(Sodium phenylbutyrate + taurursodiol) is under clinical development by Amylyx Pharmaceuticals and currently in Phase II for Alzheimer’s Disease. According to GlobalData, Phase II drugs for Alzheimer’s Disease have a 36% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how (Sodium phenylbutyrate + taurursodiol)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

(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 (genetic disorder). 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.


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.

For a complete picture of (Sodium phenylbutyrate + taurursodiol)’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.