Drug intelligence / Profile preview

low-dose naltrexone

Development stage
Unknown
Lead developer
Endo International
Modality
Small Molecules
Administration
Oral
01

Overview

Low-dose naltrexone (LDN) refers to the use of naltrexone at doses approximately one-tenth or less of the standard dose used for opioid or alcohol dependence, typically around 1.5–4.5 mg daily compared to the usual 50–100 mg daily[1][2][4]. Naltrexone is a synthetic opioid receptor antagonist originally developed and FDA-approved for treating opioid and alcohol use disorders. At low doses, however, it exhibits unique pharmacological properties distinct from its high-dose effects. The mechanism of action for LDN appears multifaceted: - It acts as a competitive antagonist at μ-opioid, κ-opioid, and δ-opioid receptors[4]. - At low doses, it may paradoxically upregulate endogenous opioid production and modulate glial cell activity in the central nervous system[2][3]. - LDN is thought to exert anti-inflammatory effects by modulating microglial cells and reducing neuroinflammation[2][3]. LDN has been studied off-label in various chronic conditions including fibromyalgia, Crohn’s disease, multiple sclerosis, chronic pain syndromes (such as complex regional pain syndrome), autoimmune thyroid disorders, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), post-COVID syndrome, postural orthostatic tachycardia syndrome (POTS), inflammatory skin disorders, cancer adjunct therapy (including melanoma and breast cancer), autism spectrum disorder symptoms management in some cases, pruritus in systemic sclerosis/autoimmune diseases,[1][2][3][6][9] among others. Despite promising early results—especially for fibromyalgia—most uses remain experimental due to limited large-scale clinical trials. LDN is generally well tolerated; side effects are uncommon but may include insomnia (~8%), vivid dreams/nightmares (<1%), nausea (<1%), headache or gastrointestinal upset; these are usually mild and transient[1][3].

Brand names
ReViaVivitrol
Other names
LDN
02

Targets

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

Beyond the preview

Go deeper on low-dose naltrexone.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on low-dose naltrexone.

Gosset Free

Get started with Gosset.

Enter your corporate email.

Work email preferred.

Book a call