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Last update 08 May 2025

Naloxone hydrochloride

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryNaloxone is a small molecule drug that acts as an antagonist at the μ opioid receptor, making it a potent tool in the treatment of opiate and drug overdose. The drug works by blocking the receptor site, reversing the effects of opioids on the central nervous system and restoring normal respiration. Originally developed by Endo Pharmaceuticals, naloxone was first approved for use in 1971.

Drug Type

Small molecule drug

Synonyms

Naloxone, Naloxone hydrochloride (JP17/USP), Naloxone hydrochloride dihydrate

+ [45]

Target

μ opioid receptor

Action

antagonists

Mechanism

μ opioid receptor antagonists(Mu opioid receptor antagonists)

Therapeutic Areas

Other DiseasesNeoplasmsImmune System Diseases+ [1]

Active Indication

Acute Lymphoblastic LeukemiaOpiate OverdoseOpioid abuse

Inactive Indication

Pain

Originator Organization

Endo Pharmaceuticals, Inc.

Bexson Biomedical, Inc.

Active Organization

Hikma Pharmaceuticals LLC

Summit Biosciences, Inc.Hikma Pharmaceuticals USA, Inc.

+ [10]

Inactive Organization

Nasus Pharma Ltd.

Mundipharma Pharmaceuticals BV

Emergent Devices, Inc.

+ [2]

License Organization

Summit Biosciences, Inc.ZMI Pharma, Inc.

Harm Reduction Therapeutics, Inc.

+ [8]

Drug Highest PhaseApproved

First Approval Date

United States (13 Apr 1971),

Opiate Overdose

RegulationOrphan Drug (European Union), Fast Track (United States), Priority Review (United States)

Structure/Sequence

Molecular FormulaC19H21NO4

InChIKeyUZHSEJADLWPNLE-GRGSLBFTSA-N

CAS Registry465-65-6

View All Structures (2)

183

Clinical Trials associated with Naloxone hydrochloride

NCT06251609

/ Not yet recruitingPhase 2IIT

Naloxone for Opioid Associated Out of Hospital Cardiac Arrest

The investigator's long-term goal is to conduct Naloxone for Opioid Associated out of Hospital Cardiac Arrest (NOPACA), a randomized, double blind, controlled trial to determine the efficacy of naloxone vs. placebo in Opioid Associated out of Hospital Cardiac Arrest. The investigative team plan to randomize patients in OHCA to early naloxone administration vs. placebo after initial resuscitation and measure ROSC and survival. Challenges to designing NOPACA include uncertainty regarding: 1) the available pool of participants and number of EMS agencies needed to meet enrollment targets; 2) acceptability among patients, EMS and Emergency Medicine provider stakeholders, and 3) estimates of the study outcomes needed for sample size estimates. Toward obtaining the necessary information to design NOPACA, the investigators propose a pilot RCT of participants at high risk for OA-OHCA to verify a reasonable recruitment rate; treatment fidelity and acceptability; and adequate retention and measurement of outcomes at follow up. The investigators propose incorporating hypothesis testing of the feasibility outcomes to determine progression to a definitive trial.

Start Date01 Nov 2026

Sponsor / Collaborator

The University of California, San Francisco

NCT04650841

/ Not yet recruitingEarly Phase 1IIT

The Role of the Opioid System in Placebo Effects on Pain and Social Rejection

The current study probes the involvement of the opioid system in placebo effects on social pain, using the opioid antagonist naloxone. 60 participants who recently experienced an unwanted breakup will experience rejection-related stimuli and receive painful heat and pressure stimuli during fMRI scanning. Participants will be randomized to receive either a naloxone or saline nasal spray, and be informed that the spray is either saline, or an effective pain and negative emotion reducing agent.

Start Date01 Sep 2025

Sponsor / Collaborator

Trustees of Dartmouth College

NCT04975334

/ Enrolling by invitationPhase 2IIT

Opioid Antagonism in Hypogonadotropic Hypogonadism

The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with idiopathic hypogonadotropic hypogonadism (HH).

Start Date15 May 2025

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

100 Clinical Results associated with Naloxone hydrochloride

100 Translational Medicine associated with Naloxone hydrochloride

100 Patents (Medical) associated with Naloxone hydrochloride

30,762

Literatures (Medical) associated with Naloxone hydrochloride

31 Dec 2025·Future Science OA

Evaluating cytidine, uridine, and gabapentin combinations for pain modulation and p-CREB expression in neuropathic model

Article

Author: Chellappan, Dinesh Kumar ; Al-Najjar, Mohammad A. A. ; Barakat, Muna ; Qnais, Esam Y. ; Alqudah, Abdelrahim ; Athamneh, Rabaa Y. ; Alzaghari, Lujain F.

AIMSTo evaluate the analgesic and neuroprotective effects of cytidine, uridine, and gabapentin-administered alone and in combination-in models of diabetic neuropathy and formalin-induced acute and inflammatory pain.MATERIALS & METHODSOral doses of cytidine, uridine, and gabapentin (100 mg/kg each) were administered to rats with streptozotocin-induced diabetic neuropathy and in a formalin test model. Behavioral responses were recorded at 30, 60, and 120 minutes following treatment after five weeks of diabetes induction. Spinal cord p-CREB expression was measured to assess molecular changes, and pretreatments with naloxone, yohimbine, and methysergide were employed to explore opioid, adrenergic, and serotonergic contributions.RESULTSAll treatments significantly reduced formalin-induced pain in both acute and inflammatory phases (p < 0.05; p < 0.001) and increased mechanical pain thresholds in the diabetic neuropathy model at all-time points (p < 0.05). Combination therapy proved more effective than gabapentin alone (p < 0.05) and was associated with decreased spinal p-CREB levels, indicating altered anti-nociceptive signaling.CONCLUSIONSThe combined use of cytidine, uridine, and gabapentin enhances analgesia and neuroprotection compared to monotherapy, supporting its potential as a novel, analgesic-free treatment strategy for diabetic neuropathy.

31 Dec 2025·Journal of Dermatological Treatment

Hailey-Hailey disease successfully treated with naloxone: 2 case reports and Review of the literature on efficacy of opioid receptor antagonist in Hailey-Hailey disease patients

Review

Author: Song, Hao ; Fang, Fang ; Xu, Beilei ; Sheng, Nan ; Duan, Zhimin ; Zheng, Junyou ; Li, Chengrang ; Wu, Jianbing

BACKGROUNDHailey-Hailey disease (HHD), a genetic blistering disease, is caused by a mutation in a calcium transporter protein in the Golgi apparatus encoded by the ATP2C1 gene. Clinically, HHD is characterized by flaccid vesicles, blisters, erosions, fissures, and maceration mainly in intertriginous regions. Some patients remain refractory to conventional treatments. Previously, a series of reports have confirmed naltrexone as an effective option for those patients. However, in China, naltrexone is unavailable in some hospitals and unaffordable for some patients.OBJECTIVETo confirm naloxone as a treatment option for HHD, and assess the efficacy rate and safety of naltrexone for patients with HHD.METHODSTwo patients with biopsy-proven HHD received naloxone (2 mg/d, via intravenous infusion). We followed up with the two patients, assessing the change of skin lesions and obtaining photographs. We searched the PubMed databases using the keywords 'Hailey-Hailey disease' or 'benign familial pemphigus', and 'naltrexone' or 'naloxone', and reviewed English publications of reports and analyzed the efficacy and safety of naltrexone.RESULTSTwo patients prescribed naloxone showed completely remission in two weeks without any adverse reactions. The total remission rate of naltrexone for HHD is approximately 80%, without severe adverse effects.CONCLUSIONNaltrexone is effective and safe in the treatment of HHD. Naloxone, an analog of naltrexone, can also effectively and safely treat HHD, potentially offering a new therapeutic option for patients with refractory HHD.

01 Aug 2025·Neuropharmacology

Aripiprazole: The antiallodynic and antihyperalgesic effects in chronic constriction injury-induced neuropathic pain and reserpine-induced fibromyalgia with possible mechanisms

Article

Author: Aykaç, Özlem ; Okcay, Yagmur ; Bektas, Nurcan ; Arslan, Rana

Neuropathic pain, caused by peripheral or central nerve damage, and fibromyalgia, a chronic musculoskeletal disorder, require complex treatment approaches. This study evaluated the antiallodynic and antihyperalgesic effects of aripiprazole (1, 5, and 10 mg/kg, i. p.) in rats with chronic constriction injury-induced neuropathic pain and reserpine-induced fibromyalgia in female Sprague-Dawley rats, using electronic von Frey and Hargreaves tests. Dopaminergic, serotonergic, and opioidergic systems' roles were assessed through pre-treatment with sulpiride (50 mg/kg), WAY 100635 (1 mg/kg), and naloxone (1 mg/kg), respectively. The effect of aripiprazole was compared with 30 mg/kg pregabalin in the neuropathic pain model and 30 mg/kg duloxetine in the fibromyalgia model. Aripiprazole demonstrated significant antiallodynic and antihyperalgesic activity in both models. It did not change locomotor activity at a dose of 1 mg/kg but caused a decrease at a dose of 5 mg/kg. Dopamine D₂, serotonin 5-HT_1A, and opioidergic receptors contributed to aripiprazole's effects at varying levels. This study highlights the potential use of aripiprazole for managing neuropathic pain and fibromyalgia by targeting multiple receptor systems. The findings demonstrate the potential use of aripiprazole alone or as an adjuvant in the treatments of neuropathic pain and fibromyalgia.

484

News (Medical) associated with Naloxone hydrochloride

29 Apr 2025

·www.fiercepharma.com

Indivior-backed paper champions fast-acting overdose reversal meds against synthetic opioids

Indivior is the maker of several treatments for opioid use disorder, as well as Opvee, which in May 2023 earned the first FDA approval for a nasal spray version of active ingredient nalmefene. A paper published this month in the journal Current Addiction Reports discusses the merits of intranasal medications that can reverse overdoses of high-potency synthetic opioids (HPSOs) such as fentanyl.Indivior funded the manuscript, which was based on the results of last summer’s Reversing Synthetic Opioid Overdose (RESPIRE) Expert Forum—also funded by the addiction-focused pharma—that brought together eight leaders representing emergency medicine, pharmacy, state health agencies, Indian Health Services, addiction research and forensic science.The company makes Opvee, an opioid overdose reversal medication that aligns with the expert panel’s recommendations.“Indivior is committed to partnering closely with healthcare providers, policymakers, and communities to ensure that advanced overdose reversal solutions reach those who need them most, especially as HPSOs drive unprecedented risks and challenges,” Christian Heidbreder, Ph.D., the company’s chief scientific officer, said in a statement.The paper’s publication came shortly before National Fentanyl Awareness Day, observed every year on April 29. Fentanyl and other synthetic opioids were involved in more than 90% of opioid overdose fatalities in the year preceding the July forum, according to the report. Indivior is the maker of several treatments for opioid use disorder, as well as Opvee, which in May 2023 earned the first FDA approval for a nasal spray version of active ingredient nalmefene.Naloxone is the current standard of care for treating opioid overdoses and is more widely available than nalmefene—helped along by its first over-the-counter FDA approval for Emergent BioSolutions’ 4 mg Narcan in early 2023. The new paper’s authors, however, suggest that nalmefene may be more effective in treating some overdoses, especially those involving HPSOs.The most crucial aspects of medications used to treat overdoses of synthetic opioids are rapid onset, long duration and high potency, according to the authors.Nalmefene outpaces naloxone on all three of those aspects: Data cited in the paper show that nalmefene has a higher opioid receptor affinity than naloxone. And, while naloxone reaches peak blood concentration in 30 minutes and has a circulating half-life of about two hours, nalmefene’s time to peak is 15 minutes and its half-life is longer than 11 hours, which may make it “particularly well-suited for reversing HPSO overdose,” they wrote.The experts also pointed to a model predicting that a single 4 mg dose of naloxone would reduce the likelihood of cardiac arrest following a fentanyl overdose from about 78% to 47%, while a single 3-mg dose of nalmefene would bring it down to 11.6%. Previous expert publications, including a September 2023 joint release (PDF) from the American College of Medical Toxicology and the American Academy of Clinical Toxicology, have suggested that more research is needed into the risks and benefits of nalmefene, as its longer duration of action could potentially lead to a longer period of the opioid withdrawal symptoms that are the primary adverse effect of all reversal meds.That longer duration may also create a “false sense of comfort that no further care is needed,” possibly leading patients to avoid seeking follow-up observation, the groups wrote at the time, concluding that nalmefene shouldn’t yet replace naloxone as the standard of care for opioid overdose reversal.Though the RESPIRE experts acknowledged the increased risk of precipitated withdrawal following overdose reversal with nalmefene, they wrote that such risks are “secondary to saving a life.”“With the ability to medically manage precipitated withdrawal, in concert with the uncertainty and unpredictability of HPSOs, overdose reversal strategies and agents that rapidly restore and sustain respiration should be aggressively implemented,” they wrote.The panel concluded by calling for greater research and real-world evidence collection around treatments for HPSO overdoses. And, to boost treatment with both naloxone and nalmefene, they “emphatically” recommended improvements to bystander education and training, greater access to reversal agents and a wide-scale destigmatization of addiction.“Only with investments in using new reversal medications, further controlled trials yielding strong evidence, adequately training bystanders and first responders, collecting outcome information, researching and developing new reversal agents, and improving access to opioid use disorder treatment and prevention will the opioid overdose epidemic be marshaled to avoid needless deaths,” they wrote.

Drug Approval

07 Apr 2025

·www.prnewswire.com

Elysium Therapeutics Announces Development of Overdose Rescue Technology Specifically Designed for Oral Fentanyl

Synthetic Opioid Overdose Prevention and Reversal (SOOPR™) targets an unmet challenge in the illicit opioid crisis as current rescue medications are not designed for synthetic opioids, including oral fentanyl. LYONS, Colo., April 7, 2025 /PRNewswire/ -- Elysium Therapeutics, an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral opioids, including synthetic opioids like fentanyl, announced its plan to accelerate development of its Synthetic Opioid Overdose Prevention and Reversal (SOOPR™) technology. The company has completed in vivo proof-of-concept studies and expects to file an Investigational New Drug (IND) application in 2026. SOOPR is a rapid-onset, long-acting rescue agent specifically designed to address overdose from synthetic opioids, including oral fentanyl. SOOPR utilizes a proprietary long-acting naloxone prodrug formulation with faster onset kinetics versus Narcan® delivered via long-acting injection (LAI) technology. The technology is designed to rapidly restore respiration and provide 18 to 24 hours of effective opioid blockade to minimize the risk of re-narcotization, while also providing protection from same-day re-use of opioids. "Fentanyl overdoses often require very high, or repeated, doses of short-acting opioid antagonists to effect a successful rescue," said Greg Sturmer, Co-Founder and CEO of Elysium Therapeutics. "Unfortunately, many who overdose face a rapid recurrence of symptoms, known as re-narcotization, which can lead to respiratory depression and increase the likelihood of hypoxic brain injury or death. SOOPR is designed to address this situation, and Elysium is now focused on advancing its development as a potential first-ever, faster-onset, longer-acting opioid rescue therapy specifically intended to treat fentanyl overdose." Currently approved short-acting opioid antagonists like Narcan and Opvee® were designed to effectively counteract overdoses from opioids such as heroin and oxycodone. However, these rescue agents are frequently ineffective in the management of synthetic opioid overdoses1, with 20 to 45% of overdose victims initially rescued with naloxone experiencing a re-narcotization event. According to reports from multiple state-affiliated health agencies, 31 to 39% of fentanyl overdose decedents had been administered naloxone.2 Data from in vivo proof-of-concept studies of SOOPR demonstrated a more rapid onset of action versus naloxone (Narcan) and a significantly longer duration of action. This profile is especially useful in counteracting oral fentanyl overdoses associated with prolonged fentanyl absorption and exposure that often outlast the short-acting profile of Narcan. "In designing SOOPR, Elysium recognized that synthetic opioids – now the number one killer of adults aged 18 to 45 in the U.S. – are particularly lethal," said Tom Jenkins, Ph.D., Co-Founder and Chief Scientific Officer of Elysium Therapeutics. "Patients initially treated with a rapid-acting, long-duration reversal agent, such as SOOPR, are expected to have less risk of hypoxic brain injury, cardiovascular events, re-narcotization, and death. Further, rescue interventions with SOOPR are expected to require less intensive monitoring in both the ambulance and emergency department and increase the likelihood of survival. Additionally, SOOPR is designed to be delivered by intramuscular injection, either using a pre-filled syringe or autoinjector, which has been demonstrated to be more rapid and predictable than intranasal delivery in urgent settings, where every second counts." "In addition to preventing overdose deaths from recreational, illicit use, the Department of Defense (DOD) has made clear the importance of improving opioid overdose rescue as a needed medical countermeasure," added Sturmer. "The DOD reported that the availability of synthetic opioids, such as fentanyl and its derivatives, represents a significant threat as a chemical weapon, which could be easily disseminated as a weapon of mass destruction into air, water or food supplies, putting countless lives at risk. We look forward to working with defense and government organizations as we develop SOOPR as a tool to prevent injury and death in these worrisome scenarios." About SOOPR™ (Synthetic Opioid Overdose Prevention and Rescue) SOOPR (Synthetic Opioid Overdose Prevention and Reversal) is a rapid-onset, long-acting rescue agent specifically designed to address overdose from synthetic opioids, including oral fentanyl. SOOPR utilizes a proprietary long-acting naloxone reversal formulation with faster onset kinetics versus Narcan® delivered via long-acting injection (LAI) technology. The technology is designed to rapidly restore respiration and provide 18 – 24 hours of effective opioid blockade to minimize the risk of re-narcotization, while also providing protection from same-day re-use of opioids. SOOPR has been endorsed by first responders and OUD treatment professionals as the effective solution urgently needed to address the global opioid overdose epidemic. About Elysium Therapeutics Elysium is an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral synthetic opioids, including fentanyl. Elysium is working to establish new standards of safety in the opioid industry by developing SMART™ (Safer Medicines Alleviate Risks and Trauma) products, first- and best-in-class medicines that address the limitations and dangers associated with opioids and overdose rescue agents to reduce suffering from opioid-use disorder, opioid overdose, and acute pain. Elysium's lead technology, SOOPR™ (Synthetic Opioid Overdose Prevention and Reversal), is a long-acting opioid antagonist specifically designed to address oral synthetic opioid, including fentanyl, overdose. Tens of thousands of unnecessary overdose deaths each year exemplifies the critical shortcomings of currently available rescue agents, including naloxone and nalmefene. In addition, Elysium is developing oral-overdose protected (O2P™) hydrocodone for the treatment of moderate-to-severe acute pain. For more information, please visit . 1 Rachael Rzasa Lynn and JL Galinkin Ther Adv Drug Saf 2018, Vol. 9(1) 63–88 (Also see footnotes 8, 9, and 10 for additional discussion). 2 Watson, W.A., Steele, M.T., Muelleman, R.L., Rush, M.D., 1998. Opioid toxicity recurrence after an initial response to naloxone. J. Toxicol. Clin. Toxicol. 36 (1-2), 11–17. . SOURCE Elysium Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

07 Apr 2025

·www.prnewswire.com

Viatris Statement on Nationwide Settlement to Resolve Opioid-Related Claims

PITTSBURGH, April 7, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) (the "Company") today announced it has reached a nationwide settlement framework to resolve opioid-related claims by states, local governments, and Tribes against the Company and certain of its subsidiaries. While the Company's presence in the U.S. opioids market is very small, the Company has agreed to this settlement to provide closure on these matters. This settlement is in no way an admission of wrongdoing or liability. Under the agreed upon framework, depending on the level of participation in the settlement, the Company would pay up to a maximum of $335 million, consisting of annual payments over a nine-year period of between approximately $27.5 and $40 million each, to help support state and local efforts to address opioid-related issues. The Company had already accrued an estimate in respect of a potential settlement, which is reflected in the Company's annual report on Form 10-K for the year ended December 31, 2024. The Company will also continue its longstanding role of working to identify solutions to address pressing public health challenges like those relating to opioids. For example, the Company manufactures a generic injectable version of the life-saving overdose reversal drug, naloxone, as well as a generic buprenorphine/naloxone product used for the treatment of opioid addiction. The Company is also developing a novel delivery for meloxicam, a non-opioid pain medication. The settlement enables the Company to further focus on its mission of empowering people worldwide to live healthier at every stage of life, advance its efforts to address unmet patient needs through an expanded innovative portfolio and continue to serve approximately 1 billion patients annually with its diverse portfolio of medicines. About Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements regarding the Company's nationwide settlement framework to resolve opioid-related claims by states, local governments, and Tribes against the Company and certain of its subsidiaries; under the agreed upon framework, depending on the level of participation in the settlement, the Company would pay up to a maximum of $335 million, consisting of annual payments over a nine-year period of between approximately $27.5 and $40 million each, to help support state and local efforts to address opioid-related issues; that the Company will also continue its longstanding role of working to identify solutions to address pressing public health challenges like those relating to opioids; the Company is also developing a novel delivery for meloxicam, a non-opioid pain medication; and that the settlement enables the Company to further focus on its mission of empowering people worldwide to live healthier at every stage of life, advance its efforts to address unmet patient needs through an expanded innovative portfolio and continue to serve approximately 1 billion patients annually with its diverse portfolio of medicines. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the inability or unwillingness on the part of any of the parties to agree to a final settlement; any legal or regulatory challenges to the settlement; the level of participation by litigants or claimants in the settlement framework; any failure by third parties to comply with their contractual obligations; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, tariffs and trade policies, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

100 Deals associated with Naloxone hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01340	Naloxone hydrochloride	A06AH04 V03AB15	DB01183

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Lymphoblastic Leukemia	Canada	Hikma Pharmaceuticals LLC	01 Feb 2025
Opiate Overdose	Canada	Eli Lilly Canada, Inc.	03 Oct 2016

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute Lymphoblastic Leukemia	NDA/BLA	-	Hikma Pharmaceuticals LLC	-
Pain	Phase 1	Belgium	Mundipharma Pharmaceuticals BV	01 Jun 2009
Pain	Phase 1	Netherlands	Mundipharma Pharmaceuticals BV	01 Jun 2009
Opiate Overdose	Phase 1	United States	Emergent Devices, Inc.	13 Apr 1971
Opioid abuse	Preclinical	United States	Consegna Pharma, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03751111 (CTgov)	Phase 1/2	Pruritus \| Pruritus Ani	126	Naloxone (Naloxone)	cegcvygkzz(fmwfdubxwv) = ommsxsvdhy tdwsgxkzyn (hwwwclbpip, iftcykuldx - lrefdgdhcv) View more	-	20 Apr 2025
				Placebo (Placebo)	cegcvygkzz(fmwfdubxwv) = czojdsysow tdwsgxkzyn (hwwwclbpip, gcdliptxjh - hhmmgrcikj) View more
NCT04473950 (CTgov)	Phase 1	Opioid-Related Disorders \| Chronic Pain	10	Placebo+Naloxone Hydrochloride (Pain Group)	znnwbppfqi(sexcwamgul) = iqleyarhri htexpuprqh (qvffngxvns, otavtzdsjn - xtgfmvmvdu) View more	-	26 Mar 2025
				Placebo+Naloxone Hydrochloride (No Pain Group)	znnwbppfqi(sexcwamgul) = tpeqlwlvld htexpuprqh (qvffngxvns, xpdgqcctcx - yiemtyuldt) View more
NCT03176316 (FusionIleus, CTgov)	Phase 4	Ileus	53	naloxone	(ysvqtdulxs) = fhyhdlhgld bbsssyhxxb (wrdprlnnxj, fdvenhjzem - gelxjeflqg) View more	-	01 Jul 2024
NCT03149770 (CTgov)	Phase 2	Diabetes Mellitus, Type 1 \| Hypoglycemia	30	Naloxone (Naloxone)	zgzcfnxrsx(hwohgsuuik) = lyngczeevg muvpxgrjwl (etfqnrzgez, rhwbonicky - ncdodepypw) View more	-	16 Apr 2024
				placebo (Placebo)	zgzcfnxrsx(hwohgsuuik) = czfpttufjj muvpxgrjwl (etfqnrzgez, snowkknkky - apuxudqehx) View more
NCT03570099 (Pubmed \| BMJ Open)	Not Applicable	Opiate Overdose	-	Take-home naloxone distribution	utllprarof(ztytmvetel) = uwtnvmoaah thfggmpmii (ejpbhuhtbm )	-	01 Jan 2024
				intranasal naloxone (Control period (2013-2017))	utllprarof(ztytmvetel) = xoubnbhoyb thfggmpmii (ejpbhuhtbm )
ADA2023	Not Applicable	Pure Autonomic Failure	-	Intranasal naloxone (IN)	mgigbvqkgd(retegbcjvs) = nkxlzfbkwx csewgrgsft (ctkaxfkcic ) View more	-	20 Jun 2023
				Placebo	mgigbvqkgd(retegbcjvs) = tkhfdkltqo csewgrgsft (ctkaxfkcic ) View more
NCT04713709 (Corporate Publications) Manual	Phase 1	Opiate Overdose	56	FMXIN001	(lvewkruwst) = qvceuygxvo saivvkziae (xwtjrqyczi ) View more	Similar	28 Jul 2022
				NARCAN	(lvewkruwst) = muqyzayfyw saivvkziae (xwtjrqyczi ) View more
NCT04764630 (CTgov)	Phase 1	-	21	naloxone (A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))	ylrvrybvbf(xyzfeuybow) = laagbvazru vjbjgrpldk (rszryebwtc, iriqbnkhpq - howgburcfe) View more	-	15 Jul 2022
				naloxone (C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))	ylrvrybvbf(xyzfeuybow) = jzduwfrocp vjbjgrpldk (rszryebwtc, swjxrhptfp - hbscembnve) View more
NCT02805972 (BEE, CTgov)	Phase 2	Obesity	41	Placebo+Naloxone (Placebo, Then Naloxone)	zllkuqdfza(vbmznckhst) = okgposeiln zrzcexwwnb (ltoxgftkye, cdpcjoyarv - bwdxqqlwef) View more	-	03 Nov 2021
				Placebo+Naloxone (Naloxone, Then Placebo)	zllkuqdfza(vbmznckhst) = uwewevplph zrzcexwwnb (ltoxgftkye, lqupgupluz - faipuizgcv) View more
NCT02469077 (CTgov)	Not Applicable	Chronic Pain	117	Placebo+naloxone+Morphine (6 Week Aerobic Exercise Intervention)	zqtudgmksj(jzdvtbzoio) = iaslduyzus rjoymdhima (ihkphlpbdb, pbiratkoap - yoxtqiumxx) View more	-	23 Sep 2020
				Placebo+naloxone+Morphine (Normal Exercise (Control))	zqtudgmksj(jzdvtbzoio) = clrsvbptpn rjoymdhima (ihkphlpbdb, cgihkysvnm - cxilpyanrs) View more

Translational Medicine

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis