{"id":"dihydralazine","rwe":[{"pmid":"40632154","year":"2026","title":"The change in the pharmacological significance of dihydralazine (Germany) and hydralazine (USA).","finding":"","journal":"Naunyn-Schmiedeberg's archives of pharmacology","studyType":"Clinical Study"},{"pmid":"39920071","year":"2025","title":"Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled study.","finding":"","journal":"BMJ open","studyType":"Clinical Study"},{"pmid":"38488570","year":"2024","title":"Anti-hypertensive therapy for preeclampsia: a network meta-analysis and systematic review.","finding":"","journal":"Hypertension in pregnancy","studyType":"Clinical Study"},{"pmid":"36699058","year":"2022","title":"Pharmaceutical administration for severe hypertension during pregnancy: Network meta-analysis.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"},{"pmid":"35206939","year":"2022","title":"Antihypertensive Medications for Severe Hypertension in Pregnancy: A Systematic Review and Meta-Analysis.","finding":"","journal":"Healthcare (Basel, Switzerland)","studyType":"Clinical Study"}],"tags":[{"label":"dihydralazine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"C02DB01","category":"atc"},{"label":"Active","category":"status"},{"label":"Antihypertensive Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Vasodilator Agents","category":"pharmacology"}],"phase":"phase_3","safety":{"safetySignals":[{"llr":210.213,"date":"","count":41,"signal":"Patent ductus arteriosus","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=210)"},{"llr":111.128,"date":"","count":13,"signal":"Shone complex","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=111)"},{"llr":102.016,"date":"","count":24,"signal":"Ventricular septal defect","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=102)"},{"llr":95.017,"date":"","count":31,"signal":"Product prescribing error","source":"DrugCentral FAERS","actionTaken":"Reported 31 times (LLR=95)"},{"llr":90.304,"date":"","count":37,"signal":"Foetal exposure during pregnancy","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=90)"},{"llr":87.9,"date":"","count":23,"signal":"Atrial septal defect","source":"DrugCentral FAERS","actionTaken":"Reported 23 times (LLR=88)"},{"llr":78.049,"date":"","count":9,"signal":"Supravalvular aortic stenosis","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=78)"},{"llr":69.279,"date":"","count":10,"signal":"Aorta hypoplasia","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=69)"},{"llr":59.712,"date":"","count":13,"signal":"Language disorder","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=60)"},{"llr":59.694,"date":"","count":23,"signal":"Premature baby","source":"DrugCentral FAERS","actionTaken":"Reported 23 times (LLR=60)"},{"llr":57.535,"date":"","count":9,"signal":"Pulmonary valve stenosis congenital","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=58)"}],"commonSideEffects":[{"effect":"Patent ductus arteriosus","drugRate":"LLR 210","severity":"common"},{"effect":"Shone complex","drugRate":"LLR 111","severity":"common"},{"effect":"Ventricular septal defect","drugRate":"LLR 102","severity":"common"},{"effect":"Product prescribing error","drugRate":"LLR 95","severity":"common"},{"effect":"Foetal exposure during pregnancy","drugRate":"LLR 90","severity":"common"},{"effect":"Atrial septal defect","drugRate":"LLR 88","severity":"common"},{"effect":"Supravalvular aortic stenosis","drugRate":"LLR 78","severity":"common"},{"effect":"Aorta hypoplasia","drugRate":"LLR 69","severity":"common"},{"effect":"Language disorder","drugRate":"LLR 60","severity":"common"},{"effect":"Premature baby","drugRate":"LLR 60","severity":"common"},{"effect":"Pulmonary valve stenosis congenital","drugRate":"LLR 58","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"nepresol","offLabel":[],"synonyms":["dihydralazine","dihydralazin","dihydrazinophthalazine","hypopresol","nepresol","nepresolin","nepressol","ophthazin","tonolysin","dihydralazine sulfate","dihydrallazine"],"timeline":[],"approvals":[],"brandName":"Nepresol","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"dihydralazine","explanation":"Imagine your blood vessels are like roads in your body. When they're narrow, it's harder for blood to flow through them. Nepresol helps to widen these roads, making it easier for blood to flow and reducing the pressure inside your blood vessels.","oneSentence":"Nepresol works by relaxing blood vessels and reducing blood pressure.","technicalDetail":"Nepresol is a vasodilator that acts on the alpha-adrenergic receptors to cause relaxation of vascular smooth muscle, leading to decreased peripheral resistance and reduced blood pressure."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/884","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DIHYDRALAZINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIHYDRALAZINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:36:35.477429","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:40:21.373902+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"hydralazine","drugSlug":"hydralazine","fdaApproval":"1953-01-15","genericCount":44,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"dihydralazine","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"hydralazine","brandName":"hydralazine","genericName":"hydralazine","approvalYear":"1953","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05230901","phase":"PHASE3","title":"Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden","status":"RECRUITING","sponsor":"University Medical Center Goettingen","startDate":"2022-02-23","conditions":["Aortic Stenosis, Severe"],"enrollment":300,"completionDate":"2026-03"},{"nctId":"NCT00311974","phase":"PHASE4","title":"The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals","status":"COMPLETED","sponsor":"Regional Hospital Holstebro","startDate":"2006-04","conditions":["Healthy"],"enrollment":16,"completionDate":"2007-11"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NUI":"N0000167108","NDDF":"004347","UNII":"PCU411F5L6","CHEBI":"CHEBI:134841","INN_ID":"245","RXNORM":"235959","UMLSCUI":"C0012271","ChEMBL_ID":"CHEMBL35505","KEGG_DRUG":"D07170","DRUGBANK_ID":"DB12945","PUBCHEM_CID":"10230","SNOMEDCT_US":"703113001","SECONDARY_CAS_RN":"7327-87-9","MESH_DESCRIPTOR_UI":"D004078"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":453,"therapeuticAreas":["Hematology"],"atcClassification":{"source":"DrugCentral","atcCode":"C02DB01","allCodes":["C02DB01","C02LG01","C02LG51"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Jan","pmid":"40632154","title":"The change in the pharmacological significance of dihydralazine (Germany) and hydralazine (USA).","journal":"Naunyn-Schmiedeberg's archives of pharmacology"},{"date":"2025 Feb 7","pmid":"39920071","title":"Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled study.","journal":"BMJ open"},{"date":"2024 Dec","pmid":"38488570","title":"Anti-hypertensive therapy for preeclampsia: a network meta-analysis and systematic review.","journal":"Hypertension in pregnancy"},{"date":"2022","pmid":"36699058","title":"Pharmaceutical administration for severe hypertension during pregnancy: Network meta-analysis.","journal":"Frontiers in pharmacology"},{"date":"2022 Feb 9","pmid":"35206939","title":"Antihypertensive Medications for Severe Hypertension in Pregnancy: A Systematic Review and Meta-Analysis.","journal":"Healthcare (Basel, Switzerland)"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nepresol, also known as dihydralazine, is a small molecule drug in the dihydralazine class. Its exact target and mechanism of action are unknown, but it is used to treat certain cardiovascular conditions. The commercial status of Nepresol is unclear, and it may be patented or available as a generic medication. Key safety considerations for Nepresol are not well-documented. Further research is needed to fully understand its pharmacology and clinical use.","enrichmentLevel":5,"visitCount":0,"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:40:21.373902+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}