{"id":"azd5363","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"HYPOKALAEMIA","source":"FDA FAERS","actionTaken":"Reported 3 times"},{"date":"","signal":"SINUS BRADYCARDIA","source":"FDA FAERS","actionTaken":"Reported 3 times"},{"date":"","signal":"SINUS ARRHYTHMIA","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"ACUTE HEPATIC FAILURE","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"ANAEMIA","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"FACIAL NERVE DISORDER","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"HAEMATEMESIS","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"HYPERCALCAEMIA","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"Reported 1 times"}],"drugInteractions":[{"drug":"CYP3A4 inhibitors","action":"Avoid","effect":"Increased AZD5363 plasma concentrations"},{"drug":"CYP3A4 inducers","action":"Avoid","effect":"Decreased AZD5363 plasma concentrations"},{"drug":"Strong CYP3A4 inhibitors","action":"Avoid","effect":"Increased AZD5363 plasma concentrations"},{"drug":"Strong CYP3A4 inducers","action":"Avoid","effect":"Decreased AZD5363 plasma concentrations"},{"drug":"CYP2C9 inhibitors","action":"Monitor","effect":"Increased AZD5363 plasma concentrations"},{"drug":"CYP2C9 inducers","action":"Monitor","effect":"Decreased AZD5363 plasma concentrations"},{"drug":"CYP2C19 inhibitors","action":"Monitor","effect":"Increased AZD5363 plasma concentrations"},{"drug":"CYP2C19 inducers","action":"Monitor","effect":"Decreased AZD5363 plasma concentrations"},{"drug":"CYP2D6 inhibitors","action":"Monitor","effect":"Increased AZD5363 plasma concentrations"},{"drug":"CYP2D6 inducers","action":"Monitor","effect":"Decreased AZD5363 plasma concentrations"},{"drug":"P-gp inhibitors","action":"Monitor","effect":"Increased AZD5363 plasma concentrations"},{"drug":"P-gp inducers","action":"Monitor","effect":"Decreased AZD5363 plasma concentrations"}],"contraindications":["Hypersensitivity to the active substance or to any of the excipients","Pregnancy","Breast-feeding","Severe renal impairment (CrCl < 30 mL/min)","Severe hepatic impairment (total bilirubin > 3 times ULN and any AST > ULN)"]},"trials":[],"_chembl":null,"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=azd5363","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:56:06.978716+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Azd5363","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:56:15.196889+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:56:13.817767+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:56:06.998459+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=azd5363","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:56:14.571448+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Serine/threonine-protein kinase AKT inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:56:15.196616+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2325741/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:56:15.099514+00:00"}},"offLabel":[],"timeline":[{"date":"2023-11-01","type":"positive","_source":"Wikipedia","milestone":"Capivasertib approved in the United States","regulator":"FDA"},{"date":"2024-06-01","type":"positive","_source":"Wikipedia","milestone":"Capivasertib approved in the European Union","regulator":"EMA"}],"_dailymed":null,"aiSummary":"AZD5363, developed by Pfizer Inc., is an anti-cancer medication used for the treatment of triple-negative breast cancer and urothelial carcinoma. It is taken by mouth. The drug has shown clinical differentiation in its ability to target specific molecular pathways. AZD5363 has significant commercial importance due to its potential to address unmet medical needs. The drug's mechanism of action involves targeting the AKT pathway. Further pipeline developments are needed to fully realize its potential. AZD5363 has shown promise in clinical trials, with 38 trials conducted and 148 publications.","brandName":"Azd5363","ecosystem":[],"isGeneric":true,"mechanism":{"target":"AKT","novelty":"best-in-class","modality":"small molecule","drugClass":"phosphatidylinositol 3-kinase (PI3K) inhibitor","explanation":"","oneSentence":"","technicalDetail":"AZD5363 is a small molecule inhibitor of AKT, specifically targeting the AKT1 and AKT2 isoforms. This inhibition leads to a decrease in phosphorylation of downstream targets, including mTOR and GSK3β. The resulting decrease in cell survival and proliferation signals leads to apoptosis in cancer cells."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:28:44.646Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"title":"Capivasertib","extract":"Capivasertib, sold under the brand name Truqap, is an anti-cancer medication used for the treatment of breast cancer. It is taken by mouth.","wiki_history":"== History ==\nEfficacy was evaluated in CAPItello-291 (NCT04305496), a randomized, double-blind, placebo-controlled, multicenter trial in 708 participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer, of which 289 participants had tumors with PIK3CA/AKT1/PTEN-alterations.","wiki_medical_uses":"== Medical uses ==\nCapivasertib, used in combination with fulvestrant (Faslodex), is indicated for adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within twelve months of completing adjuvant therapy.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nCapivasertib was approved for medical use in the United States in November 2023. The applicant for this medicinal product is AstraZeneca AB. Capivasertib was approved for medical use in the European Union in June 2024."},"commercial":{"annualCostUS":"Generic pricing varies by manufacturer","genericStatus":"Generic — off-patent","patientPopulation":"Generic — multiple manufacturers","peakSalesEstimate":"Not publicly reported"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=azd5363","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=azd5363","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://en.wikipedia.org/wiki/azd5363","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":6,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":7,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:56:16.952176+00:00","fieldsConflicting":1,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"LY2835219","company":"Eli Lilly and Company","advantage":"LY2835219 is a potent inhibitor of AKT, similar to AZD5363, but with a different chemical structure and potentially different side effects.","genericName":"Linsitinib"},{"name":"GSK2141795","company":"GlaxoSmithKline","advantage":"GSK2141795 is another AKT inhibitor that has shown promise in preclinical studies, but its development status is unclear.","genericName":"GSK2141795"},{"name":"MK-2206","company":"Merck & Co.","advantage":"MK-2206 is an AKT inhibitor that has been studied in clinical trials for various cancers, and has shown some promise in combination with other therapies.","genericName":"MK-2206"}],"genericName":"azd5363","indications":{"approved":[{"name":"Triple-negative breast cancer","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab and in patients who are not eligible for pembrolizumab plus nivolumab","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab and in patients who are not eligible for pembrolizumab plus nivolumab and in patients who are not eligible for pembrolizumab plus avelumab","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab and in patients who are not eligible for pembrolizumab plus nivolumab and in patients who are not eligible for pembrolizumab plus avelumab and in patients who are not eligible for pembrolizumab plus durvalumab","regulator":"FDA"},{"name":"Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab and in patients who are not eligible for pembrolizumab plus nivolumab and in patients who are not eligible for pembrolizumab plus avelumab and in patients who are not eligible for pembrolizumab plus durvalumab and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan plus cetrelimab","regulator":"FDA"},{"name":"Triple-negative breast cancer with disease progression on or after chemotherapy in the neoadjuvant or adjuvant setting and/or in patients with measurable disease by RECIST v1.1","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06635447","phase":"PHASE3","title":"Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2024-09-26","conditions":"Breast Cancer","enrollment":258},{"nctId":"NCT02465060","phase":"PHASE2","title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening 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Singapore","startDate":"2018-12-03","conditions":"Solid Tumor, Adult","enrollment":40},{"nctId":"NCT01226316","phase":"PHASE1","title":"Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2010-12-01","conditions":"Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics","enrollment":285},{"nctId":"NCT02664935","phase":"PHASE2","title":"National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Birmingham","startDate":"2015-05","conditions":"Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell, Adenocarcinoma","enrollment":423},{"nctId":"NCT02423603","phase":"PHASE2","title":"PAKT: AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer","status":"COMPLETED","sponsor":"Queen Mary University of 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