What is Low-dose naltrexone (LDN)?

The short answer

Low-dose naltrexone is the drug naltrexone, which is lab-made, in a much smaller amount than usual.

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What it is

Type
Opioid antagonist (not a peptide)

Regulatory status

Not FDA-approved for this use How we label status

As of October 4, 2026, Low-dose naltrexone (LDN) is not FDA-approved. FDA has approved a drug for human use with the same active ingredient, for alcohol dependence; blocking the effects of opioids (50 mg tablets); preventing relapse to opioid dependence after detox (Vivitrol).

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Federal (FDA)
Approved Rx for naltrexone alone only as tablets (ReVia NDA018932 1984, disc.; generic 50 mg ANDAs; SpecGx ANDA076264 also lists 25 and 100 mg) and Vivitrol NDA021897 2006; no naltrexone-alone product below 25 mg is approved. Contrave NDA200063 2014 pairs naltrexone 8 mg with bupropion 90 mg per tablet for weight management (not a low-dose naltrexone product). Low dose is compounded/off-label. No FDA statement on LDN found
503A compounding
Approved-drug component (not in any 503A category) (as of May 14, 2026)
WADA 2026
Not named

References

Sources as of October 4, 2026

  1. FDA: www.fda.gov/media/94164/download
  2. Drugs@FDA: www.accessdata.fda.gov/scripts/cder/daf/index.cfm (1 of 4)
  3. Drugs@FDA: www.accessdata.fda.gov/scripts/cder/daf/index.cfm (2 of 4)
  4. Drugs@FDA: www.accessdata.fda.gov/scripts/cder/daf/index.cfm (3 of 4)
  5. Drugs@FDA: www.accessdata.fda.gov/scripts/cder/daf/index.cfm (4 of 4)