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Low Bup/Nal Dose

New York State Psychiatric Institute · Phase 3 active Small molecule

A combination of buprenorphine (partial opioid agonist) and naloxone (opioid antagonist) at reduced doses to treat opioid use disorder with potentially improved safety and tolerability.

A combination of buprenorphine (partial opioid agonist) and naloxone (opioid antagonist) at reduced doses to treat opioid use disorder with potentially improved safety and tolerability. Used for Opioid use disorder.

At a glance

Generic nameLow Bup/Nal Dose
Also known asSuboxone
SponsorNew York State Psychiatric Institute
Drug classOpioid agonist-antagonist combination
TargetMu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)
ModalitySmall molecule
Therapeutic areaPsychiatry / Substance Use Disorder
PhasePhase 3

Mechanism of action

Buprenorphine acts as a partial agonist at the mu-opioid receptor, providing sufficient opioid activity to prevent withdrawal while having a ceiling effect on respiratory depression. Naloxone is included to discourage intravenous misuse by precipitating withdrawal if injected. The low-dose formulation aims to optimize the risk-benefit profile for opioid use disorder treatment.

Approved indications

Common side effects

Key clinical trials

Primary sources

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SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results