CLINICAL TRIALS PROFILE FOR NALOXONE HYDROCHLORIDE

505(b)(2) Clinical Trials for NALOXONE HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00637000 ↗	Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone	Completed	Indivior Inc.	Phase 2	2008-03-01	The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.
OTC	NCT02137213 ↗	Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation	Completed	Academic Health Science Centres	Phase 2	2014-08-01	At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from constipation that often affects effectiveness of MMT and increases its impact on health care system. Existing treatments include several over-the-counter medications which do not target the pathobiological basis of opioid-induced constipation and have limited effectiveness. At the same time well-known medication, naloxone, was already shown to help with constipation in patients receiving methadone for chronic pain, but was never tried in patients receiving methadone for opioid dependence. This study is aimed to try naloxone for treatment of opioid-induced constipation in MMT settings. The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced constipation. The study has a crossover design - all patients will receive one week of their regular methadone doses and one week of their regular methadone doses with naloxone added. Normal saline will be added to methadone-only formulations as placebo. Order of the weeks will be chosen randomly. Both subjects and investigators will be blinded to the study condition (i.e. whether naloxone or normal saline is added to methadone preparation on a given week). Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1 will have less severe symptoms of constipation compared to those receiving methadone only. Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause clinically significant opioid withdrawal symptoms.
OTC	NCT02137213 ↗	Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation	Completed	Centre for Addiction and Mental Health	Phase 2	2014-08-01	At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from constipation that often affects effectiveness of MMT and increases its impact on health care system. Existing treatments include several over-the-counter medications which do not target the pathobiological basis of opioid-induced constipation and have limited effectiveness. At the same time well-known medication, naloxone, was already shown to help with constipation in patients receiving methadone for chronic pain, but was never tried in patients receiving methadone for opioid dependence. This study is aimed to try naloxone for treatment of opioid-induced constipation in MMT settings. The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced constipation. The study has a crossover design - all patients will receive one week of their regular methadone doses and one week of their regular methadone doses with naloxone added. Normal saline will be added to methadone-only formulations as placebo. Order of the weeks will be chosen randomly. Both subjects and investigators will be blinded to the study condition (i.e. whether naloxone or normal saline is added to methadone preparation on a given week). Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1 will have less severe symptoms of constipation compared to those receiving methadone only. Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause clinically significant opioid withdrawal symptoms.
New Formulation	NCT02158117 ↗	Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use	Completed	St. Olavs Hospital	Phase 1	2014-03-01	Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. A pilot study in this hospital has shown no significant side effects or adverse reaction. While significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. Therefore this preclinical study in healthy volunteers will be undertaken.
New Formulation	NCT02158117 ↗	Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use	Completed	Norwegian University of Science and Technology	Phase 1	2014-03-01	Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. A pilot study in this hospital has shown no significant side effects or adverse reaction. While significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. Therefore this preclinical study in healthy volunteers will be undertaken.
New Formulation	NCT02307721 ↗	Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use	Completed	St. Olavs Hospital	Phase 1/Phase 2	2014-12-01	Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose (intranasal) has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil.
New Formulation	NCT02307721 ↗	Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use	Completed	Norwegian University of Science and Technology	Phase 1/Phase 2	2014-12-01	Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose (intranasal) has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil.

All Clinical Trials for NALOXONE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000192 ↗	Neurobiology of Opioid Dependence: 1 - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
NCT00000192 ↗	Neurobiology of Opioid Dependence: 1 - 1	Withdrawn	Yale University	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
NCT00000193 ↗	Neurobiology of Opioid Dependence: 2 - 2	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.
NCT00000193 ↗	Neurobiology of Opioid Dependence: 2 - 2	Withdrawn	Yale University	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.
NCT00000194 ↗	Neurobiology of Opioid Dependence: 3 - 3	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1993-01-01	The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal.
NCT00000194 ↗	Neurobiology of Opioid Dependence: 3 - 3	Withdrawn	Yale University	Phase 2	1993-01-01	The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal.
NCT00000243 ↗	Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone	Terminated	National Institute on Drug Abuse (NIDA)	N/A	2002-09-01	Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.

Clinical Trial Conditions for NALOXONE HYDROCHLORIDE

Condition Name

Condition Name for NALOXONE HYDROCHLORIDE
Intervention	Trials
Opioid-Related Disorders	41
Pain	29
Opioid Use Disorder	27
Opioid Dependence	21

Condition MeSH

Condition MeSH for NALOXONE HYDROCHLORIDE
Intervention	Trials
Opioid-Related Disorders	130
Substance-Related Disorders	36
Disease	20
Pain, Postoperative	18

Clinical Trial Locations for NALOXONE HYDROCHLORIDE

Trials by Country

Trials by Country for NALOXONE HYDROCHLORIDE
Location	Trials
United States	491
China	24
Canada	23
Norway	14
Germany	12

Trials by US State

Trials by US State for NALOXONE HYDROCHLORIDE
Location	Trials
New York	43
California	37
Maryland	37
Massachusetts	23
Pennsylvania	19

Clinical Trial Progress for NALOXONE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for NALOXONE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	5
PHASE2	3

Clinical Trial Status

Clinical Trial Status for NALOXONE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	211
Recruiting	51
Not yet recruiting	39

Clinical Trial Sponsors for NALOXONE HYDROCHLORIDE

Sponsor Name

Sponsor Name for NALOXONE HYDROCHLORIDE
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	70
Indivior Inc.	14
Johns Hopkins University	13

Sponsor Type

Sponsor Type for NALOXONE HYDROCHLORIDE
Sponsor	Trials
Other	368
Industry	131
NIH	84

Clinical Trials Update, Market Analysis, and Projection for Naloxone Hydrochloride

Last updated: February 19, 2026

What Is the Current Status of Clinical Trials for Naloxone Hydrochloride?

Recent developments in clinical trials for naloxone hydrochloride focus primarily on extended-release formulations and nasal delivery systems to enhance overdose reversal efficacy. Notable updates include:

• Extended-Release Formulations: Trials investigating intranasal and injectable versions designed for rapid absorption with sustained action are ongoing. The US Food and Drug Administration (FDA) approved a 4 mg intranasal naloxone product in 2020, with additional formulations in Phase II and III stages.

• Combination Therapies: Some studies explore naloxone combined with other medications for treating opioid use disorder (OUD), aiming to improve compliance and reduce relapse rates. These trials are primarily in early phases, with some anticipated to complete enrollment within 2023.

• Population-Specific Efficacy: Trials targeting vulnerable groups such as pregnant women, elderly patients, or individuals with comorbidities are underway, assessing safety and dosage parameters.

The overall clinical pipeline remains active, driven by the rising opioid overdose crisis globally and ongoing efforts to improve administration routes and formulation efficacy.

How Does the Market for Naloxone Hydrochloride Stand Currently?

Market Size and Revenue

The global naloxone market was valued at approximately US$ 400 million in 2022. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 6% from 2023 to 2030, reaching US$ 700 million by 2030.

Key Market Segments

• By Formulation: Nasal sprays account for roughly 55% of sales, owing to ease of administration. Injectable formulations contribute about 30%, mostly used in medical settings. Auto-injectors and other devices constitute 15%.

• By Application:

  • Overdose reversal in emergency settings
  • Community-based Naloxone distribution programs
  • Treatment for opioid dependence, in combination with other medications

• By Region: North America leads the market with over 70% share in 2022, driven by high opioid misuse rates and supportive policies. Europe accounts for 15%, with Asia-Pacific emerging as a significant growth area with a CAGR of 8%.

Major Players

• Amphastar Pharmaceuticals
• Mylan (a subsidiary of Viatris)
• Teva Pharmaceutical Industries
• Kaleo, Inc.
• Hikma Pharmaceuticals

These companies hold the majority share of patent-protected and off-patent formulations and are actively investing in next-generation delivery systems.

What Are the Market Drivers and Barriers?

Drivers

• Heightened prevalence of opioid overdoses globally.
• Increased awareness and education campaigns encouraging wider naloxone distribution.
• Regulatory approvals expanding access, such as standing orders and over-the-counter sales in several US states.

Barriers

• High cost of branded formulations limits access in some regions.
• Regulatory delays for new formulations.
• Public stigma associated with opioid misuse hampers distribution initiatives.

What Are the Market Projections for the Next Decade?

Future Growth Factors

• Expansion of over-the-counter availability.
• Innovation in non-injectable administration devices.
• Development of combination overdose prevention therapies.

Projected Trends

Year	Market Size (US$ millions)	CAGR	Notes
2023	420	6%	Steady growth, primarily driven by North America
2025	530		Increased adoption of nasal sprays
2028	650		Emergence of new formulations and markets
2030	700		Market saturation in mature regions

Key Markets to Watch

• United States: Continued growth driven by policy changes and epidemic dynamics.
• Europe: Regulatory adaptations are expected to broaden access.
• Asia-Pacific: Rapid expansion expected owing to increasing opioid misuse and healthcare investments.

Summary of Regulatory Dynamics

Over the past three years, multiple jurisdictions have relaxed restrictions on naloxone, including:

• Over-the-counter (OTC) status approval in several US states.
• Expanded emergency use authorizations (EUAs) during the COVID-19 pandemic.
• Approval of auto-injectors and intranasal forms to enable layperson administration.

Policymakers are increasingly recognizing naloxone as an essential medication, reducing barriers to access.

Key Takeaways

• Clinical trials are focusing on novel formulations, including extended-release and combination therapies.
• The global naloxone market was valued at US$ 400 million in 2022, with solid growth prospects driven by the opioid epidemic.
• North America leads market size and adoption, while Asia-Pacific presents significant future growth potential.
• Market expansion depends on regulatory approvals, cost reductions, and increased public awareness.
• Innovations in delivery systems and broadening access policies will shape the competitive landscape.

FAQs

1. What are the most promising new formulations of naloxone?
Extended-release nasal sprays and auto-injectors are in advanced stages of approval, promising faster, longer-lasting overdose reversal.

2. How does the regulatory environment affect market growth?
States and countries easing OTC access and enabling wider distribution facilitate increased consumption and market expansion.

3. What are the primary barriers to market penetration in low-income regions?
High costs, lack of awareness, and regulatory delays restrict access. Efforts focus on lowering prices and expanding distribution.

4. Which companies lead innovation in naloxone delivery?
Kaleo Inc. with its auto-injector Narcan, and Amphastar Pharmaceuticals with nasal spray formulations, are at the forefront.

5. How does the COVID-19 pandemic impact naloxone market dynamics?
Pandemic-related policies increased emergency access, but supply chain disruptions posed challenges. Long-term effects include expanded telehealth and distribution programs.

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References

[1] Grand View Research. (2023). Naloxone Market Size, Share & Trends Analysis Report.
[2] US Food and Drug Administration. (2020). FDA approves first nasal spray medication for opioid overdose.
[3] MarketWatch. (2023). Naloxone market forecast 2023-2030.
[4] World Health Organization. (2022). Global Atlas of the Opioid Overdose Crisis.
[5] IQVIA. (2022). Global prescribing and market analysis for overdose reversal medications.