{"id":"gran","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"EVIVE Biotechnology","category":"company"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Menorrhagia","drugRate":"27%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"10.6%","severity":"common","organSystem":""}],"contraindications":["Conduction disorder of the heart","Congenital long QT syndrome","Doxorubicin Induced Cardiomyopathy","Hypokalemia","Hypomagnesemia","Prolonged QT interval"],"seriousAdverseEvents":[{"effect":"Discontinuation due to bleeding events (EINSTEIN Junior)","drugRate":"1.8%","severity":"serious"},{"effect":"Discontinuation due to bleeding events (UNIVERSE)","drugRate":"1.6%","severity":"serious"}]},"trials":[],"aliases":["Filgrastim"],"company":"EVIVE Biotechnology","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=GRAN®","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:39:58.256662+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T02:40:12.766466+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:40:03.355025+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GRAN®","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:40:04.115278+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Granulocyte colony stimulating factor receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:40:05.363267+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201567/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:40:05.019735+00:00"}},"allNames":["gran®"],"offLabel":[],"synonyms":[],"timeline":[],"aiSummary":"GRAN®, marketed by EVIVE Biotechnology, is a small molecule indicated for chemotherapy-induced nausea and vomiting. The drug's key strength lies in its specific mechanism of action, which targets a unique pathway in the body, potentially offering a differentiated therapeutic profile. The primary risk to GRAN® is the expiration of its key composition patent in 2028, which could lead to increased competition from generics.","approvals":[],"ecosystem":[],"mechanism":{"target":"5-hydroxytryptamine receptor 3B, Multidrug and toxin extrusion protein 1, Solute carrier family 22 member 2","modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Gran's mechanism of action involves binding to a specific protein or receptor in the body, which can modulate its activity and produce a therapeutic effect."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=gran%C2%AE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=gran®","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:18:53.272291","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:40:12.766546+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"gran®","indications":{"approved":[{"name":"Chemotherapy-induced nausea and vomiting","diseaseId":"chemotherapy-induced-nausea-and-vomiting","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Post-Operative Nausea and Vomiting","diseaseId":"post-operative-nausea-and-vomiting","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Prevention of Post-Operative Nausea and Vomiting","diseaseId":"prevention-of-post-operative-nausea-and-vomiting","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Prevention of Radiation-Induced Nausea and Vomiting","diseaseId":"prevention-of-radiation-induced-nausea-and-vomiting","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04174599","phase":"PHASE3","title":"Study to Compare the Efficacy and Safety of F-627 and GRAN®","status":"COMPLETED","sponsor":"EVIVE Biotechnology","startDate":"2018-04-12","conditions":["Breast Cancer","Neutropenia"],"enrollment":242,"completionDate":"2019-06-19"},{"nctId":"NCT04200092","phase":"PHASE1","title":"Staccato® Granisetron Single Dose PK","status":"COMPLETED","sponsor":"Alexza Pharmaceuticals, Inc.","startDate":"2019-11-04","conditions":["Healthy"],"enrollment":36,"completionDate":"2020-01-31"},{"nctId":"NCT03956446","phase":"NA","title":"Tick-borne Encephalitis and Borrelial Antibodies in Serum","status":"RECRUITING","sponsor":"University Medical Centre Ljubljana","startDate":"2014-09-01","conditions":["Tick Borne Encephalitis"],"enrollment":80,"completionDate":"2027-12-31"},{"nctId":"NCT00834717","phase":"PHASE1","title":"Granisetron 1 mg Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2005-09","conditions":["Healthy"],"enrollment":40,"completionDate":"2005-09"},{"nctId":"NCT00834522","phase":"PHASE1","title":"Granisetron 1 mg Tablets, Non-fasting","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2005-07","conditions":["Healthy"],"enrollment":80,"completionDate":"2005-07"},{"nctId":"NCT01596426","phase":"PHASE1","title":"Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years","status":"WITHDRAWN","sponsor":"Kyowa Kirin Pharmaceutical Development Ltd","startDate":"","conditions":["Chemotherapy Induced Nausea and Vomiting"],"enrollment":0,"completionDate":""},{"nctId":"NCT01596413","phase":"PHASE1","title":"Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years","status":"WITHDRAWN","sponsor":"Kyowa Kirin Pharmaceutical Development Ltd","startDate":"","conditions":["Chemotherapy Induced Nausea and Vomiting"],"enrollment":0,"completionDate":""},{"nctId":"NCT00868764","phase":"PHASE1","title":"An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2009-04","conditions":["Pharmacokinetics"],"enrollment":60,"completionDate":"2009-09"},{"nctId":"NCT00890565","phase":"PHASE1","title":"Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2009-05","conditions":["Healthy"],"enrollment":240,"completionDate":"2009-09"},{"nctId":"NCT01596400","phase":"PHASE1","title":"Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years","status":"COMPLETED","sponsor":"Kyowa Kirin Pharmaceutical Development Ltd","startDate":"2012-05","conditions":["Chemotherapy Induced Nausea and Vomiting"],"enrollment":19,"completionDate":"2016-12"},{"nctId":"NCT00873197","phase":"PHASE1","title":"PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron","status":"COMPLETED","sponsor":"Kyowa Kirin Co., Ltd.","startDate":"2009-04","conditions":["Healthy"],"enrollment":12,"completionDate":"2009-05"},{"nctId":"NCT05325190","phase":"PHASE2","title":"Granisetron Transdermal Patch System for Prevention of CINV by CapeOX","status":"UNKNOWN","sponsor":"Tianjin Medical University Cancer Institute and Hospital","startDate":"2021-10-10","conditions":["Chemotherapy-induced Nausea and Vomiting"],"enrollment":57,"completionDate":"2023-06-01"},{"nctId":"NCT01989221","phase":"PHASE3","title":"Sancuso® for Gastroparesis: An Open Label Study.","status":"COMPLETED","sponsor":"Temple University","startDate":"2012-11","conditions":["Gastroparesis"],"enrollment":14,"completionDate":"2018-12"},{"nctId":"NCT02230371","phase":"PHASE4","title":"Study on the Effect of Granisetron on Myofascial Pain in the Orofacial Muscles","status":"COMPLETED","sponsor":"Karolinska Institutet","startDate":"2007-03","conditions":["Myofascial Pain","Temporomandibular Disorders"],"enrollment":40,"completionDate":"2014-12"},{"nctId":"NCT02282514","phase":"PHASE1,PHASE2","title":"Stem Cell Transplantation for Stiff Person Syndrome (SPS)","status":"TERMINATED","sponsor":"Northwestern University","startDate":"2014-10","conditions":["Stiff-Person Syndrome"],"enrollment":23,"completionDate":"2019-08-30"},{"nctId":"NCT01445821","phase":"PHASE3","title":"Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial","status":"TERMINATED","sponsor":"Northwestern University","startDate":"2011-09-15","conditions":["Scleroderma, Systemic"],"enrollment":44,"completionDate":"2019-10-10"},{"nctId":"NCT01633203","phase":"","title":"Observational Study of Perioperative Chemotherapy in Gastric Cancer","status":"COMPLETED","sponsor":"Grupo Oncologico Cooperativo Chileno de Investigation","startDate":"2010-08","conditions":["Gastric Cancer"],"enrollment":61,"completionDate":"2018-12"},{"nctId":"NCT03958058","phase":"","title":"Tick-borne Encephalitis and Possible Borrelial Serology","status":"COMPLETED","sponsor":"University Medical Centre Ljubljana","startDate":"2007-01-01","conditions":["Tick Borne Encephalitis","Lyme Disease"],"enrollment":690,"completionDate":"2013-12-31"},{"nctId":"NCT02463942","phase":"NA","title":"Tick-borne Encephalitis and Positive Borrelial Antibodies","status":"UNKNOWN","sponsor":"University Medical Centre Ljubljana","startDate":"2014-09","conditions":["Tick-borne Encephalitis"],"enrollment":100,"completionDate":"2020-09"},{"nctId":"NCT00293384","phase":"NA","title":"Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant","status":"COMPLETED","sponsor":"Barbara Ann Karmanos Cancer Institute","startDate":"2004-10","conditions":["Breast Cancer","Chronic Myeloproliferative Disorders","Gestational Trophoblastic Tumor","Leukemia","Lymphoma","Multiple Myeloma and Plasma Cell Neoplasm","Myelodysplastic Syndromes","Myelodysplastic/Myeloproliferative Neoplasms","Nausea and Vomiting","Neuroblastoma","Ovarian Cancer","Testicular Germ Cell Tumor"],"enrollment":40,"completionDate":"2012-02"},{"nctId":"NCT01767714","phase":"PHASE3","title":"Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation","status":"COMPLETED","sponsor":"Sanofi","startDate":"2013-04","conditions":["Non-Hodgkin's Lymphoma"],"enrollment":100,"completionDate":"2014-11"},{"nctId":"NCT00003213","phase":"PHASE3","title":"Drugs to Reduce the Side Effects of Chemotherapy","status":"COMPLETED","sponsor":"Swiss Cancer Institute","startDate":"1996-05","conditions":["Nausea and Vomiting","Unspecified Adult Solid Tumor, Protocol Specific"],"enrollment":267,"completionDate":"1999-08"},{"nctId":"NCT00781638","phase":"NA","title":"ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis","status":"COMPLETED","sponsor":"Otsuka Frankfurt Research Institute GmbH","startDate":"2008-10","conditions":["Ulcerative Colitis"],"enrollment":24,"completionDate":"2012-03"},{"nctId":"NCT00366925","phase":"NA","title":"CESA 5.10 Investigation to Compare the Efficacy and Safety of the Adacolumn® Apheresis Device in Patients With Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Otsuka Frankfurt Research Institute GmbH","startDate":"2006-04","conditions":["Ulcerative Colitis"],"enrollment":174,"completionDate":"2008-07"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"chemblId":"CHEMBL1201567"},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"EVIVE Biotechnology","relationship":"Original Developer"}],"publicationCount":1726,"therapeuticAreas":["Other"],"biosimilarFilings":[],"originalDeveloper":"EVIVE Biotechnology","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"GRAN®","companyName":"EVIVE Biotechnology","companyId":"evive-biotechnology","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":46,"withResults":14},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:40:12.766546+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}