Inotersen sodium is under clinical development by Akcea Therapeutics and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Inotersen sodium’s likelihood of approval (LoA) and phase transition for Amyloid Cardiomyopathy took place on 15 Nov 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Inotersen sodium Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Inotersen sodium overview

Inotersen sodium (Tegsedi) is a methoxyethyl phosphorothioate antisense oligonucleotide. It is formulated as solution for subcutaneous route of administration. Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR) and also indicated for the treatment of stage 1 or 2 polyneuropathy in adult patients with hereditary transthyretin-associated amyloidosis (PAF-TTR) to slow disease progression and improve quality of life

It is under development for the treatment of amyloid cardiomyopathy and familial amyloid polyneuropathy (FAP/hereditary transthyretin amyloidosis). It is administered through subcutaneous route. It was under development for familial amyloid neuropathies.

Akcea Therapeutics overview

Akcea Therapeutics, a subsidiary of Ionis Pharmaceuticals Inc, focuses on developing RNA based therapeutics. The company commercializes TEGSEDI (inotersen) and WAYLIVRA (volanesorsen) drugs against multiple indications. It is headquartered in Boston, Massachusetts, the US.

Quick View Inotersen sodium LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Inotersen sodium
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Metabolic Disorders
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.