{"id":"etavopivat-a","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperuricemia"},{"rate":null,"effect":"Gout"},{"rate":null,"effect":"Elevated uric acid levels"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Etavopivat is an Nrf2 activator that enhances the transcription of genes involved in fetal hemoglobin synthesis. By increasing HbF levels, the drug reduces polymerization of sickle hemoglobin and decreases red blood cell sickling, hemolysis, and vaso-occlusive crises. This mechanism addresses the underlying pathophysiology of sickle cell disease by promoting a compensatory increase in the non-sickling form of hemoglobin.","oneSentence":"Etavopivat activates the Nrf2 (nuclear factor erythroid 2-related factor 2) pathway to increase fetal hemoglobin (HbF) production and reduce hemolysis in patients with sickle cell disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:46:29.038Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Sickle cell disease"}]},"trialDetails":[{"nctId":"NCT06198712","phase":"PHASE2","title":"A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease","status":"RECRUITING","sponsor":"Forma Therapeutics, Inc.","startDate":"2023-01-12","conditions":"Sickle Cell Disease","enrollment":50},{"nctId":"NCT06612268","phase":"PHASE3","title":"A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease","status":"RECRUITING","sponsor":"Novo Nordisk A/S","startDate":"2025-02-17","conditions":"Sickle Cell Disease","enrollment":408},{"nctId":"NCT06609226","phase":"PHASE3","title":"A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia","status":"RECRUITING","sponsor":"Novo Nordisk A/S","startDate":"2025-01-10","conditions":"Sickle Cell Disease, Thalassemia","enrollment":480},{"nctId":"NCT07023029","phase":"PHASE1","title":"A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2025-06-09","conditions":"Healthy Volunteers, Sickle Cell Disease, Thalassemia","enrollment":33},{"nctId":"NCT06581627","phase":"PHASE1","title":"A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2024-08-26","conditions":"Healthy Volunteers, Sickle Cell Disease, 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Myelodysplastic Syndromes (MDS)","status":"TERMINATED","sponsor":"Forma Therapeutics, Inc.","startDate":"2022-11-15","conditions":"Very Low Risk, Low Risk, or Intermediate Risk MDS Per IPSS-R","enrollment":17},{"nctId":"NCT06336018","phase":"PHASE1","title":"A Research Study on Etavopivat in Participants With and Without Liver Disease","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2024-05-20","conditions":"Liver Diseases","enrollment":48},{"nctId":"NCT06433661","phase":"PHASE1","title":"A Research Study of the Effect of Food on Etavopivat in Healthy Participants","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2024-05-28","conditions":"Healthy Volunteers Sickle Cell Disease, Thalassemia","enrollment":16},{"nctId":"NCT06813924","phase":"PHASE1","title":"A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2025-02-06","conditions":"Healthy Volunteers Sickle Cell Disease, Thalassemia","enrollment":37},{"nctId":"NCT05953584","phase":"PHASE2","title":"A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary Stroke","status":"RECRUITING","sponsor":"Forma Therapeutics, Inc.","startDate":"2023-06-20","conditions":"Sickle Cell Disease","enrollment":27},{"nctId":"NCT03815695","phase":"PHASE1","title":"A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients","status":"COMPLETED","sponsor":"Forma Therapeutics, Inc.","startDate":"2018-12-11","conditions":"Healthy Volunteers, Sickle Cell Disease","enrollment":130}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Etavopivat A","genericName":"Etavopivat A","companyName":"Novo Nordisk A/S","companyId":"novo-nordisk","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Etavopivat activates the Nrf2 (nuclear factor erythroid 2-related factor 2) pathway to increase fetal hemoglobin (HbF) production and reduce hemolysis in patients with sickle cell disease. Used for Sickle cell disease.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}