{"id":"apalutamide-oral-tablet","safety":{"commonSideEffects":[{"rate":"25-35","effect":"Fatigue"},{"rate":"20-30","effect":"Hot flashes"},{"rate":"25-30","effect":"Rash"},{"rate":"15-20","effect":"Diarrhea"},{"rate":"10-15","effect":"Nausea"},{"rate":"10-15","effect":"Falls"},{"rate":"0.5-1","effect":"Seizures"}]},"_chembl":{"chemblId":"CHEMBL2108778","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Apalutamide binds to the ligand-binding domain of the androgen receptor with high affinity and specificity, preventing androgen (testosterone and DHT) from activating the receptor. This blocks downstream signaling that drives prostate cancer cell proliferation and survival. It also inhibits nuclear translocation of the androgen receptor, providing dual mechanisms of androgen receptor antagonism.","oneSentence":"Apalutamide is an androgen receptor inhibitor that blocks the binding and nuclear translocation of androgens, preventing androgen-driven prostate cancer cell growth.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:02:01.513Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic castration-resistant prostate cancer (mCRPC)"},{"name":"Non-metastatic castration-resistant prostate cancer (nmCRPC)"}]},"trialDetails":[{"nctId":"NCT04325828","phase":"PHASE2","title":"A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2020-04-07","conditions":"Salivary Gland Neoplasms","enrollment":31},{"nctId":"NCT01946204","phase":"PHASE3","title":"A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Aragon Pharmaceuticals, Inc.","startDate":"2013-10-14","conditions":"Prostatic Neoplasms","enrollment":1207},{"nctId":"NCT02489318","phase":"PHASE3","title":"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Aragon Pharmaceuticals, Inc.","startDate":"2015-11-27","conditions":"Prostate Cancer","enrollment":1052},{"nctId":"NCT03767244","phase":"PHASE3","title":"A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2019-06-11","conditions":"Prostatic Neoplasms","enrollment":2517},{"nctId":"NCT02257736","phase":"PHASE3","title":"An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Aragon Pharmaceuticals, Inc.","startDate":"2014-11-26","conditions":"Prostatic Neoplasms","enrollment":982},{"nctId":"NCT04108208","phase":"PHASE4","title":"A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2019-12-17","conditions":"Prostatic Neoplasms","enrollment":75},{"nctId":"NCT04662580","phase":"PHASE1","title":"ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2021-05-03","conditions":"Metastatic Prostate Cancer","enrollment":183},{"nctId":"NCT06894511","phase":"PHASE2","title":"An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-09-11","conditions":"Metastatic Castration Resistant Prostate Cancer (mCRPC)","enrollment":7},{"nctId":"NCT07333066","phase":"PHASE3","title":"Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.","status":"NOT_YET_RECRUITING","sponsor":"Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD","startDate":"2026-03-31","conditions":"Metastatic Hormone-sensitive Prostate Cancer","enrollment":320},{"nctId":"NCT03009981","phase":"PHASE3","title":"A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer","status":"COMPLETED","sponsor":"Alliance Foundation Trials, LLC.","startDate":"2017-03-06","conditions":"Prostate Cancer","enrollment":504},{"nctId":"NCT06320067","phase":"PHASE3","title":"A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer","status":"RECRUITING","sponsor":"University College, London","startDate":"2024-06-11","conditions":"Prostate Cancer Metastatic","enrollment":3360},{"nctId":"NCT05649943","phase":"NA","title":"Multimodal Approach in Patients With mHSPC. 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It is administered as an intervention in clinical trials, often in comparison to a placebo or in combination with other treatments like intermittent hormone therapy (IHT).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}