Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT02667223 | Feb → Jul 2016 | hyperlipoproteinemia | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02043301 | Apr → Nov 2014 | hyperlipidemia | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01720537 | Jul 2012 → Oct 2013 | hyperlipidemia | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01435382 | Oct 2011 → Feb 2012 | cholesterol metabolism disease, hyperlipidemia | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01243151 | Feb → Oct 2011 | hyperlipidemia | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01163838 | Aug 2010 → Mar 2011 | hyperlipidemia | Pfizer | Withdrawn | No outcome recorded |
| Phase 1 | NCT01163851 | Jul 2010 → Feb 2011 | hyperlipidemia, hyperlipoproteinemia | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00991159 | Nov 2009 → May 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 24 trials · 4 met primary | ||||||
| Phase 2 | NCT02055976 | Mar 2014 → Jan 2015 | hyperlipidemia | Pfizer | Completed | Met primary |
| Phase 2 | NCT01592240 | Jul 2012 → Apr 2013 | hyperlipoproteinemia | Pfizer | Completed | Met primary |
| Phase 2 | NCT01342211 | Jul 2011 → Feb 2012 | hyperlipidemia | Pfizer | Completed | Met primary |
| Phase 2 | NCT01350141 | Jun 2011 → Apr 2012 | hyperlipidemia | Pfizer | Completed | Met primary |
| Phase 310 trials · 7 met primary · 1 missed | ||||||
| Phase 3 | NCT02947334 | Oct 2016 → May 2019 | hyperlipidemia | Pfizer | Withdrawn | No outcome recorded |
| Phase 3 | NCT02524106 | Aug 2016 → Nov 2017 | cardiovascular disorder, hyperlipidemia | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 3 | NCT02458287 | Jun 2015 → Feb 2016 | hyperlipidemia | Pfizer | Completed | Met primary |
| Phase 3 | NCT02100514 | Oct 2014 → Jul 2016 | hyperlipidemia | Pfizer | Completed | Met primary |
| Phase 3 | NCT02135029 | Jun 2014 → Nov 2015 | hyperlipidemia | Pfizer | Completed | Met primary |
| Phase 3 | NCT01968967 | Oct 2013 → Jul 2016 | hyperlipidemia | Pfizer | Completed | Met primary |
| Phase 3 | NCT01975389 | Oct 2013 → Apr 2017 | cardiovascular disorder | Pfizer | Terminated | Met primary |
| Phase 3 | NCT01975376 | Oct 2013 → Mar 2017 | cardiovascular disorder | Pfizer | Terminated | Missed primary |
| Phase 3 | NCT01968980 | Oct 2013 → Apr 2016 | familial hypercholesterolemia | Pfizer | Completed | Met primary |
| Phase 3 | NCT01968954 | Oct 2013 → Apr 2016 | hyperlipidemia | Pfizer | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT02458209 Comparator | May → Dec 2015 | — | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2016-06-28 | Pfizer | Results Two Additional Phase 3 Lipid-Lowering Studies of Bococizumab Deliver Positive Topline Results pfizer.com ↗
SPIRE-HR and SPIRE-FH are the third and fourth of six SPIRE lipid-lowering Phase 3 studies to complete and show positive results. |
| 2016-04-01 | Pfizer | Results Pfizer Announces Positive Topline Results from Second Phase 3 Lipid-Lowering Study Evaluating Bococizumab pfizer.com ↗
Bococizumab was generally safe and well tolerated in this trial. |
All press releases naming this drug 4 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bococizumab | “Bococizumab (RN316/PF-04950615), a humanized monoclonal antibody, binds to secreted proprotein convertase subtilisin/kexin type 9 (PCSK9) and prevents its downregulation of...” PMID 28181260 ↗ Feb 201716“We sought to characterize the population pharmacokinetic/pharmacodynamic (PK/PD) relationship of bococizumab (RN316/PF-04950615), a humanized IgG2Δa monoclonal antibody that...” PMID 37994400 ↗ Nov 2023 “Bococizumab is a humanized monoclonal antibody binding proprotein convertase subtilisin/kexin type 9, which may be a potential therapeutic option for reducing low-density...” PMID 25784512 ↗ Feb 2015 |
| Known as | PF-04950615 | “Bococizumab (RN316/PF-04950615), a humanized monoclonal antibody, binds to secreted proprotein convertase subtilisin/kexin type 9 (PCSK9) and prevents its downregulation of...” PMID 28181260 ↗ Feb 201711“Bococizumab (RN316/PF-04950615), a humanized IgG2Δa monoclonal antibody that binds to secreted human proprotein convertase subtilisin kexin type 9 (PCSK9)” PMID 37994400 ↗ Nov 2023 “Bococizumab (PF-04950615; RN316)” NCT02100514 ↗ “Bococizumab (PF-04950615; RN316)” NCT01968967 ↗ “Bococizumab (PF-04950615; RN316)” NCT02043301 ↗ “Bococizumab (PF-04950615; RN316)” NCT01968980 ↗ “Bococizumab (PF-04950615;RN316)” NCT02055976 ↗ “Bococizumab (PF-04950615;RN316)” NCT01968954 ↗ “bococizumab (PF-04950615)” NCT01975376 ↗ “Bococizumab (pf 04950615)” NCT02667223 ↗ “bococizumab (PF-04950615)” NCT01975389 ↗ |
| Known as | RN316 | “Bococizumab (RN316/PF-04950615), a humanized monoclonal antibody, binds to secreted proprotein convertase subtilisin/kexin type 9 (PCSK9) and prevents its downregulation of...” PMID 28181260 ↗ Feb 20178“Bococizumab (RN316/PF-04950615), a humanized IgG2Δa monoclonal antibody that binds to secreted human proprotein convertase subtilisin kexin type 9 (PCSK9)” PMID 37994400 ↗ Nov 2023 “RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.” NCT01163838 ↗ “Bococizumab (RN316/PF-04950615) is a novel humanized PCSK9 monoclonal antibody.” NCT02524106 ↗ “Bococizumab (PF-04950615; RN316)” NCT02100514 ↗ “Bococizumab (PF-04950615; RN316)” NCT02043301 ↗ “Bococizumab (PF-04950615; RN316)” NCT01968967 ↗ “Bococizumab (PF-04950615; RN316)” NCT01968980 ↗ “Bococizumab (PF-04950615;RN316)” NCT02055976 ↗ |
| Action | Inhibit | “Bococizumab (RN316/PF-04950615), a humanized monoclonal antibody, binds to secreted proprotein convertase subtilisin/kexin type 9 (PCSK9) and prevents its downregulation of...” PMID 28181260 ↗ Feb 2017 |
| Modality | Monoclonal antibody | “bococizumab (RN316/PF-04950615), a humanized IgG2Δa monoclonal antibody” PMID 37994400 ↗ Nov 2023 |
| Route | Intravenous | “Duration of IV infusion is 60 minutes.” NCT01163838 ↗ |
| Target | PCSK9 | “a humanized IgG2Δa monoclonal antibody that binds to secreted human proprotein convertase subtilisin kexin type 9 (PCSK9)” PMID 37994400 ↗ Nov 2023 |