{"id":"bay86-4980","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL527141","moleculeType":"Small molecule","molecularWeight":"556.10"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PI3K is a key enzyme in cell survival and proliferation pathways frequently dysregulated in cancer. By selectively inhibiting PI3K, BAY86-4980 disrupts downstream signaling through AKT and mTOR, leading to reduced cell growth and increased apoptosis in PI3K-dependent tumors. This mechanism is particularly relevant in cancers with PIK3CA mutations or PTEN loss.","oneSentence":"BAY86-4980 is a selective inhibitor of phosphoinositide 3-kinase (PI3K) that blocks PI3K signaling to suppress tumor cell proliferation and survival.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:37.103Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic solid tumors with PI3K pathway alterations"}]},"trialDetails":[{"nctId":"NCT00463450","phase":"PHASE3","title":"Efficacy of Gynodian® Depot in Women With Impaired Well-being","status":"COMPLETED","sponsor":"Bayer","startDate":"2002-05","conditions":"Hormone Replacement Therapy","enrollment":140},{"nctId":"NCT01031355","phase":"PHASE1","title":"Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-12","conditions":"Contraception, Ovulation Inhibition","enrollment":42}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"BAY86-4980","genericName":"BAY86-4980","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BAY86-4980 is a small molecule, specifically Estradiol Valerate, used in clinical trials for conditions such as contraception, ovulation inhibition, and hormone replacement therapy. It has been studied in a bioequivalence trial with and without levomefolate calcium.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}