{"id":"p1101-ribavirin","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Flu-like symptoms"},{"rate":null,"effect":"Elevated transaminases"}]},"_chembl":null,"_fixedAt":"2026-03-30T18:41:22.578682","_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"P1101 (interferon lambda-1b) activates innate immune responses through the interferon lambda receptor, promoting antiviral state in infected cells. Ribavirin is a broad-spectrum antiviral that inhibits viral RNA-dependent RNA polymerase and inosine monophosphate dehydrogenase. Together, they provide complementary antiviral mechanisms targeting hepatitis C virus replication and immune activation.","oneSentence":"P1101 is an interferon lambda that enhances antiviral immunity, combined with ribavirin, a nucleoside analog that inhibits viral RNA synthesis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:25:21.182Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis C virus infection (genotype-dependent)"}]},"_fixedFields":["pubmed(1)"],"trialDetails":[{"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":"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":"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"recentPublications":[{"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"}],"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"],"phase":"phase_3","status":"active","brandName":"P1101 + Ribavirin","genericName":"P1101 + Ribavirin","companyName":"PharmaEssentia","companyId":"pharmaessentia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"P1101, a small molecule inosine-5'-monophosphate dehydrogenase 1 inhibitor, was studied in combination with Ribavirin for the treatment of Chronic Hepatitis C Virus Infection and Hepatitis C. This combination was evaluated in a Phase 3 clinical trial (NCT04382937) for its efficacy compared to PEG-Intron + Ribavirin and PEGASYS 180 µg Q1W.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}