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Kynamro

(mipomersen)

RNA therapy

KKastle Therapeutics, LLC

0

Indications

15

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

1

Patents

Clinical

Trials by Indication[1]

Familial Hypercholesterolemia3 trials

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

Completed·KKastle Therapeutics, LLC·Phase 3·NCT00694109·144 enrolled

A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol

Completed·KKastle Therapeutics, LLC·Phase 3·NCT01475825·309 enrolled

Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia

Completed·KKastle Therapeutics, LLC·Phase 2·NCT00477594·21 enrolled

Safety and Efficacy2 trials

Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects

Completed·KKastle Therapeutics, LLC·Phase 2·NCT00707746·34 enrolled

Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients

Completed·KKastle Therapeutics, LLC·Phase 3·NCT00770146·158 enrolled

Hypercholesterolemia1 trial

Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis

Completed·KKastle Therapeutics, LLC·Phase 3·NCT00794664·58 enrolled

Homozygous Familial Hypercholesterolemia1 trial

Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia

Completed·KKastle Therapeutics, LLC·Phase 3·NCT00607373·51 enrolled

Metabolism1 trial

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

Completed·KKastle Therapeutics, LLC·Phase 1·NCT01414881·20 enrolled

7 more indications

Liver1 trial

Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration

Completed·KKastle Therapeutics, LLC·Phase 2·NCT00362180·38 enrolled

LDL-cholesterol1 trial

Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis

Completed·LLudwig-Maximilians - University of Munich·Phase 3·NCT01598948·17 enrolled

Coronary Artery Disease1 trial

Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease

Completed·KKastle Therapeutics, LLC·Phase 3·NCT00706849·124 enrolled

Tics1 trial

A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin

Completed·KKastle Therapeutics, LLC·Phase 1·NCT01133366·18 enrolled

Cardiac Repolarization1 trial

A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects

Completed·KKastle Therapeutics, LLC·Phase 1·NCT01090661·60 enrolled

Single Dose1 trial

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers

Completed·KKastle Therapeutics, LLC·Phase 1·NCT01299298·20 enrolled

Unspecified1 trial

A Study to Evaluate 3 Different Dosing Regimens of Mipomersen Administered Via Subcutaneous Injections to Healthy Volunteers

Completed·KKastle Therapeutics, LLC·Phase 1·NCT01061814·84 enrolled

Regulatory

FDA Approval Timeline[3]

Jan 29, 2013

KYNAMRO

NDA NDA203568

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for mipomersen. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — mipomersen compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA203568). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Kynamro. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Kastle Therapeutics, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: RNA therapy[2]
Company: KKastle Therapeutics, LLC

Patent Landscape[4]

Patent Cliff

Jan 29, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7511131Jan 29, 2027

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