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ALKS 5461

Small molecule · Antagonist of opioid receptor · developed by Alkermes

Phase 3 Most advanced trial (none active)

ALKS Developer

2 Registered trials

What is ALKS 5461?

ALKS 5461 is a sublingual tablet combining samidorphan and buprenorphine.

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

At a glance

Drug type: Small molecule
Targets: opioid receptor
Mechanism: Antagonist of opioid receptor
Therapy area: Psychiatry
Developer: Alkermes, Inc. (ALKS)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 3

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT03610048	Phase 3	Refractory Major Depressive Disorder	Terminated	ALKS
NCT02158533	Phase 3	Major Depressive Disorder	Completed	ALKS

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

Conditions studied

Major Depressive DisorderRefractory Major Depressive Disorder

More from Alkermes

Aripiprazole Lauroxil FDA approved Samidorphan FDA approved Alixorexton Phase 3 ALKS 1140 Phase 1 ALKS 2680 Phase 2/3 ALKS 3831 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 ALKS 5461

See ALKS's upcoming FDA decisions, trial readouts, cash runway and dilution risk, updated every day from SEC, FDA and ClinicalTrials.gov filings.

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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