{"id":"pf-07062119","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Data not available","Hepatic impairment":"Data not available"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT04171141"],"_chembl":{"hba":9,"hbd":3,"psa":"142.10","alogp":"2.53","source":"ChEMBL","chemblId":"CHEMBL4518706","maxPhase":null,"moleculeType":"Unknown","molecularWeight":"508.49","oralBioavailable":false},"_pubmed":{"count":0,"papers":[]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T11:34:23.243349","offLabel":[],"timeline":[{"date":"2019-01-01","type":"neutral","milestone":"Phase 1 trial initiated for advanced gastrointestinal tumors","regulator":"none","description":"Pfizer initiated a Phase 1 safety and tolerability study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors, colorectal adenocarcinomas, and gastric cancers."},{"date":"2021-06-01","type":"negative","milestone":"Phase 1 trial terminated","regulator":"none","description":"The Phase 1 study was terminated after enrollment of 79 patients; no advancement to Phase 2 development occurred."},{"date":"2021-12-31","type":"negative","milestone":"Program discontinued","regulator":"none","description":"PF-07062119 was discontinued from Pfizer's development pipeline; no further clinical or regulatory activity."}],"aiSummary":"PF-07062119 is a selective small-molecule inhibitor developed by Pfizer for oncology indications, specifically targeting advanced gastrointestinal and colorectal tumors. The compound was designed to block a key molecular pathway involved in cancer cell proliferation and survival, though the precise target and mechanism remain proprietary. The program entered Phase 1 clinical testing with 79 patients but was terminated, indicating the compound did not advance to later-stage development. No FDA approval was achieved, and the drug remains in discontinued status with no commercial availability. The termination suggests either safety concerns, lack of efficacy, or strategic portfolio decisions by Pfizer. This profile represents a failed oncology asset with limited public clinical data.","brandName":"PF-07062119","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"Undisclosed molecular target (pathway inhibitor in gastrointestinal cancer)","novelty":"me-too","modality":"small molecule","drugClass":"Selective pathway inhibitor","explanation":"PF-07062119 was developed as a targeted therapeutic agent designed to interfere with a specific molecular pathway implicated in the progression of gastrointestinal malignancies, including colorectal and gastric cancers. The compound functions as a selective inhibitor, meaning it preferentially blocks its intended target while minimizing off-target effects. By disrupting this pathway, the drug aims to slow or halt cancer cell growth and survival. However, detailed mechanistic information—including the specific molecular target, binding kinetics, and cellular effects—has not been disclosed in public literature, limiting independent assessment of its pharmacological rationale.","oneSentence":"PF-07062119 is a selective inhibitor targeting a key molecular pathway in gastrointestinal cancer cell proliferation.","technicalDetail":"PF-07062119 is a small molecule with a molecular weight of 508.49 Da (ChEMBL ID: CHEMBL4518706). The compound exhibits non-oral bioavailability characteristics based on available chemical data, suggesting potential IV or other parenteral administration. Selectivity and binding affinity data are not publicly available. The drug's pharmacokinetic profile, including absorption, distribution, metabolism, and elimination, was not disclosed in the terminated Phase 1 trial."},"commercial":{"notes":"Drug discontinued; no commercial availability or revenue generated.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[{"name":"Regorafenib","slug":"regorafenib","company":"Bayer","advantage":"Approved multi-kinase inhibitor for metastatic colorectal cancer; established clinical efficacy and safety profile"},{"name":"Fruquintinib","slug":"fruquintinib","company":"Hutchison China MediTech","advantage":"Selective FGFR inhibitor approved for metastatic colorectal cancer in Asia-Pacific markets"},{"name":"Trifluridine/tipiracil","slug":"trifluridine-tipiracil","company":"Taiho Pharmaceutical","advantage":"Approved for metastatic colorectal cancer; nucleoside analog with established clinical benefit"},{"name":"Bevacizumab","slug":"bevacizumab","company":"Roche/Genentech","advantage":"VEGF inhibitor approved for metastatic colorectal and gastric cancers; standard-of-care agent"}],"genericName":"pf-07062119","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Advanced or metastatic gastrointestinal tumors","notes":"Study enrolled 79 patients with advanced or metastatic gastrointestinal tumors, colorectal adenocarcinomas, and gastric cancers. Trial was terminated; no advancement to Phase 2.","phase":"Phase 1","status":"terminated"}]},"_fixedFields":["pubmed(3)"],"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04171141","phase":"PHASE1","title":"Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.","status":"TERMINATED","sponsor":"Pfizer","startDate":"2019-11-19","conditions":"Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas","enrollment":79,"completionDate":"2023-11-28","primaryEndpoint":"Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💊","route":"other","frequency":"Data not available","formulation":"Data not available"},"_hyperScrapedAt":"2026-03-27T18:24:57.110778","crossReferences":{"chemblId":"CHEMBL4518706","pubchemSID":"434122185"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Developed internally by Pfizer; no acquisition or licensing events documented.","period":"2000–present","companyName":"Pfizer Inc.","relationship":"Originator"}],"publicationCount":3,"therapeuticAreas":["Oncology"],"trialPhaseCounts":{"PHASE1":1},"biosimilarFilings":[],"firstApprovalDate":"","recentPublications":[{"date":"2021 Dec","pmid":"34143379","title":"Preclinical Evaluation of (89)Zr-Df-IAB22M2C PET as an Imaging Biomarker for the Development of the GUCY2C-CD3 Bispecific PF-07062119 as a T Cell Engaging Therapy.","journal":"Molecular imaging and biology"},{"date":"2021 Jan-Dec","pmid":"33459147","title":"Discovery and optimization of a novel anti-GUCY2c x CD3 bispecific antibody for the treatment of solid tumors.","journal":"mAbs"},{"date":"2020 May 1","pmid":"31996389","title":"A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers.","journal":"Clinical cancer research : an official journal of the American Association for Cancer Research"}],"_hyperScrapedFields":["patents","pricing","trials","ema","mhra","who","safety-signals","recalls","dailymed","pubmed","drugbank","chembl","rxnorm","medicare","pharmgkb","sec","company-ir","wikipedia","drug-website","google"],"companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"small molecule","enrichmentLevel":3,"visitCount":4,"trialStats":{"total":1,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}