Naltrexone is under clinical development by Aardvark Therapeutics and currently in Phase I for Fibromyalgia (Fibromyalgia Syndrome). According to GlobalData, Phase I drugs for Fibromyalgia (Fibromyalgia Syndrome) have an 84% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Naltrexone’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.

Naltrexone overview

ARD-301 is under development for the treatment of fibromyalgia (fibromyalgia syndrome), chronic pain and chronic post-COVID syndrome. It comprises of delayed burst release low dose naltrexone (DBR-LDN). It acts by targeting delta, kappa and mu opioid receptors. It is administered through oral route.

Aardvark Therapeutics overview

Aardvark Therapeutics is the US based biopharmaceutical company. The company develops small molecule therapies for treating inflammatory and metabolic diseases. It also commercializes its leading product (ARD-101).

For a complete picture of Naltrexone’s drug-specific PTSR and LoA scores, buy the report here.


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.