{"id":"cs-8958","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CS-8958 (peramivir) inhibits viral neuraminidase, an enzyme required for the release of newly formed influenza virus particles from host cells. By blocking this enzyme, the drug prevents viral spread and reduces the duration and severity of influenza infection. It is active against both influenza A and B viruses.","oneSentence":"CS-8958 is a neuraminidase inhibitor that prevents influenza virus release from infected cells by blocking sialic acid cleavage.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:03.189Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute uncomplicated influenza A and B infection in adults and children"}]},"trialDetails":[{"nctId":"NCT02014649","phase":"PHASE1, PHASE2","title":"Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza","status":"TERMINATED","sponsor":"Biota Scientific Management Pty Ltd","startDate":"2013-11","conditions":"Influenza","enrollment":15},{"nctId":"NCT00803595","phase":"PHASE3","title":"A Multinational Phase III Study of CS-8958 (MARVEL)","status":"COMPLETED","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2008-11","conditions":"Influenza, Human","enrollment":1002},{"nctId":"NCT00657111","phase":"PHASE1","title":"CS-8958 Single Inhaled Dose in Elderly","status":"COMPLETED","sponsor":"Biota Scientific Management Pty Ltd","startDate":"2008-04","conditions":"Influenza","enrollment":38},{"nctId":"NCT01793883","phase":"PHASE2","title":"Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza","status":"COMPLETED","sponsor":"Biota Scientific Management Pty Ltd","startDate":"2013-05","conditions":"Influenza","enrollment":639},{"nctId":"NCT00995826","phase":"PHASE1","title":"Safety, Tolerability and Pharmacokinetic Study of Multiple Doses of CS-8958","status":"COMPLETED","sponsor":"Biota Scientific Management Pty Ltd","startDate":"2009-04","conditions":"Influenza","enrollment":16},{"nctId":"NCT02022761","phase":"PHASE1","title":"Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate TwinCaps® DPI in Adults With Chronic Asthma","status":"COMPLETED","sponsor":"Biota Scientific Management Pty Ltd","startDate":"2013-10","conditions":"Asthma","enrollment":32},{"nctId":"NCT00311714","phase":"PHASE1","title":"Safety, Tolerability and Pharmacokinetic Study of Biota-CS-8958","status":"COMPLETED","sponsor":"Biota Scientific Management Pty Ltd","startDate":"2007-04","conditions":"Influenza","enrollment":40}],"_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":["Laninamivir"],"phase":"phase_3","status":"active","brandName":"CS-8958","genericName":"CS-8958","companyName":"Daiichi Sankyo Co., Ltd.","companyId":"daiichi-sankyo-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CS-8958 is a neuraminidase inhibitor that prevents influenza virus release from infected cells by blocking sialic acid cleavage. Used for Acute uncomplicated influenza A and B infection in adults and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}