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.
- 5 sources
- Status as of
- How we source
- Ellum doesn't sell peptides.
Get updates on Low-dose naltrexone (LDN)
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).
- 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
- FDA: www.fda.gov/media/94164/download
- Drugs@FDA: www.accessdata.fda.gov/scripts/cder/daf/index.cfm (1 of 4)
- Drugs@FDA: www.accessdata.fda.gov/scripts/cder/daf/index.cfm (2 of 4)
- Drugs@FDA: www.accessdata.fda.gov/scripts/cder/daf/index.cfm (3 of 4)
- Drugs@FDA: www.accessdata.fda.gov/scripts/cder/daf/index.cfm (4 of 4)