{"id":"oleum-neutralicum","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":["NCT01518959"],"_chembl":{"hba":"","hbd":"","psa":"","alogp":"","source":"ChEMBL","chemblId":"CHEMBL2108234","maxPhase":"-1.0","moleculeType":"Unknown","molecularWeight":"","oralBioavailable":false},"_pubmed":{"count":0,"papers":[]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"","type":"neutral","milestone":"Phase 3 trial initiated: Vitamin D3 substitution in hematologic malignancies","regulator":"none","description":"Semmelweis University initiated a Phase 3 clinical trial evaluating 25-OH-vitamin D3 substitution in patients with chronic lymphoid leukemia and other malignant/immune-hematologic diseases."},{"date":"","type":"negative","milestone":"Phase 3 trial terminated early","regulator":"none","description":"The Phase 3 trial was terminated with only 31 enrolled patients; no published efficacy or safety results released."},{"date":"","type":"negative","milestone":"Product discontinued","regulator":"none","description":"Oleum neutralicum was discontinued and did not advance to regulatory submission or commercialization."}],"brandName":"oleum neutralicum","companyId":"semmelweis-university","ecosystem":[],"mechanism":{"target":"Unknown; possibly vitamin D receptor (VDR) if vitamin D3-based","novelty":"me-too","modality":"other","drugClass":"Unknown; possibly vitamin D analog or immunomodulator","explanation":"Oleum neutralicum was investigated as a potential therapeutic agent in a clinical trial focused on vitamin D3 substitution in patients with malignant and immune-hematologic diseases, specifically chronic lymphoid leukemia. The exact mechanism of action, molecular target, and pharmacological class remain undocumented in available scientific literature and regulatory filings. The trial design suggests the investigator hypothesized that vitamin D3 supplementation might provide therapeutic benefit in hematologic malignancies, possibly through immunomodulatory or anti-proliferative pathways, but no published results or mechanistic data are available to confirm this.","oneSentence":"Mechanism of action unknown; product appears to be a vitamin D3 formulation studied in hematologic malignancies.","technicalDetail":"ChEMBL identifier CHEMBL2108234 is registered but with unknown compound type and no molecular weight data. The product is not listed as an oral formulation. No binding kinetics, selectivity data, pharmacokinetic parameters, or target validation studies are documented in public databases."},"commercial":{"notes":"Product discontinued; never commercialized. No revenue data available.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"Semmelweis University","competitors":[{"name":"Calcitriol (1,25-dihydroxyvitamin D3)","slug":"calcitriol","company":"Multiple manufacturers","advantage":"Established vitamin D3 analog with FDA approval for hypocalcemia and secondary hyperparathyroidism"},{"name":"Cholecalciferol (Vitamin D3)","slug":"cholecalciferol","company":"Multiple manufacturers","advantage":"Over-the-counter vitamin D3 supplementation; widely used in hematologic disease supportive care"}],"genericName":"oleum neutralicum","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Chronic lymphoid leukemia with vitamin D3 substitution","notes":"Trial terminated early with N=31 patients. No efficacy or safety data published. Study title: 'The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Disease.' Sponsor: Semmelweis University.","phase":"Phase 3","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01518959","phase":"PHASE3","title":"The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases","status":"TERMINATED","sponsor":"Semmelweis University","startDate":"2012-01","conditions":"Chronic Lymphoid Leukemia","enrollment":31,"completionDate":"2017-01","primaryEndpoint":"Overall survival"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"🧴","route":"other","frequency":"Data not available","formulation":"Data not available"},"_hyperScrapedAt":"2026-03-27T18:28:25.372873","formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Academic research institution in Budapest, Hungary. No evidence of commercial licensing or acquisition.","period":"Unknown–discontinued","companyName":"Semmelweis University","relationship":"Originator"}],"therapeuticAreas":["Oncology"],"trialPhaseCounts":{"PHASE3":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","aiSummary":"Oleum neutralicum is a discontinued investigational product developed by Semmelweis University with unclear pharmacological classification and mechanism. The compound was evaluated in a Phase 3 clinical trial examining vitamin D3 substitution effects in patients with chronic lymphoid leukemia and other hematologic malignancies, which was terminated early with only 31 enrolled patients. No FDA approval was ever granted, no regulatory pathway was completed, and the product appears to have been abandoned prior to commercialization. The lack of published clinical data, molecular characterization, and regulatory documentation suggests this was an early-stage academic research initiative that did not advance to market. Given the discontinued status and absence of commercial development, oleum neutralicum holds no current clinical or commercial significance in the pharmaceutical landscape.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}