{"id":"buccalin","rwe":[{"pmid":"41210828","year":"2025","title":"Correction to \"Identification of a G Protein-Coupled Receptor for Buccalin-Type Peptides in the Mollusk Aplysia: Evolutionary Insights into Neuropeptide Signaling\".","finding":"","journal":"ACS omega","studyType":"Clinical Study"},{"pmid":"41092634","year":"2025","title":"Key neuropeptide and neuroendocrine pathways of the optic lobe are affected by high temperatures in the female Octopus maya.","finding":"","journal":"Comparative biochemistry and physiology. Part D, Genomics & proteomics","studyType":"Clinical Study"},{"pmid":"41078795","year":"2025","title":"Identification of a G Protein-Coupled Receptor for Buccalin-Type Peptides in the Mollusk Aplysia: Evolutionary Insights into Neuropeptide Signaling.","finding":"","journal":"ACS omega","studyType":"Clinical Study"},{"pmid":"35581232","year":"2022","title":"Analysis of rhodopsin G protein-coupled receptor orthologs reveals semiochemical peptides for parasite (Schistosoma mansoni) and host (Biomphalaria glabrata) interplay.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"34659116","year":"2021","title":"Evolution and Potential Function in Molluscs of Neuropeptide and Receptor Homologues of the Insect Allatostatins.","finding":"","journal":"Frontiers in endocrinology","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Laboratorio Farmaceutico SIT srl","category":"company"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"company":"Laboratorio Farmaceutico SIT srl","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BUCCALIN®","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:51:46.241128+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:51:53.090195+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BUCCALIN®","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:51:53.880242+00:00"}},"allNames":["buccalin®"],"offLabel":[],"synonyms":[],"timeline":[],"approvals":[],"ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Buccalin's mechanism of action involves binding to a specific receptor or enzyme, which triggers a cascade of downstream effects that can influence various physiological processes."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=buccalin%C2%AE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=buccalin®","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:31:56.595739","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:51:56.148669+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"buccalin®","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06736288","phase":"PHASE4","title":"Post Authorization Efficacy and Safety Study (PAES) to Confirm and Collect More Clinical Data of Buccalin® Tablets In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).","status":"RECRUITING","sponsor":"Laboratorio Farmaceutico SIT srl","startDate":"2025-10-21","conditions":["Respiratory Infection","Lower Respiratory Tract Infection (LRTI)"],"enrollment":240,"completionDate":"2029-04"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Laboratorio Farmaceutico SIT srl","relationship":"Original Developer"}],"publicationCount":43,"therapeuticAreas":["Other"],"biosimilarFilings":[],"originalDeveloper":"Laboratorio Farmaceutico SIT srl","recentPublications":[{"date":"2025 Nov 4","pmid":"41210828","title":"Correction to \"Identification of a G Protein-Coupled Receptor for Buccalin-Type Peptides in the Mollusk Aplysia: Evolutionary Insights into Neuropeptide Signaling\".","journal":"ACS omega"},{"date":"2025 Dec","pmid":"41092634","title":"Key neuropeptide and neuroendocrine pathways of the optic lobe are affected by high temperatures in the female Octopus maya.","journal":"Comparative biochemistry and physiology. Part D, Genomics & proteomics"},{"date":"2025 Oct 7","pmid":"41078795","title":"Identification of a G Protein-Coupled Receptor for Buccalin-Type Peptides in the Mollusk Aplysia: Evolutionary Insights into Neuropeptide Signaling.","journal":"ACS omega"},{"date":"2022 May 17","pmid":"35581232","title":"Analysis of rhodopsin G protein-coupled receptor orthologs reveals semiochemical peptides for parasite (Schistosoma mansoni) and host (Biomphalaria glabrata) interplay.","journal":"Scientific reports"},{"date":"2021","pmid":"34659116","title":"Evolution and Potential Function in Molluscs of Neuropeptide and Receptor Homologues of the Insect Allatostatins.","journal":"Frontiers in endocrinology"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"BUCCALIN®","companyName":"Laboratorio Farmaceutico SIT srl","companyId":"laboratorio-farmaceutico-sit-srl","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:51:56.148669+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}