Inotersen clinical trials
Also written TEGSEDI and ISIS 420915.
How each study uses Inotersen is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- 5 Oct 2018 · TEGSEDI · NDA 211172 (FDA, Drugs@FDA)
- European Union
- 6 Jul 2018 · Tegsedi · EMEA/H/C/004782 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
4 studies that test it; most in 2013 (1)
| Year | Studies |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
| 2019 | 1 |
| 2021 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 3 · Other 1
Ionis Pharmaceuticals, Inc. (2) · Brigham and Women's Hospital (1) · Akcea Therapeutics (1)
Studies
Open first, then newest update. How each study uses Inotersen is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 4
- 24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy PatientsTerminatedPhase 2Brigham and Women's HospitalNCT03702829Written as Inotersen
- A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PNTerminatedPhase 4Akcea TherapeuticsNCT04306510Written as TEGSEDI
- Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)CompletedPhase 3Ionis Pharmaceuticals, Inc.NCT02175004Written as Inotersen
- Efficacy and Safety of Inotersen in Familial Amyloid PolyneuropathyCompletedPhase 2/3Ionis Pharmaceuticals, Inc.NCT01737398Written as Inotersen
Given beside what is tested · 1 — Inotersen is usual care or a partner of the new treatment
Codes
What other systems call Inotersen · ClinicalTrials.gg INT001028
- MeSH (NLM) C000629536InotersenConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) 0IEO0F56LVINOTERSENConfirmed FDA, NLM
- RxNorm 2099289One source FDA
- NCI Thesaurus C121667InotersenOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000629536 | Inotersen | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | 0IEO0F56LV | INOTERSEN | Confirmed FDA, NLM |
| RxNorm | 2099289 | — | One source FDA |
| NCI Thesaurus | C121667 | Inotersen | One source FDA |
Also registered as inotersen sodium (UNII 950736UC77 · RxNorm 2099290).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.