CLINICAL TRIALS PROFILE FOR ZUBSOLV

All Clinical Trials for ZUBSOLV

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01848054 ↗	Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence	Completed	Worldwide Clinical Trials	Phase 3	2013-06-01	The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only. The hypothesis is that starting directly on OX219 works equally well (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on Day 3.
NCT01848054 ↗	Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence	Completed	Orexo AB	Phase 3	2013-06-01	The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only. The hypothesis is that starting directly on OX219 works equally well (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on Day 3.
NCT01903005 ↗	Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence	Completed	Worldwide Clinical Trials	Phase 4	2013-07-01	The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.
NCT01903005 ↗	Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence	Completed	Orexo AB	Phase 4	2013-07-01	The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.
NCT01908842 ↗	Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults	Completed	Worldwide Clinical Trials	Phase 3	2013-08-01	The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.
NCT01908842 ↗	Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults	Completed	Orexo AB	Phase 3	2013-08-01	The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.

Clinical Trial Conditions for ZUBSOLV

Condition Name

Condition Name for ZUBSOLV
Intervention	Trials
Opioid Dependence, on Agonist Therapy	2
Opioid Use Disorder	2
Opioid-Related Disorders	1
Opioid-Related Disorders,	1

Condition MeSH

Condition MeSH for ZUBSOLV
Intervention	Trials
Opioid-Related Disorders	7
Anemia, Sickle Cell	1
Chronic Pain	1

Clinical Trial Locations for ZUBSOLV

Trials by Country

Trials by Country for ZUBSOLV
Location	Trials
United States	60

Trials by US State

Trials by US State for ZUBSOLV
Location	Trials
Maryland	5
Florida	4
California	4
New Jersey	4
Utah	4

Clinical Trial Progress for ZUBSOLV

Clinical Trial Phase

Clinical Trial Phase for ZUBSOLV
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for ZUBSOLV
Clinical Trial Phase	Trials
Completed	5
RECRUITING	2
Active, not recruiting	1

Clinical Trial Sponsors for ZUBSOLV

Sponsor Name

Sponsor Name for ZUBSOLV
Sponsor	Trials
Worldwide Clinical Trials	3
Orexo AB	3
Indivior Inc.	2

Sponsor Type

Sponsor Type for ZUBSOLV
Sponsor	Trials
Other	7
Industry	6
NIH	2

Zubsolv clinical trials update, market analysis, and near-term projection: dosing, competitors, FDA status, and patent/exclusivity-driven entry risk

Last updated: July 28, 2026

Zubsolv (buprenorphine and naloxone sublingual tablets; Endo/strong partnership, now managed by Camber and other post-realignment channels) is an established maintenance therapy for opioid use disorder (OUD). Its near-term market trajectory is driven by (1) continuing unit demand for office-based medication for OUD, (2) competitive displacement from alternative buprenorphine/naloxone sublingual products and long-acting injectables, and (3) payer access decisions that increasingly favor lower acquisition cost and formulary positioning. The current clinical-trials signal is low-to-moderate activity, with incremental studies more likely tied to dosing access, switching, or real-world evaluations than new molecular registrations.

Note: Producing a complete, accurate clinical trials update, market sizing, and patent/exclusivity-driven projections requires drug-specific FDA/Orange Book, trial registries, and revenue data. No such dataset was provided in the prompt, and generating it without source-backed inputs would risk factual errors.