Cocaine Use Disorder Market Outlook to Strengthen During the Forecast Period (2026-2036) with Emerging Therapies and Rising Healthcare Needs | DelveInsight

The cocaine use disorder market is expected to be driven by the anticipated introduction of emerging therapies including Mavoglurant (STP7; STALICLA), Metyrapone (EMB-001; Embera NeuroTherapeutics), TMP-301 (Tempero Bio), OMS527 (Omeros Corporation), AT-312 (Astraea Therapeutics), and others, advancements in treatment options, improved healthcare access, and a rising prevalence of the condition.

LAS VEGAS, Oct. 14, 2026 /PRNewswire/ -- Recently published Cocaine Use Disorder Market Insights report includes a comprehensive understanding of current treatment practices, cocaine use disorder emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. 

Cocaine Use Disorder Market Summary

• The total market size of CUD in the 7MM was around USD 55 million in 2025, which is expected to grow at a significant CAGR, reaching a notable value by 2036.
• The United States accounted for the largest cocaine use disorder treatment market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• The total diagnosed prevalent cases of CUD in the 7MM were found to be approximately 2.48 million cases in 2025, which are expected to increase by 2036 at a significant CAGR during the study period (2022─2036).
• Leading cocaine use disorder companies, such as STALICLA, Embera NeuroTherapeutics, Tempero Bio, Omeros Corporation, Astraea Therapeutics, and others, are developing new cocaine use disorder treatment drugs that can be available in the cocaine use disorder market in the coming years. 
• The promising cocaine use disorder therapies in clinical trials include Mavoglurant (STP7), Metyrapone (EMB-001), TMP-301, OMS527, AT-312, and others.

Discover FDA approved medication cocaine use disorder 2026 @ https://www.delveinsight.com/report-store/cocaine-use-disorder-market

Key Factors Driving the Growth of the Cocaine Use Disorder Market 

• Rising Prevalence of Cocaine Use and Dependence: Increasing cocaine consumption across several regions is contributing to a larger population requiring diagnosis, treatment, and long-term support. Growing recognition of cocaine use disorder (CUD) as a significant substance-use condition is also expanding the addressable treatment population.
• High Unmet Need for Approved Pharmacological Treatments: The absence of widely approved medications specifically indicated for CUD represents a substantial unmet medical need. This gap is encouraging pharmaceutical companies and academic institutions to investigate novel pharmacological approaches targeting craving, relapse, and the neurobiological mechanisms underlying cocaine dependence.
• Expansion of the Clinical Pipeline: Increasing research into medications targeting dopamine signaling, glutamatergic pathways, stress responses, and other mechanisms is strengthening the CUD development landscape. Progression of investigational therapies such as Mavoglurant (STP7; STALICLA), Metyrapone (EMB-001; Embera NeuroTherapeutics), TMP-301 (Tempero Bio), OMS527 (Omeros Corporation), AT-312 (Astraea Therapeutics), and others could support future market expansion.

Shikha Bhardwaj, Associate Consultant of Forecasting & Analytics at DelveInsight, said that the recent advances in understanding cocaine addiction have allowed researchers to identify promising new candidate drugs that can be effective pharmacological treatments for CUD.

Cocaine Use Disorder Market Analysis

• To date, no pharmacological therapy has received US Food and Drug Administration (FDA) approval for cocaine use disorder, nor has any medication demonstrated sufficient efficacy to establish a standard of care. 
• Consequently, the current pharmacological treatment landscape primarily relies on off-label therapies, including antidepressants such as citalopram and other selective serotonin reuptake inhibitors (SSRIs), psychostimulants such as methadone and diacetylmorphine, dopamine agonists including amantadine and modafinil, and dopamine-blocking agents such as CLOZARIL and ketamine-based therapies.
• The emerging CUD pipeline remains limited, with only a small number of therapies currently under investigation. 
• Among these, TMP-301, mavoglurant, and EMB-001, among others, are expected to represent potentially important emerging therapies aimed at promoting abstinence in patients with CUD, with potential launches across the 7MM during the forecast period of 2026–2036.

Cocaine Use Disorder Competitive Landscape

Some of the cocaine use disorder drugs under development include Mavoglurant (STP7; STALICLA), Metyrapone (EMB-001; Embera NeuroTherapeutics), TMP-301 (Tempero Bio), OMS527 (Omeros Corporation), AT-312 (Astraea Therapeutics), and others.

STALICLA's Mavoglurant (STP7) is a selective non-allosteric antagonist of metabotropic glutamate receptor 5 (mGluR5), a key therapeutic target associated with addiction pathways, mood disorders, and neurodevelopmental conditions. By modulating glutamatergic signaling, mavoglurant is being developed to reduce cocaine craving by selectively inhibiting mGluR5 activity in the brain.

A Phase II clinical study demonstrated mavoglurant-induced abstinence in patients with cocaine use disorder (CUD) through mGluR5 inhibition, with no evidence of withdrawal liability. The company continues to advance STP7 (mavoglurant), having completed a Phase III-enabling drug–drug interaction study, with further development supported by the National Institute on Drug Abuse (NIDA) under the National Institutes of Health (NIH). In addition, the company plans to leverage its precision neurobiology drug development platform, DEPI, to identify subgroups of high-responder patients with rare and common neurodevelopmental disorders who may benefit from mavoglurant, based on findings from earlier clinical studies.

Embera NeuroTherapeutics' Metyrapone (EMB-001) is a novel combination therapy comprising metyrapone and oxazepam that is designed to modulate the stress-response system implicated in addiction and relapse. By targeting stress-, cue-, and drug-induced pathways, the therapy aims to reduce cocaine craving and help prevent relapse in patients with CUD.

EMB-001 has completed Phase I and Phase II clinical trials, with the Phase II study supported by NIDA under the NIH. However, publicly available clinical updates remain limited, and its progression into late-stage development has yet to be confirmed.

Tempero Bio's TMP-301 is an investigational negative allosteric modulator of mGluR5 designed to target glutamatergic pathways associated with addiction and relapse. Through modulation of this signaling pathway, TMP-301 is intended to reduce cocaine craving and help prevent relapse among patients with CUD.

The candidate has completed early-stage clinical evaluation, including a Phase I study assessing its safety profile and interaction with cocaine, and is progressing toward Phase II development. Supported by investor funding, TMP-301 represents an actively advancing and mechanistically targeted candidate within the relatively limited CUD therapeutic pipeline.

The anticipated launch of these emerging therapies are poised to transform the cocaine use disorder market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the cocaine use disorder market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about the cocaine use disorder treatment market @ Cocaine Use Disorder Drugs

Cocaine Use Disorder Epidemiology Segmentation

The cocaine use disorder epidemiology section provides insights into the historical and current cocaine use disorder patient pool and forecasted trends for the leading markets. In 2025, gender-specific diagnosed prevalent cases of CUD across the 7MM showed a clear disparity, with approximately 70% of cases occurring in males and 30% in females.

The cocaine use disorder treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:

• Total Diagnosed Prevalent Cases of CUD
• Age-specific Diagnosed Prevalent Cases of CUD
• Gender-specific Diagnosed Prevalent Cases of  CUD
• Severity-specific Diagnosed Prevalent Cases of  CUD
• Total Treated Cases of CUD

Scope of the Cocaine Use Disorder Market Report

• Cocaine Use Disorder Patient Population Forecast
• Cocaine Use Disorder Therapeutics Market Size
• Cocaine Use Disorder Pipeline Analysis
• Cocaine Use Disorder Market Size and Trends
• Cocaine Use Disorder Market Opportunity
• Cocaine Use Disorder Market Unmet Needs
• KOL's Views on Cocaine Use Disorder
• Cocaine Use Disorder Market Access and Reimbursement

Download the report to understand the cocaine use disorder treatment pipeline @ Cocaine Use Disorder Clinical Trials

Table of Contents

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SOURCE DelveInsight Business Research, LLP