BUPRENORPHINE HYDROCHLORIDE

Post-LOE

buprenorphine hcl

Ascentage Pharma

ANDASUBLINGUALTABLET

Approved

Dec 2025

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

BUPRENORPHINE HYDROCHLORIDE (buprenorphine hcl) by Ascentage Pharma is buprenorphine, a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Approved for opioid dependence. First approved in 2025.

Drug data last refreshed 21h ago

Mechanism of Action

buprenorphine, a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.

Indications (1)

opioid dependence

Clinical Trials (1)

NCT01075971Phase 2Completed

Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)

Started Sep 2005

52 enrolled

Opioid Dependency

Company

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.