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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

PubMedGeneral dentistry2026-10-28

Acute methotrexate toxicity with severe oral ulcerations following inadvertent ingestion: a case report.

Alias Ankitha Miriya AM, Srikantannair Sreela Leela SL, SivaPrasad Twinkle T, Mathew Philips P et al.

Inadvertent ingestion of high-risk medications such as methotrexate may lead to serious and potentially fatal complications. This case report describes the oral manifestations observed in a 68-year-old woman who developed acute methotrexate toxicity after inadvertent ingestion of the drug. The patient presented with oral erosions resembling erythema multiforme along with blistering skin lesions that developed over a 2-week period. She was undergoing treatment with hydroxychloroquine, deflazacort, and mirtazapine for inflammatory arthritis. When she presented for evaluation of the mucocutaneous lesions, it was discovered that she had been taking methotrexate (7.5 mg) instead of the prescribed mirtazapine (7.5 mg) for approximately 1 month due to a dispensing error at a local pharmacy. Laboratory investigations revealed bicytopenia involving leukocytes and erythrocytes, likely attributable to acute methotrexate toxicity. Methotrexate was discontinued, and the patient received intravenous folinic acid, benzydamine mouthwash, triamcinolone oral paste, oral antihistamines, and subcutaneous filgrastim. The mucocutaneous lesions resolved, leukocyte counts improved, hemoglobin remained stable at 11.0 g/dL, and the patient was subsequently discharged. This incident draws attention to the critical need for clinicians to remain alert to potential medication errors when erythema multiforme--like lesions are observed in the oral cavity.

PMID 42949941
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PubMedPharmaceuticals (Basel, Switzerland)2026-10-27

Propolis vs. Chlorhexidine Gluconate and Benzydamine Hydrochloride on Sequelae After Third Molar Surgery: A Randomized Controlled Trial.

Bayramoğlu Zeynep Z, Halıcı Zekai Z, Özakar Emrah E, Sevinç Özakar Rukiye R

Background. Impacted lower third molar surgery is characterized by postoperative sequelae such as pain, edema, and trismus. While chlorhexidine (CHX) is the gold-standard antiseptic, its side effects prompt the search for natural alternatives. The aim of this study is to examine the effects of propolis gargle on wound healing following third molar surgery and to compare it with chlorhexidine gluconate and benzydamine hydrochloride (CHX+BENZ). Methods. In this prospective, randomized, double-blind, active-controlled trial, 52 patients were assigned to 3% Propolis (n = 24) or 0.12% CHX+BENZ (n = 28) groups. Mouthwashes were applied twice daily from postoperative days 2 to 7, and pain (VAS), edema, and trismus were evaluated preoperatively and on days 2 and 7. Statistical significance was set at p < 0.05. Results. No significant differences were found in pain and trismus (p > 0.05). However, the Propolis group exhibited significantly lower edema on day 2 compared to the CHX+BENZ group (p = 0.004), and complication rates were also notably lower in the Propolis group. Conclusions. The novel, non-alcoholic 3% propolis mouthwash demonstrated no statistically significant differences in short-term pain and trismus outcomes compared to CHX+BENZ, alongside a statistically smaller day-2 facial edema measurement. While these findings support its potential as a supportive oral rinse following third molar surgery, adequately powered prospective trials are warranted to validate these preliminary observations before routine clinical adoption.

PMID 42943312
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PubMedSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2026-10-12

Reporting quality and spin in abstracts of randomized clinical trials related to oral mucositis.

Al-Abedalla Khadijeh K, Hamdan Ahmad A AA, Alsaghir Qais Q, Hassona Yazan Y et al.

Oral mucositis is a common debilitating side effect of cancer therapy. Numerous randomized controlled trials (RCTs) have examined interventions for this complication. Accurate reporting of RCT results in abstracts is crucial to treatment decisions. Spin undermines the integrity of the information presented and compromises evidence-based practice. This study evaluated the reporting quality of, and spin in, abstracts of RCTs of four interventions for oral mucositis: benzydamine, photobiomodulation therapy, oral cryotherapy, and keratinocyte growth factor, and assessed factors that can affect reporting quality and spin. PubMed, Cochrane, and Scopus were systematically searched for RCTs related to oral mucositis treatments published until September 2024. The CONSORT for Abstracts (CONSORT-A) and spin checklists were then applied to assess reporting quality of and spin in their abstracts. Among 112 RCTs that were analyzed, the overall CONSORT-A score for reporting quality was low, and key elements such as study design and outcome reporting were frequently not reported. Only 16 of these RCTs were analyzed for spin and only two RCTs had no spin. Higher reporting quality was significantly correlated with greater abstract word counts (r = 0.35; p < 0.001) and pharmaceutical funding when compared with articles that did not report funding (p = 0.015). Spin was negatively correlated with the Altmetric attention score (r =  - 0.652; p = 0.006). Abstracts of RCTs on oral mucositis interventions frequently did not meet the reporting standards defined by the CONSORT-A checklist. Enhanced adherence to reporting guidelines is necessary to support evidence-based clinical practices.

PMID 42860472
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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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