{"id":"danicopan","rwe":[],"tags":[],"safety":{"boxedWarnings":["SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA: VOYDEYA increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B."],"drugInteractions":[{"details":"Monitor patients more frequently for adverse reactions and consider dose reduction of the BCRP substrate drug. For rosuvastatin, the dose should not exceed 10 mg once daily.","interaction":"BCRP Substrates"},{"details":"Dose adjustment might be necessary for P-gp substrates where minimal concentration changes may lead to serious adverse reactions.","interaction":"P-gp Substrates"}],"commonSideEffects":[{"effect":"Headache","drugRate":"≥10%","severity":"Mild to Moderate"}],"contraindications":["Initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae type B."],"specialPopulations":{}},"trials":[],"_chembl":{"chemblId":"CHEMBL4250860","moleculeType":"Small molecule","molecularWeight":"580.42"},"aliases":[],"patents":[{"type":"Compound","number":"9796741","applicant":"ALEXION PHARMACEUTICALS INC","territory":"US","tradeName":"VOYDEYA","expiryDate":"2035-02-25"},{"type":"Method of Use","number":"12076319","applicant":"ALEXION PHARMACEUTICALS INC","territory":"US","tradeName":"VOYDEYA","expiryDate":"2038-08-02"}],"pricing":[],"offLabel":[],"timeline":[{"date":"Not Available","type":"Regulatory","milestone":"Approval","regulator":"FDA"}],"_dailymed":{"setId":"437a17ba-6ef6-1a7b-e063-6394a90a6565","title":"VOYDEYA (DANICOPAN) TABLET, FILM COATED [CATALENT PHARMA SOLUTIONS, LLC]"},"aiSummary":"Danicopan (VOYDEYA) is a complement factor D inhibitor developed by Alexion Pharmaceuticals for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). It is used as an add-on therapy to ravulizumab or eculizumab. The drug targets the alternative complement pathway to control C3 fragment-mediated EVH. Key safety concerns include serious infections caused by encapsulated bacteria, hepatic enzyme increases, and hyperlipidemia. Common side effects include headache. Danicopan has specific drug interactions with BCRP and P-gp substrates, requiring careful monitoring and potential dose adjustments.","ecosystem":[],"mechanism":{"target":"Complement Factor D","novelty":"Danicopan is the first complement Factor D inhibitor approved for the treatment of PNH, offering a new approach to managing EVH.","modality":"Small Molecule","drugClass":"Complement Factor D Inhibitor","explanation":"Danicopan binds to complement Factor D, inhibiting its activity and thus blocking the alternative complement pathway. This prevents the formation of C3 convertase, reducing the generation of C3 fragments and the amplification of the terminal pathway.","oneSentence":"Danicopan is a selective inhibitor of complement Factor D, preventing the cleavage of Factor B and the formation of the C3 convertase in the alternative complement pathway.","technicalDetail":"Danicopan selectively inhibits the cleavage of complement Factor B into Ba and Bb fragments, which are essential for the formation of the C3 convertase (C3bBb). By inhibiting this step, Danicopan controls C3 fragment-mediated extravascular hemolysis (EVH) in PNH."},"_scrapedAt":"2026-03-28T00:33:06.647Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not Available","launchDate":"Not Available","annualCostUS":"Not Available","currentRevenue":"Not Available","patientPopulation":"Adults with PNH","peakSalesEstimate":"Not Available"},"references":[],"biosimilars":[],"competitors":[],"indications":{"approved":["Add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH)"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05389449","phase":"PHASE3","title":"A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alexion Pharmaceuticals, 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Patients With C3G or IC-MPGN Treated With ACH-0144471","status":"TERMINATED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2018-06-20","conditions":"C3 Glomerulonephritis, C3 Glomerulopathy, Immune Complex Membranoproliferative Glomerulonephritis","enrollment":22},{"nctId":"NCT04988035","phase":"PHASE2","title":"ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2021-08-03","conditions":"COVID-19","enrollment":201},{"nctId":"NCT03181633","phase":"PHASE2","title":"A Long-Term Treatment Study of ACH-0144471 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2017-06-22","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":8},{"nctId":"NCT04551599","phase":"PHASE1","title":"A Study of the Effects of Food and Age on 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