(Sodium phenylbutyrate + taurursodiol) is under clinical development by Amylyx Pharmaceuticals 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 (Sodium phenylbutyrate + taurursodiol)’s likelihood of approval (LoA) and phase transition for Alzheimer’s Disease took place on 30 Sep 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 30 Sep 2022 increased (Sodium phenylbutyrate + taurursodiol)’s Phase Transition Success Rate (PTSR) for Mild Cognitive Impairment.

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

(Sodium phenylbutyrate + taurursodiol) overview

Sodium phenylbutyrate and Taurursodiol (Albrioza, Relyvrio) is a fixed dose combination product. It is formulated as powder for suspension for oral route of administration. Albrioza is indicated in the treatment of adult patients with amyotrophic lateral sclerosis (ALS). Relyvrio is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.

AMX-0035 is under development for the treatment of Alzheimer's disease, amyotrophic lateral sclerosis, multiple sclerosis and wolfram syndrome. It is a combination of sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA). The drug candidate is administered as powder for oral suspension. It acts by targeting the translocation of the Bcl-2 associated X-protein(Bax). It was also under development for the treatment of Friedreich's ataxia.

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Amylyx Pharmaceuticals overview

Amylyx Pharmaceuticals (Amylyx) discovers and develops pharmaceutical products for the treatment of neurodegenerative diseases. The company is investigating AMX0035, an oral coformulation of sodium phenylbutyrate and taurursodiol compounds to treat amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Wolfram syndrome. Its product candidate focuses on reducing neuronal death by mitigating endoplasmic reticulum stress and mitochondrial dysfunction. Amylyx seeks to work in collaboration with researchers and biotechnology companies to develop its products. The company has operational presence in Calgary, Canada; and Amsterdam, the Netherlands. Amylyx is headquartered in Cambridge, Massachusetts, the US.

Quick View (Sodium phenylbutyrate + taurursodiol) LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • (Sodium phenylbutyrate + taurursodiol)
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Genetic 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.