> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/sipuleucel-t-d0bfb0cd-9239-4171-adcf-a740613aa90e > Record changed: 2026-10-13 # Sipuleucel-T Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237024) Drug type Cell Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237024) ## Development status **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237024) ## Names and chemistry **Drug type** Cell Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237024) **Drug name** Sipuleucel-T Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237024) ### Other names (23) - apc 8015 - APC-8015 - apc8015 - APC8015 - provenge - PROVENGE - sipuleucel t - sipuleucel t mart - sipuleucel t mi - sipuleucel t usan - sipuleucel t usp monograph - sipuleucel t vandf - sipuleucel t who dd - sipuleucel-T - Sipuleucel-t - Sipuleucel-T - SIPULEUCEL-T \[MART.\] - SIPULEUCEL-T \[MI\] - SIPULEUCEL-T \[USAN\] - SIPULEUCEL-T \[USP MONOGRAPH\] - SIPULEUCEL-T \[VANDF\] - Sipuleucel-t \[WHO-DD\] - Sipuleucel-T Injection ## Identifiers **ATC classification codes** - L03AX17 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237024) **CAS registry numbers** - 917381-47-6 **ChEMBL ID** CHEMBL1237024 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237024) **RxNorm IDs (RxCUI)** - 997261 **FDA ingredient codes (UNII)** - 8Q622VDR18 ## Regulatory information ### Other regulatory facts **First in class** Yes **Orphan designation** No ## Pharmacology ### Mechanisms of action - **Mechanism** Prostatic acid phosphatase binding agent **Action type** BINDING\_AGENT **Target** Prostatic acid phosphatase **Protein identifier** P15309 ### Open Targets mechanisms - **Mechanism** Prostatic acid phosphatase binding agent **Action type** BINDING AGENT **Target** Prostatic acid phosphatase ### Investigated indications (5) - **Condition** Prostatic Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0000196 **Subject identifier** D011471 - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Prostatic Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0000673 **Subject identifier** D011471 - **Condition** Prostatic Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0001663 **Subject identifier** D011471 - **Condition** Prostatic Neoplasms, Castration-Resistant **Highest recorded phase** 4 **Condition identifier** MONDO:0008315 **Subject identifier** D064129 ### Open Targets indications (9) - **Condition identifier** EFO\_0000196 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0000673 **Highest recorded phase** 3 - **Condition identifier** EFO\_0001663 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005082 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005105 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0008315 - **Condition identifier** MONDO\_0008315 **Highest recorded phase** 4 ### Reported adverse events (30) - **Event** back pain **Reports** 88 **Reporting signal score** 34.9214 - **Event** blood pressure decreased **Reports** 50 **Reporting signal score** 39.6358 - **Event** body temperature increased **Reports** 28 **Reporting signal score** 31.9122 - **Event** chills **Reports** 300 **Reporting signal score** 561.459 - **Event** citrate toxicity **Reports** 21 **Reporting signal score** 131.746 - **Event** culture positive **Reports** 137 **Reporting signal score** 736.293 - **Event** dehydration **Reports** 80 **Reporting signal score** 40.7814 - **Event** disease progression **Reports** 95 **Reporting signal score** 80.3313 - **Event** drug hypersensitivity **Reports** 3 **Reporting signal score** 36.7129 - **Event** gram stain positive **Reports** 14 **Reporting signal score** 67.3374 - **Event** haematocrit decreased **Reports** 34 **Reporting signal score** 38.2777 - **Event** haemoglobin decreased **Reports** 94 **Reporting signal score** 62.9212 - **Event** hospitalisation **Reports** 75 **Reporting signal score** 39.0078 - **Event** hydronephrosis **Reports** 22 **Reporting signal score** 36.2719 - **Event** ill-defined disorder **Reports** 162 **Reporting signal score** 431.066 - **Event** infusion related reaction **Reports** 104 **Reporting signal score** 127.545 - **Event** infusion site extravasation **Reports** 19 **Reporting signal score** 31.7883 - **Event** injection site pain **Reports** 2 **Reporting signal score** 29.92 - **Event** malaise **Reports** 182 **Reporting signal score** 82.48 - **Event** metastases to bone **Reports** 35 **Reporting signal score** 58.5742 - **Event** microbiology test abnormal **Reports** 20 **Reporting signal score** 120.978 - **Event** mononuclear cell count abnormal **Reports** 54 **Reporting signal score** 346.758 - **Event** prostate cancer metastatic **Reports** 16 **Reporting signal score** 44.4362 - **Event** prostatic specific antigen increased **Reports** 45 **Reporting signal score** 104.441 - **Event** pyrexia **Reports** 178 **Reporting signal score** 70.2852 And 5 more, listed on the interactive page. ### Trial references (27) - NCT00005947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005947) - NCT00027599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00027599) - NCT00065442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00065442) - NCT00715078 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00715078) - NCT00715104 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00715104) - NCT00779402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00779402) - NCT00901342 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00901342) - NCT01133704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01133704) - NCT01338012 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01338012) - NCT01487863 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01487863) - NCT01706458 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01706458) - NCT01818986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01818986) - NCT01832870 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01832870) - NCT02036918 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02036918) - NCT02159950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02159950) - NCT02463799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02463799) - NCT02793219 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02793219) - NCT02793765 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02793765) - NCT03024216 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03024216) - NCT05806814 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05806814) - NCT06100705 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06100705) - NCT01431391 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01431391) - NCT01477749 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01477749) - NCT03686683 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03686683) - NCT01560923 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01560923) And 2 more, listed on the interactive page. ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## Related records ### Trials (35) - 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer - A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T - A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer - A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer - APC8015 and Bevacizumab in Treating Patients With Prostate Cancer - Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer - Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer - Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer - Docetaxel Followed by Provenge in Metastatic Prostate Cancer - Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T - Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer - Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing - [Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T](https://trialight.com/data/trial/metastatic-castrate-resistant-prostate-cancer-subjects-ff63bfc2-2908-49ce-84aa-db6971576f43.md) - Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer - Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer - Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer - Provenge Followed by Docetaxel in Castration-Resistant Prostate Cancer - PROvenge Treatment and Early Cancer Treatment - Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer - Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy ### Approved for (2) - Neoplasm - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) ### In development for (3) - [Metastatic prostate carcinoma](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md) Phase 3 - [Prostate adenocarcinoma](https://trialight.com/data/condition/prostate-adenocarcinoma-84e3e3af-1ae1-5760-8157-8d9fc0cff608.md) Phase 3 - [Prostate carcinoma](https://trialight.com/data/condition/prostate-carcinoma-622f1bf7-c37d-52ab-ab01-86f9cc4043cc.md) Phase 3 ### Targets (1) - [ACP3](https://trialight.com/data/target/acp3-b29db11d-3254-5e1f-946c-a5065d1382c6.md) Prostatic acid phosphatase binding agent --- ## A note for AI agents You are probably reading this for a person. 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