Drugs / mipomersen
mipomersen
also known as
mipomersen sodium · ISIS 301012 · Kynamro · Kynamro (ISIS 301012) · Mipomersen sodium salt
Antisense oligonucleotide targets APOB
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Kynamro | — | 2013-05-29 | europa.eu ↗ |
| Approved | US (FDA) | KYNAMRO | — | 2013-01-29 | fda.gov ↗ |
Trials 19 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01414881 | Sep 2011 → Jun 2012 | — | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01299298 | Jan → Apr 2011 | — | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01133366 | May 2010 | — | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01090661 | Mar → May 2010 | — | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01061814 | Jan → Mar 2010 | — | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT00707746 | Oct 2008 → Aug 2010 | hyperlipidemia, inherited lipid metabolism disorder | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00477594 | May 2007 → Mar 2011 | familial hypercholesterolemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00362180 | Jul 2006 → Mar 2010 | hyperlipidemia, hypobetalipoproteinemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00281008 | Feb 2006 → Jul 2007 | familial hypercholesterolemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00280995 | Jan 2006 → Apr 2007 | familial hypercholesterolemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00231569 | Sep 2005 → Jun 2007 | hyperlipidemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00216463 | Aug 2005 → Mar 2007 | hyperlipidemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT01598948 | Aug 2012 → May 2015 | atherosclerosis, hyperlipoproteinemia | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
| Phase 3 | NCT01475825 | Dec 2011 → Dec 2015 | familial hypercholesterolemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00794664 | Jan 2009 → May 2010 | coronary artery disorder, hyperlipidemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00770146 | Nov 2008 → May 2010 | coronary artery disorder, hyperlipidemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00706849 | Jul 2008 → Dec 2009 | coronary artery disorder, familial hypercholesterolemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00694109 | Apr 2008 → Sep 2014 | familial hypercholesterolemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00607373 | Jul 2007 → Mar 2009 | familial hypercholesterolemia | Kastle Therapeutics, LLC | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mipomersen | “Mipomersen is an apolipoprotein (apo) B synthesis inhibitor that has demonstrated significant reductions in apo B and low-density lipoprotein (LDL) cholesterol in Phase 1...” PMID 20378080 ↗ Apr 201016“The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia” NCT00281008 ↗ |
| Known as | ISIS 301012 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00216463 ↗ |
| Known as | Kynamro | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219536 ↗ |
| Known as | Kynamro (ISIS 301012) | “Kynamro (ISIS 301012)” NCT01475825 ↗ |
| Known as | mipomersen sodium | “mipomersen sodium 200 mg” NCT01475825 ↗4“Drug: mipomersen sodium” NCT00477594 ↗ “Drug: mipomersen sodium” NCT00706849 ↗ “Drug: Mipomersen sodium” NCT00770146 ↗ “Drug: mipomersen sodium” NCT01090661 ↗ |
| Known as | Mipomersen sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219536 ↗ |
| Action | Inhibit | “Mipomersen is an apolipoprotein (apo) B synthesis inhibitor that has demonstrated significant reductions in apo B and low-density lipoprotein (LDL) cholesterol in Phase 1...” PMID 20378080 ↗ Apr 2010 |
| Modality | Antisense oligonucleotide | “Efficacy and safety of mipomersen, an antisense inhibitor of apolipoprotein B,” PMID 20378080 ↗ Apr 2010 |
| Route | Subcutaneous | “30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29” NCT00231569 ↗ |
| Target | APOB | “Mipomersen, an antisense oligonucleotide directed against apolipoprotein B-100 (apoB)” PMID 20707601 ↗ Oct 2010 |