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Drug

Mipomersen

In clinical development
Emerging researchLate-stage development

Also known as Kynamro.

RxNorm1367839UNII9GJ8S4GU0M
1
Research papers
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Apolipoprotein B(ApoB) Reduction by ISIS 301012 on Liver Triglyceride Content in Subjects With Varying Degrees of Hyperlipidemia

Clinical trial2016-10-21Results posted · ClinicalTrials.gov

A Prospective Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis

Clinical trial2016-09-09Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of ISIS 301012 Administration in High Risk Statin Intolerant Subjects

Clinical trial2016-09-09Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen as Add-on Therapy in Homozygous Familial Hypercholesterolemia Subjects

Clinical trial2016-09-09Results posted · ClinicalTrials.gov

Effect of Mipomersen on LDL-Cholesterol Levels in Patients With Severe LDL-Hypercholesterolemia and Atherosclerosis Treated by Regular LDL-Apheresis

Clinical trial2015-06-01Completed · ClinicalTrials.gov

Randomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy.

Research2012-11-13PloS one

A Phase 1 Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects

Clinical trial2012-11-01Completed · ClinicalTrials.gov

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen Administered Subcutaneously to Japanese Healthy Subjects

Clinical trial2011-04-01Completed · ClinicalTrials.gov

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Relative Bioavailability, Pharmacokinetics, Safety, and Tolerability of Daily, Thrice Weekly, and Weekly Dosing Regimens of Mipomersen Administered Subcutaneously to Healthy Volunteers

Clinical trial2010-06-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mipomersen
Aliases & brands
Kynamro
RxNorm CUI
1367839
UNII
9GJ8S4GU0M

Clinical trials

8 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
8
registered trials across all phases
LATEST COMPLETION 2015
3
Late-stage (III+)
8
Completed
PHASE DISTRIBUTIONn = 8
Phase 13Phase 22Phase 33

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Effect of Mipomersen on LDL-Cholesterol Levels in Patients With Severe LDL-Hypercholesterolemia and Atherosclerosis Treated by Regular LDL-Apheresis

CompletedPH IIILudwig-Maximilians - University of Munichn=172015

A Prospective Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis

CompletedPH IIIKastle Therapeutics, LLCn=582010

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen as Add-on Therapy in Homozygous Familial Hypercholesterolemia Subjects

CompletedPH IIIKastle Therapeutics, LLCn=512009

Recent completions

Trials that read out recently, adding to the completed evidence base.

Effect of Mipomersen on LDL-Cholesterol Levels in Patients With Severe LDL-Hypercholesterolemia and Atherosclerosis Treated by Regular LDL-Apheresis

CompletedPH IIILudwig-Maximilians - University of Munichn=172015

A Phase 1 Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects

CompletedPH IKastle Therapeutics, LLCn=202012

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen Administered Subcutaneously to Japanese Healthy Subjects

CompletedPH IKastle Therapeutics, LLCn=202011

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of ISIS 301012 Administration in High Risk Statin Intolerant Subjects

CompletedPH IIKastle Therapeutics, LLCn=342011

A Prospective Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis

CompletedPH IIIKastle Therapeutics, LLCn=582010

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Apolipoprotein B(ApoB) Reduction by ISIS 301012 on Liver Triglyceride Content in Subjects With Varying Degrees of Hyperlipidemia

CompletedPH IIKastle Therapeutics, LLCn=382010

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • PloS one1
Leading researchers
  • Burgess LJ1
  • Ceska R1
  • Chasan-Taber S1
  • Gouni-Berthold I1
  • McGowan MP1
  • Soran H1
  • Tardif JC1
  • Wagener G1
Leading institutions
free-text, unnormalised
  • Cardiometabolic Risk Reduction and Research Center of New England1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials