Drugs / Bococizumab
last change Nov 2023 re-read 2 minutes ago

Bococizumab

also known as PF-04950615 · RN316

Monoclonal antibody targets PCSK9 via inhibition

Developed for
hyperlipidemia · cardiovascular disorder · hyperlipoproteinemia · familial hypercholesterolemia
Investigated by
Pfizer · Halozyme Therapeutics · San Francisco General Hospital · University of California, San Francisco

Trials 22 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT02667223 Feb → Jul 2016 hyperlipoproteinemia Pfizer Terminated No outcome recorded
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Phase 1 NCT01163838 Aug 2010 → Mar 2011 hyperlipidemia Pfizer Withdrawn No outcome recorded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
Phase 2 NCT02055976 Mar 2014 → Jan 2015 hyperlipidemia Pfizer Completed No outcome recorded
Phase 2 NCT01592240 Jul 2012 → Apr 2013 hyperlipoproteinemia Pfizer Completed No outcome recorded
Phase 2 NCT01342211 Jul 2011 → Feb 2012 hyperlipidemia Pfizer Completed No outcome recorded
Phase 2 NCT01350141 Jun 2011 → Apr 2012 hyperlipidemia Pfizer Completed No outcome recorded
Phase 310 trials
Phase 3 NCT02947334 Oct 2016 → May 2019 hyperlipidemia Pfizer Withdrawn No outcome recorded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 No outcome recorded
Phase 3 NCT02100514 Oct 2014 → Jul 2016 hyperlipidemia Pfizer Completed No outcome recorded
Phase 3 NCT02135029 Jun 2014 → Nov 2015 hyperlipidemia Pfizer Completed No outcome recorded
Phase 3 NCT01975376 Oct 2013 → Mar 2017 cardiovascular disorder Pfizer Terminated No outcome recorded
Phase 3 NCT01975389 Oct 2013 → Apr 2017 cardiovascular disorder Pfizer Terminated No outcome recorded
Phase 3 NCT01968967 Oct 2013 → Jul 2016 hyperlipidemia Pfizer Completed No outcome recorded
Phase 3 NCT01968980 Oct 2013 → Apr 2016 familial hypercholesterolemia Pfizer Completed No outcome recorded
Phase 3 NCT01968954 Oct 2013 → Apr 2016 hyperlipidemia Pfizer Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT02458209 Comparator May → Dec 2015 Pfizer Completed No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2016-11-01 Pfizer Pfizer Discontinues Global Development of Bococizumab, Its Investigational PCSK9 Inhibitor pfizer.com
2016-06-28 Pfizer Two Additional Phase 3 Lipid-Lowering Studies of Bococizumab Deliver Positive Topline Results pfizer.com
2016-04-26 Pfizer Bococizumab SPIRE-2 Cardiovascular Outcome Study Fully Enrolled pfizer.com
2016-04-01 Pfizer Pfizer Announces Positive Topline Results from Second Phase 3 Lipid-Lowering Study Evaluating Bococizumab pfizer.com

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 19 sources stand behind the page.

FieldValueCited 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 2017
16

“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

NCT02135029

NCT02458209

NCT01968954

NCT02667223

NCT01968967

NCT02043301

NCT02947334

NCT01975389

NCT01975376

NCT01968980

NCT02055976

NCT02100514

NCT02524106

NCT02458287

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 2017
11

“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)” NCT02043301

“Bococizumab (PF-04950615; RN316)” NCT01968967

“Bococizumab (PF-04950615; RN316)” NCT01968980

“Bococizumab (PF-04950615;RN316)” NCT01968954

“Bococizumab (PF-04950615;RN316)” NCT02055976

“Bococizumab (pf 04950615)” NCT02667223

“bococizumab (PF-04950615)” NCT01975376

“bococizumab (PF-04950615)” NCT01975389

NCT01720537

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 2017
8

“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)” NCT02043301

“Bococizumab (PF-04950615; RN316)” NCT02100514

“Bococizumab (PF-04950615; RN316)” NCT01968980

“Bococizumab (PF-04950615; RN316)” NCT01968967

“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 antibodyPMID 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