CLINICAL TRIALS PROFILE FOR BRIXADI

All Clinical Trials for BRIXADI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04454411 ↗	Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder	Not yet recruiting	University of Pennsylvania	Phase 2	2021-08-02	This study will investigate the mechanisms of cognitive-behavioral response to medications used for relapse prevention in opioid use disorder (opioid addiction, OUD), through investigation of the neural circuits underlying key cognition functions. The study will use previously validated cognitive probes, functional Magnetic Resonance Imaging (fMRI), and novel extended-release injectable preparations of opioid partial agonist buprenorphine and antagonist naltrexone, in OUD patients to explain the individual heterogeneity of OUD treatment response.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Columbia University	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Columbia University Irving Medical Center	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Harvard Medical School	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Harvard Medical School (HMS and HSDM)	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	Mclean Hospital	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
NCT04464980 ↗	Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)	Recruiting	National Institute on Drug Abuse (NIDA)	Phase 2	2021-06-07	This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.

Clinical Trial Conditions for BRIXADI

Condition Name

Condition Name for BRIXADI
Intervention	Trials
Opioid Use Disorder	4
Buprenorphine	1
Incarceration	1
Medications for Opioid Use Disorder	1

Condition MeSH

Condition MeSH for BRIXADI
Intervention	Trials
Opioid-Related Disorders	7
Substance-Related Disorders	3
Narcotic-Related Disorders	1

Clinical Trial Locations for BRIXADI

Trials by Country

Trials by Country for BRIXADI
Location	Trials
United States	25

Trials by US State

Trials by US State for BRIXADI
Location	Trials
West Virginia	2
Pennsylvania	2
Oregon	2
Maryland	2
Connecticut	2

Clinical Trial Progress for BRIXADI

Clinical Trial Phase

Clinical Trial Phase for BRIXADI
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for BRIXADI
Clinical Trial Phase	Trials
Not yet recruiting	2
NOT_YET_RECRUITING	2
Recruiting	2

Clinical Trial Sponsors for BRIXADI

Sponsor Name

Sponsor Name for BRIXADI
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	3
The Emmes Company, LLC	2
University of Pennsylvania	2

Sponsor Type

Sponsor Type for BRIXADI
Sponsor	Trials
Other	21
NIH	4
Industry	2

Last updated: April 28, 2026

BRIXADI (buprenorphine) clinical trials update, market analysis, and projection

BRIXADI (extended-release injectable buprenorphine) is a branded, long-acting opioid use disorder (OUD) therapy in a mature market with ongoing life-cycle activity around dosing regimens, switching, and safety/data expansions. Commercial trajectory is shaped by (1) U.S. schedule and payer dynamics for medication-assisted treatment, (2) dose mix between monthly strengths, (3) competitive pressure from other long-acting buprenorphine formulations and long-acting full agonists, and (4) manufacturing and supply continuity.

What is BRIXADI’s current clinical development and data direction?

No public, regulator-facing trial readouts that clearly alter BRIXADI’s approved label (new pivotal efficacy endpoints, new indication expansion, or new dosing intervals) were identified in the information provided in this request. A complete and accurate “clinical trials update” requires case-level trial identifiers (NCT numbers), dates of last update, and whether results were positive, neutral, or negative. Those specifics are not available in the materials provided here, so a complete update cannot be produced in the required evidence-based format.

How does BRIXADI’s market position look today?

BRIXADI competes primarily in the long-acting buprenorphine segment for OUD in the U.S. The key market attributes that drive uptake are:

• Administration convenience: monthly dosing reduces adherence burden versus daily sublingual therapy.
• Formulation life-cycle: dose switching and patient retention are central to commercial performance.
• Payer access and coverage rules: plans often favor established products with clear utilization patterns and contracting history.
• Clinical practice behavior: office-based and opioid treatment program preferences and protocols influence product selection.

Business reality in this segment is that differentiation is less about pharmacology (all are buprenorphine-based) and more about dose flexibility, availability, and payer/provider contracting.

Which market forces most affect BRIXADI unit sales and revenue growth?

1. Dose mix and conversion dynamics

   • Patients often start on a product and then convert to a specific long-acting strength based on stabilization, tolerability, and clinic workflows.
   • Revenue tends to track conversion velocity and retention rather than new-to-brand incidence alone.

2. Managed care contracting

   • Net pricing is driven by rebate structures, formulary placement, and prior authorization (PA) requirements.
   • Products that achieve preferred status in formularies and in clinic purchasing programs typically grow faster at the pharmacy benefit level.

3. Supply and continuity

   • Long-acting injectables are vulnerable to supply chain disruptions; any manufacturing constraint can temporarily cap demand fulfillment and shift patients to alternative formulations.

4. Therapeutic substitution

   • Long-acting buprenorphine and long-acting full agonist therapies (e.g., extended-release injectable naltrexone) compete for the same patient pool.
   • Switching risk rises when payers or providers push formulary alternatives after initial stabilization.

What does a practical market projection for BRIXADI require (and what can be projected)?

A defensible projection must rest on measurable inputs: baseline sales or units by geography, adoption rates (new starts and conversions), pricing/discount assumptions, and competitive churn. This request does not provide baseline sales/units, net price, geography split, or a current growth rate. Without those numeric anchors, a complete and accurate projection cannot be produced.

To keep decision-grade rigor, the projection below is constrained to scenario frameworks rather than falsifiable point estimates. It specifies how revenue would respond to identifiable drivers, in a way that can be parameterized once baseline data is applied.

Scenario framework (parameterized, not point-forecast)

Let:

• Units = long-acting OUD injections administered (by dose strength mix)
• Revenue = Units × Net price (after rebates and payer contracts)

Key levers:

Driver	Increases when	Decreases when	Impact on Units	Impact on Revenue per Unit
Formulary preference	Preferred tier placement	Non-preferred placement or PA tightening	Higher	Lower via rebates, higher via mix (depends on contract)
Patient retention	Fewer discontinuations, stable supply	Supply constraints, poor tolerability conversions	Higher	Neutral to slightly negative
Dose mix	More patients convert to higher-volume strengths	Shift to lower-strength or competitor	Higher or lower	Neutral to positive if higher-strength mix grows
Competitive churn	Competitor access constrained	Competitor preferred contracting or better access	Lower	Neutral
Supply continuity	Manufacturing stability	Manufacturing outage or distribution limits	Capped at supply	Often neutral unless contracts renegotiated

What matters for timeline planning

For long-acting OUD brands, growth typically follows an S-curve pattern tied to contracting and clinic behavior:

• early: adoption through targeted clinics and payer wins
• mid: broadening through network effect and dose conversion
• later: plateau and churn-driven change

Without the numeric baseline, no credible end-to-end forecast range can be anchored to calendar years.

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Key Takeaways

• BRIXADI’s commercial outcomes in OUD are driven less by new clinical mechanism and more by dose mix, contracting, supply continuity, and retention.
• A complete clinical trials update cannot be completed from the information provided because the request does not include trial identifiers, readout dates, or label-impact details.
• A complete numeric market projection cannot be produced without baseline sales/units, net pricing, and geography/discount inputs; however, the decision levers and how they affect units and net revenue are clear and operational.

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FAQs

1) What is BRIXADI used for?

BRIXADI is an extended-release injectable buprenorphine product used for opioid use disorder (OUD).

2) What drives BRIXADI uptake in practice?

Administration convenience, payer access (formulary and PA rules), and patient retention after stabilization.

3) What are the main competitive threats to BRIXADI?

Other long-acting buprenorphine formulations and long-acting OUD therapies that win formulary access or are preferred by payers and clinics.

4) How does dose mix affect BRIXADI revenue?

Revenue follows both injection volume and the distribution across available strengths, which changes based on conversion and stabilization patterns.

5) Why does supply continuity matter for long-acting injectables?

Because dosing intervals are fixed, any supply constraint can immediately reduce fill rates and shift patients to alternatives.

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References

[1] ClinicalTrials.gov. (n.d.). BRIXADI (buprenorphine) search results. Retrieved from https://clinicaltrials.gov
[2] U.S. Food and Drug Administration. (n.d.). BRIXADI prescribing information and label history. Retrieved from https://www.accessdata.fda.gov