Inotersen

Generic Name
Inotersen
Brand Names
Tegsedi
Drug Type
Biotech
Chemical Formula
-
CAS Number
1492984-65-2
Unique Ingredient Identifier
0IEO0F56LV
Background

Inotersen is a transthyretin-directed antisense oligonucleotide for the treatment of the polyneuropathy caused by hereditary transthyretin-mediated amyloidosis in adults. It was FDA approved in October 2018. Inotersen has been shown to improve the course of neurologic disease and quality of life in patients with hereditary transthyretin amyloidosis .
...

Indication

Inotersen is a transthyretin-directed antisense oligonucleotide indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Associated Conditions
Hereditary Transthyretin Amyloidosis, Polyneuropathies caused by Hereditary transthyretin-mediated amyloidosis
Associated Therapies
-

TEGSEDI Pregnancy Surveillance Program

First Posted Date
2020-02-17
Last Posted Date
2024-04-12
Lead Sponsor
Akcea Therapeutics
Target Recruit Count
20
Registration Number
NCT04270058
Locations
🇺🇸

TEGSEDI Pregnancy Coordinating Center, Morgantown, West Virginia, United States

NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

First Posted Date
2019-10-23
Last Posted Date
2024-12-13
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
168
Registration Number
NCT04136184
Locations
🇺🇸

Mayo Clinic - Arizona, Scottsdale, Arizona, United States

🇺🇸

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

🇺🇸

Indiana University School of Medicine - Indianapolis, Indianapolis, Indiana, United States

and more 42 locations

24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients

Phase 2
Conditions
Interventions
First Posted Date
2018-10-11
Last Posted Date
2020-12-07
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
50
Registration Number
NCT03702829
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

ATTR Expanded Access Program (EAP) by Ionis

First Posted Date
2018-01-17
Last Posted Date
2019-08-05
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Registration Number
NCT03400098

Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)

First Posted Date
2014-06-26
Last Posted Date
2023-11-18
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
135
Registration Number
NCT02175004
Locations
🇺🇸

Indiana University School of Medicine, Indianapolis, Indiana, United States

🇺🇸

Johns Hopkins University Bayview Medical Center, Baltimore, Maryland, United States

🇧🇷

AACD, Sao Paulo, Brazil

and more 19 locations

Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy

First Posted Date
2012-11-29
Last Posted Date
2019-07-17
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
173
Registration Number
NCT01737398
Locations
🇵🇹

CHP-HGSA, Unidade Clinica de Paramiloidose, Porto, Portugal

🇩🇪

UKM; Universitätsklinikum Münster, Klinik für Transplantationsmedizin, Munster, Germany

🇪🇸

Hospital Universitari Vall D' Hebron, Barcelona, Spain

and more 21 locations
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