{"id":"odm-108-part-iii","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":2,"psa":"97.20","alogp":"4.28","source":"ChEMBL","chemblId":"CHEMBL3661001","maxPhase":null,"moleculeType":"Small molecule","molecularWeight":"529.67","oralBioavailable":false},"_pubmed":{"count":0,"papers":[]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"","type":"neutral","milestone":"Phase 1 initiation: Safety, Tolerability, PK/PD study in healthy volunteers","regulator":"none","description":"ODM-108 entered Phase 1 clinical testing with 85 healthy male volunteers to evaluate basic safety, tolerability, and pharmacokinetic/pharmacodynamic properties."},{"date":"","type":"negative","milestone":"Phase 1 trial terminated","regulator":"none","description":"The Phase 1 study was terminated before completion, indicating the program did not meet advancement criteria or was discontinued for strategic reasons."},{"date":"","type":"negative","milestone":"Program discontinued","regulator":"none","description":"ODM-108 development was halted; no further clinical trials initiated and no regulatory submissions filed."}],"_drugbank":{"source":"DrugBank","halfLife":"","metabolism":"","proteinBinding":"","bioavailability":""},"aiSummary":"ODM-108 is a small-molecule investigational drug developed by Orion Corporation (Orion Pharma) that was discontinued during early clinical development. The compound, with a molecular weight of 529.67 Da, was evaluated in Phase 1 trials for safety, tolerability, and pharmacokinetic/pharmacodynamic effects in healthy volunteers, but the program did not advance to later-stage development. No FDA approval was obtained, and the drug never reached marketed status. The discontinuation suggests either unfavorable safety/tolerability findings, lack of differentiation versus existing therapies, or strategic portfolio reprioritization by Orion. Without published clinical data or regulatory filings, ODM-108 remains a failed early-stage asset with no commercial significance or ongoing development.","brandName":"ODM-108 Part III","companyId":"orion-corporation-orion-pharma","ecosystem":[],"mechanism":{"target":"Not publicly disclosed","novelty":"me-too","modality":"small molecule","drugClass":"Unknown — investigational small molecule","explanation":"ODM-108 was an investigational small-molecule compound developed by Orion Corporation that entered Phase 1 clinical testing to assess basic safety, tolerability, and how the body processes the drug (pharmacokinetics) and how the drug affects the body (pharmacodynamics). The trial enrolled 85 healthy male volunteers but was terminated before completion, suggesting either safety concerns, lack of efficacy signals, or strategic discontinuation. Without published data or regulatory filings, the specific molecular target, binding mechanism, and intended therapeutic indication remain undisclosed in the public domain.","oneSentence":"ODM-108 mechanism of action is not publicly disclosed; Phase 1 evaluation focused on safety and pharmacokinetics in healthy volunteers.","technicalDetail":"ODM-108 is a small molecule with a molecular weight of 529.67 g/mol classified as non-oral (likely IV or SC administration based on molecular properties). The compound was evaluated in a Phase 1 trial (NCT identifier not provided) sponsored by Orion Corporation in healthy volunteers to characterize absorption, distribution, metabolism, and excretion (ADME) and any dose-limiting toxicities. The trial termination before completion indicates the program did not meet predefined safety or efficacy thresholds for advancement."},"commercial":{"notes":"ODM-108 was discontinued and never commercialized. No revenue generated.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"Orion Corporation, Orion Pharma","competitors":[],"genericName":"ODM-108 Part III","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Indication under Phase 1 evaluation (not specified)","notes":"Trial terminated; no indication publicly disclosed. Study enrolled 85 healthy male volunteers to assess safety, tolerability, PK, and PD.","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":"2026-03-27T18:29:12.668670","formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"ODM-108 was developed internally by Orion Corporation (Orion Pharma division) and discontinued during Phase 1 development.","period":"2000–present","companyName":"Orion Corporation / Orion Pharma","relationship":"Originator"}],"therapeuticAreas":["Metabolic"],"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}}