{"id":"tulobuterol-patch-with-placebo-dry-syrup","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Nervousness"},{"rate":null,"effect":"Skin irritation at patch site"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Tulobuterol patch with placebo dry syrup","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:28:13.908438+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T05:28:27.467609+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:28:19.433920+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Tulobuterol patch with placebo dry syrup","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:28:19.784012+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1256478/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:28:20.979616+00:00"}},"_dailymed":null,"aiSummary":"Tulobuterol patch with placebo dry syrup, marketed by SamA Pharmaceutical Co., Ltd., holds a niche position in the respiratory therapy market. The drug's key strength lies in its unique delivery mechanism, which may offer improved patient compliance compared to traditional oral formulations. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.","mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tulobuterol activates beta-2 adrenergic receptors on bronchial smooth muscle, leading to increased intracellular cAMP and smooth muscle relaxation. This results in bronchodilation and improved airway patency. The transdermal patch formulation provides sustained systemic delivery, while the placebo dry syrup component serves as a control comparator in the marketed formulation.","oneSentence":"Tulobuterol is a beta-2 adrenergic agonist that stimulates beta-2 receptors on airway smooth muscle to cause bronchodilation and improve airflow.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:36:49.925Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T05:28:27.467681+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"name":"Asthma"},{"name":"Chronic obstructive pulmonary disease (COPD)"}]},"trialDetails":[{"nctId":"NCT06411925","phase":"PHASE4","title":"The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients","status":"RECRUITING","sponsor":"SamA Pharmaceutical Co., Ltd","startDate":"2023-11-10","conditions":"Acute Bronchitis","enrollment":296}],"_emaApprovals":[],"_faersSignals":[],"crossReferences":{"chemblId":"CHEMBL1256478"},"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Tulobuterol patch with placebo dry syrup","genericName":"Tulobuterol patch with placebo dry syrup","companyName":"SamA Pharmaceutical Co., Ltd","companyId":"sama-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","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":1,"lastValidatedAt":"2026-04-20T05:28:27.467681+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}