[{"orgOrder":0,"company":"Essa Pharma","sponsor":"Johnson & Johnson Innovative Medicine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ESSA Pharma Inks Clinical Collaboration with Janssen to Evaluate EPI-7386 Combination in Metastatic Castration-Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Presents Results from Phase 3 ACIS Study for Prostate Cancer Patients Treated with Apalutamide and Abiraterone Acetate 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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Pipeline","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Veracyte, Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data Published in JAMA Oncology Demonstrate Prognostic Utility of Veracyte\u2019s Decipher Prostate Genomic Classifier in Locally Advanced Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New ERLEADA\u00ae (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Kairos Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kairos Pharma Announces FDA Clearance of Investigational New Drug (IND) for ENV105 for the Treatment of Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"BDR Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BDR Pharmaceutical Launches Generic Drug for Treating Prostate Cancer in India","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase IV","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase IV"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ERLEADA\u00ae (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor with Once-Daily, Single-Tablet Option Now Available in the U.S.","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase IV"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Announces European Commission Approval for Expanded Use of Erleada\u00ae\u25bc (apalutamide) for Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase IV"},{"orgOrder":0,"company":"Kairos Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kairos Pharma Doses First Patient in Phase 2 Trial of Lead Drug Candidate ENV105 with Apalutamide to Improve Therapy Sensitivity for Castrate-Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phase 2 Data for ERLEADA\u00ae (apalutamide) Plus Androgen Deprivation Therapy Following Radical Prostatectomy in Patients with High-Risk Localized Prostate Cancer Show 100% Biochemical Free Recurrence Rate More than Two Years Post-Surgery","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"}]
Find Clinical Drug Pipeline Developments & Deals for Apalutamide
Erleada (apalutamide) is an androgen receptor inhibitor which is being investigated for the treatment of patients with hih-risk locally advanced prostate cancer in combination with androgen deprivation therapy.
Lead Product(s):Apalutamide,Androgen Deprivation Therapy
ENV105 (carotuximab) is a endoglin inhibitor which is being evaluated in phase 2 clinical trials in combination with apalutamide for the treatment of castrate-resistant prostate cancer.
Erleada® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
APATIDE (generic version of Apalutamide) is a potent androgen receptor (AR) antagonist that selectively binds to the ligand-binding domain and blocks AR nuclear translocation or binding to androgen response elements. Product has been launched in India to treat prostate cancer.
ENV105 has been demonstrated to complement standard of care androgen targeted therapy with non-steroidal anti-androgens such as XTANDI® (enzalutamide) and Zytiga® (abiraterone acetate) in limiting therapeutic resistance to these drugs in a previous Phase II trial.
ERLEADA® has shown a statistically significant improvement in overall survival with a consistent safety profile, while maintaining patients’ health-related quality of life in both approved indications of mCSPC and non-metastatic castration resistant prostate cancer (nmCRPC).
Lead Product(s):Apalutamide,Androgen deprivation therapy
Notably, the addition of apalutamide to ADT improved the MFS percentage among the Decipher high-risk patients to a level similar to the percentage among patients classified as Decipher low-to-average-risk.
RYBREVANT is being studied in a comprehensive clinical development program for people with untreated advanced EGFR-mutated NSCLC, including the Phase 3 MARIPOSA trial studying RYBREVANT in combination with lazertinib.
Lead Product(s):Apalutamide,Androgen deprivation therapy
ERLEADA® is an androgen receptor inhibitor indicated for treatment of patients with non-metastatic castration-resistant prostate cancer. The TITAN study previously demonstrated statistically significant improvement in overall survival in patients receiving ERLEADA® plus ADT.
Lead Product(s):Apalutamide,Androgen deprivation therapy
The ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); however, combination treatment did not show significant benefit over the active control ZYTIGA® plus prednisone in key secondary endpoints, including overall survival (OS).