{"id":"pegylated-proline-interferon-alpha-2b","safety":{"commonSideEffects":[{"rate":null,"effect":"Flu-like symptoms (fever, fatigue, myalgia)"},{"rate":null,"effect":"Hematologic toxicity (thrombocytopenia, neutropenia)"},{"rate":null,"effect":"Psychiatric effects (depression, anxiety)"},{"rate":null,"effect":"Thyroid dysfunction"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"This drug combines interferon alpha-2b, a cytokine that stimulates antiviral and anti-tumor immune responses, with pegylation and proline modification to improve pharmacokinetics and reduce dosing frequency. The pegylation extends circulating half-life, while the proline modification may enhance stability and reduce immunogenicity. It binds to interferon-alpha receptors on immune cells and hepatocytes to induce antiviral and immunomodulatory effects.","oneSentence":"Pegylated-Proline-interferon alpha-2b is a modified interferon alpha-2b with extended half-life that activates innate immune responses through interferon-alpha receptor signaling.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:48:04.025Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C"},{"name":"Chronic hepatitis B"}]},"trialDetails":[{"nctId":"NCT04182100","phase":"PHASE2","title":"Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply","status":"COMPLETED","sponsor":"PharmaEssentia Japan K.K.","startDate":"2019-12-20","conditions":"Polycythemia Vera (PV)","enrollment":29},{"nctId":"NCT06002490","phase":"PHASE3","title":"A Study to Evaluate P1101 in Japanese PV Patients","status":"COMPLETED","sponsor":"PharmaEssentia Japan K.K.","startDate":"2023-10-17","conditions":"Polycythemia Vera (PV)","enrollment":21},{"nctId":"NCT03003325","phase":"PHASE2","title":"The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV","status":"COMPLETED","sponsor":"FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS","startDate":"2017-02-02","conditions":"Polycythemia Vera","enrollment":127},{"nctId":"NCT03117816","phase":"PHASE3","title":"ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission","status":"COMPLETED","sponsor":"Philipps University Marburg","startDate":"2017-05-04","conditions":"Chronic Myeloid Leukemia in Remission","enrollment":214},{"nctId":"NCT02218047","phase":"PHASE3","title":"AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.","status":"COMPLETED","sponsor":"AOP Orphan Pharmaceuticals AG","startDate":"2014-11","conditions":"Polycythemia Vera","enrollment":170},{"nctId":"NCT01193699","phase":"PHASE1, PHASE2","title":"Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera","status":"COMPLETED","sponsor":"AOP Orphan Pharmaceuticals AG","startDate":"2010-08","conditions":"Polycythemia Vera","enrollment":24},{"nctId":"NCT02523638","phase":"PHASE3","title":"Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients","status":"COMPLETED","sponsor":"AOP Orphan Pharmaceuticals AG","startDate":"2015-07","conditions":"Polycythemia Vera","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3920,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["AOP2014"],"phase":"phase_3","status":"active","brandName":"Pegylated-Proline-interferon alpha-2b","genericName":"Pegylated-Proline-interferon alpha-2b","companyName":"AOP Orphan Pharmaceuticals AG","companyId":"aop-orphan-pharmaceuticals-ag","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Pegylated-Proline-interferon alpha-2b is a modified interferon alpha-2b with extended half-life that activates innate immune responses through interferon-alpha receptor signaling. Used for Chronic hepatitis C, Chronic hepatitis B.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}