{"id":"p1101","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Thrombotic events"},{"rate":null,"effect":"Bone pain"}]},"_chembl":null,"_fixedAt":"2026-03-30T18:41:31.211534","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"P1101 mimics the action of endogenous thrombopoietin, a cytokine that regulates megakaryopoiesis and platelet production. By activating TPO receptors on hematopoietic stem cells and megakaryocyte progenitors, it increases platelet counts in patients with thrombocytopenia. This mechanism is particularly useful in treating immune thrombocytopenia and chemotherapy-induced thrombocytopenia.","oneSentence":"P1101 is a recombinant human thrombopoietin (TPO) analog that stimulates platelet production by binding to the thrombopoietin receptor.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:25:22.747Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Immune thrombocytopenia (ITP)"},{"name":"Chemotherapy-induced thrombocytopenia"}]},"_fixedFields":["pubmed(7)"],"trialDetails":[{"nctId":"NCT07468916","phase":"PHASE2","title":"Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia","status":"NOT_YET_RECRUITING","sponsor":"Jonsson Comprehensive Cancer Center","startDate":"2026-03-29","conditions":"Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm","enrollment":35},{"nctId":"NCT07047885","phase":"PHASE1","title":"Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)","status":"RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2025-08-27","conditions":"Cutaneous T Cell Lymphoma","enrollment":38},{"nctId":"NCT07269470","phase":"PHASE2","title":"Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase","status":"NOT_YET_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2026-05-01","conditions":"Chronic Myeloid Leukemia","enrollment":40},{"nctId":"NCT02370329","phase":"PHASE2","title":"P1101 in Treating Patients With Myelofibrosis","status":"TERMINATED","sponsor":"Mayo Clinic","startDate":"2015-08-12","conditions":"Primary Myelofibrosis, Secondary Myelofibrosis","enrollment":11},{"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":"NCT04285086","phase":"PHASE3","title":"Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance","status":"ACTIVE_NOT_RECRUITING","sponsor":"PharmaEssentia","startDate":"2020-08-25","conditions":"Essential Thrombocythemia","enrollment":174},{"nctId":"NCT05481151","phase":"PHASE3","title":"A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV","status":"ACTIVE_NOT_RECRUITING","sponsor":"PharmaEssentia","startDate":"2022-10-26","conditions":"Polycythemia Vera","enrollment":111},{"nctId":"NCT06468033","phase":"PHASE3","title":"P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk","status":"RECRUITING","sponsor":"PharmaEssentia","startDate":"2025-07-18","conditions":"Primary Myelofibrosis, Myeloproliferative Neoplasm","enrollment":150},{"nctId":"NCT05482971","phase":"PHASE2","title":"A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET","status":"ACTIVE_NOT_RECRUITING","sponsor":"PharmaEssentia","startDate":"2022-09-29","conditions":"Essential Thrombocythemia","enrollment":91},{"nctId":"NCT05485948","phase":"PHASE2","title":"A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU","status":"ACTIVE_NOT_RECRUITING","sponsor":"PharmaEssentia","startDate":"2021-10-08","conditions":"Polycythemia Vera","enrollment":49},{"nctId":"NCT06290765","phase":"PHASE4","title":"Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera","status":"NOT_YET_RECRUITING","sponsor":"PharmaEssentia","startDate":"2026-02-01","conditions":"Polycythemia Vera, Myeloproliferative Neoplasm","enrollment":70},{"nctId":"NCT07053904","phase":"PHASE1","title":"Phase I Open-Label Study of P1101 Followed by P1801 in Advanced Solid Tumors","status":"ENROLLING_BY_INVITATION","sponsor":"PharmaEssentia","startDate":"2025-04-21","conditions":"Advanced Solid Tumors","enrollment":54},{"nctId":"NCT04638439","phase":"PHASE1","title":"The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection","status":"COMPLETED","sponsor":"PharmaEssentia","startDate":"2022-08-17","conditions":"Chronic Hepatitis B Infection, Chronic Hepatitis D Infection","enrollment":20},{"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":"NCT04655092","phase":"PHASE3","title":"Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients","status":"RECRUITING","sponsor":"PharmaEssentia Japan K.K.","startDate":"2021-01-19","conditions":"Polycythemia Vera (PV)","enrollment":67},{"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":"NCT05770466","phase":"PHASE3","title":"Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2022-04-01","conditions":"COVID-19","enrollment":134},{"nctId":"NCT05808322","phase":"PHASE2, PHASE3","title":"Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2023-05-15","conditions":"COVID-19","enrollment":60},{"nctId":"NCT05467553","phase":"PHASE2","title":"A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2023-02-24","conditions":"Hepatitis D","enrollment":30},{"nctId":"NCT05494528","phase":"NA","title":"Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2021-05-04","conditions":"Chronic Hepatitis B Virus Infection","enrollment":90},{"nctId":"NCT04774107","phase":"PHASE1","title":"The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection","status":"COMPLETED","sponsor":"PharmaEssentia","startDate":"2020-11-26","conditions":"Hepatitis C, Chronic","enrollment":17},{"nctId":"NCT04233840","phase":"PHASE1, PHASE2","title":"P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma","status":"UNKNOWN","sponsor":"National Taiwan University Hospital","startDate":"2019-02-12","conditions":"Hepatocellular Carcinoma","enrollment":72},{"nctId":"NCT04382937","phase":"PHASE3","title":"Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection","status":"COMPLETED","sponsor":"PharmaEssentia","startDate":"2016-01-12","conditions":"Chronic Hepatitis C Virus Infection","enrollment":222},{"nctId":"NCT05129644","phase":"PHASE1","title":"Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects","status":"COMPLETED","sponsor":"PharmaEssentia","startDate":"2009-11-07","conditions":"Healthy Volunteers","enrollment":48},{"nctId":"NCT01587586","phase":"PHASE2","title":"Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection","status":"COMPLETED","sponsor":"PharmaEssentia","startDate":"2011-10-18","conditions":"Hepatitis C, Chronic","enrollment":107},{"nctId":"NCT03546465","phase":"PHASE1","title":"Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects","status":"COMPLETED","sponsor":"PharmaEssentia Japan K.K.","startDate":"2018-05-07","conditions":"Healthy Volunteers","enrollment":36},{"nctId":"NCT01933906","phase":"PHASE1","title":"Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response","status":"COMPLETED","sponsor":"Arbeitsgemeinschaft medikamentoese Tumortherapie","startDate":"2013-08-30","conditions":"Chronic Phase Chronic Myeloid Leukemia","enrollment":12},{"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":"NCT01949805","phase":"PHASE3","title":"Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera","status":"COMPLETED","sponsor":"AOP Orphan Pharmaceuticals AG","startDate":"2013-09","conditions":"Polycythemia Vera","enrollment":257}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"recentPublications":[{"date":"2022 Sep","pmid":"35924546","title":"SURPASS-ET: phase III study of ropeginterferon alfa-2b versus anagrelide as second-line therapy in essential thrombocythemia.","journal":"Future oncology (London, England)"},{"date":"2021 Aug","pmid":"34386602","title":"Ropeginterferon alfa-2b in patients with genotype 1 chronic hepatitis C: Pharmacokinetics, safety, and preliminary efficacy.","journal":"JGH open : an open access journal of gastroenterology and hepatology"},{"date":"2020 Dec","pmid":"33099752","title":"Ropeginterferon alfa-2b every 2 weeks as a novel pegylated interferon for patients with chronic hepatitis B.","journal":"Hepatology international"},{"date":"2019 Nov 15","pmid":"31689263","title":"Pharmacokinetics and safety of a raltegravir-containing regimen in HIV-infected children aged 2-12 years on rifampicin for tuberculosis.","journal":"AIDS (London, England)"},{"date":"2015 Nov","pmid":"26693281","title":"Virgibacillus senegalensis sp. nov., a new moderately halophilic bacterium isolated from human gut.","journal":"New microbes and new infections"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Ropeginterferon alfa-2b","ropeginterferon alfa-2b","PEG-Proline-Interferon alpha-2b"],"phase":"phase_3","status":"active","brandName":"P1101","genericName":"P1101","companyName":"PharmaEssentia Japan K.K.","companyId":"pharmaessentia-japan-k-k","modality":"Small molecule","firstApprovalDate":"","aiSummary":"P1101 is a recombinant human thrombopoietin (TPO) analog that stimulates platelet production by binding to the thrombopoietin receptor. Used for Immune thrombocytopenia (ITP), Chemotherapy-induced thrombocytopenia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}