{"id":"apd421-amisulpride-for-iv-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Restlessness / Akathisia"},{"rate":null,"effect":"Extrapyramidal symptoms"}]},"_chembl":{"chemblId":"CHEMBL243712","moleculeType":"Small molecule","molecularWeight":"369.49"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Amisulpride selectively antagonizes dopamine D2 and D3 receptors in the chemoreceptor trigger zone and gastrointestinal tract, which are key pathways involved in nausea and vomiting. By blocking these receptors, it prevents the emetic signal from reaching the vomiting center in the brain. The IV formulation allows for rapid onset of action in the perioperative setting.","oneSentence":"APD421 is an intravenous formulation of amisulpride, a dopamine D2/D3 receptor antagonist that blocks dopamine signaling to prevent postoperative nausea and vomiting.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:42:49.544Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of postoperative nausea and vomiting (PONV)"}]},"trialDetails":[{"nctId":"NCT01991821","phase":"PHASE3","title":"European Phase III Study of APD421 in PONV","status":"COMPLETED","sponsor":"Acacia Pharma Ltd","startDate":"2013-07","conditions":"PONV","enrollment":368},{"nctId":"NCT02337062","phase":"PHASE3","title":"Phase IIIb Study of APD421 in Combination as PONV Prophylaxis","status":"COMPLETED","sponsor":"Acacia Pharma Ltd","startDate":"2015-02","conditions":"PONV","enrollment":1147},{"nctId":"NCT01991860","phase":"PHASE3","title":"US Phase III Study of APD421 in PONV","status":"COMPLETED","sponsor":"Acacia Pharma Ltd","startDate":"2013-08","conditions":"PONV","enrollment":364},{"nctId":"NCT02646566","phase":"PHASE3","title":"Study of APD421 as PONV Treatment (Prior Prophylaxis)","status":"COMPLETED","sponsor":"Acacia Pharma Ltd","startDate":"2016-03","conditions":"Postoperative Nausea and Vomiting","enrollment":705},{"nctId":"NCT02449291","phase":"PHASE3","title":"Study of APD421 as PONV Treatment (no Prior Prophylaxis)","status":"COMPLETED","sponsor":"Acacia Pharma Ltd","startDate":"2015-09","conditions":"Postoperative Nausea and Vomiting","enrollment":568}],"_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":["Amisulpride for IV injection"],"phase":"phase_3","status":"active","brandName":"APD421- Amisulpride for IV injection","genericName":"APD421- Amisulpride for IV injection","companyName":"Acacia Pharma Ltd","companyId":"acacia-pharma-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"APD421, also known as Amisulpride for IV injection, is a serotonin (5-HT) receptor antagonist used as a treatment for established post-operative nausea and vomiting. It is a small molecule that belongs to the antagonist class of drugs.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}