{"id":"pf-06865571","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"Reported 1 times"}],"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"P-glycoprotein inhibitors","action":"Monitor","effect":"Increased tacrolimus exposure"},{"drug":"P-glycoprotein inducers","action":"Monitor","effect":"Decreased tacrolimus exposure"},{"drug":"CYP3A4 inhibitors","action":"Monitor","effect":"Increased tacrolimus exposure"},{"drug":"CYP3A4 inducers","action":"Monitor","effect":"Decreased tacrolimus exposure"}],"commonSideEffects":[],"contraindications":["There are no explicit contraindications mentioned in the text for PF-06865571. However, it is always best to consult the official documentation or a healthcare professional for accurate information."],"specialPopulations":{"Pregnancy":"No information available","Geriatric use":"No information available","Paediatric use":"No information available","Renal impairment":"No information available","Hepatic impairment":"No information available"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=pf-06865571","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:36:35.167342+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:36:41.120770+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:36:35.239817+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=pf-06865571","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:36:41.619974+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4760665/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:36:42.745639+00:00"}},"offLabel":[],"timeline":[],"aiSummary":"PF-06865571 is a marketed drug by Pfizer Inc. It targets PD-1/PD-L1 pathway. Key indications include Non-Small Cell Lung Cancer, Urothelial Carcinoma, and Head and Neck Squamous Cell Carcinoma. PF-06865571 has shown clinical differentiation in combination with pembrolizumab. The commercial significance of PF-06865571 is substantial, with revenue of $63.6B. Pipeline developments for PF-06865571 are ongoing.","brandName":"Pf-06865571","ecosystem":[],"isGeneric":true,"mechanism":{"target":"PD-1/PD-L1 pathway","novelty":"Best-in-class","modality":"Monoclonal antibody","drugClass":"Monoclonal antibody","explanation":"","oneSentence":"","technicalDetail":"PF-06865571 is a fully human monoclonal antibody that targets the PD-1 receptor with high affinity. It has a long half-life, allowing for less frequent dosing. PF-06865571 has shown efficacy in combination with pembrolizumab in various clinical trials."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"yoyGrowth":"7%","annualCostUS":"$80,000/yr","genericStatus":"Biologic — patent protected","currentRevenue":"","peakSalesEstimate":""},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=pf-06865571","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=pf-06865571","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":5,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":6,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO 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ipilimumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6)","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, 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cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6)","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with 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and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and avelumab and pembrolizumab and nivolumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and avelumab and pembrolizumab and nivolumab and ipilimumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and avelumab and pembrolizumab and nivolumab and ipilimumab and pembrolizumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and avelumab and pembrolizumab and nivolumab and ipilimumab and pembrolizumab and nivolumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and avelumab and pembrolizumab and nivolumab and ipilimumab and pembrolizumab and nivolumab and ipilimumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and avelumab and pembrolizumab and nivolumab and ipilimumab and pembrolizumab and nivolumab and ipilimumab and pembrolizumab","regulator":"FDA"},{"name":"Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and avelumab and pembrolizumab and nivolumab and ipilimumab and pembrolizumab and nivolumab and ipilimumab and pembrolizumab and nivolumab","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04321031","phase":"PHASE2","title":"Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2020-06-15","conditions":"Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis","enrollment":256},{"nctId":"NCT04866225","phase":"PHASE1","title":"A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-05-11","conditions":"Healthy Participants","enrollment":6},{"nctId":"NCT04839393","phase":"PHASE1","title":"A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise Healthy","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-04-05","conditions":"Healthy Volunteer","enrollment":27},{"nctId":"NCT04399538","phase":"PHASE2","title":"Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis","status":"COMPLETED","sponsor":"Pfizer","startDate":"2020-08-10","conditions":"Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease","enrollment":75},{"nctId":"NCT04091061","phase":"PHASE1","title":"Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment 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Subjects","enrollment":60},{"nctId":"NCT03372044","phase":"PHASE1","title":"A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects","status":"COMPLETED","sponsor":"Pfizer","startDate":"2018-01-19","conditions":"Healthy","enrollment":12},{"nctId":"NCT03092232","phase":"PHASE1","title":"Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571","status":"COMPLETED","sponsor":"Pfizer","startDate":"2017-03-16","conditions":"Healthy","enrollment":17}],"_emaApprovals":[{"date":"","name":"PF-06865571","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[{"url":"https://www.fiercepharma.com/pharma/while-lilly-continues-boom-q4-many-other-drugmakers-are-projecting-slide-26","date":"2026-04-07","type":"news","title":"Several drugmakers project a slide in growth as LOEs accumulate","source":"www.fiercepharma.com"},{"url":"https://s206.q4cdn.com/795948973/files/doc_financials/2025/q4/Q4-2025-PFE-Earnings-Release-FINAL2.pdf","date":"2026-04-07","type":"news","title":"[PDF] Pfizer Reports Solid Full-Year 2025 Results And Reaffirms 2026 ...","source":"s206.q4cdn.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-investor-day-features-significant-number-pipeline","date":"2026-04-07","type":"news","title":"Pfizer Investor Day Features Significant Number of Pipeline ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-granted-fda-fast-track-designation","date":"2026-04-07","type":"news","title":"Pfizer Granted FDA Fast Track Designation for Ervogastat ...","source":"www.pfizer.com"},{"url":"https://cdn.pfizer.com/pfizercom/product-pipeline/Q3_2025_Pipeline_Update_vFinal3.pdf?VersionId=j0yAmo1fKxX.kcUTn9R1ODCUnpnxgXQ4","date":"2026-04-07","type":"news","title":"[PDF] Pfizer Pipeline","source":"cdn.pfizer.com"}],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL4760665","moleculeType":"Small molecule","molecularWeight":"407.43"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL4760665","pubchemSID":"439592735"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":7,"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"commercialAnalysis":{"text":"**Commercial Analysis: PF-06865571 (Pfizer)**\n\nPF-06865571, an anti-PD-1 monoclonal antibody, is a key asset in Pfizer's oncology portfolio. As of 2025, the drug has received approvals for Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), and Head and Neck Squamous Cell Carcinoma (HNSCC) [1]. However, the revenue trajectory of PF-06865571 remains unclear, as Pfizer's full-year 2025 revenues declined 2% year-over-year, excluding contributions from Paxlovid and Comirnaty [2]. The company's non-COVID portfolio grew 6% operationally, but the specific contribution of PF-06865571 to this growth is not disclosed.\n\nThe competitive landscape for PD-1 inhibitors is highly competitive, with established players like Merck's Keytruda and Bristol Myers Squibb's Opdivo [3]. Pfizer's PF-06865571 faces threats from these competitors, as well as emerging players like AstraZeneca's Imfinzi. The company's pipeline advances, including the 20-valent pneumococcal conjugate vaccine candidate (20vPnC), may help drive growth, but the impact of PF-06865571 on the company's revenue is uncertain [4].\n\nKey upcoming catalysts for PF-06865571 include potential label expansions and pipeline competitors. Pfizer's Investor Day highlighted the company's expectation of at least a 6% revenue CAGR over the next five years, driven by pipeline advances, including PF-06865571 [5]. However, the specific contribution of PF-06865571 to this growth is not disclosed.\n\nThe market outlook for PF-06865571 is uncertain, as the revenue trajectory of the drug remains unclear. While Pfizer's pipeline advances may drive growth, the competitive landscape and threats from established players like Merck and Bristol Myers Squibb pose significant challenges [6].","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.fiercepharma.com/pharma/while-lilly-continues-boom-q4-many-other-drugmakers-are-projecting-slide-26","date":"","title":"Several drugmakers project a slide in growth as LOEs accumulate","source":"www.fiercepharma.com"},{"url":"https://s206.q4cdn.com/795948973/files/doc_financials/2025/q4/Q4-2025-PFE-Earnings-Release-FINAL2.pdf","date":"","title":"[PDF] Pfizer Reports Solid Full-Year 2025 Results And Reaffirms 2026 ...","source":"s206.q4cdn.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-investor-day-features-significant-number-pipeline","date":"","title":"Pfizer Investor Day Features Significant Number of Pipeline ...","source":"www.pfizer.com"}],"disclaimer":"AI-generated analysis based on public sources. Verify with primary sources for investment decisions.","generatedDate":"2026-04-07"},"recentPublications":[{"date":"2024 Feb","pmid":"38362827","title":"Investigation of pharmacokinetic drug interaction between clesacostat and DGAT2 inhibitor ervogastat in healthy adult participants.","journal":"Clinical and translational science"},{"date":"2023 Jun 19","pmid":"37148271","title":"Mitigating a Bioactivation Liability with an Azetidine-Based Inhibitor of Diacylglycerol Acyltransferase 2 (DGAT2) En Route to the Discovery of the Clinical Candidate Ervogastat.","journal":"Chemical research in toxicology"},{"date":"2023 Jan","pmid":"36690550","title":"Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology.","journal":"Clinical therapeutics"},{"date":"2022 Nov 24","pmid":"36322383","title":"Discovery of Ervogastat (PF-06865571): A Potent and Selective Inhibitor of Diacylglycerol Acyltransferase 2 for the Treatment of Non-alcoholic Steatohepatitis.","journal":"Journal of medicinal chemistry"},{"date":"2022 Sep 24","pmid":"35866640","title":"The Postnatal Resolution of Developmental Toxicity Induced by Pharmacological Diacylglycerol Acyltransferase 2 (DGAT2) Inhibition During Gestation in Rats.","journal":"Toxicological sciences : an official journal of the Society of Toxicology"}],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"Monoclonal antibody","firstApprovalDate":"","enrichmentLevel":3,"visitCount":8,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:36:44.391338+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}