbonate rinses. Weekly world health organization mucositis grading and patient-reported oral mucositis symptoms (10-item Visual Analogue Scale assessing pain, speech, eating, swallowing, and taste) were recorded across seven weeks. Spearman's correlation was performed, and descriptive comparisons were made between rinse groups. All patients developed mucositis by week 7. Peak severity ranged from grade 1 to grade 4, with most patients reaching grade 3. Median onset of ulcerative mucositis (grade 2 or worse) was week 3. Patient-reported oral mucositis symptoms correlated with World Health Organization grades (Spearman's ρ=0.72, p<0.01) and increased with ulcerative progression. Taste alteration and difficulty eating solids were most affected domains. Some patients reported symptoms despite absent visible lesions. No significant differences were found between the two rinse groups. Patient-reported outcome measure symptoms scale strongly complement World Health Organization grading, capturing symptom escalation and functional impairments under-recognized by clinician assessment. Findings support the need for larger multicentre studies integrating clinician and patient assessments.

PMID 42566859
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PubMedPolymers2026-07-28

Supercritical CO2-Assisted Impregnation of Absorbable Surgical Sutures with Carvacrol and Benzydamine Hydrochloride: Comparative In Vitro Release Profiles and Drug Release Kinetics.

Akpınar Aysun A, Öztürk Merve M, Aybastıer Önder Ö, Çelik Halil H et al.

The development of bioactive surgical sutures capable of delivering therapeutic agents directly at the wound site has gained increasing attention in biomedical research. Functionalized sutures may provide localized antimicrobial or anti-inflammatory activity, potentially reducing postoperative complications and promoting tissue healing. In this study, absorbable surgical sutures were impregnated with carvacrol, a natural phenolic compound with well-known antimicrobial properties, using supercritical carbon dioxide (scCO2) technology. The impregnation process was carried out at 35 °C and 10 MPa for 120 min, allowing for the incorporation of carvacrol into the polymeric matrix of the sutures. The in vitro release behavior of the impregnated sutures was evaluated in phosphate-buffered saline (PBS, pH 7.4) at 37 °C over an 8-day period. The concentration of released compounds was determined by UV-Vis spectrophotometry using previously established calibration curves. An analysis of the experimental release data demonstrated that both carvacrol and benzydamine hydrochloride (HCl) (Tantum Verde®) exhibited a sustained release profile throughout the incubation period. Carvacrol release increased progressively from 2.02 ± 0.15 ppm on day 1 to 7.45 ± 0.15 ppm on day 7, followed by a slight stabilization on day 8 (7.25 ± 0.31 ppm). Similarly, benzydamine HCl (Tantum Verde®) release increased from 1.83 ± 0.11 ppm on day 1 to 3.29 ± 0.13 ppm on day 8. Release kinetics were analyzed using the Korsmeyer-Peppas model, indicating that the release mechanism was predominantly diffusion-controlled during the initial stage of the experiment. The results demonstrate that supercritical CO2 impregnation is an effective solvent-free technique for incorporating bioactive compounds into absorbable sutures, enabling controlled release under physiological conditions.

PMID 42514751
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PubMedPharmaceuticals (Basel, Switzerland)2026-07-28

Effect of Benzydamine Hydrochloride on Dental Plaque Accumulation During Short-Term Restricted Oral Hygiene: A Randomized, Placebo-Controlled Trial.

Puhar Ivan I, Paleško Tubikanec Tina T, Glavina Sabina S, Borovac Matija M et al.

Background/Objectives: Benzydamine hydrochloride (B-HCl) is a non-steroidal anti-inflammatory agent with antimicrobial properties that may be beneficial in oral biofilm control. The aim of this study was to evaluate the effect of a 0.15% B-HCl mouthrinse on dental plaque accumulation and gingival inflammation under short-term conditions of restricted mechanical oral hygiene. Methods: Fifty periodontally healthy female subjects (aged 16-27 years) were randomly assigned (1:1) to receive either a 0.15% B-HCl mouthrinse or a placebo. Following professional prophylaxis, subjects rinsed with 15 mL twice daily for 30 s and refrained from all other oral hygiene procedures for 3 days. Full-Mouth Plaque Score (FMPS) was the primary outcome, and Full-Mouth Bleeding Score (FMBS) was the secondary outcome, recorded at baseline (Day 0) and Day 3. This study was conducted in accordance with CONSORT guidelines. Results: All subjects (n = 50) completed the study. FMPS increased significantly in both groups (p < 0.001). However, plaque accumulation at Day 3 was significantly lower in the B-HCl group compared with placebo (47.9% vs. 73.8%, p < 0.001), representing an absolute reduction of 25.9% and a relative reduction of 35.1%. No statistically significant differences were observed between groups in FMBS at Day 3 (p = 0.180). Conclusions: A 0.15% B-HCl mouthrinse reduced dental plaque accumulation compared with placebo during a 3-day period of restricted mechanical oral hygiene (mean difference: 25.9%; 95% CI: 16.1% to 35.7%). Given the short study duration, the anti-inflammatory properties of B-HCl could not be adequately evaluated. Longer-term studies are needed to determine whether B-HCl provides clinically meaningful benefits as an adjunct to mechanical oral hygiene. Trial registration: ClinicalTrials.gov (Identifier: NCT07565766).

PMID 42515697
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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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