Volanesorsen
- Generic Name
- Volanesorsen
- Brand Names
- Waylivra
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 915430-78-3
- Unique Ingredient Identifier
- 2O4BE0K238
- Background
Volanesorsen is an antisense oligonucleotide that binds to apoC-III mRNA to prevent its translation. It is indicated to treat familial chylomicronemia, a genetic condition that prevents breakdown of triglycerides and chylomicrons. This drug is not commonly prescribed as it is used as an adjunct to diet in patients at high risk for pancreatitis, who have had inadequate response to triglyceride lowering therapy.
Volanesorsen was granted a conditional approval by the European Medicines Agency.
- Indication
Volanesorsen is conditionally approved by the EMA as an adjunct to diet in adults with familial chylomicronemia, at high risk for pancreatitis, and who have had an inadequate response to diet and triglyceride lowering therapy.
- Associated Conditions
- Familial Chylomicronemia Syndrome (FCS)
- Associated Therapies
- -
Volanesorsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)
- Conditions
- First Posted Date
- 2018-06-01
- Last Posted Date
- 2021-09-16
- Lead Sponsor
- Akcea Therapeutics
- Registration Number
- NCT03544060
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers
- Conditions
- Interventions
- First Posted Date
- 2016-09-22
- Last Posted Date
- 2022-01-28
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Target Recruit Count
- 52
- Registration Number
- NCT02910635
- Locations
- 🇺🇸
Covance, Dallas, Texas, United States
The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome
- Conditions
- Interventions
- First Posted Date
- 2016-01-18
- Last Posted Date
- 2021-08-26
- Lead Sponsor
- Akcea Therapeutics
- Target Recruit Count
- 68
- Registration Number
- NCT02658175
- Locations
- 🇬🇧
IONIS Investigative Site, Manchester, United Kingdom
The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy
- Conditions
- Interventions
- First Posted Date
- 2015-08-19
- Last Posted Date
- 2021-10-18
- Lead Sponsor
- Akcea Therapeutics
- Target Recruit Count
- 40
- Registration Number
- NCT02527343
- Locations
- 🇷🇺
IONIS Investigative Site, Moscow, Russian Federation
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
- First Posted Date
- 2014-11-24
- Last Posted Date
- 2022-04-13
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Target Recruit Count
- 114
- Registration Number
- NCT02300233
- Locations
- 🇬🇧
IONIS Investigative Site, Peterborough, United Kingdom
The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome
- Conditions
- Interventions
- First Posted Date
- 2014-08-07
- Last Posted Date
- 2022-04-13
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Target Recruit Count
- 67
- Registration Number
- NCT02211209
- Locations
- 🇬🇧
IONIS Investigative Site, Peterborough, United Kingdom
Drug Development Updates
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