{"id":"sama","rwe":[{"pmid":"41726360","year":"2026","title":"Central Venous-arterial Carbon Dioxide Difference (pCO(2) gap) as a Guide to Predict Complications in Postoperative High-risk Surgical Patients: A Prospective Observational Study.","finding":"","journal":"Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine","studyType":"Clinical Study"},{"pmid":"41634298","year":"2026","title":"Development of a novel dismantlable adhesive for orthodontic use triggered by thermal stimulation.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41400820","year":"2026","title":"Increased mortality in dementia patients using inhaled anticholinergics: A nationwide register study from the Swedish registry on dementia/cognitive disorders, SveDem.","finding":"","journal":"Journal of Alzheimer's disease : JAD","studyType":"Clinical Study"},{"pmid":"41393010","year":"2025","title":"Investing in youth public mental health in India: multi-stakeholder co-production of a whole school program to promote the mental health of Indian adolescents.","finding":"","journal":"Frontiers in public health","studyType":"Clinical Study"},{"pmid":"41378529","year":"2025","title":"Safeguarding healthcare in conflict: SAMA's suspension of relations with the Israeli Medical Association.","finding":"","journal":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Lantheus Medical","category":"company"}],"phase":"marketed","safety":{"contraindications":["Bone marrow depression","Breastfeeding (mother)","Chronic heart failure","Kidney disease","Neutropenic disorder","Pregnancy, function","Secondary malignant neoplasm of bone marrow","Thrombocytopenic disorder"]},"trials":[],"aliases":[],"company":"Lantheus Medical","patents":[],"pricing":[],"allNames":["sama"],"offLabel":[],"synonyms":[],"timeline":[{"date":"2000-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from Novartis Pharmaceuticals to Lantheus Medical"}],"approvals":[],"ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"Imagine Sama as a key that fits into a lock on a cell. When it binds to the lock, it triggers a series of events that ultimately lead to a desired outcome, such as treating a disease or condition. This process is complex and involves many molecular interactions, but essentially, Sama helps to restore balance to the body's natural processes.","oneSentence":"Sama is a small molecule that works by interacting with a specific biological target to produce a therapeutic effect.","technicalDetail":"Sama's exact mechanism of action is not well-documented, but it is believed to involve binding to a specific receptor or enzyme, which triggers a cascade of downstream effects that ultimately lead to its therapeutic effects."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=sama","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=sama","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-31T10:28:28.835810","biosimilars":[],"competitors":[],"genericName":"sama","indications":{"approved":[{"name":"Pain due to Osteoblastic Bone Metastasis","diseaseId":"pain-due-to-osteoblastic-bone-metastasis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"currentOwner":"Lantheus Medical","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT07451756","phase":"NA","title":"Effects of Pranayama Breathing Technique on Stress Level, Sleep Quality, and Quality of Life Among Older Adults","status":"COMPLETED","sponsor":"Namik Kemal University","startDate":"2023-11-03","conditions":["Individuals Aged 60 and Over","Individuals Who Are Physically and Mentally Suitable to Practice Pranayama Breathing Technique","Individuals Without a Malignant Respiratory System Disease (Such as Bronchial and Lung Cancer)","Individuals Without a Pathological Condition Affecting Their Level of Consciousness and Concentration","Those Who Voluntarily Agreed to Participate in the Research"],"enrollment":74,"completionDate":"2025-09-10"},{"nctId":"NCT07066384","phase":"NA","title":"Comparison of Breathing Yoga and Progressive Muscle Relaxation Techniques After Transplantation","status":"COMPLETED","sponsor":"Bitlis Eren University","startDate":"2025-03-10","conditions":["Breathing, Mouth","Muscle Relaxation","Pain, Postoperative","Kinesiophobia"],"enrollment":125,"completionDate":"2025-10-30"},{"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,"completionDate":"2027-09"},{"nctId":"NCT07062133","phase":"NA","title":"Effectiveness of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction in Pediatric Tethered Cord Syndrome Post-Surgery","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Institute of Acupuncture, Moxibustion and Meridian","startDate":"2025-11-01","conditions":["Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome"],"enrollment":50,"completionDate":"2027-03-31"},{"nctId":"NCT06279494","phase":"PHASE1,PHASE2","title":"Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors","status":"NOT_YET_RECRUITING","sponsor":"Peking University People's Hospital","startDate":"2024-03","conditions":["Acute Leukemia","Myelodysplastic Syndromes","Severe Aplastic Anemia"],"enrollment":6,"completionDate":"2025-03"},{"nctId":"NCT05748977","phase":"EARLY_PHASE1","title":"Short Acting Agents Vs Long Acting in Frequent Excerbator COPD Patients","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2023-02-20","conditions":["Copd"],"enrollment":80,"completionDate":"2024-03-20"},{"nctId":"NCT05632874","phase":"NA","title":"The Effect of Relaxing Breathing Exercise Applied to Patients Before Bone Marrow Biopsy on Vital Signs, Pain and Anxiety Levels","status":"UNKNOWN","sponsor":"Uskudar University","startDate":"2022-11","conditions":["Bone Marrow Cancer"],"enrollment":72,"completionDate":"2023-03"},{"nctId":"NCT03219866","phase":"PHASE4","title":"Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)","status":"TERMINATED","sponsor":"Wake Forest University Health Sciences","startDate":"2017-10-03","conditions":["COPD","COPD Exacerbation"],"enrollment":40,"completionDate":"2020-04-01"},{"nctId":"NCT03170232","phase":"PHASE2","title":"A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD)","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2017-10-16","conditions":["Pulmonary Disease, Chronic Obstructive"],"enrollment":54,"completionDate":"2018-11-15"},{"nctId":"NCT01985334","phase":"PHASE4","title":"Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-02-14","conditions":["COPD"],"enrollment":4389,"completionDate":"2016-04-29"},{"nctId":"NCT02576626","phase":"PHASE4","title":"Single Dose Ultibro Breezhaler by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in COPD","status":"COMPLETED","sponsor":"Wouter H. van Geffen","startDate":"2015-12","conditions":["COPD"],"enrollment":40,"completionDate":"2017-09-29"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"_patentsChecked":true,"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Novartis Pharmaceuticals","relationship":"Original Developer"},{"period":"present","companyName":"Lantheus Medical","relationship":"Current Owner"}],"publicationCount":0,"therapeuticAreas":["Pain"],"biosimilarFilings":[],"originalDeveloper":"Novartis Pharmaceuticals","recentPublications":[{"date":"2026 Jan","pmid":"41726360","title":"Central Venous-arterial Carbon Dioxide Difference (pCO(2) gap) as a Guide to Predict Complications in Postoperative High-risk Surgical Patients: A Prospective Observational Study.","journal":"Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine"},{"date":"2026 Feb 3","pmid":"41634298","title":"Development of a novel dismantlable adhesive for orthodontic use triggered by thermal stimulation.","journal":"Scientific reports"},{"date":"2026 Feb","pmid":"41400820","title":"Increased mortality in dementia patients using inhaled anticholinergics: A nationwide register study from the Swedish registry on dementia/cognitive disorders, SveDem.","journal":"Journal of Alzheimer's disease : JAD"},{"date":"2025","pmid":"41393010","title":"Investing in youth public mental health in India: multi-stakeholder co-production of a whole school program to promote the mental health of Indian adolescents.","journal":"Frontiers in public health"},{"date":"2025 Nov 4","pmid":"41378529","title":"Safeguarding healthcare in conflict: SAMA's suspension of relations with the Israeli Medical Association.","journal":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"active","brandName":"SAMA","companyName":"Lantheus Medical","companyId":"lantheus-medical","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sama is a small molecule developed by Novartis Pharmaceuticals and currently owned by Lantheus Medical. Unfortunately, there is limited information available on its target, drug class, and approved indications. As it is off-patent, there are no active Orange Book patents. The commercial status of Sama is not well-documented, and its safety considerations are unknown. Further research is needed to understand its clinical applications and pharmacological properties.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}