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Narcan

(Naloxone)

ApprovedSmall molecule

Naloxone is used to rapidly reverse the effects of opioid overdose, such as those from heroin or prescription painkillers, by blocking opioids in the body and restoring normal breathing. It's often given as an emergency treatment to save someone's life during an overdose.[2] Narcan is currently approved and in use across 26 indications[4].[1]

Narcan is one of 447 small molecule programs targeting Opioid Dependence. It is currently in Approved.

26

Indications

74

Total Trials

9

Active Trials

446

Competitors

18

FDA Applications

NDA/BLA/ANDA regulatory filings

35

Patents

Pipeline

Status by Indication[4][1]

Indication

Opioid DependenceActive, not recruiting

OpioidRecruiting

AnalgesiaCompleted

Heroin DependenceApproved

OsteoarthritisApproved

Reproductive System DiseaseApproved

Pain AgnosiaApproved

Diabetic PolyneuropathyApproved

Type 1 Diabetes MellitusApproved

Major Depressive DisorderApproved

Opioid DependenceApproved

Active, not recruiting

OpioidPhase 1

Recruiting

AnalgesiaPhase 1

Completed

Heroin DependenceApproved

Approved

OsteoarthritisApproved

Approved

Reproductive System DiseaseApproved

Approved

Pain AgnosiaApproved

Approved

Diabetic PolyneuropathyApproved

Approved

Type 1 Diabetes MellitusApproved

Approved

Major Depressive DisorderApproved

Approved

Showing 10 of 24 indications

Competition

Competitive Landscape

143 competitors in Osteoarthritis

#DrugCompanyPhaseTrials

Narcan

Toradol

Cataflam

Bayer Aspirin

Enbrel

Glucophage

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Protonix

WWyeth-Lederle Vaccines

Catapres

Boehringer Ingelheim

MS Contin

HHikma Pharmaceuticals LLC

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Chronic Pain

NCT04851301

Q4 2027

Phase 1Recruiting

Study completion

NCT05490134

Q1 2029

Phase 2Not yet recruiting

Heart Arrest, Out-of-Hospital

NCT06251609

Q1 2030

Phase 3Active, not recruiting

Opioid Use Disorder

NCT06089707

Clinical

Trials by Indication[1]

Opioid7 trials

Sensory and Opioid Mechanisms of Affective Touch

Completed·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 1·NCT03096353·29 enrolled

The Relationships Between the Noradrenergic, Opioid and Pain System

Withdrawn·RRambam Health Care Campus·N/A·NCT01851486

Opioid Effects on Swallowing and Esophageal Sphincter Pressure

Completed·RRegion Örebro County·Phase 4·NCT01191645·14 enrolled

Show 4 more trials

Pharmacodynamics and Arteriovenous Differences of Naloxone in Healthy Participants Exposed to an Opioid

Completed·NNorwegian University of Science and Technology·N/A·NCT02405988·12 enrolled

Endogenous Opioid Response to Injections

Recruiting·MMiddle Tennessee Research Institute·Phase 4·NCT06666621·33 enrolled

Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank

Completed·—·Phase 1·NCT04975347·47 enrolled

Multi-System Analysis of Opioid Receptor Binding

Recruiting·UUniversity of Pennsylvania·Phase 1·NCT05528848·60 enrolled

Hypoglycemia2 trials

Mechanisms of Hypoglycemia Associated Autonomic Failure

Unknown status·—·Phase 2·NCT00678145·116 enrolled

Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)

Terminated·—·Phase 4·NCT03608163·4 enrolled

Analgesic2 trials

Mechanism of Analgesic Effect on Prolonged Continuous Theta Burst Stimulation

Completed·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT05360030·45 enrolled

Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function

Completed·VVanderbilt University Medical Center·N/A·NCT02469077·117 enrolled

Low back pain2 trials

Chronic Low Back Pain and Meditation

Completed·UUniversity of California, San Diego·Phase 1·NCT04034004·88 enrolled

Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain

Active, not recruiting·RRush University Medical Center·Phase 1·NCT04744883·140 enrolled

Buprenorphine2 trials

Drug Interaction & Methadone & Buprenorphine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02045693·32 enrolled

Determine the Safety of a Sublingual Tablet Formulation of Buprenorphine and Naloxone by Extending the Combination Tablet Availability to Physicians in Office-Based Practice

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00007527·600 enrolled

45 more indications

Tics2 trials

Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use

Completed·NNorwegian University of Science and Technology·Phase 1/2·NCT02307721·12 enrolled

Comparison of Naloxone Pharmacokinetics

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT03386591·30 enrolled

Hyperalgesia2 trials

Effect of High Dose Naloxone on Secondary Hyperalgesia

Completed·RRigshospitalet, Denmark·Phase 1·NCT01935206·15 enrolled

The Effect of Ultra-low-dose Naloxone on Remifentanil-induced Postoperative Hyperalgesia - A Randomized Controlled Study

Completed·SSeoul National University Hospital·N/A·NCT02856087·92 enrolled

Respiratory Depression2 trials

Nalmefene vs Naloxone for the Treatment of Recurrent Respiratory Depression After Opioid Overdose

Withdrawn·UUniversity of New Mexico·Phase 3·NCT06408714

The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.

Completed·UUniversity College Dublin·Phase 4·NCT02885948·96 enrolled

Overdose2 trials

Nasal Naloxone for Narcotic Overdose

Unknown status·JJudith Feinberg·Phase 4·NCT01912573·236 enrolled

Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital

Completed·NNorwegian University of Science and Technology·Phase 3·NCT03518021·286 enrolled

Intravenous2 trials

Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers.

Completed·PParc de Salut Mar·Phase 1·NCT06306391·8 enrolled

Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

Completed·BBausch Health Americas, Inc.·Phase 1·NCT01367561·15 enrolled

Opioid Use Disorder2 trials

Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms

Completed·VVanderbilt University Medical Center·Approved·NCT05142267·101 enrolled

Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl

Active, not recruiting·JJohns Hopkins University·Phase 3·NCT06089707·3 enrolled

Injury1 trial

Effect of High-dose Target-controlled Naloxone Infusion on Pain and Hyperalgesia During a Burn Injury

Completed·Mmads u werner·Phase 2·NCT02684669·80 enrolled

Withdrawal1 trial

Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal

Terminated·NNew York State Psychiatric Institute·Phase 2·NCT05114460·2 enrolled

Hypoxemia1 trial

Naloxone for Optimizing Hypoxemia Of Lung Donors

Completed·WWashington University School of Medicine·Phase 2/3·NCT02581111·199 enrolled

Pruritus1 trial

Naloxone for the Treatment of Opioid-Induced Pruritus

Completed·UUniversity of British Columbia·Phase 2/3·NCT01071057·92 enrolled

MPA1 trial

Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.

Completed·UUniversity Medicine Greifswald·Phase 1·NCT01596764·16 enrolled

Effectiveness1 trial

European Cohort Study of the Effectiveness of Take Home Naloxone

Unknown status·KKing's College London··NCT05072249·6,000 enrolled

Peptides1 trial

Neuropeptides in Human Reproduction

Completed·MMassachusetts General Hospital·Phase 1·NCT01952782·61 enrolled

Cesarean Section1 trial

Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section

Completed·MMahidol University·N/A·NCT00890942·60 enrolled

Opioid Withdrawal1 trial

Tramadol to Reduce Opioid Withdrawal Symptoms

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00142896·16 enrolled

Eating Disorder1 trial

Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray

Unknown status·LLightlake Sinclair Ltd.·Phase 2/3·NCT01567670·138 enrolled

Methadone1 trial

Drug Discrimination in Methadone-Maintained Humans Study 1

Completed·UUniversity of Arkansas·Phase 1·NCT00593463·40 enrolled

Pilot Study1 trial

A Pilot Study of the Bioavailability of Nasal Naloxone

Completed·NNorwegian University of Science and Technology·Phase 2·NCT01939444·5 enrolled

Complication1 trial

Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications

Unknown status·RRegion Skane··NCT03570099·2,000 enrolled

Randomized1 trial

Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Morphine and Naloxone on Motivation (MBBAnalgesic)

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 2·NCT02267304·37 enrolled

TED1 trial

Bioavailability of Nasal Naloxone and Injected Naloxone Compared

Completed·NNorwegian University of Science and Technology·Phase 1·NCT02598856·22 enrolled

Brain Death1 trial

Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination

Withdrawn·PPrisma Health-Midlands·Phase 1·NCT03743805

Constipation1 trial

Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation

Completed·CCentre for Addiction and Mental Health·Phase 2·NCT02137213·20 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Role of Endorphins in Perception of Dyspnea With Resistive Loading in Chronic Obstructive Pulmonary Disease (COPD)

Completed·—·N/A·NCT00958919·14 enrolled

Analgesia1 trial

The Role of Opioidergic Systems in Breathing Based Analgesia

Completed·UUniversity of California, San Diego·Phase 1·NCT03419858·60 enrolled

Obesity1 trial

Biology and Experience of Eating in Women With Obesity

Completed·UUniversity of California, San Francisco·Phase 2·NCT02805972·41 enrolled

Virtual Reality1 trial

Subjective Analgesic Effects of Naloxone and Virtual Reality

Unknown status·UUniversity of Washington·N/A·NCT01105871·50 enrolled

Postoperative Recovery1 trial

Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery

Completed·—·N/A·NCT01531439·84 enrolled

Hypogonadotropic Hypogonadism1 trial

Opioid Antagonism in Hypogonadotropic Hypogonadism

Completed·—·Phase 1·NCT04975334·23 enrolled

Third Molar1 trial

Effect of High-dose Naloxone Following Third Molar Extraction

Completed·Mmads u werner·Phase 2·NCT02976337·23 enrolled

Spinal Fusion1 trial

The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus

Terminated·LLoyola University·Phase 4·NCT03176316·53 enrolled

Epilepsy1 trial

Efficacy of Naloxone in Reducing Postictal Central Respiratory Dysfunction in Patients With Epilepsy

Completed·HHospices Civils de Lyon·Phase 3·NCT02332447·485 enrolled

Patient-Controlled Analgesia1 trial

Anti Emetic Efficacy of Combination of Ramosetron and Premixture of Naloxone With Patient-controlled Analgesia

Completed·KKyungpook National University Hospital·N/A·NCT02416115·90 enrolled

Treatment1 trial

Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone

Completed·XXiangya Hospital of Central South University·Phase 1/2·NCT03751111·126 enrolled

Cancer Pain1 trial

To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain

Completed·MMundipharma Research GmbH & Co KG·Phase 2/3·NCT02321397·155 enrolled

Irritable Bowel Syndrome1 trial

Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00108446

Chronic pain1 trial

Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

Active, not recruiting·UUniversity of Maryland, Baltimore·Phase 1/2·NCT04851301·259 enrolled

Ischemia1 trial

Opioid Receptors Influence Ischemia-Reperfusion Injury

Suspended·RRadboud University Medical Center·N/A·NCT00184938·40 enrolled

Humans1 trial

The Effects of ∆-9-THC and Naloxone in Humans

Completed·YYale University·Phase 1·NCT01591629·6 enrolled

Age1 trial

The Effect of Naloxone and Methylnaltrexone on Esophageal Sensitivity in Health

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT03014843·12 enrolled

Hysterectomy1 trial

A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

Completed·UUllevaal University Hospital·Phase 4·NCT01109511·85 enrolled

Side Effects1 trial

Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents

Completed·JJohns Hopkins University·Phase 2·NCT00330343·75 enrolled

Heart Arrest, Out-Of-Hospital1 trial

Naloxone for Opioid Associated Out of Hospital Cardiac Arrest

Not yet recruiting·UUniversity of California, San Francisco·Phase 2·NCT06251609·98 enrolled

Heart1 trial

Naloxone for In-Hospital Cardiac Arrest

Not yet recruiting·RRegion Skane·Preclinical·NCT07806565·850 enrolled

Unspecified9 trials

Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers

Completed·PPocket Naloxone Corp·Phase 1·NCT05363501·76 enrolled

Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use

Completed·NNorwegian University of Science and Technology·Phase 1·NCT02158117·12 enrolled

RM1 Project 1 - tAN Naloxone

Recruiting·MMedical University of South Carolina·Phase 1·NCT05490134·136 enrolled

Show 6 more trials

Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT02572089·30 enrolled

Abuse Liability of Suboxone Versus Subutex

Completed·NNew York State Psychiatric Institute·Phase 3·NCT00710385·19 enrolled

Neural Correlates of Hypoalgesia Driven by Observation

Recruiting·UUniversity of Maryland, Baltimore·Phase 2·NCT03897998·182 enrolled

Evaluation of Intranasal Naltrexone and Naloxone

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT03851731·12 enrolled

Effect of Intrathecal Naloxone in the Incidence of Pruritis After C.S

Completed·TTanta University·N/A·NCT04518618·96 enrolled

Buccal Versus Injectable Naloxone: a Phase I Healthy Volunteer Study

Unknown status·KKing's College London·Phase 1·NCT02733822·4 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

NARCAN

NDA NDA016636

Apr 3, 2014

EVZIO

NDA NDA205787

Nov 18, 2015

NARCAN

NDA NDA208411

Oct 19, 2016

EVZIO (AUTOINJECTOR)

NDA NDA209862

Jan 24, 2017

NARCAN

NDA NDA208411

Sep 23, 2019

NARCAN

NDA NDA208411

Aug 6, 2020

NARCAN

NDA NDA208411

Oct 15, 2021

ZIMHI

NDA NDA212854

Feb 28, 2022

NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

NDA NDA215457

Mar 7, 2023

REXTOVY

NDA NDA208969

Mar 27, 2023

NARCAN

NDA NDA208411

Mar 29, 2023

NARCAN

NDA NDA208411

Jul 28, 2023

RIVIVE

NDA NDA217722

Apr 19, 2024

REZENOPY

NDA NDA215487

Aug 25, 2025

KLOXXADO

NDA NDA212045

Nov 21, 2025

NARCAN

NDA NDA208411

Jan 9, 2026

NARCAN

NDA NDA208411

Feb 11, 2026

NARCAN

NDA NDA208411

Sources

References

[1]
ClinicalTrials.gov — 74 trial records for Naloxone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Narcan drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Naloxone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Naloxone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208411). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Narcan. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Scienture company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Opioid Receptors; Mu/kappa/delta Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SScienture

Patent Landscape[6]

Patent Cliff

Feb 20, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9278182Feb 1, 2026

8926594Mar 31, 2026

7731686Jun 1, 2026

10960155Jun 25, 2026

9238108Feb 20, 2027

30 more patents

8206360Feb 27, 2027

9724471May 23, 2027

7947017Mar 12, 2028

7749194Oct 30, 2028

8226610Apr 10, 2029

8021344Nov 2, 2029

10322239Feb 28, 2031

8939943Feb 28, 2031

9022022Feb 28, 2031

9814838Feb 28, 2031

9474869Feb 28, 2031

10143792May 24, 2031

10143972May 24, 2031

8627816Feb 4, 2032

11806428May 11, 2032

12458591May 11, 2032

11020343May 11, 2032

9517307Jul 18, 2034

11135155Aug 26, 2034

11628139Aug 26, 2034

10973814Aug 26, 2034

10722510Aug 26, 2034

11975096Aug 26, 2034

12414915Aug 26, 2034

11617713Aug 26, 2034

10220158Mar 20, 2035

11027072May 24, 2039

12514854Feb 5, 2041

12622903Feb 5, 2041

11571518Jun 14, 2041

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