Drug intelligence / Profile preview

ARD-301

Development stage
Unknown
Lead developer
Scilex Holding
Modality
Small Molecules
Administration
Oral
01

Overview

**ARD-301** is a proprietary delayed burst release low-dose oral formulation of the opioid receptor antagonist naltrexone being developed as a non-opioid, non-addictive therapy for chronic pain conditions including fibromyalgia and chronic post-COVID (long COVID) syndrome, as well as broader chronic pain indications. It is based on low-dose naltrexone, which at sub-analgesic doses is thought to modulate microglial activation and central pain processing rather than provide classic opioid antagonism, potentially improving a broad range of fibromyalgia symptoms and pain-related outcomes while avoiding dependence or abuse. The drug was originated by Aardvark Therapeutics, which licensed it under an exclusive term sheet to Sorrento Therapeutics and its majority-owned subsidiary Scilex Holding for planned Phase 2 clinical programs in fibromyalgia, chronic pain, and chronic post-COVID syndrome.[7][10][19]

Other names
Delayed Burst Release Low Dose Naltrexone
02

Targets

DOR (Opioid Receptor Delta 1)KOR (Kappa opioid receptor)MOR (Mu opioid receptor)

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