{"id":"odm-108-part-i","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Data not available","Hepatic impairment":"Data not available"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT02432664"],"_chembl":{"hba":9,"hbd":3,"psa":"128.57","alogp":"0.74","source":"ChEMBL","chemblId":"CHEMBL5787531","maxPhase":null,"moleculeType":null,"molecularWeight":"369.39","oralBioavailable":false},"_pubmed":{"count":0,"papers":[]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"","type":"neutral","milestone":"Phase 1 trial initiation: Safety, Tolerability, PK/PD in Healthy Volunteers","regulator":"none","description":"Single Phase 1 trial enrolled 85 healthy male volunteers to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic effects of ODM-108."},{"date":"","type":"negative","milestone":"Phase 1 trial terminated","regulator":"none","description":"Phase 1 trial was terminated; development of ODM-108 Part I was discontinued with no advancement to Phase 2."}],"aiSummary":"ODM-108 Part I is an early-stage investigational compound developed by Orion Corporation (Orion Pharma) that was discontinued after Phase 1 clinical evaluation. The drug is a small molecule with a molecular weight of 369.39 Da, though its precise mechanism of action and molecular target remain undisclosed in available literature. A single Phase 1 trial enrolling 85 healthy male volunteers was terminated, assessing safety, tolerability, pharmacokinetic, and pharmacodynamic effects. The compound did not advance to Phase 2 development, indicating either safety/tolerability concerns or strategic portfolio decisions by Orion. No approved indications, commercial revenue, or regulatory approvals exist. This profile represents a discontinued early-stage asset with limited clinical data and no commercial significance.","brandName":"ODM-108 Part I","companyId":"orion-corporation-orion-pharma","ecosystem":[],"mechanism":{"target":"Not disclosed","novelty":"me-too","modality":"small molecule","drugClass":"Small molecule (investigational)","explanation":"ODM-108 Part I is an investigational small molecule compound developed by Orion Corporation. The specific molecular target, binding mechanism, and pharmacological pathway have not been disclosed in publicly available sources. The compound underwent a single Phase 1 clinical trial in healthy volunteers to evaluate basic safety, tolerability, and pharmacokinetic properties before development was discontinued. Without published preclinical or clinical data, the precise mechanism of action cannot be determined from available sources.","oneSentence":"ODM-108 Part I mechanism of action is not publicly disclosed; Phase 1 development was terminated.","technicalDetail":"ODM-108 Part I has a molecular weight of 369.39 Da (ChEMBL ID: CHEMBL5787531) and is classified as a non-oral small molecule. The compound was not advanced beyond Phase 1 evaluation, and no peer-reviewed publications describing its molecular target, binding kinetics, selectivity profile, or pharmacokinetic parameters are available in the public domain."},"commercial":{"notes":"ODM-108 Part I was discontinued during Phase 1 development and never commercialized. No revenue, pricing, or market data available.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"Orion Corporation, Orion Pharma","competitors":[],"genericName":"ODM-108 Part I","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Indication under Phase 1 evaluation (not specified)","notes":"Single Phase 1 trial in 85 healthy male volunteers assessing safety, tolerability, PK, and PD effects. Trial was terminated; no Phase 2 advancement.","phase":"Phase 1","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02432664","phase":"PHASE1","title":"Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ODM-108: in Healthy Male Volunteers","status":"TERMINATED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2015-04-14","conditions":"Healthy","enrollment":85,"completionDate":"2016-04-22","primaryEndpoint":"Number of participants with adverse events in Part I and Part II."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💊","route":"other","frequency":"Data not available","formulation":"Data not available"},"_hyperScrapedAt":"2026-03-27T18:10:47.129324","formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"ODM-108 Part I was developed by Orion Corporation (Orion Pharma) and discontinued after Phase 1 clinical evaluation.","period":"Development–discontinued","companyName":"Orion Corporation / Orion Pharma","relationship":"Originator"}],"therapeuticAreas":["Other"],"trialPhaseCounts":{"PHASE1":1},"biosimilarFilings":[],"firstApprovalDate":"","_hyperScrapedFields":["patents","pricing","trials","ema","mhra","who","safety-signals","recalls","dailymed","pubmed","drugbank","chembl","rxnorm","medicare","pharmgkb","sec","company-ir","wikipedia","drug-website","google"],"companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}