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Inotersen

DRUG6 trials

Sponsors

Ionis Pharmaceuticals, Inc., Brigham and Women's Hospital, Akcea Therapeutics

Conditions

AmyloidosisAmyloidosis, HereditaryFAPFamilial Amyloid PolyneuropathyHereditary Transthyretin-Mediated Amyloid PolyneuropathyHereditary Transthyretin-mediated Amyloidosis With PolyneropathyPregnancyTTR

Phase 2

Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy
CompletedNCT01737398
Ionis Pharmaceuticals, Inc.Amyloidosis, Familial Amyloid Polyneuropathy, FAP +2
Start: 2013-03-15End: 2017-11-07Updated: 2019-07-17
24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients
TerminatedNCT03702829
Brigham and Women's HospitalAmyloidosis
Start: 2019-02-28End: 2022-01-15Updated: 2026-02-20

Phase 3

Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)
CompletedNCT02175004
Ionis Pharmaceuticals, Inc.Amyloidosis, Familial Amyloid Polyneuropathy, FAP +2
Start: 2014-06-26End: 2021-01-07Updated: 2023-11-18
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
CompletedNCT04136184
Ionis Pharmaceuticals, Inc.Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Start: 2019-12-11End: 2023-07-12Updated: 2024-12-13

Unknown Phase

ATTR Expanded Access Program (EAP) by Ionis
NCT03400098
Ionis Pharmaceuticals, Inc.Amyloidosis, Hereditary
Updated: 2019-08-05
TEGSEDI Pregnancy Surveillance Program
Not yet recruitingNCT04270058
Akcea TherapeuticsHereditary Transthyretin-mediated Amyloidosis With Polyneropathy, Pregnancy
Start: 2025-12-31End: 2030-11-15Target: 20Updated: 2025-08-19

Related Papers

Eplontersen for Hereditary Transthyretin Amyloidosis With Polyneuropathy: An Exploratory Analysis of Treatment Effect in Male and Female Patients.
2026-04-06
Effect of Eplontersen in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy Across Genetic Variants: An Exploratory Analysis From the NEURO-TTRansform Trial.
2026-04-01
Eplontersen for Hereditary Transthyretin Amyloidosis With Polyneuropathy
JAMA2023-09-28169 citations
Evaluation of methodologies for indirect comparison of eplontersen and vutrisiran for the treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy (P12-4.005)
Neurology2023-04-25
The impact of inotersen on Neuropathy Impairment Score in patients with hereditary transthyretin amyloidosis with polyneuropathy.
2023-03-179 citations
Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen.
2022-12-1625 citations
Long-term efficacy and safety of inotersen for hereditary transthyretin amyloidosis: NEURO-TTR open-label extension 3-year update
Journal of Neurology2022-07-3134 citations
<scp>Long‐term</scp> treatment effects of inotersen on <scp>health‐related</scp> quality of life in patients with <scp>hATTR</scp> amyloidosis with polyneuropathy: Analysis of the <scp>open‐label</scp> extension of the <scp>NEURO‐TTR</scp> trial
Muscle & Nerve2022-07-089 citations
Factors associated with increased <scp>health‐related</scp> quality‐of‐life benefits in hereditary transthyretin amyloidosis polyneuropathy patients treated with inotersen
Muscle & Nerve2022-06-293 citations
Long-term efficacy and safety of inotersen in patients with hereditary transthyretin amyloid polyneuropathy with or without cardiomyopathy: post hoc analysis of NEURO-TTR open-label extension
European Heart Journal2021-10-01
Early Data on Long-term Impact of Inotersen on Quality-of-Life in Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy: Open-Label Extension of NEURO-TTR.
2021-08-0512 citations
Responder analysis for neuropathic impairment and quality-of-life assessment in patients with hereditary transthyretin amyloidosis with polyneuropathy in the NEURO-TTR study
Journal of Neurology2021-06-148 citations
Design and Rationale of the Global Phase 3 NEURO-TTRansform Study of Antisense Oligonucleotide AKCEA-TTR-L<sub>Rx</sub> (ION-682884-CS3) in Hereditary Transthyretin-Mediated Amyloid Polyneuropathy.
2021-02-2645 citations
Ligand Conjugated Antisense Oligonucleotide for the Treatment of Transthyretin Amyloidosis: Preclinical and Phase 1 Data
ESC Heart Failure2020-12-0785 citations
Immunogenicity Assessment of Inotersen, a 2′- <i>O</i> -(2-Methoxyethyl) Antisense Oligonucleotide in Animals and Humans: Effect on Pharmacokinetics, Pharmacodynamics, and Safety
Nucleic Acid Therapeutics2020-08-2421 citations
Neuropathy symptom and change: Inotersen treatment of hereditary transthyretin amyloidosis
Muscle & Nerve2020-07-1218 citations
<scp>mNIS</scp>+7 <scp>and lower limb function in inotersen treatment of</scp> hereditary transthyretin‐mediated amyloidosis
Muscle & Nerve2020-07-1210 citations
Early data on long‐term efficacy and safety of inotersen in patients with hereditary transthyretin amyloidosis: a 2‐year update from the open‐label extension of the NEURO‐TTR trial
European Journal of Neurology2020-04-2870 citations
Inotersen preserves or improves quality of life in hereditary transthyretin amyloidosis
Journal of Neurology2019-12-1827 citations
PS1221 LONG‐TERM EFFICACY AND SAFETY OF INOTERSEN FOR HEREDITARY TRANSTHYRETIN AMYLOIDOSIS: NEURO‐TTR OPEN‐LABEL EXTENSION 2‐YEAR UPDATE
HemaSphere2019-06-011 citations

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