{"id":"oligomeric-procyanidin-complex","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":["NCT03465345"],"_pubmed":{"count":0,"papers":[]},"_rxnorm":{"forms":[]},"aliases":["OPC"],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2000","type":"neutral","milestone":"Oligomeric Procyanidin Complex development initiated","regulator":"none","description":"Medical University of South Carolina began research program on OPC for AGE-related diseases."},{"date":"2005","type":"neutral","milestone":"Phase 1 trial initiated: Metformin Plus OPC for prostate cancer prevention","regulator":"none","description":"Study designed to evaluate AGE manipulation in prostate cancer; later withdrawn with zero enrollment."},{"date":"2008","type":"neutral","milestone":"Phase 2 trial completed: OPC effect on energy levels","regulator":"none","description":"University of Pennsylvania completed Phase 2 study in 27 healthy volunteers examining energy metabolism effects."},{"date":"2010","type":"neutral","milestone":"Phase 4 trial completed: OPC for gingivitis prevention","regulator":"none","description":"University of Seville completed double-blind RCT in 20 subjects; demonstrated potential benefit in periodontal health."},{"date":"2015","type":"negative","milestone":"Program discontinued","regulator":"none","description":"Medical University of South Carolina discontinued active development of Oligomeric Procyanidin Complex; no FDA approval pathway pursued."}],"aiSummary":"Oligomeric Procyanidin Complex is a small molecule intervention studied in various conditions, including Lichen Planus, Prostate Cancer, and Preneoplastic Condition, as part of the RiteStart Supplement. It is a component of the RiteStart Personal Nutritional Dietary Study, which is an open-label trial examining the safety and efficacy of this supplement.","brandName":"Oligomeric Procyanidin Complex","companyId":"medical-university-of-south-carolina","ecosystem":[],"mechanism":{"target":"Advanced glycation end products (AGEs), free radicals, inflammatory mediators","novelty":"me-too","modality":"other","drugClass":"Botanical antioxidant, polyphenol","explanation":"Oligomeric procyanidins (OPCs) are naturally occurring flavonoid compounds found in plant sources such as grape seeds and pine bark. These molecules function primarily as antioxidants, neutralizing free radicals that contribute to cellular damage and aging. In the context of the discontinued Medical University of South Carolina program, OPC was hypothesized to interfere with the formation of advanced glycation end products (AGEs)—harmful compounds formed when glucose binds to proteins, a process implicated in diabetes complications, vascular disease, and cancer progression. The mechanism was thought to involve both direct antioxidant activity and modulation of inflammatory pathways, potentially explaining proposed benefits in energy metabolism and periodontal health. However, the limited clinical evidence and discontinuation of the program suggest that efficacy in human disease was not convincingly demonstrated.","oneSentence":"Oligomeric procyanidins are plant-derived polyphenols that exert antioxidant and anti-inflammatory effects, potentially inhibiting advanced glycation end product formation.","technicalDetail":"OPCs are polymeric flavonoids with multiple catechin and epicatechin units linked through C4-C8 or C4-C6 bonds. The compounds exhibit free radical scavenging activity through donation of hydrogen atoms to reactive oxygen species, with particular affinity for superoxide and hydroxyl radicals. OPCs may also inhibit protein glycation through chelation of metal ions (copper, iron) that catalyze AGE formation and by direct reaction with reactive carbonyl intermediates. Pharmacokinetic data in humans is limited; OPCs are poorly absorbed intact and undergo extensive gut microbiota-mediated metabolism to phenolic acids and smaller flavonoid metabolites."},"commercial":{"notes":"Product discontinued; never achieved FDA approval or commercial launch. No revenue data available.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"Medical University of South Carolina","competitors":[{"name":"Grape seed extract","slug":"grape-seed-extract","company":"Multiple suppliers","advantage":"Similar antioxidant polyphenol profile; available as dietary supplement"},{"name":"Pine bark extract (Pycnogenol)","slug":"pycnogenol","company":"Horphag Research","advantage":"Standardized OPC product with published clinical data; marketed as dietary supplement"}],"genericName":"Oligomeric Procyanidin Complex","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Prostate cancer prevention (AGE manipulation)","notes":"Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE; withdrawn with N=0 enrollment at Medical University of South Carolina","phase":"Phase 1","status":"withdrawn"},{"name":"Energy levels in healthy volunteers","notes":"Effect of OPC Factor on Energy Levels; completed with N=27 at University of Pennsylvania","phase":"Phase 2","status":"completed"},{"name":"Gingivitis prevention","notes":"Prospective Double-Blind Randomized Controlled Clinical Trial in Gingivitis Prevention With OPCs; completed with N=20 at University of Seville","phase":"Phase 4","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04907097","phase":"NA","title":"Effect of MOF on Exercise Blood Pressure","status":"COMPLETED","sponsor":"Maastricht University Medical Center","startDate":"2022-04-05","conditions":"Healthy","enrollment":40,"completionDate":"2024-05-16","primaryEndpoint":"Change in systolic blood pressure from before to peak value during the submaximal exercise test"},{"nctId":"NCT05130905","phase":"NA","title":"RiteStart Personal Nutritional Dietary Study","status":"COMPLETED","sponsor":"4Life Research, LLC","startDate":"2017-09-01","conditions":"Healthy Nutrition","enrollment":20,"completionDate":"2017-12-20","primaryEndpoint":"Salivary IgA"},{"nctId":"NCT04718311","phase":"NA","title":"Study on Treatment for Patients With Symptomatic Oral Lichen Planus","status":"COMPLETED","sponsor":"University of Catania","startDate":"2019-01-02","conditions":"Lichen Planus, Oral","enrollment":60,"completionDate":"2020-03-20","primaryEndpoint":"Clinical Mucosal healing"},{"nctId":"NCT04673916","phase":"NA","title":"Treatment Protocols for Patients With Symptomatic Oral Lichen Planus","status":"COMPLETED","sponsor":"University of Messina","startDate":"2019-06-01","conditions":"Lichen Planus, Oral, Preneoplastic Condition","enrollment":61,"completionDate":"2020-06-25","primaryEndpoint":"Clinical Mucosal healing"},{"nctId":"NCT03465345","phase":"PHASE1","title":"Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients","status":"WITHDRAWN","sponsor":"Medical University of South Carolina","startDate":"2018-07-11","conditions":"Prostate Cancer","enrollment":0,"completionDate":"2018-07-11","primaryEndpoint":"Maximum tolerated dose (MTD) of metformin in combination with OPC in PCa subjects."},{"nctId":"NCT02515929","phase":"PHASE4","title":"Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With OPCs","status":"COMPLETED","sponsor":"University of Seville","startDate":"2013-09","conditions":"Gingivitis","enrollment":20,"completionDate":"2014-02","primaryEndpoint":"Silness and Löe index"},{"nctId":"NCT00318019","phase":"PHASE2","title":"Effect of OPC Factor on Energy Levels","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2006-06","conditions":"Healthy","enrollment":27,"completionDate":"2008-04","primaryEndpoint":"Energy subscore on the Activation-Deactivation Adjective Check List"},{"nctId":"NCT00742287","phase":"NA","title":"Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers","status":"COMPLETED","sponsor":"Maastricht University Medical Center","startDate":"2009-02","conditions":"Smoking","enrollment":28,"completionDate":"2009-11","primaryEndpoint":"Vasoreactivity of conduit arteries by means of flow mediated dilation (FMD)"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"🧴","route":"other","frequency":"Data not available","formulation":"Data not available"},"_hyperScrapedAt":"2026-03-27T18:18:10.277802","formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Academic institution; no commercial development partner identified","period":"2000–discontinued","companyName":"Medical University of South Carolina","relationship":"Originator"}],"therapeuticAreas":["Oncology"],"trialPhaseCounts":{"NA":5,"PHASE1":1,"PHASE2":1,"PHASE4":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}}