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Samidorphan · Lybalvi, ALKS-33

Small molecule · Antagonist of opioid receptor · developed by Alkermes

Approved FDA

ALKS Developer

2 Registered trials

What is Samidorphan?

Samidorphan is an opioid antagonist that is combined with olanzapine, an atypical antipsychotic, in a single product. The label states that its mechanism could be mediated through opioid receptor antagonism. It is used in the treatment of schizophrenia and bipolar I disorder, and is also studied in alcohol use disorder.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Lybalvi, ALKS-33
Drug type: Small molecule
Targets: opioid receptor
Mechanism: Antagonist of opioid receptor
Therapy area: Psychiatry
Developer: Alkermes, Inc. (ALKS)
FDA status: Approved as Lybalvi, NDA213378 · FDA label
UNII: 7W2581Z5L8

✅ FDA-approved uses

Schizophrenia
Bipolar I disorder

From the indications section of the FDA label (version of Jan 31, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT02161718	Phase 2	Schizophrenia	Completed	ALKS
NCT01903837	Phase 2	Schizophrenia	Completed	ALKS

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Alcohol Use DisorderSchizophrenia

More from Alkermes

Aripiprazole Lauroxil FDA approved Alixorexton Phase 3 ALKS 1140 Phase 1 ALKS 2680 Phase 2/3 ALKS 3831 Phase 3 ALKS 5461 Phase 3 ALKS 7290 Phase 2 RDN-929 Phase 1

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the ALKS page.

Follow ALKS, the company behind Samidorphan

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z