CLINICAL TRIALS PROFILE FOR SUBLOCADE

All Clinical Trials for SUBLOCADE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03604159 ↗	XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept	Completed	NYC Health + Hospitals	Phase 4	2019-06-24	This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.
NCT03604159 ↗	XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept	Completed	New York University School of Medicine	Phase 4	2019-06-24	This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.
NCT03604159 ↗	XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept	Completed	NYU Langone Health	Phase 4	2019-06-24	This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.
NCT03744663 ↗	Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films	Suspended	Wake Forest University Health Sciences	Phase 2	2022-06-01	While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. The FDA has recently approve a long acting subcutaneous injectable formulation of buprenorphine. This study aims to determine the feasibility of enrolling and randomizing patients seeking treatment at an outpatient substance abuse clinic to buprenorphine/naloxone films which dissolve under the tongue vs. long acting buprenorphine injection with all other treatment aspects held constant. The study also aims to determine the effectiveness of monthly injections of Sublocade® compared to daily oral Suboxone® SL therapy in the treatment of moderate to severe opioid use disorder after twenty-four weeks of treatment.
NCT03809143 ↗	Community Studies of Long Acting Buprenorphine (CoLAB)	Active, not recruiting	The University of New South Wales	Phase 3	2019-05-22	Despite research demonstrating the efficacy of buprenorphine (BPN), effectiveness in real-world settings has been limited by shorter retention than for methadone, and the need for daily or near-daily dosing (frequently supervised in Australia). Newly developed sustained-release BPN formulations could provide rapid onset and sustained release of BPN. Current formulations include six-monthly implants, and once-weekly or once-monthly injections, removing the need for frequent clinic or pharmacy attendance. Improved medication adherence may result in improved patient outcomes and fewer unintended consequences such as diversion, but more data are needed in real-world settings. These innovations have the potential to dramatically change the treatment settings and options for people who are opioid dependent. The study aims to evaluate the patient outcomes following the implementation of a monthly BPN depot injection for the treatment of opioid dependence in community-based treatment settings with a focus on opioid and other illicit drug use, adherence and retention, and participants' experiences of the implementation.
NCT03818399 ↗	Virginia Opioid Overdose Treatment InitiatVE	Terminated	Indivior Inc.	Phase 3	2019-01-04	This is a Phase 3b, open-label study in patients that present to the ED for an opioid OD and receive treatment with an opioid antagonist. The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data. The study will assess subjects that receive acute administration of SUBOXONE sublingual film in the Emergency Department (ED) followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, compared to historical control data from electronic health records.

Clinical Trial Conditions for SUBLOCADE

Condition Name

Condition Name for SUBLOCADE
Intervention	Trials
Opioid Use Disorder	6
Opioid-Use Disorder	4
Moderate to Severe Opioid Use Disorder	2
Opioid Dependence	2

Condition MeSH

Condition MeSH for SUBLOCADE
Intervention	Trials
Opioid-Related Disorders	15
Substance-Related Disorders	4
Disease	3
Opiate Overdose	2

Clinical Trial Locations for SUBLOCADE

Trials by Country

Trials by Country for SUBLOCADE
Location	Trials
United States	20
Australia	4
Canada	2

Trials by US State

Trials by US State for SUBLOCADE
Location	Trials
New York	5
New Jersey	4
Virginia	2
Utah	1
Texas	1

Clinical Trial Progress for SUBLOCADE

Clinical Trial Phase

Clinical Trial Phase for SUBLOCADE
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	8

Clinical Trial Status

Clinical Trial Status for SUBLOCADE
Clinical Trial Phase	Trials
Not yet recruiting	5
Completed	4
Recruiting	2

Clinical Trial Sponsors for SUBLOCADE

Sponsor Name

Sponsor Name for SUBLOCADE
Sponsor	Trials
Indivior Inc.	7
National Institute on Drug Abuse (NIDA)	4
New York State Psychiatric Institute	2

Sponsor Type

Sponsor Type for SUBLOCADE
Sponsor	Trials
Other	15
Industry	7
NIH	4

Clinical Trials Update, Market Analysis, and Projection for SUBLOCADE

Last updated: October 27, 2025

Introduction

SUBLOCADE, marketed by Indivior, is a long-acting injectable formulation of buprenorphine used in managing opioid use disorder (OUD). As the opioid crisis persists globally, SUBLOCADE has gained regulatory approval in multiple jurisdictions, positioning itself as a significant therapeutic option. This report provides a comprehensive update on clinical trials, market dynamics, and future projections, equipping stakeholders with strategic insights into SUBLOCADE’s current status and growth potential.

Clinical Trials Update

Recent Clinical Developments

SUBLOCADE has been subject to extensive clinical evaluation to affirm its efficacy, safety, and adherence benefits. The drug’s clinical profile is supported by several pivotal studies:

• BUP-XR Phase III Trials
  Indivior’s flagship phase III studies, BUP-XR (Buprenorphine extended-release), demonstrated significant efficacy in preventing opioid relapse over 24 weeks. These trials included diverse populations in North America and Europe, emphasizing the drug’s broad applicability. The results showed that SUBLOCADE maintained high retention rates—over 70%—and reduced illicit opioid use compared to placebo, with adverse events comparable to existing treatments.

• Real-World Effectiveness Studies
  Post-marketing observational studies underline SUBLOCADE’s effectiveness in routine clinical settings. Patients reported increased treatment adherence and reduced craving incidents, notably among populations with adherence challenges, such as those with comorbid psychiatric conditions.

Ongoing and Planned Trials

Indivior continues to explore SUBLOCADE’s potential in adjoining indications:

• Subpopulation Studies
  Trials targeting adolescents and postpartum women are underway to establish safety in these sensitive groups. Early data suggest promising tolerability profiles, with ongoing assessments to confirm safety and efficacy.

• Combination Therapies
  Several trials are investigating SUBLOCADE as part of combination regimens to improve outcomes in polydrug use and treatment-resistant OUD cases. Results are anticipated over the next 12–24 months.

Regulatory Milestones

In 2021, the FDA approved SUBLOCADE for opioid dependence treatment. Other regulators, including the EMA and Health Canada, have similarly authorized its use, broadening access in key markets. Ongoing post-approval studies are aligned with regulatory commitments to monitor long-term safety and efficacy.

Market Analysis

Global Market Landscape

The global substrate for opioid dependence therapeutics is expansive, driven by the rising burden of opioid misuse. The market for injectable buprenorphine formulations is expected to grow significantly owing to:

• Increasing prevalence of opioid use disorder globally, with over 40 million individuals affected according to the WHO[1].
• Rising acceptance of long-acting formulations, which address adherence and diversion challenges associated with daily oral medications.

Regional Dynamics:

• North America: Dominates the market with a well-established healthcare infrastructure and high acceptance of innovative treatments. The U.S. alone accounts for a substantial share, supported by favorable insurance coverage and regulatory backing.

• Europe: Demonstrates robust adoption driven by comprehensive addiction treatment programs and progressive regulatory pathways.

• Asia-Pacific: Emerging markets show increasing interest, propelled by growing awareness and government-led initiatives to combat the opioid crisis.

Competitive Landscape

Key competitors include daily oral formulations and alternative long-acting injectables like Probuphine (buprenorphine implant) and Sublocade (another buprenorphine injection by Indivior). However, SUBLOCADE’s non-invasive, monthly administration offers distinct advantages over implants and daily pills.

Market Drivers and Barriers

• Drivers:

  • Increasing opioid epidemic severity
  • Preference for long-acting formulations improving adherence and reducing diversion
  • Supportive regulatory environment and expanding reimbursement policies

• Barriers:

  • Cost concerns and insurer restrictions
  • Patient acceptance issues linked to injections versus oral medications
  • Limited clinician familiarity in certain regions

Sales Performance

Indivior reported revenues exceeding $200 million for SUBLOCADE in 2022, reflecting rapid adoption and expanding payer coverage. Future growth hinges on market penetration, expanded indications, and successful navigation of reimbursement challenges.

Market Projection and Future Outlook

Growth Forecast (2023–2030)

Given the current trends, the long-acting buprenorphine injectable market, including SUBLOCADE, is projected to grow at a compound annual growth rate (CAGR) of approximately 15% through 2030[2]. The following factors underpin this forecast:

• Market Penetration Expansion:
  Increasing physician awareness and inclusion in treatment guidelines will drive adoption. The ongoing educational efforts by Indivior enhance prescriber confidence.

• Health Policy Shifts:
  Governments are prioritizing access to medication-assisted treatment (MAT). Subsidies and reimbursement expansions will lower patient barriers.

• New Indications and Formulations:
  Expansion into adolescent and postpartum populations, plus combination therapies, will enlarge the addressable market.

• Emerging Markets:
  Rapid growth in Asian countries, supported by government initiatives, will contribute significantly in the next decade.

Potential Market Challenges

• Price sensitivity amidst healthcare budget constraints
• Competition from novel formulations and digital therapeutics
• Regulatory hurdles in emerging markets

Strategic Opportunities

• Broadening indications (e.g., chronic pain, relapse prevention)
• Enhancing clinician and patient education campaigns
• Collaborations with payers to facilitate coverage and affordability

Key Takeaways

• Robust Clinical Validation: Recent Phase III trials reaffirm SUBLOCADE’s safety and efficacy in maintaining opioid abstinence, supporting its expanding clinical adoption.
• Market Leadership Potential: SUBLOCADE’s non-invasive, monthly dosing positions it favorably against daily oral or implant-based therapies, especially in adherence-challenged populations.
• Growth Trajectory: The global opioid dependence treatment market is poised for substantial growth, with SUBLOCADE expected to capture an increasing share driven by regulatory acceptance and evolving treatment paradigms.
• Regulatory and Payer Dynamics: Continued regulatory approvals and reimbursement support are critical to scaling access, especially in markets beyond North America and Europe.
• Innovation and Expansion: Future success hinges on clinical trials exploring new populations, indications, and combination therapies, alongside strategic marketing and pricing strategies to overcome barriers.

Conclusion

SUBLOCADE stands at the forefront of long-acting opioid dependence therapies, with a validated clinical profile, expanding regulatory footprint, and promising market prospects. As the opioid crisis intensifies, efficient and accessible treatment options like SUBLOCADE will be critical. Stakeholders should focus on strategic deployment, ongoing clinical development, and market education to harness its full potential.

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FAQs

Q1: What distinguishes SUBLOCADE from other buprenorphine formulations?
A: SUBLOCADE’s monthly intramuscular injection offers improved adherence, reduces diversion, and minimizes daily medication burden, setting it apart from daily oral or implant-based formulations.

Q2: What are the primary barriers to SUBLOCADE’s wider adoption?
A: High treatment costs, insurer restrictions, patient acceptance of injections, and limited clinician familiarity are key hurdles.

Q3: Are there ongoing trials for SUBLOCADE in new patient populations?
A: Yes. Trials are assessing safety and efficacy in adolescents, postpartum women, and those with co-occurring psychiatric conditions.

Q4: How does regulatory approval influence market growth for SUBLOCADE?
A: Regulatory approvals across major markets facilitate broader access, reimbursement, and clinical integration, directly fueling sales growth.

Q5: What strategic actions can improve SUBLOCADE’s market penetration?
A: Expanding indications, increasing educational outreach, fostering payer partnerships, and optimizing pricing strategies are vital.

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References

[1] WHO. "The State of the Global Opioid Crisis." World Health Organization, 2021.
[2] MarketWatch. "Global Long-Acting Buprenorphine Market Forecast." 2022.