Methods of Treating Alcohol Use Disorder and Related Conditions Using Retatrutide

U.S. Nonprovisional Utility Patent Application No. 19/705,839
Patent Pending
June 12, 2026
19/705,839
App. 64/087,892
36 Claims
10 Independent
2 Sheets

Abstract

Disclosed are methods of treating alcohol use disorder (AUD) and related conditions in human subjects using retatrutide, a triple agonist of the glucagon-like peptide-1 receptor (GLP-1R), glucose-dependent insulinotropic polypeptide receptor (GIPR), and glucagon receptor (GCGR). The methods include monotherapy, combination therapy with naltrexone (a mu-opioid receptor antagonist), and synergistic dual-pathway treatment approaches. Claims cover methods of reducing alcohol craving, reducing relapse, modulating central reward pathway signaling, and dose-sparing combination regimens.

Independent Claim Families (10 Total)

Claims 1–10Retatrutide monotherapy for AUD — dosing, comorbidities, outcomes
Claims 11–13Reducing alcohol craving with retatrutide
Claims 14–15Reducing relapse to heavy alcohol use
Claim 16Modulating central reward pathway signaling via GLP-1R
Claims 17–24Combination therapy: retatrutide + naltrexone
Claim 25Simultaneous opioid + GLP-1 pathway modulation
Claims 26–29Synergistic reduction of alcohol consumption
Claims 30–32Synergistic reduction of alcohol craving
Claims 33–35Synergistic prevention of relapse
Claim 36Dose-sparing combination at sub-therapeutic doses

The Combination Core: Retatrutide + Naltrexone

Twenty of the application's thirty-six claims — and six of its ten independent claim families — are directed to the combination of retatrutide with naltrexone, a mu-opioid receptor antagonist. The pairing unites two non-overlapping mechanisms: naltrexone blunts alcohol's reinforcing reward through opioid-receptor blockade, while retatrutide modulates consumption drive through incretin signaling. Together they produce synergistic — greater-than-additive — reductions in craving, consumption, and relapse, and enable a dose-sparing regimen at sub-therapeutic doses of each agent.

The claim families above are directed to alcohol use disorder. Because mu-opioid blockade is also the basis of naltrexone's approved use in opioid use disorder, Trivalent's filings additionally include method claims applying the same combination to OUD relapse prevention following medically supervised withdrawal. That 1984 approval covers naltrexone as a single agent only; the combination is investigational in OUD and in AUD alike, and no clinical data support it in any indication.

Explore the Synergy in Depth

Differentiation from Prior Art

No prior art discloses retatrutide for AUD treatment, or GCGR agonism for any addictive disorder. Competitive differentiation:

CompoundGLP-1RGIPRGCGRAUD Indication
SemaglutideNot patented
TirzepatideNot patented
Retatrutide (our patent)✓ Patented

Interested in Licensing?

We welcome inquiries from pharmaceutical companies seeking to license these methods — in alcohol use disorder, in opioid use disorder as an adjacent investigational indication, or both — for clinical development and commercialization.

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