3 completed, 2 terminated, 1 approved for marketing, 1 not yet recruiting. 3 Phase 3, 2 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Completed 3 |
| Phase 2 | 2 | Completed 1, Terminated 1 |
| Phase 4 | 1 | Terminated 1 |
Follow Inotersen: new trials by email Literature Review of Inotersen trials Research Report on Inotersen
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| TEGSEDI Pregnancy Surveillance Program inotersen - Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy, Pregnancy | Not yet recruiting | Akcea Therapeutics | 20 | 2025-12-01 | 2025-08-19 | |
| A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PN TEGSEDI - Hereditary Transthyretin Amyloidosis With Polyneuropthy | Phase 4 | Terminated | Akcea Therapeutics | 8 | 2021-01-21 | 2025-04-10 |
| 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 Inotersen, Eplontersen - Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | Phase 3 | Completed | Ionis Pharmaceuticals, Inc. | 168 | 2019-12-11 | 2024-12-13 |
| 24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients Inotersen - Amyloidosis | Phase 2 | Terminated | Brigham and Women's Hospital | 31 | 2019-02-28 | 2026-02-20 |
| Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP) Inotersen - FAP, Familial Amyloid Polyneuropathy | Phase 3 | Completed | Ionis Pharmaceuticals, Inc. | 135 | 2014-06-26 | 2023-11-18 |
| Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy Inotersen, Placebo - FAP, Familial Amyloid Polyneuropathy | Phase 2 / Phase 3 | Completed | Ionis Pharmaceuticals, Inc. | 173 | 2013-03-15 | 2019-07-17 |
| ATTR Expanded Access Program (EAP) by Ionis Inotersen - Amyloidosis, Hereditary | Approved for marketing | Ionis Pharmaceuticals, Inc. | 2019-08-05 |
Amyloidosis (5) · Amyloid Neuropathies, Familial (2) · Amyloidosis, Hereditary, Transthyretin-Related (2) · Amyloidosis, Familial (1) · Polyneuropathies (1) · Rare Diseases (1)
Ionis Pharmaceuticals, Inc. (4) · Akcea Therapeutics (2) · Brigham and Women's Hospital (1)
United States (5) · Argentina (3) · Brazil (3) · France (3) · Germany (3) · Italy (3) · Portugal (3) · Spain (3) · Canada (2) · New Zealand (2) · United Kingdom (2) · Australia (1) · Cyprus (1) · Greece (1) · Sweden (1)
Rodney Falk, MD (1)
PMID 34355354, PMID 35799473, PMID 38065307, PMID 41913562, PMID 41937511, PMID 29972757, PMID 30169969, PMID 30219500, PMID 31853709, PMID 32343462, PMID 32654156, PMID 32654212, PMID 32833564, PMID 33638113, PMID 34125267, PMID 35766224, PMID 35908242, PMID 36525140, PMID 37768671
2019 (1)