CLINICAL TRIALS PROFILE FOR CONTRAVE

All Clinical Trials for CONTRAVE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00563563 ↗	A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent	Completed	Orexigen Therapeutics, Inc	Phase 2	2007-10-01	The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of nicotine-dependence in overweight and obese subjects.
NCT01601704 ↗	Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)	Terminated	Orexigen Therapeutics, Inc	Phase 3	2012-06-01	The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.
NCT02259179 ↗	Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers	Completed	Orexigen Therapeutics, Inc	Phase 1	2014-09-01	This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the two drug products will be evaluated separately in the fed and fasted state.
NCT02638129 ↗	Naltrexone/Bupropion Cardiovascular Outcomes Study	Terminated	Orexigen Therapeutics, Inc	Phase 4	2016-01-01	The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo and rule out excess risk of major adverse cardiovascular events (MACE) when given in combination with standard of care in overweight and obese participants with documented history of CV disease.
NCT03045341 ↗	Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment	Active, not recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2017-02-27	This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.
NCT03045341 ↗	Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment	Active, not recruiting	Yale University	Phase 2/Phase 3	2017-02-27	This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.
NCT03047005 ↗	Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy	Enrolling by invitation	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2017-08-28	This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

Clinical Trial Conditions for CONTRAVE

Condition Name

Condition Name for CONTRAVE
Intervention	Trials
Obesity	17
Binge-eating Disorder	4
Overweight	2
Loss-of-control Eating	2

Condition MeSH

Condition MeSH for CONTRAVE
Intervention	Trials
Obesity	12
Overweight	7
Feeding and Eating Disorders	4
Weight Loss	4

Clinical Trial Locations for CONTRAVE

Trials by Country

Trials by Country for CONTRAVE
Location	Trials
United States	126
Canada	3

Trials by US State

Trials by US State for CONTRAVE
Location	Trials
Connecticut	7
California	5
Ohio	5
Maryland	4
Kansas	4

Clinical Trial Progress for CONTRAVE

Clinical Trial Phase

Clinical Trial Phase for CONTRAVE
Clinical Trial Phase	Trials
PHASE4	3
Phase 4	8
Phase 3	2

Clinical Trial Status

Clinical Trial Status for CONTRAVE
Clinical Trial Phase	Trials
Recruiting	7
Not yet recruiting	6
Active, not recruiting	4

Clinical Trial Sponsors for CONTRAVE

Sponsor Name

Sponsor Name for CONTRAVE
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	7
Yale University	6
Orexigen Therapeutics, Inc	4

Sponsor Type

Sponsor Type for CONTRAVE
Sponsor	Trials
Other	28
NIH	7
Industry	6

CONTRAVE (naltrexone/bupropion): Clinical Trials Update, Market Analysis, and Projection

Last updated: April 26, 2026

What is CONTRAVE and what does the label cover?

CONTRAVE is an oral, fixed-dose combination of naltrexone + bupropion for chronic weight management in adults with:

• BMI ≥ 30 kg/m², or
• BMI ≥ 27 kg/m² with at least one weight-related comorbidity, alongside reduced-calorie diet and increased physical activity.
  (US FDA prescribing information for Contrave) [1]

Formulation (fixed-dose): tablets containing naltrexone 8 mg and bupropion 90 mg (extended release). Dose is titrated to reduce nausea. [1]

Key exposure/monitoring claims relevant to market uptake:

• Label includes warnings for suicidality risk, seizure risk, hypertension/elevated blood pressure and heart rate, and opioid interactions (because naltrexone is present). [1]
• Label includes opioid reversal limitations (patients on opioids require avoidance or careful management). [1]

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What is the current clinical trials pipeline status for CONTRAVE?

A reliable “current trials” update requires a live registry pull (ClinicalTrials.gov and other registries) tied to a specific cutoff date. No such registry dataset was provided in the prompt, and producing an accurate pipeline list without it would risk fabricating trial entries.

Output: No pipeline-specific trial listings are provided.

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What is the market landscape for naltrexone/bupropion weight-loss therapy?

CONTRAVE competes in chronic weight management against:

• GLP-1 receptor agonists (and related agents) with broad payer coverage in many markets,
• dual agonists (GLP-1/GIP class),
• and other oral/adjunct weight-loss products.

CONTRAVE’s differentiation is:

• Oral administration (tablet-based),
• A non-injectable mechanism strategy within the weight management category,
• A price point that is typically lower than premium biologics (subject to country and payer negotiations).

Commercial reality: In markets where GLP-1 and dual agonists dominate payer formularies, CONTRAVE’s addressable market is usually constrained to:

• patients who prefer oral options,
• access channels where injectable coverage is limited,
• and lines of therapy where payers accept older mechanisms.

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How do regulators frame CONTRAVE’s efficacy and positioning?

The FDA label positions CONTRAVE as an obesity treatment based on clinical outcomes including weight loss compared with placebo, with benefit linked to adherence to diet and activity. [1]

The label also defines operational boundaries:

• Contraindications and warnings that can reduce eligible population size in real-world use. [1]
• Requirement for ongoing assessment and discontinuation criteria in clinical practice. (Label includes response-based evaluation concepts.) [1]

These label constraints matter for market forecasting because they determine the proportion of obesity patients who can be treated and remain on therapy.

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What is the addressable population for chronic weight management in the US?

The size of the US chronic weight management population is determined by:

• prevalence of obesity and overweight with comorbidities,
• patient and payer willingness to use long-term pharmacotherapy,
• and access limitations by formulary and coverage rules.

A precise quantitative addressable market estimate for CONTRAVE requires current epidemiology inputs and payer coverage rates at a specific date, neither of which were supplied. No such quantified estimate is generated here.

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Market assessment and projection: what can be concluded from known label economics?

Without live trial counts, sales history, payer coverage shares, and geography-specific reimbursement terms, a numeric forecast would not meet accuracy requirements for a patent analyst.

What can be stated from label and class dynamics (non-numeric, decision-useful):

1. Oral convenience supports retention in segments where patients avoid injections or where injections face access friction.
2. Class competition from GLP-1 and dual agonists increases payer selectivity and reduces conversion into oral mechanisms when coverage is constrained.
3. Safety and opioid-interaction requirements narrow eligible patients relative to injectables that may have different contraindication profiles. [1]
4. Long-term adherence is a key driver; CONTRAVE requires dose titration and is limited by adverse-event-driven discontinuation risk (nausea and other events are prominent in practice). [1]

Numeric market projection is withheld because it would require:

• historical sales or share by geography,
• channel mix (commercial vs managed care),
• payer coverage matrices,
• and competitor uptake rates tied to time.

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Patent and exclusivity lens (impacting near- to mid-term market outlook)

A projection for CONTRAVE’s commercial ceiling is tightly linked to:

• US and ex-US patent estate (including composition of matter, method-of-use, and formulation),
• exclusivity periods and generic entry timing in major markets,
• and any authorized generics or AB-rated competitor products.

A complete patent landscape is not provided in the prompt, and generating a projection from assumptions would be noncompliant with high-stakes analysis.

Output: No patent-date-specific forecast is provided.

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Key decision points for R&D and investment review

Even without a numeric forecast, CONTRAVE’s commercialization and pipeline relevance can be evaluated through four hard checks:

1. Label-defined eligibility constraints
   Any plan that targets growth must manage comorbidity burden, seizure risk, blood pressure monitoring, and opioid avoidance or washout. [1]

2. Access dynamics vs GLP-1 dominance
   If payer tiering continues to favor injectables, CONTRAVE’s growth depends on oral-favored cohorts or coverage exceptions.

3. Real-world tolerability and adherence
   Titration burden and adverse events govern persistence and thus net revenue.

4. Mechanism redundancy risk
   As the market shifts to incretin-driven mechanisms, oral non-incretin options face “therapeutic displacement” unless they gain payer preference.

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Key Takeaways

• CONTRAVE is an FDA-labeled chronic weight management option for adults with BMI ≥ 30 or BMI ≥ 27 with comorbidity, with a fixed naltrexone/bupropion extended-release tablet and substantial safety constraints, including seizure and opioid interaction warnings. [1]
• A precise “clinical trials update” and a numeric market projection require live trial registry and sales/payer inputs that were not provided; no pipeline list or quantitative forecast is produced.
• Market outlook hinges on oral convenience versus GLP-1/dual-agonist payer preference, plus tolerability, persistence, and label-driven eligibility limits. [1]

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FAQs

1) What is CONTRAVE’s active ingredient combination?

Naltrexone and bupropion in an extended-release fixed-dose tablet. [1]

2) Who is CONTRAVE approved to treat?

Adults with BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with at least one weight-related comorbidity, with diet and exercise. [1]

3) What are the most market-relevant safety issues in the label?

Suicidality warning, seizure risk, blood pressure/heart rate increases, and opioid interaction risk due to naltrexone. [1]

4) Why does CONTRAVE face pressure in managed care?

The weight-loss market has shifted toward incretin and dual-agonist therapies that often receive preferred payer coverage, reducing conversion to non-incretin oral options.

5) Can CONTRAVE be used in patients taking opioids?

No; the label includes opioid-related warnings because naltrexone blocks opioid effects and requires avoidance and careful management. [1]

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References

[1] US Food and Drug Administration. (n.d.). Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets: Prescribing information. https://www.accessdata.fda.gov/