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terbinafine hydrochloride (MOB015B / MOB 015 / MOB015)

✓ Approved

DongKoo Bio & Pharma · SQLE · Small Molecule

What is terbinafine hydrochloride?

terbinafine hydrochloride is a small molecule developed by DongKoo Bio & Pharma. It is approved for therapeutic indications via topical.

Drug Profile

Brand NamesMOB015B, MOB 015, MOB015
CompanyDongKoo Bio & Pharma
Drug ClassSmall Molecule
Molecular TargetSQLE
RouteTopical
StatusApproved
Sources: ClinicalTrials.gov, DongKoo Bio & Pharma

Mechanism of Action

Molecular Targets

terbinafine hydrochloride acts on 1 molecular target:

SQLEsqualene epoxidase ()
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

terbinafine hydrochloride is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsOnychomycosis✓ Approved

Related Research Articles

PubMedJournal of International Society of Preventive & Community Dentistry2026-07-25

Repurposing Antifungal Drugs for Oral Cancer Treatment: Mechanistic Insights and Clinical Potential-A Narrative Review.

Mayadevi Nair Anju A, Esvanth Rao Bounika B, Kondaveeti Satish Srinivas SS, Anand Kumar Abhi Venkatshree AV et al.

Oral squamous cell carcinoma (OSCC) continues to pose significant therapeutic challenges due to high recurrence rates and treatment-related toxicity. Drug repurposing offers an accelerated, cost-effective pathway to discover novel therapeutic indications for established medications. This narrative review evaluates the mechanistic rationale and clinical potential of repurposing antifungal agents, such as azoles and allylamines, as adjuvant therapies for OSCC. A comprehensive literature search was performed across PubMed and Scopus (up to November 14, 2025). Studies were selected based on their focus on antifungal-mediated inhibition of OSCC growth and metastasis. Methodological quality was assessed using the Scale for the Evaluation of Narrative Review Articles. Antifungal agents, particularly itraconazole and terbinafine, exhibit potent antitumor activity by targeting key oncogenic pathways, including the Sonic Hedgehog (SHH) and phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin signaling axes. Preclinical evidence indicates that these agents induce apoptosis, inhibit angiogenesis, and sensitize OSCC cells to standard chemotherapy and radiotherapy. Specifically, itraconazole shows promise in treating SHH-high tumors, while terbinafine reduces tumor proliferation through antiangiogenic mechanisms. Antifungal drugs represent a biologically viable and resource-efficient strategy for enhancing OSCC treatment outcomes. To maximize clinical translation, future research must prioritize the development of nanoformulations and liposomal azoles to overcome existing bioavailability limitations.

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PubMedCureus2026-07-25

Economic Burden and Cost Differences Between Branded and Generic Topical Antifungals in India.

Dt Prateek P, Dongerkery Kavitha K, Deolekar Pradnya P, Dahibhate Atharva A et al.

India's pharmaceutical market is characterized by a significant presence of both generic and branded drugs, particularly for common ailments such as superficial mycoses (SFMs), which pose a substantial public health and economic burden. Patients in tropical countries like India, which have common superficial mycoses, need prolonged treatment because of their recurrence rates after initial treatment and due to incomplete therapy. Given the high variability in drug pricing and the imperative for cost-effective healthcare, a pharmacoeconomic analysis comparing generic and branded topical antifungals in India is crucial to inform prescribing practices and optimize resource allocation. The price comparison of various topical antifungal medications from different brands was conducted by using the latest information from the "Monthly Index of Medical Specialties" August to October 2025, and 1mg online pharmacy and Jan Aushadhi website. The study calculated the total expenses for 30 mL and 30 g dosage forms, which included cream, ointment, lotion, eye drops, and shampoo products of each drug brand. We conducted a comparison between different drug brands through their cost ratio, and percentage cost variation (PCV) analysis was done, keeping generic medicines prices (retrieved from the Jan Aushadhi website) as baseline values. The data analysis showed a significant variation in the costs of different brands of topical antifungals in the Indian market. After analysis, we identified itraconazole 1% ointment to have the highest cost variation at 8335.1%, followed by clotrimazole dusting powder (4740%). Ketoconazole 2% cream, bifonazole 1% lotion, and sertaconazole shampoo showed the smallest variation at 3.29%, 3.5%, and 11.3%, respectively. When generic and branded topical antifungals were compared, the highest cost variation was seen for clotrimazole 1% cream (3431.7%), and the least variation was observed for ketoconazole 2% powder (135.4%). When combination topical antifungals were compared, the highest percentage cost variation of 1479.4% was seen for clotrimazole 1%w/w and beclomethasone dipropionate 0.025%w/w cream, and the least percentage cost variation of 38.8% was seen for terbinafine (1% w/w) + ciprofloxacin (1% w/w) + metronidazole (1% w/w) + clobetasol (0.05% w/w). The market for topical antifungal agents demonstrates substantial price variation among available products. Regulatory authorities, pharmaceutical manufacturers, and clinicians must collaborate to achieve optimal reductions in drug costs. Strict implementation of cost regulation policies, along with increased awareness among clinicians regarding the rational selection of cost-effective therapies, is essential.

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PubMedInternational journal of pharmaceutics2026-07-25

Development of propranolol hydrochloride extended-release lipid matrix tablets for pediatric use.

Broocks Stefanie S, Gebhardt Melanie M, Klein Sandra S

Although solid oral dosage forms are widely used in adult drug therapy, age-appropriate formulations for pediatric patients remain limited. The development of suitable dosage forms is challenged by specific requirements regarding excipient safety, tablet size, and dose flexibility, as well as the need to improve therapy adherence in the context of frequent dosing. This study aimed to develop a pediatric-appropriate extended-release matrix tablet based on lipid matrix formers, with particular attention to the use of safe excipients and the selection of excipients based on sustainability considerations. Lipid-based excipients, selected due to their natural origin and similarity to dietary fats, were investigated and compared with conventional matrix formers. A formulation screening approach was applied to identify promising candidates based on drug release after one hour, followed by further evaluation of manufacturability, tablet hardness, and extended-release performance. In addition, the influence of a physiological pH-gradient, bile salts, and long-term storage on drug release was assessed. The selected formulations showed good manufacturability, uniformity, and sustained drug release. Overall, several lipid-based matrix formulations suitable for pediatric use were identified, providing a promising basis for the development of solid oral extended-release dosage forms for children.

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Multifunctional antimicrobial effects of Lactobacillus johnsonii against A/E pathogens Enteropathogenic E. coli and Citrobacter rodentium.

Vasamsetti Sai Madhuri SM, Khaderbad Yasaswi Y, Sarmah Novelina N, Atham Hari Naga Papa Rao HNPR et al.

Enteropathogenic Escherichia coli (EPEC) remains a leading cause of childhood diarrhea in low-resource settings, and escalating antimicrobial resistance necessitates non-antibiotic therapeutic approaches. This study investigates Lactobacillus johnsonii as a probiotic candidate capable of limiting A/E-pathogen colonization and attenuating infection-associated intestinal inflammation. The probiotic properties of L. johnsonii were evaluated through assays of gastrointestinal tolerance, epithelial adhesion, antimicrobial activity, biofilm inhibition, and pathogen exclusion. Secreted antimicrobial activity was investigated by fractionation and untargeted metabolomic profiling. Therapeutic efficacy was further assessed in an antibiotic-perturbed Citrobacter rodentium mouse infection. L. johnsonii exhibited robust gastrointestinal resilience (acid pH 1.5-2.5; 0.3% bile) and strong adhesion to human intestinal epithelial cells. In vitro, live L. johnsonii markedly inhibited EPEC growth, disrupted pre-formed biofilms, and displaced adherent pathogens from epithelial surfaces. In an antibiotic-perturbed Citrobacter rodentium infection model, oral L. johnsonii administration reduced pathogen loads in feces and colonic tissues by 3-4 log units, restored colon length, and alleviated epithelial ulceration and inflammatory infiltration. Mechanistic analyses revealed dual antimicrobial actions: nutrient competition and secretion of low-molecular-weight (<75 kDa) bactericidal factors active at ~30 µg mL-1. Untargeted metabolomic profiling of the active fraction generated putative annotations of chemically diverse small molecules, including fatty-acid and hydroxy-acid class compounds, as well as candidate metabolites such as quinine hydrochloride, aloperine, and γ-glutamylglutamine, thereby providing a foundation for future targeted validation of individual antimicrobial components. Notably, probiotic treatment reduced mucosal neutrophil infiltration and preserved epithelial architecture, suggesting attenuation of infection-associated inflammation. Collectively, these findings support L. johnsonii as a multifunctional probiotic that integrates biofilm disruption, metabolic competition, and immune-protective activity. The study highlights its translational potential as a probiotic-based intervention to manage attaching-and-effacing enteric infections and mitigate antibiotic reliance in vulnerable populations.

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PubMedHospital pharmacy2026-07-25

Artificial Intelligence and Large Language Models as Decision-Support Tools in Hospital Compounding Pharmacy: A Proof-of-Concept Study.

Castellana Eleonora E, Chiappetta Maria Rachele MR

To evaluate the efficiency and reliability of a large language model (LLM) as a decision-support tool in hospital compounding pharmacy for pediatric extemporaneous preparations requiring assessment of drug crushability, regulatory compliance, and formulation feasibility. A proof-of-concept study compared a structured LLM-assisted workflow with the traditional manual information retrieval process in a hospital pharmacy setting. The LLM (Claude Sonnet 4.6) was configured with a standardized prompt to extract and consolidate data from multiple authoritative sources: the Friuli Venezia Giulia "Do Not Crush" list, the Italian Medicines Agency (AIFA) database for Summary of Product Characteristics (SmPC), AIFA Law 648/96 off-label use lists, and the Stabilis database for oral liquid formulation stability. Two representative drugs, propranolol hydrochloride and imatinib mesylate, were analyzed. For each drug, the model generated a structured output including crushability, regulatory information, off-label status, and extemporaneous formulation data. The same queries were manually performed by an experienced hospital pharmacist. Primary outcome was information retrieval time; secondary outcomes included completeness and accuracy. The LLM-assisted workflow reduced retrieval time to less than 2 minutes per drug (mean 1 minute 45 seconds), compared with a mean of 20 minutes (range 15-25 minutes) for the manual process, plus an additional 5 to 10 minutes for transcription. Output completeness was 100%, with all predefined fields correctly populated. The model accurately classified drug crushability and correctly identified Law 648/96 regulatory status. For propranolol, the system identified crushability, pediatric off-label authorization, and SyrSpend-based formulations with stability data of up to 146 days at room temperature. For imatinib, the model highlighted cytotoxic handling precautions, identified the absence of SyrSpend formulations, and retrieved alternative formulation stability data (30 days refrigerated). A properly configured LLM can function as an effective decision-support tool in hospital compounding pharmacy, improving efficiency while maintaining high standards of completeness, accuracy, and regulatory compliance. These preliminary results support further investigation into the integration of the LLM system into routine pediatric galenical preparation practice.

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PubMedJournal of cutaneous medicine and surgery2026-07-24

Diagnosis and Treatment of Onychomycosis in Psoriasis Patients: A Single-Center Cohort Study.

Zur Aviran Noa N, Berkovich Davidson Danielle D, Sherman Shany S, Mimouni Daniel D et al.

Literature on onychomycosis prevalence, causative agents, and systemic antifungal treatment efficacy in psoriasis are sparse. The objectives of the study were to determine onychomycosis prevalence in psoriasis patients with nail changes and to evaluate the efficacy and safety of 2 systemic antifungal treatments, terbinafine, and fluconazole. Records from the Division of Dermatology at Rabin Medical Center (2012-2022), were retrospectively analyzed, including nail samples from consecutive psoriasis patients referred to the institutional mycological laboratory. One hundred thirty-nine psoriasis patients with suspected onychomycosis were referred for mycological testing (46.8% female, median age 62 years), onychomycosis was diagnosed in 67.6% of cases. Fifty-one point one percent of patients were on systemic psoriasis treatments, 60.6% of them receiving biologic therapies. Trichophyton rubrum was the most prevalent (81.3%) isolated fungi of all positive cultures. Fifty-one patients received systemic antifungal treatment, with 47.1% receiving terbinafine and 52.9% fluconazole. Clinical improvement was observed in 70.8% of terbinafine-treated cases and 40.7% of fluconazole-treated cases (P = .002). No psoriasis flare-ups were attributed to systemic antifungal treatment. This cohort provides insights into prevalence of onychomycosis, and the efficacy and safety of systemic antifungal treatment in psoriasis patients, including patients on biologic therapies. Further prospective studies are recommended.

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