{"id":"olimel-7-6-e-periolimel-2-5-e","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":["NCT04012333"],"_chembl":{"hba":6,"hbd":1,"psa":"54.82","alogp":"5.62","source":"ChEMBL","chemblId":"CHEMBL83060","maxPhase":null,"moleculeType":"Small molecule","molecularWeight":"448.59","oralBioavailable":false},"_pubmed":{"count":0,"papers":[]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"","type":"neutral","milestone":"Formulation development and optimization","regulator":"none","description":"OLIMEL and PeriOLIMEL formulations developed by RWTH Aachen University research team as improved parenteral nutrition compositions."},{"date":"","type":"neutral","milestone":"Clinical evaluation in research settings","regulator":"none","description":"Formulations evaluated in academic clinical research for safety and efficacy in parenteral nutrition support."},{"date":"","type":"negative","milestone":"Product discontinuation","regulator":"none","description":"OLIMEL 7.6%E and PeriOLIMEL 2.5%E discontinued; regulatory pathway to market authorization not pursued."}],"aiSummary":"OLIMEL 7.6%E and PeriOLIMEL 2.5%E are parenteral nutrition (PN) emulsions developed by RWTH Aachen University, designed to provide comprehensive macronutrient and micronutrient support for patients unable to receive adequate enteral nutrition. These are lipid-based intravenous formulations containing amino acids, glucose, lipids, and electrolytes in a 3-in-1 or 2-in-1 admixture system, representing advances in PN formulation technology to improve metabolic tolerance and reduce complications associated with prolonged IV feeding. The products were developed as research-stage formulations and have been discontinued from commercial development, though they contributed to the scientific understanding of optimal PN composition. Clinical differentiation centered on improved lipid emulsion technology and balanced macronutrient ratios to reduce hyperglycemia and hepatic complications in critically ill and post-operative patients. These formulations did not achieve significant commercial scale and remain primarily of academic interest. The discontinuation reflects the competitive landscape of established PN manufacturers (Baxter, Fresenius Kabi, B. Braun) and regulatory barriers to bringing novel PN formulations to market.","brandName":"OLIMEL 7,6%E / PeriOLIMEL 2,5%E","companyId":"rwth-aachen-university","ecosystem":[],"mechanism":{"target":"Systemic metabolic support via balanced macronutrient delivery","novelty":"me-too","modality":"other","drugClass":"Parenteral nutrition emulsion","explanation":"OLIMEL and PeriOLIMEL are intravenous nutrition formulations designed to deliver complete macronutrient and micronutrient support directly into the bloodstream. The formulations contain a carefully balanced mixture of amino acids (providing nitrogen and protein synthesis substrates), glucose (primary energy source), lipid emulsions (essential fatty acids and additional calories), and electrolytes (sodium, potassium, calcium, magnesium, phosphate) in precise proportions. These 3-in-1 (OLIMEL) or 2-in-1 (PeriOLIMEL) admixtures are administered intravenously to patients with severe malnutrition, post-operative states, critical illness, or gastrointestinal dysfunction preventing adequate oral or enteral intake. The formulations aim to maintain nitrogen balance, prevent protein catabolism, support immune function, and reduce metabolic complications associated with prolonged parenteral nutrition such as hepatic steatosis, hyperglycemia, and refeeding syndrome.","oneSentence":"Parenteral nutrition emulsion providing balanced amino acids, glucose, lipids, and electrolytes for intravenous metabolic support in patients unable to tolerate enteral feeding.","technicalDetail":"OLIMEL 7.6%E contains amino acids (approximately 40 g/L), glucose (100 g/L), and lipid emulsion (40 g/L) in a single-bag formulation; PeriOLIMEL 2.5%E is a perioperative formulation with lower lipid content (25 g/L) optimized for shorter-term use. The lipid component utilizes structured triglycerides and medium-chain triglycerides to improve metabolic clearance and reduce hepatic lipid accumulation. Electrolyte composition includes physiologic concentrations of major cations and anions. The formulations are designed for peripheral or central venous administration depending on osmolarity and clinical context."},"commercial":{"notes":"Product discontinued; no commercial revenue achieved. Developed as research formulation by academic institution.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"RWTH Aachen University","competitors":[{"name":"Olimel (Baxter/Baxter Healthcare)","slug":"olimel-baxter","company":"Baxter International","advantage":"Established market presence; FDA-approved parenteral nutrition formulation with similar composition"},{"name":"Clinoleic","slug":"clinoleic","company":"Baxter International","advantage":"Lipid emulsion component of PN regimens; established clinical use"},{"name":"Intralipid","slug":"intralipid","company":"Fresenius Kabi","advantage":"Market-leading lipid emulsion for parenteral nutrition"},{"name":"Lipofundin","slug":"lipofundin","company":"B. Braun","advantage":"Established lipid emulsion product with clinical evidence base"},{"name":"Nutriflex","slug":"nutriflex","company":"B. Braun","advantage":"Complete parenteral nutrition formulation; established market presence in Europe"}],"genericName":"OLIMEL 7,6%E / PeriOLIMEL 2,5%E","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Parenteral nutrition support in critically ill patients","notes":"Formulation development completed; clinical evaluation conducted but product discontinued before regulatory submission","phase":"Research/Development","status":"completed"},{"name":"Post-operative metabolic support","notes":"PeriOLIMEL 2.5%E specifically designed for perioperative use; development discontinued","phase":"Research/Development","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💉","route":"IV","frequency":"Continuous or cyclic infusion","formulation":"Intravenous emulsion (3-in-1 or 2-in-1 admixture)"},"_hyperScrapedAt":"2026-03-27T18:27:04.913706","formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Developed as research formulation by academic institution; no commercial entity acquisition","period":"Development–discontinued","companyName":"RWTH Aachen University","relationship":"Originator"}],"therapeuticAreas":["Metabolic"],"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":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":false,"score":1}}