Naloxone

also known as Naloxone Hydrochloride · Naloxone HCl · Naloxone: Narcan · Narcan · Anhydrous naloxone hydrochloride · Dbl naloxone · EN-15304 · Evzio · +36 more

Small molecule

Developed for: opiate dependence · substance-related disorder · acute opioid poisoning · chronic pain syndrome · heroin dependence · constipation disorder · cancer · type 1 diabetes mellitus
+19 more
· opioid-induced constipation · substance withdrawal syndrome · morphine dependence · poisoning · respiratory underresponsiveness to hypoxia and hypercapnia · substance abuse · cardiac arrest · epilepsy · ileus · osteoarthritis · stroke disorder · binge eating disorder · diabetic polyneuropathy · dyskinesia of esophagus · interstitial cystitis · mycosis fungoides · Parkinson disease · pathological gambling · Sezary syndrome
Investigated by: National Institute on Drug Abuse (NIDA) · Indivior Inc. · Norwegian University of Science and Technology · St. Olavs Hospital · New York State Psychiatric Institute · Johns Hopkins University
+120 more
· Mundipharma Research GmbH & Co KG · University of California, Los Angeles · University of California, San Francisco · Food and Drug Administration (FDA) · Mundipharma (China) Pharmaceutical Co. Ltd · Mundipharma Korea Ltd · National Center for Complementary and Integrative Health (NCCIH) · University of Arkansas · University of Kentucky · University of Pennsylvania · Vanderbilt University Medical Center · Yale University · Albert Einstein College of Medicine · INSYS Therapeutics Inc · Kuopio University Hospital · Massachusetts General Hospital · Merck Sharp & Dohme LLC · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Purdue Pharma LP · Rigshospitalet, Denmark · The University of Texas Health Science Center, Houston · US Department of Veterans Affairs · University of Alabama at Birmingham · University of California, San Diego · University of Colorado, Denver · University of Minnesota · University of Washington · VA Office of Research and Development · mads u werner · A/S Den norske Eterfabrikk · Academic Health Science Centres · Alkermes, Inc. · Bausch Health Americas, Inc. · BioDelivery Sciences International · Boehringer Ingelheim · Braeburn Pharmaceuticals · CAMC Health System · Centre for Addiction and Mental Health · Children's Mercy Hospital Kansas City · DEKA S.r.l. · Dana-Farber Cancer Institute · Dartmouth-Hitchcock Medical Center · Develco Pharma Schweiz AG · Emergent BioSolutions · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · French National Institute of Health and Medical Research · Henan Cancer Hospital · Ho Chi Minh City CDC · Hospices Civils de Lyon · Institute of Applied Medicine and Epidemiology (IMEA) · International Collaboration on Repair Discoveries · International Pain and Spine Intervention Society · Isfahan University of Medical Sciences · Johnson County ClinTrials · Judith Feinberg · King's College London · Kyungpook National University Hospital · Leiden University Medical Center · Lifespan · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Loyola University · Mahidol University · Massachusetts General Hospital · Mclean Hospital · Medical University of South Carolina · Middle Tennessee Research Institute · Mundipharma Oy · Mundipharma Pharmaceuticals B.V. · Napp Pharmaceuticals Limited · National Cancer Institute (NCI) · National Center for Advancing Translational Sciences (NCATS) · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Drug Abuse · National Institute on Aging (NIA) · all 126 on the full record

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed acute opioid poisoning 2 milestones
Filed	US (FDA)	NARCAN	acute opioid poisoning	2023-02-27	“FDA has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg” amneal.com ↗ “acceptance and priority review of supplemental New Drug Application for NARCAN® (naloxone HCl) Nasal Spray 4 mg” emergentbiosolutions.com ↗
Filed	US (FDA)	NARCAN	acute opioid poisoning	2022-12-06	“FDA has accepted for review its supplemental New Drug Application (sNDA) for NARCAN® (naloxone HCI) Nasal Spray” emergentbiosolutions.com ↗
Approved Indication not stated 5 milestones
Label expansion	US (FDA)	REXTOVY	—	2026-06-16	fda.gov ↗
Label expansion	US (FDA)	KLOXXADO	—	2025-08-25	fda.gov ↗
Label expansions (3)	US (FDA)	NARCAN	—	1992-05-29 – 2023-03-29	fda.gov ↗
Approved	EU (EMA)	Suboxone	—	2006-09-26	europa.eu ↗
Approved	US (FDA)	NARCAN	—	1971-04-13	fda.gov ↗

Trials 147 · started per year

today

US approved 1971

EU approved 2006

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Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 010 trials · 1 missed
Phase 0	NCT04650841	Sep 2026 → Mar 2027 expected	—	Trustees of Dartmouth College	Not yet recruiting	No outcome recorded
Phase 0	NCT05490134	Mar 2023 → Jan 2027 expected	pain agnosia	Medical University of South Carolina	Recruiting	No outcome recorded
Phase 0	NCT05099614	Mar → Apr 2021	acute opioid poisoning	University of Washington	Completed	No outcome recorded
Phase 0	NCT04034004	Jan 2021 → Dec 2022	—	University of California, San Diego	Completed	Missed primary
Phase 0	NCT04744883	Aug 2020 → Nov 2024 overdue	chronic pain syndrome	Rush University Medical Center	Active not recruiting	No outcome recorded
Phase 0	NCT03743805	Jan 2019 → Jul 2021	acute opioid poisoning, brain hypoxia - ischemia, cardiac arrest	Prisma Health-Midlands	Withdrawn	No outcome recorded
Phase 0	NCT03766893	Sep → Dec 2018	opiate dependence	Lifespan	Completed	No outcome recorded
Phase 0	NCT03096353	Aug 2017 → Oct 2018	—	National Center for Complementary and Integrative Health (NCCIH)	Completed	No outcome recorded
Phase 0	NCT03419858	Mar → Jun 2017	—	University of California, San Diego	Completed	No outcome recorded
Phase 0	NCT01591629	Nov 2011 → Jun 2012	—	Yale University	Completed	No outcome recorded
Phase 131 trials · 2 met primary
Phase 1	NCT04975334	Jun → Sep 2025	hypogonadotropic hypogonadism	Massachusetts General Hospital	Completed	No outcome recorded
Phase 1	NCT07180420	Mar → Apr 2024	—	STAT Therapeutics Inc	Completed	No outcome recorded
Phase 1	NCT06306391	Mar → May 2024	—	Parc de Salut Mar	Completed	No outcome recorded
Phase 1	NCT05528848	Sep 2022 → Sep 2027 expected	substance-related disorder	University of Pennsylvania	Active not recruiting	No outcome recorded
Phase 1	NCT05338632	Jun 2022 → Aug 2026 overdue	respiratory underresponsiveness to hypoxia and hypercapnia, substance-related disorder	Leiden University Medical Center	Recruiting	Mixed
Phase 1	NCT04975347	Jun 2022 → Aug 2025	reproductive system disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 1	NCT05377255	Mar → May 2022	acute opioid poisoning	Emergent BioSolutions	Completed	No outcome recorded
Phase 1	NCT04764630	Mar 2021	—	Food and Drug Administration (FDA)	Completed	Met primary
Phase 1	NCT05264493	Oct 2020 → Jan 2021	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT04454281	Oct → Dec 2020	dry eye syndrome, neuropathy, painful	Seema Capoor	Completed	No outcome recorded
Phase 1	NCT04473950	Jan 2020 → Oct 2022	chronic pain syndrome, opiate dependence	University of California, San Francisco	Terminated	No outcome recorded
Phase 1	NCT03827642	Apr → May 2018	—	INSYS Therapeutics Inc	Completed	No outcome recorded
Phase 1	NCT03386591	Jan → Feb 2018	opiate dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 1	NCT03827629	Aug 2017	—	INSYS Therapeutics Inc	Completed	No outcome recorded
Phase 1	NCT02733822	Jun 2016 → Jun 2017	substance-related disorder	King's College London	Unknown	No outcome recorded
Phase 1	NCT02598856	Mar → Dec 2016	—	Norwegian University of Science and Technology	Completed	No outcome recorded
Phase 1	NCT03851731	Oct → Nov 2015	substance-related disorder	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 1	NCT02572089	Oct 2014 → Jan 2015	substance-related disorder	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 1	NCT02880475	Jun 2014 → Jun 2015	chronic pain syndrome	Mundipharma (China) Pharmaceutical Co. Ltd	Completed	No outcome recorded
Phase 1	NCT01952782	Apr 2014 → May 2016	hypogonadotropic hypogonadism	Massachusetts General Hospital	Completed	No outcome recorded
Phase 1	NCT02158117	Mar → Nov 2014	—	Norwegian University of Science and Technology	Completed	No outcome recorded
Phase 1	NCT01935206	Jun → Nov 2013	—	Rigshospitalet, Denmark	Completed	No outcome recorded
Phase 1	NCT02070718	Jan → Jul 2013	—	University of Washington	Completed	Met primary
Phase 1	NCT01396005	Sep → Dec 2011	hepatitis C virus infection	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT01068847	Feb 2010 → Oct 2012	drug dependence	University of Arkansas	Completed	No outcome recorded
Phase 1	NCT00750048	Sep → Nov 2008	—	University Hospital, Clermont-Ferrand	Completed	No outcome recorded
Phase 1	NCT00733239	Aug 2008 → Oct 2010	opiate dependence	University of Arkansas	Completed	No outcome recorded
Phase 1	NCT00733720	Aug → Dec 2008	cocaine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 1	NCT00593463	Sep 2006 → May 2010	drug dependence	University of Arkansas	Completed	No outcome recorded
Phase 1	NCT01367561	Oct 2002 → May 2003	—	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 1	NCT00015288	Nov 1996 → ?	heroin dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded

Phase 1/23 trials
Phase 1/2	NCT03751111	Feb → Mar 2019	—	Xiangya Hospital of Central South University	Completed	No outcome recorded
Phase 1/2	NCT02700048	Jun 2016 → Jul 2021	type 1 diabetes mellitus	University of Minnesota	Terminated	No outcome recorded Stop: Business
Phase 1/2	NCT02307721	Dec 2014 → Apr 2015	—	Norwegian University of Science and Technology	Completed	No outcome recorded
Phase 226 trials · 2 met primary
Phase 2	NCT04737603	Jul 2025	opiate dependence	University of California, Davis	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT04480554	Jan 2023 → Jun 2025	HIV infectious disease, opiate dependence	University of Pennsylvania	Terminated	No outcome recorded Stop: Business
Phase 2	NCT05114460	Nov 2021 → Oct 2024	acute opioid poisoning	New York State Psychiatric Institute	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03420313	Mar 2018 → Jul 2021	opiate dependence	University of Vermont	Unknown	Met primary
Phase 2	NCT02976337	Oct 2017 → Nov 2023	—	mads u werner	Completed	No outcome recorded
Phase 2	NCT03149770	Sep 2017 → May 2022	type 1 diabetes mellitus	University of Minnesota	Completed	No outcome recorded
Phase 2	NCT02805972	May 2017 → Jul 2018	obesity disorder	University of California, San Francisco	Completed	No outcome recorded
Phase 2	NCT02684669	Feb → Sep 2016	—	mads u werner	Completed	No outcome recorded
Phase 2	NCT01992146	Nov → Dec 2015	—	Rigshospitalet, Denmark	Completed	No outcome recorded
Phase 2	NCT02137213	Aug 2014 → Mar 2015	constipation disorder	Centre for Addiction and Mental Health	Completed	No outcome recorded
Phase 2	NCT02267304	Oct 2013 → Aug 2016	—	French National Institute of Health and Medical Research	Completed	No outcome recorded
Phase 2	NCT01939444	Aug 2013 → Oct 2014	—	Norwegian University of Science and Technology	Completed	No outcome recorded
Phase 2	NCT01582347	Mar → Nov 2012	opiate dependence	Indivior Inc.	Completed	No outcome recorded
Phase 2	NCT00984334	Oct 2009 → Jan 2012	chronic pain syndrome, opioid-induced constipation	S.L.A. Pharma AG	Completed	No outcome recorded
Phase 2	NCT00678145	Mar 2008 → Aug 2018	autonomic nervous system disorder, hypoglycemia, type 1 diabetes mellitus	Albert Einstein College of Medicine	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00640835	Feb → Oct 2008	opiate dependence	Indivior Inc.	Completed	No outcome recorded
Phase 2	NCT01293058	Mar → Jun 2007	acute opioid poisoning	Isfahan University of Medical Sciences	Completed	No outcome recorded
Phase 2	NCT01967641	Nov 2005 → Jun 2011	opiate dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT00125931	Sep 2005 → Aug 2008	bipolar disorder	Mclean Hospital	Completed	Met primary
Phase 2	NCT00142896	Feb → Dec 2005	opiate dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2	NCT00149539	Jun 2004 → Jan 2006	substance-related disorder	National Institute on Drug Abuse (NIDA)	Terminated	No outcome recorded Stop: Business
Phase 2	NCT00330343	May 2004 → Jun 2009	—	Johns Hopkins University	Completed	No outcome recorded
Phase 2	NCT00108446	Oct 2003 → Mar 2006	irritable bowel syndrome	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 2	NCT00000331	Dec 2002	heroin dependence	University of Colorado, Denver	Withdrawn	No outcome recorded
Phase 2	NCT00000328	Jul → Aug 1997	heroin dependence	University of Colorado, Denver	Withdrawn	No outcome recorded
Phase 2	NCT00000298	Aug 1995 → ?	substance-related disorder	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded

Phase 2/33 trials · 1 missed
Phase 2/3	NCT05011266	Apr 2023 → Jan 2027 expected	opiate dependence	New York State Psychiatric Institute	Recruiting	No outcome recorded
Phase 2/3	NCT02581111	Sep 2015 → Sep 2017	—	Washington University School of Medicine	Completed	Missed primary
Phase 2/3	NCT00992576	Jan 2010 → Nov 2011	constipation disorder	Mundipharma Research GmbH & Co KG	Completed	No outcome recorded
Phase 322 trials · 5 met primary · 3 missed
Phase 3	NCT03678792	Nov 2019 → Sep 2020	opiate dependence, substance withdrawal syndrome	University of Alabama at Birmingham	Withdrawn	No outcome recorded
Phase 3	NCT03711318	Nov 2018 → Dec 2021	heroin dependence	New York State Psychiatric Institute	Terminated	No outcome recorded
Phase 3	NCT03518021	May 2018 → Oct 2020	acute opioid poisoning, substance abuse	Norwegian University of Science and Technology	Completed	Missed primary
Phase 3	NCT03687268	Jul 2017 → Nov 2019	opioid-induced constipation	Develco Pharma Schweiz AG	Unknown	No outcome recorded
Phase 3	NCT02651584	Dec 2015 → Oct 2016	opiate dependence	Braeburn Pharmaceuticals	Completed	Met primary
Phase 3	NCT02332447	Jun 2015 → Jul 2020	epilepsy	Hospices Civils de Lyon	Completed	No outcome recorded
Phase 3	NCT02109640	Oct 2014 → Aug 2015	—	University of Edinburgh	Completed	Missed primary
Phase 3	NCT01918098	Sep 2013 → Mar 2017	—	Mundipharma (China) Pharmaceutical Co. Ltd	Completed	Met primary
Phase 3	NCT01885182	Jun 2013 → Aug 2015	cancer	Mundipharma (China) Pharmaceutical Co. Ltd	Completed	No outcome recorded
Phase 3	NCT01438567	Sep 2011 → Feb 2014	constipation disorder	Mundipharma Research GmbH & Co KG	Completed	No outcome recorded
Phase 3	NCT01427270	Aug 2011 → Oct 2014	—	Purdue Pharma LP	Completed	No outcome recorded
Phase 3	NCT01358526	May 2011 → Oct 2012	—	Purdue Pharma LP	Completed	Met primary
Phase 3	NCT01112644	Apr 2010 → Jun 2011	—	Mundipharma Research GmbH & Co KG	Completed	Met primary
Phase 3	NCT01167699	Jun 2009 → Apr 2011	—	Mundipharma Pharmaceuticals B.V.	Completed	No outcome recorded
Phase 3	NCT01760473	May 2009 → Dec 2014	heroin dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 3	NCT00679614	Dec 2007 → May 2011	—	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Completed	No outcome recorded
Phase 3	NCT00412100	Apr 2006 → Jul 2008	—	Mundipharma Research GmbH & Co KG	Completed	Met primary
Phase 3	NCT00286052	Dec 2002 → Aug 2004	substance-related disorder	University of Texas Southwestern Medical Center	Completed	Missed primary
Phase 3	NCT00032955	Feb 2001 → Aug 2002	heroin dependence, morphine dependence, substance withdrawal syndrome	University of California, Los Angeles	Completed	No outcome recorded
Phase 3	NCT00032968	Jan 2001 → Aug 2002	heroin dependence, morphine dependence, substance withdrawal syndrome	University of California, Los Angeles	Completed	No outcome recorded
Phase 3	NCT00020605	May 2000 → ?	cancer of unknown primary site, constipation disorder	Dana-Farber Cancer Institute	Unknown	No outcome recorded
Phase 3	NCT01713803	? → May 2017	opiate dependence	BioDelivery Sciences International	Withdrawn	No outcome recorded

Phase 434 trials · 4 met primary · 4 missed
Phase 4	NCT06897917	Apr → Dec 2025 overdue	opioid-induced constipation	Henan Cancer Hospital	Not yet recruiting	No outcome recorded
Phase 4	NCT06666621	Aug 2024 → Oct 2025 overdue	arthritic joint disease	Middle Tennessee Research Institute	Recruiting	No outcome recorded
Phase 4	NCT05876572	Aug → Dec 2024	acute opioid poisoning	Johns Hopkins University	Withdrawn	No outcome recorded
Phase 4	NCT05142267	Mar 2022 → Feb 2026	substance-related disorder	Vanderbilt University Medical Center	Completed	No outcome recorded
Phase 4	NCT04303000	Jul 2021 → Jan 2022	acute opioid poisoning	University of Alabama at Birmingham	Completed	No outcome recorded
Phase 4	NCT04811014	Apr 2021 → Aug 2030 expected	acute opioid poisoning, opiate dependence	The University of Texas Health Science Center, Houston	Recruiting	No outcome recorded
Phase 4	NCT04375033	Nov 2020 → Sep 2028 expected	substance-related disorder	VA Office of Research and Development	Recruiting	No outcome recorded
Phase 4	NCT04088266	Jan → Dec 2020	—	Teva Pharmaceuticals USA	Withdrawn	No outcome recorded
Phase 4	NCT03179475	Sep 2019 → Nov 2021	chronic pain syndrome	University of British Columbia	Completed	No outcome recorded
Phase 4	NCT03908437	Jul 2019 → Mar 2022	opiate dependence, poisoning	University of Pennsylvania	Completed	No outcome recorded
Phase 4	NCT03608163	Jan → Aug 2019	hypoglycemia, type 1 diabetes mellitus	Albert Einstein College of Medicine	Terminated	No outcome recorded
Phase 4	NCT03740243	Nov 2018 → Mar 2020	substance-related disorder	Stony Brook University	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT05301712	Aug 2018 → Oct 2022	stroke disorder	Samjin Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 4	NCT03396276	Apr 2018 → Aug 2030 expected	substance-related disorder	The University of Texas Health Science Center, Houston	Enrolling by invitation	No outcome recorded
Phase 4	NCT03176316	Sep 2017 → Feb 2020	ileus	Loyola University	Terminated	No outcome recorded
Phase 4	NCT02885948	Apr 2016 → Dec 2017	respiratory underresponsiveness to hypoxia and hypercapnia	University College Dublin	Completed	Met primary
Phase 4	NCT01875848	Dec 2013 → Jun 2015	—	VA Office of Research and Development	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02038790	Nov 2013	opiate dependence	Indivior Inc.	Completed	Missed primary
Phase 4	NCT01912573	Sep 2013 → Sep 2014	—	Judith Feinberg	Unknown	No outcome recorded
Phase 4	NCT01675531	Dec 2012 → Dec 2013	cancer	Mundipharma Korea Ltd	Completed	No outcome recorded
Phase 4	NCT01846455	Sep 2012 → Apr 2013	chronic hepatitis C virus infection, liver failure	Indivior Inc.	Completed	No outcome recorded
Phase 4	NCT01719757	Jul 2012 → Oct 2013	cancer	Mundipharma Korea Ltd	Completed	No outcome recorded
Phase 4	NCT02573922	May 2012 → Dec 2014	constipation disorder	Kuopio University Hospital	Completed	Missed primary
Phase 4	NCT01313780	May 2011 → Oct 2013	cancer	Mundipharma Korea Ltd	Completed	Met primary
Phase 4	NCT01083485	Mar → Oct 2010	—	Mundipharma Oy	Completed	Met primary
Phase 4	NCT00955162	Aug 2009 → May 2010	opiate dependence	Indivior Inc.	Completed	No outcome recorded
Phase 4	NCT00879996	Apr 2009 → Oct 2011	opiate dependence	State University of New York at Buffalo	Completed	Missed primary
Phase 4	NCT00901875	Mar → Nov 2009	opiate dependence	Indivior Inc.	Completed	No outcome recorded
Phase 4	NCT00784810	Feb 2009 → Mar 2010	osteoarthritis	Napp Pharmaceuticals Limited	Completed	Met primary
Phase 4	NCT00604188	Feb 2008 → Dec 2009	opiate dependence	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 4	NCT00799201	Aug 2007 → Oct 2012	constipation disorder	CAMC Health System	Terminated	No outcome recorded
Phase 4	NCT00684073	Jul → Dec 2007	opiate dependence, substance abuse	Indivior Inc.	Completed	Missed primary
Phase 4	NCT00315341	Apr 2006 → Aug 2010	opiate dependence	University of California, Los Angeles	Completed	No outcome recorded
Phase 4	NCT00007527	Aug 1999 → Jan 2002	opiate dependence	US Department of Veterans Affairs	Completed	No outcome recorded

Phase not applicable18 trials · 2 met primary
—	NCT05360030	May → Dec 2022	chronic pain syndrome	Second Affiliated Hospital, School of Medicine, Zhejiang University	Completed	No outcome recorded
—	NCT04518618	Sep 2020 → Mar 2021	—	Tanta University	Completed	No outcome recorded
—	NCT02469077	Aug 2015 → Sep 2019	chronic pain syndrome	Vanderbilt University Medical Center	Completed	Mixed
—	NCT02405988	Apr 2015 → Feb 2016	—	Norwegian University of Science and Technology	Completed	No outcome recorded
—	NCT02856087	Nov 2014 → Apr 2015	—	Seoul National University Hospital	Completed	Met primary
—	NCT02416115	Jul → Sep 2014	—	Kyungpook National University Hospital	Completed	No outcome recorded
—	NCT01160432	May → Jul 2013	opiate dependence	Kuopio University Hospital	Withdrawn	No outcome recorded
—	NCT01531439	Nov 2011 → May 2015	scoliosis	Children's Mercy Hospital Kansas City	Completed	No outcome recorded
—	NCT00947284	Jan 2010 → Jun 2012	—	University of California, San Francisco	Terminated	No outcome recorded
—	NCT00958919	Aug 2009 → Aug 2010	chronic obstructive pulmonary disease	Dartmouth-Hitchcock Medical Center	Completed	Met primary
—	NCT00890942	May → Oct 2009	poisoning	Mahidol University	Completed	No outcome recorded
—	NCT00679458	Sep 2008 → Nov 2009	—	University of California, Los Angeles	Completed	No outcome recorded
—	NCT00716807	Jan 2008 → Jun 2010	burning mouth syndrome, temporomandibular joint dysfunction syndrome	University of California, San Francisco	Terminated	No outcome recorded Stop: Enrollment
—	NCT00486330	May 2006 → May 2007	HIV infectious disease	Yale University	Completed	No outcome recorded
—	NCT00184938	Jan 2005 → ?	ischemic disease	Radboud University Medical Center	Suspended	No outcome recorded
—	NCT00134888	Dec 2000 → Nov 2002	opiate dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
—	NCT00134875	Dec 2000 → Dec 2002	substance-related disorder	National Institute of Allergy and Infectious Diseases (NIAID)	Terminated	No outcome recorded
—	NCT00158236	Jan 1997 → Mar 1998	opioid abuse	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded

Comparator or background therapy78 trials
Phase 0	NCT06726200 Comparator	Feb 2026 → Jan 2029 expected	substance-related disorder	Rachel R. Luba	Recruiting	No outcome recorded
Phase 0	NCT03489161 Background	Aug 2018	opiate dependence, substance withdrawal syndrome	Virginia Commonwealth University	Completed	No outcome recorded
Phase 1	NCT06406400 Background	May → Jul 2024	opiate dependence	AstraZeneca	Terminated	No outcome recorded
Phase 1	NCT06719986 Comparator	Oct → Dec 2022	acute opioid poisoning	Purdue Pharma LP	Completed	No outcome recorded
Phase 1	NCT04828005 Comparator	Mar 2021 → Mar 2022	—	Opiant Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT05363501 Comparator	Jan 2021 → Apr 2022	acute opioid poisoning	Pocket Naloxone Corp	Completed	No outcome recorded
Phase 1	NCT04447287 Background	Jun → Nov 2020	substance-related disorder	Astellas Pharma Global Development, Inc.	Completed	No outcome recorded
Phase 1	NCT02045693 Comparator	Feb → Apr 2014	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT01622504 Comparator	Jun → Jul 2012	acute opioid poisoning	Mitovie Pharma Ltd	Unknown	No outcome recorded
Phase 1	NCT01596764 Comparator	May → Jul 2011	intestinal obstruction	University Medicine Greifswald	Completed	No outcome recorded
Phase 1	NCT01275599 Background	Jan → Apr 2011	chronic hepatitis C virus infection, opiate dependence	Vertex Pharmaceuticals Incorporated	Completed	No outcome recorded
Phase 1	NCT00829777 Background	Mar → Sep 2009	opiate dependence	California Pacific Medical Center Research Institute	Completed	No outcome recorded
Phase 1	NCT00886002 Background	Nov 2004 → Jan 2005	—	Janssen-Cilag A.G., Switzerland	Completed	No outcome recorded
Phase 1	NCT00714558 Background	Apr → May 2003	—	Alza Corporation	Completed	No outcome recorded
Phase 1/2	NCT04851301 Comparator	Nov 2021 → Dec 2025 overdue	temporomandibular joint disorder	University of Maryland, Baltimore	Active not recruiting	No outcome recorded
Phase 1/2	NCT04818086 Comparator	May 2021 → Apr 2023	substance-related disorder	Virginia Commonwealth University	Completed	No outcome recorded
Phase 1/2	NCT03580902 Background	Jan 2019 → Nov 2021	opiate dependence	CBT4CBT, LLC	Completed	No outcome recorded
Phase 1/2	NCT01188421 Comparator	Oct 2010 → Jun 2015	opiate dependence	Johns Hopkins University	Completed	Missed primary
Phase 2	NCT06251609 Comparator	Mar 2027 → Feb 2029 expected	acute opioid poisoning, cardiac arrest	University of California, San Francisco	Not yet recruiting	No outcome recorded
Phase 2	NCT07459166 Comparator	May → Jul 2026 overdue	acute opioid poisoning	Clear Scientific, Inc.	Recruiting	No outcome recorded
Phase 2	NCT03066739 Comparator	Feb 2023 → Dec 2024	—	University of California, Irvine	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03744663 Comparator	Jun → Dec 2022	substance-related disorder	Wake Forest University Health Sciences	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT05027919 Background	Dec 2021 → Nov 2026 expected	opiate dependence, substance withdrawal syndrome	University of Maryland, Baltimore	Recruiting	No outcome recorded
Phase 2	NCT03897998 Comparator	Nov 2021 → Dec 2025	—	University of Maryland, Baltimore	Completed	No outcome recorded
Phase 2	NCT03430180 Comparator	Feb 2018 → Aug 2019	pathological gambling	Finnish Institute for Health and Welfare	Unknown	No outcome recorded
Phase 2	NCT03223896 Comparator	Feb → Jun 2017	pathological gambling, substance-related disorder	Finnish Institute for Health and Welfare	Completed	No outcome recorded
Phase 2	NCT02307305 Background	Aug 2014 → Dec 2016	neuropathy, painful	Hanyang University Seoul Hospital	Unknown	No outcome recorded
Phase 2	NCT02044094 Background	Nov 2013 → Jul 2014	substance-related disorder	Indivior Inc.	Completed	No outcome recorded
Phase 2	NCT01666119 Background	Aug 2012 → Jan 2013	opiate dependence	BioDelivery Sciences International	Completed	No outcome recorded
Phase 2	NCT01197261 Comparator	Sep 2010 → Mar 2013	interstitial cystitis	Mundipharma Research GmbH & Co KG	Completed	No outcome recorded
Phase 2	NCT00944697 Comparator	Jul 2009 → Mar 2010	diabetic polyneuropathy	Mundipharma Research GmbH & Co KG	Completed	No outcome recorded
Phase 2	NCT01218984 Background	Mar 2002 → May 2003	opiate dependence	Alkermes, Inc.	Completed	No outcome recorded
Phase 2	NCT00000236 Background	—	substance-related disorder	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2/3	NCT07806565 Comparator	Jan 2027 → Jan 2030 expected	cardiac arrest	Region Skane	Not yet recruiting	No outcome recorded
Phase 2/3	NCT04893525 Comparator	Jul 2021 → Dec 2027 expected	substance-related disorder	University of British Columbia	Recruiting	No outcome recorded
Phase 2/3	NCT02321397 Comparator	Nov 2014 → Mar 2016	—	Mundipharma Research GmbH & Co KG	Completed	No outcome recorded
Phase 2/3	NCT01567670 Comparator	Aug 2011 → Jun 2012	binge eating disorder	Lightlake Sinclair Ltd.	Unknown	No outcome recorded
Phase 2/3	NCT01071057 Comparator	Dec 2010 → Apr 2013	—	University of British Columbia	Completed	No outcome recorded
Phase 3	NCT06408714 Comparator	Aug → Dec 2024	acute opioid poisoning	University of New Mexico	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT06089707 Background	Jan 2024 → Jan 2026 overdue	opiate dependence	Johns Hopkins University	Recruiting	No outcome recorded
Phase 3	NCT03616236 Background	Jul 2022 → Aug 2026	substance-related disorder	Friends Research Institute, Inc.	Suspended	No outcome recorded Stop: Enrollment
Phase 3	NCT02811783 Comparator	Jan 2017 → Sep 2022	Sezary syndrome, mycosis fungoides	Elorac, Inc.	Terminated	No outcome recorded Stop: Business
Phase 3	NCT01717963 Comparator	Oct 2012 → Aug 2016	opiate dependence	University of Oslo	Completed	Met primary
Phase 3	NCT01439100 Comparator	Oct 2011 → Aug 2013	Parkinson disease	Mundipharma Research GmbH & Co KG	Completed	No outcome recorded
Phase 3	NCT01014559 Comparator	Feb 2010 → Jun 2011	constipation disorder	Mundipharma SAS	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01167127 Comparator	Jun 2009 → Apr 2011	—	Mundipharma Pharmaceuticals B.V.	Completed	No outcome recorded
Phase 3	NCT00710385 Comparator	Sep 2007 → Aug 2008	substance-related disorder	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 3	NCT01971632 Comparator	Jan 2005 → May 2006	—	Mundipharma Research GmbH & Co KG	Completed	No outcome recorded
Phase 4	NCT07439549 Background	Apr → Sep 2026 overdue	opiate dependence	Pouya Azar	Recruiting	No outcome recorded
Phase 4	NCT05808881 Comparator	Jun 2023 → May 2024	acute opioid poisoning	Purdue Pharma LP	Withdrawn	No outcome recorded
Phase 4	NCT05594121 Comparator	Dec 2022 → Dec 2023	opiate dependence	Royal Victoria Hospital, Canada	Unknown	No outcome recorded
Phase 4	NCT04771689 Comparator	Jul 2022 → Dec 2025	—	Massachusetts General Hospital	Withdrawn	No outcome recorded Stop: Business
Phase 4	NCT04234516 Comparator	Jan 2020 → Jun 2021	opiate dependence	New York State Psychiatric Institute	Withdrawn	No outcome recorded
Phase 4	NCT02939248 Comparator	Oct 2016 → Dec 2018	intermediate coronary syndrome	Collegium Medicum w Bydgoszczy	Completed	No outcome recorded
Phase 4	NCT02516059 Comparator	Sep 2015 → Feb 2017	urinary bladder cancer	Insel Gruppe AG, University Hospital Bern	Completed	No outcome recorded
Phase 4	NCT02032927 Comparator	Jun 2013 → Jun 2015	chronic pain syndrome	Fondazione IRCCS Policlinico San Matteo di Pavia	Withdrawn	No outcome recorded
Phase 4	NCT01838616 Comparator	Apr 2013 → Jan 2014	neuropathy, painful	Grünenthal GmbH	Completed	Met primary
Phase 4	NCT01559454 Background	Feb 2012 → May 2014	—	State University of New York at Buffalo	Completed	Missed primary
Phase 4	NCT01816581 Comparator	Jul 2011 → May 2012	postoperative ventricular dysfunction	Medical University of Vienna	Completed	No outcome recorded
Phase 4	NCT01374763 Comparator	Jul → Dec 2011	—	Kati Järvelä	Completed	No outcome recorded
Phase 4	NCT01191645 Comparator	Oct → Nov 2010	dyskinesia of esophagus	Region Örebro County	Completed	No outcome recorded
Phase 4	NCT01109511 Comparator	Mar 2010 → Jun 2011	opioid-induced constipation	Ullevaal University Hospital	Completed	No outcome recorded
Phase 4	NCT00921765 Comparator	Dec 2009 → Dec 2017	—	Ullevaal University Hospital	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01015066 Comparator	Nov 2009 → Jun 2014	opiate dependence	State University of New York at Buffalo	Withdrawn	No outcome recorded Stop: Business
Phase 4	NCT00605033 Comparator	Mar 2008 → Apr 2009	opiate dependence	Indivior Inc.	Completed	No outcome recorded
—	NCT06390046 Background	Apr → Dec 2024	—	Jagiellonian University	Completed	No outcome recorded
—	NCT04673812 Comparator	Dec 2020 → Mar 2021	—	Kasr El Aini Hospital	Completed	No outcome recorded
—	NCT03586466 Background	Dec 2018 → Sep 2020	opiate dependence	MedicaSafe, Inc.	Unknown	No outcome recorded
—	NCT03372486 Comparator	Dec 2017 → Apr 2018	—	Mansoura University	Completed	No outcome recorded
—	NCT02922959 Background	Feb 2017 → Jul 2019	drug dependence, substance abuse	University of Cincinnati	Completed	No outcome recorded
—	NCT03230474 Comparator	May 2016 → Feb 2017	—	Assiut University	Completed	No outcome recorded
—	NCT03014843 Comparator	Oct 2013 → Jan 2014	—	Universitaire Ziekenhuizen KU Leuven	Completed	No outcome recorded
—	NCT01851486 Comparator	Jan 2013 → Sep 2016	—	Rambam Health Care Campus	Withdrawn	No outcome recorded
—	NCT01550341 Comparator	Feb 2012 → Nov 2015	AIDS, opiate dependence	Yale University	Completed	No outcome recorded
—	NCT01549652 Background	Apr 2011 → Apr 2015	drug dependence, substance withdrawal syndrome	Stanford University	Completed	Missed primary
—	NCT01105871 Comparator	Aug 2010 → Jun 2014	—	University of Washington	Unknown	No outcome recorded
—	NCT00458419 Comparator	Sep 2005 → May 2007	chronic obstructive pulmonary disease	Dartmouth-Hitchcock Medical Center	Completed	No outcome recorded
—	NCT00249574 Background	Jun 2003 → Mar 2004	hepatitis C virus infection, heroin dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 20

Date	Issuer	Release
2026-02-12	Emergent BioSolutions	Regulatory Emergent BioSolutions Receives U.S. FDA Approval of Supplemental New Drug Application (sNDA) for NARCAN® Nasal Spray Multipacks emergentbiosolutions.com ↗ Today, Emergent BioSolutions (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for new multipack configurations of over-the-counter (OTC) NARCAN® Nasal Spray.
2026-01-14	Emergent BioSolutions	Regulatory Emergent BioSolutions Receives U.S. FDA Approval on Supplemental New Drug Application for NARCAN® Nasal Spray to be Packaged in a New Carrying Case, Making Life-Saving Naloxone More Accessible for Everyday Preparedness emergentbiosolutions.com ↗
2025-05-28	STAT Therapeutics Inc	Results Exciting news from ASCPT 2025! stattherapeutics.com ↗ We showed that IM administration of naloxone in the posterior forearm muscle is nearly the same as IM administration in the thigh muscle.
2025-03-20	Roxane Laboratories	Regulatory Hikma announces Health Canada approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg hikma.com ↗
2025-03-20	Emergent BioSolutions	Regulatory Hikma announces Health Canada approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg emergentbiosolutions.com ↗
2024-07-22	Emergent BioSolutions	Regulatory Emergent BioSolutions Announces Shelf-Life Extension for NARCAN® Nasal Spray in Canada emergentbiosolutions.com ↗ Today, Emergent BioSolutions announced the shelf-life extension for NARCAN® Nasal Spray from three years (36 months) to four years (48 months) to all newly manufactured product.
2024-06-18	Indivior Inc.	Results Indivior \| Indivior Announces the Publication of New Data on the Comparative Effectiveness of Intranasal Nalmefene and IN Naloxone in a Translational Model Assessing the Impact of a Synthetic Opioid Overdose on Respiratory Depression and Cardiac Arrest indivior.com ↗ Across scenarios of fentanyl or carfentanil overdoses, simultaneous administration of four doses of IN naloxone (4×4 mg) was needed to reduce the incidence of simulated cardiac arrest to values approaching those obtained with a single dose of OPVEE (3mg).
2024-04-24	Impax Laboratories, LLC	Regulatory Amneal Announces U.S. FDA Approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray for Emergency Treatment of an Opioid Overdose amneal.com ↗ Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the availability of Over the Counter (“OTC”) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, following Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”).
2024-03-11	Indivior Inc.	Results Indivior \| Indivior Announces Publication Demonstrating that OPVEE® (nalmefene) Nasal Spray Rapidly Reverses Effects of Opioid-Induced Respiratory Depression in Head-to-Head Study Against Intranasal Naloxone indivior.com ↗ By contrast, naloxone required 20 minutes to restore respiration to levels equaling those observed 5 minutes after OPVEE.
2023-03-29	Emergent BioSolutions	Regulatory U.S. FDA Approves Over-the-Counter Designation for Emergent BioSolutions’ NARCAN® Nasal Spray, a Historic Milestone for the Opioid Overdose Emergency Treatment emergentbiosolutions.com ↗ Today, Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved NARCAN® Naloxone HCl Nasal Spray 4 mg as an over-the-counter (OTC) emergency treatment of opioid overdose.
2023-03-02	Impax Laboratories, LLC	Regulatory Amneal Announces U.S. FDA Filing Acceptance of Abbreviated New Drug Application for Naloxone Hydrochloride Nasal Spray, USP, 4mg amneal.com ↗ Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg
2023-02-15	Emergent BioSolutions	Regulatory Emergent BioSolutions Reports FDA Advisory Committees’ Unanimous Vote in Favor of NARCAN® (naloxone HCI) Nasal Spray for Over-the-Counter Use emergentbiosolutions.com ↗
2022-12-06	Emergent BioSolutions	Regulatory Emergent BioSolutions Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for Over-the-Counter NARCAN® (naloxone HCl) Nasal Spray emergentbiosolutions.com ↗ Today, Emergent BioSolutions Inc. (NYSE:EBS) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for NARCAN® (naloxone HCI) Nasal Spray, as an over-the-counter (OTC) emergency treatment for known or suspected opioid overdose.
2021-04-13	Nasus Pharma	Results Nasus Pharma announces positive Results in Naloxone Pivotal Trial. nasuspharma.com ↗ The results of this single-dose, bioequivalence study of FMXIN001001 4 mg microspheres powder and Narcan® 4 mg/0.1 ml nasal spray showed that FMXIN001- Nasus Pharma powder-based Naloxone was absorbed significantly faster into the blood.
2020-08-17	Emergent BioSolutions	Regulatory Emergent BioSolutions Announces FDA Approval of NARCAN® (naloxone HCl) Nasal Spray Shelf Life Extension to 36 Months emergentbiosolutions.com ↗ Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the shelf life of NARCAN® (naloxone HCl) Nasal Spray from 24 months to 36 months.
2019-01-07	Orexo AB	Results Positive results from human PK study assessing Orexo’s new intranasal naloxone formulations for opioid overdose reversal orexo.com ↗ All formulations of OX124 were well tolerated and showed substantially higher plasma concentrations of naloxone, sustained duration of elevated plasma concentrations, and equivalent or superior onset time when compared to Narcan®.
2017-11-14	Alkermes, Inc.	Results VIVITROL® and Value of Medication-Assisted Treatment for Opioid Dependence Featured in Study Sponsored by National Institute on Drug Abuse alkermes.com ↗ Results from a National Institute on Drug Abuse (NIDA)-funded study, were published in The Lancet today, comparing extended-release naltrexone (VIVITROL®) and buprenorphine-naloxone, two options for opioid dependence.
2017-10-18	Alkermes, Inc.	Results New Study Comparing Effectiveness of Extended-Release Naltrexone to Buprenorphine-Naloxone for Opioid Dependence Published in JAMA Psychiatry alkermes.com ↗ Ten patients discontinued treatment due to adverse events: four in the extended-release naltrexone group and six in the buprenorphine-naloxone group.
2017-07-31	Indivior Inc.	Regulatory Indivior \| Indivior’s NALSCUE® Receives Marketing Authorization from French Regulatory Agency ANSM indivior.com ↗ French Regulatory Agency ANSM Approves Marketing Authorisation for Indivior’s NALSCUE® (Naloxone Hydrochloride) Nasal Spray for the Emergency Treatment of Characterized or Suspected Opioid Overdose
2016-02-10	Indivior Inc.	Regulatory Indivior \| Indivior Inc. Receives a Paragraph IV Notice of Certification Letter (‘PIV Notice’) from Teva Pharmaceuticals USA, Inc. indivior.com ↗ Teva is already amongst the six ANDA filers to serve a PIV Notice on Indivior regarding Suboxone® sublingual film; this latest notice adds a new dosage strength to the range in its previous PIV notice.

All press releases naming this drug 58 releases

Date	Issuer	Release
2026-08-31	Emergent BioSolutions	Emergent BioSolutions Awarded Government of Canada Standing Offer for NARCAN® Nasal Spray emergentbiosolutions.com ↗
2026-06-04	Emergent BioSolutions	Emergent BioSolutions Supports Victoria’s Voice Foundation’s National Naloxone Awareness Day to Help Save Lives from Opioid Overdose emergentbiosolutions.com ↗
2026-04-29	Emergent BioSolutions	Emergent BioSolutions Partners with Professional Baseball Player Davis Schneider to Raise Awareness of NARCAN® Nasal Spray Among Canadians and Help Save Lives emergentbiosolutions.com ↗
2026-04-09	Emergent BioSolutions	Emergent BioSolutions Partners with British Columbia to Supply NARCAN® Nasal Spray for the Launch of the Expanded BC Take Home Naloxone Program emergentbiosolutions.com ↗
2026-04-07	Emergent BioSolutions	Emergent BioSolutions Launches New NARCAN® Nasal Spray Carrying Case and Multipacks Alongside College Campus Outreach to Expand Opioid Overdose Preparedness emergentbiosolutions.com ↗
2026-02-12	Emergent BioSolutions	Emergent BioSolutions Receives U.S. FDA Approval of Supplemental New Drug Application (sNDA) for NARCAN® Nasal Spray Multipacks emergentbiosolutions.com ↗
2026-01-14	Emergent BioSolutions	Emergent BioSolutions Receives U.S. FDA Approval on Supplemental New Drug Application for NARCAN® Nasal Spray to be Packaged in a New Carrying Case, Making Life-Saving Naloxone More Accessible for Everyday Preparedness emergentbiosolutions.com ↗
2025-11-18	Emergent BioSolutions	Emergent BioSolutions Marks 10-Year Anniversary of the U.S. FDA Approval of NARCAN® Nasal Spray and Reinforces its Commitment to Increasing Naloxone Access emergentbiosolutions.com ↗
2025-09-24	Emergent BioSolutions	Emergent BioSolutions Recognizes Several Important Observances to Help Save Lives from Opioid Poisoning and Encourages Preparedness with Life-Saving Naloxone emergentbiosolutions.com ↗
2025-08-29	Emergent BioSolutions	Emergent BioSolutions Underscores Continued Support of Increasing Naloxone Awareness Through Public Education Campaign on International Overdose Awareness Day emergentbiosolutions.com ↗
2025-07-28	Emergent BioSolutions	Emergent Applauds Availability of Over-the-Counter Naloxone in U.S. House of Representatives emergentbiosolutions.com ↗
2025-07-02	Emergent BioSolutions	Emergent BioSolutions Expands NARCANDirect® to Offer KLOXXADO® (naloxone HCl) Nasal Spray 8 mg and Convenience Kits Amid Changes in Overdose Death Rate emergentbiosolutions.com ↗
2025-06-05	Emergent BioSolutions	Emergent BioSolutions Supports Victoria's Voice Foundation’s National Naloxone Awareness Day Efforts on June 6 to Encourage Americans to Be Prepared for Opioid Emergencies emergentbiosolutions.com ↗
2025-05-28	STAT Therapeutics Inc	Exciting news from ASCPT 2025! stattherapeutics.com ↗
2025-03-20	Roxane Laboratories	Hikma announces Health Canada approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg hikma.com ↗
2025-03-20	Emergent BioSolutions	Hikma announces Health Canada approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg emergentbiosolutions.com ↗
2025-03-13	Emergent BioSolutions	Emergent BioSolutions Reinforces its Commitment to Expanding Access to NARCAN® Nasal Spray by Supporting Organizations with New Opioid Overdose Preparedness Programs emergentbiosolutions.com ↗
2025-01-14	Roxane Laboratories	Hikma announces exclusive commercial partnership with Emergent BioSolutions for KLOXXADO® (naloxone HCl) nasal spray 8 mg hikma.com ↗
2025-01-14	Emergent BioSolutions	Emergent BioSolutions Gains Exclusive Commercial Rights to KLOXXADO® (naloxone HCI) Nasal Spray from Hikma Pharmaceuticals emergentbiosolutions.com ↗
2024-10-08	Emergent BioSolutions	Emergent BioSolutions Demonstrates Commitment to Increasing Access & Awareness of NARCAN® Nasal Spray to Help Combat the Opioid Epidemic emergentbiosolutions.com ↗
2024-08-20	Roxane Laboratories	Hikma Pharmaceuticals participates in naloxone training event with U.S. Congressman Buddy Carter ahead of National Fentanyl Awareness and Prevention Day hikma.com ↗
2024-08-15	Roxane Laboratories	KLOXXADO® 8mg Naloxone Nasal Spray Shelf-Life Extended from 24 months to 36 months hikma.com ↗
2024-08-06	Emergent BioSolutions	Emergent BioSolutions Expands NARCAN® Nasal Spray Distribution Capabilities to Enhance Customer Delivery Experience Across the Country emergentbiosolutions.com ↗
2024-07-22	Emergent BioSolutions	Emergent BioSolutions Announces Shelf-Life Extension for NARCAN® Nasal Spray in Canada emergentbiosolutions.com ↗
2024-06-18	Indivior Inc.	Indivior \| Indivior Announces the Publication of New Data on the Comparative Effectiveness of Intranasal Nalmefene and IN Naloxone in a Translational Model Assessing the Impact of a Synthetic Opioid Overdose on Respiratory Depression and Cardiac Arrest indivior.com ↗
2024-06-06	Roxane Laboratories	Hikma Pharmaceuticals reaffirms commitment to expanding access to overdose-reversal medicine naloxone at White House meeting hikma.com ↗
2024-06-06	Emergent BioSolutions	Emergent BioSolutions Continues Driving Progress Against the Opioid Epidemic & Recognizes National Naloxone Awareness Day emergentbiosolutions.com ↗
2024-05-22	Impax Laboratories, LLC	Amneal Begins Supplying Over-the-Counter Naloxone Hydrochloride Nasal Spray to U.S. Retail Pharmacies and the State of California amneal.com ↗
2024-05-01	Emergent BioSolutions	Emergent BioSolutions Releases New Survey Findings Underscoring the Need to Continue Expanding Access & Increasing Awareness to Naloxone emergentbiosolutions.com ↗
2024-04-24	Impax Laboratories, LLC	Amneal Announces U.S. FDA Approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray for Emergency Treatment of an Opioid Overdose amneal.com ↗
2024-03-28	Emergent BioSolutions	Emergent BioSolutions Continues to Broaden Access, Awareness and Availability of NARCAN® Nasal Spray to Help Save Lives from the Ongoing Opioid Crisis emergentbiosolutions.com ↗
2024-03-11	Indivior Inc.	Indivior \| Indivior Announces Publication Demonstrating that OPVEE® (nalmefene) Nasal Spray Rapidly Reverses Effects of Opioid-Induced Respiratory Depression in Head-to-Head Study Against Intranasal Naloxone indivior.com ↗
2023-10-03	Roxane Laboratories	Hikma marks two-year anniversary of KLOXXADO® launch by surpassing 375,000 doses donated in the US hikma.com ↗
2023-08-30	Emergent BioSolutions	Emergent BioSolutions’ NARCAN® Nasal Spray Launches Over the Counter Making it Possible for Everyone to Help Save a Life from an Opioid Overdose Emergency emergentbiosolutions.com ↗
2023-03-29	Emergent BioSolutions	U.S. FDA Approves Over-the-Counter Designation for Emergent BioSolutions’ NARCAN® Nasal Spray, a Historic Milestone for the Opioid Overdose Emergency Treatment emergentbiosolutions.com ↗
2023-03-02	Impax Laboratories, LLC	Amneal Announces U.S. FDA Filing Acceptance of Abbreviated New Drug Application for Naloxone Hydrochloride Nasal Spray, USP, 4mg amneal.com ↗
2023-02-15	Emergent BioSolutions	Emergent BioSolutions Reports FDA Advisory Committees’ Unanimous Vote in Favor of NARCAN® (naloxone HCI) Nasal Spray for Over-the-Counter Use emergentbiosolutions.com ↗
2022-12-06	Emergent BioSolutions	Emergent BioSolutions Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for Over-the-Counter NARCAN® (naloxone HCl) Nasal Spray emergentbiosolutions.com ↗
2021-12-22	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Launch of First-to-Market Generic Version of Narcan® (Naloxone Hydrochloride Nasal Spray), in the U.S. tevapharm.com ↗
2021-04-28	Indivior Inc.	Indivior \| Indivior Statement Regarding State Attorney General’s Recent Announcements Relating to SUBOXONE® (buprenorphine and naloxone) Film Settlements indivior.com ↗
2021-04-13	Nasus Pharma	Nasus Pharma announces positive Results in Naloxone Pivotal Trial. nasuspharma.com ↗
2020-09-24	Emergent BioSolutions	Emergent BioSolutions Applauds Pharmacy Leaders on Consensus Guidelines for Naloxone emergentbiosolutions.com ↗
2020-08-17	Emergent BioSolutions	Emergent BioSolutions Announces FDA Approval of NARCAN® (naloxone HCl) Nasal Spray Shelf Life Extension to 36 Months emergentbiosolutions.com ↗
2019-06-18	Indivior Inc.	Indivior \| Indivior Announces Validation of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for SUBOXONE (buprenorphine and naloxone) Sublingual Film indivior.com ↗
2019-02-20	Indivior Inc.	Indivior \| Indivior Announces Launch of SUBOXONE® (buprenorphine and naloxone) Sublingual Film Authorized Generic indivior.com ↗
2019-02-04	Indivior Inc.	Indivior \| Indivior Enters into Agreement with Alvogen on Generic (buprenorphine and naloxone) Sublingual Film indivior.com ↗
2019-01-25	Indivior Inc.	Indivior \| Indivior Is Granted Temporary Restraining Order on Generic (buprenorphine and naloxone) Sublingual Film indivior.com ↗
2019-01-07	Orexo AB	Positive results from human PK study assessing Orexo’s new intranasal naloxone formulations for opioid overdose reversal orexo.com ↗
2018-11-21	Indivior Inc.	Indivior \| Court of Appeals for the Federal Circuit Lifts Preliminary Injunction on Generic (buprenorphine and naloxone) Sublingual Film indivior.com ↗
2018-10-26	Perrigo Company	Perrigo Confirms Patent Challenge For Generic Version Of Narcan® perrigo.com ↗
2018-10-24	Emergent BioSolutions	Emergent BioSolutions to Offer All Public Libraries and YMCAs in the U.S. Free Opioid Awareness Education and NARCAN® (naloxone HCl) Nasal Spray emergentbiosolutions.com ↗
2018-10-15	Emergent BioSolutions	Emergent BioSolutions Completes Acquisition of Adapt Pharma and Flagship Product Narcan® (Naloxone HCI) Nasal Spray emergentbiosolutions.com ↗
2018-08-28	Emergent BioSolutions	Emergent BioSolutions Joins Effort to Combat National Public Health Threat From Opioid Overdose Through Acquisition of Adapt Pharma and Its Flagship Product NARCAN® (naloxone HCl) Nasal Spray emergentbiosolutions.com ↗
2018-07-31	Indivior Inc.	Indivior \| Indivior Preliminary Injunction on Generic (buprenorphine and naloxone) Sublingual Film Upheld indivior.com ↗
2017-11-14	Alkermes, Inc.	VIVITROL® and Value of Medication-Assisted Treatment for Opioid Dependence Featured in Study Sponsored by National Institute on Drug Abuse alkermes.com ↗
2017-10-18	Alkermes, Inc.	New Study Comparing Effectiveness of Extended-Release Naltrexone to Buprenorphine-Naloxone for Opioid Dependence Published in JAMA Psychiatry alkermes.com ↗
2017-07-31	Indivior Inc.	Indivior \| Indivior’s NALSCUE® Receives Marketing Authorization from French Regulatory Agency ANSM indivior.com ↗
2016-02-10	Indivior Inc.	Indivior \| Indivior Inc. Receives a Paragraph IV Notice of Certification Letter (‘PIV Notice’) from Teva Pharmaceuticals USA, Inc. indivior.com ↗

Evidence & citations 48 cited values

Every value below carries the sentence it was read from. 228 sources stand behind the page.

Field	Value	Cited text
Known as	Naloxone	“The objectives of this study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN) prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10...” NCT02880475 ↗ 221 “The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy,...” NCT00000331 ↗ “The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of...” NCT00733720 ↗ “A single Suboxone sublingual film strip containing 8mg buprenorphine and 2mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment.” NCT02038790 ↗ “determine the ability of intranasal and intravenous naloxone and intravenous nalmefene to reverse opioid (fentanyl and sufentanil)- induced respiratory depression” NCT05338632 ↗ “The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.” NCT00000328 ↗ “To establish proof of concept regarding efficacy of an oral kappa agonist (KA), Pentazocine/Naloxone 50/0.5 mg, for the treatment of menopausal hot flashes.” NCT02070718 ↗ “Targinact is a combination of prolonged release opioid analgesic (oxycodone hydrochloride) and naloxone hydrochloride (an opioid receptor blocker).” NCT02109640 ↗ “oral Targin (a combination of oxycodone-hydrochloride and the opioid antagonist naloxone hydrochloride-dihydrate) or patient-controlled IV morphine” PMID 24375220 ↗ Dec 2013 “BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.” NCT01666119 ↗ “Sublingual Subutex® tablets containing 8 mg buprenorphine and and sublingual Suboxone® tablets containing 8 mg buprenorphine and 2 mg naloxone.” NCT01582347 ↗ Show 211 more sources
Known as	Anhydrous naloxone hydrochloride	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Dbl naloxone	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	EN-15304	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Evzio	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Evzio (autoinjector)	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Kloxxado	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxon B Braun	“Administered as 1 ml Naloxon B Braun 0.4 mg/ml (0.4 mg naloxone), in an intravenous cannula in the opposite arm of which the blood samples are drawn from. IV bolus will be...” NCT02598856 ↗
Known as	Naloxona	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone B Braun 0,4 mg/ml	“Naloxone B Braun 0,4 mg/ml” NCT02405988 ↗
Known as	Naloxone B. Braun	“IV naloxone (Naloxone B. Braun 0.4mg/ml) administered slowly over 1-2 min in the recumbent position” NCT01939444 ↗
Known as	Naloxone chlorhydrate	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone HCl	“Treatment C: Naloxone HCl Intravenous (IV) Injection” NCT03827642 ↗ 1 “Naloxone HCl intranasal” NCT06719986 ↗
Known as	Naloxone Hydrichloride	“A 0.15 mg/kg bolus dose of naloxone (Naloxone Hydrichloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline was administered over 10 minutes.” NCT03419858 ↗
Known as	Naloxone Hydrochloride	“A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes.” NCT04034004 ↗ 11 “Intramuscular comparator Naloxone Hydrochloride 0.4 mg/ml will be administered as a 2 ml intramuscular (IM) injection in the deltoid muscle, total dose of 0,8 mg naloxone IM” NCT03518021 ↗ “Naloxone hydrochloride 20 mg Extended Release Capsule equivalent to 18 mg naloxone (hard gelatine capsule containing a single NLX-ER tablet and multiple sugar spheres)” NCT01596764 ↗ “Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration.” NCT01622504 ↗ “Naloxone hydrochloride will be dosed at 4mg / dose (one spray of 0.1ml of the 40mg/ml formulation into one nostril)” NCT03430180 ↗ “naloxone (naloxone hydrochloride) + oxycodone (oxycodone hydrochloride)” NCT06390046 ↗ “Naloxone Hydrochloride 0.4 MG/ML” NCT07439549 ↗ “Naloxone hydrochloride 5.0mg/5ml” NCT05301712 ↗ “Naloxone hydrochloride 20mg/ml” NCT03223896 ↗ NCT07459166 ↗ NCT01167127 ↗ Show 1 more source
Known as	Naloxone hydrochloride (autoinjector)	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone hydrochloride anhydrous	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone hydrochloride component of bunavail	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone hydrochloride component of cassipa	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone hydrochloride component of suboxone	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone hydrochloride component of talwin nx	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone hydrochloride component of targiniq	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone hydrochloride component of zubsolv	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	naloxone hydrochloride dihydrate	“Oxycodone hydrochloride and naloxone hydrochloride dihydrate combined oral prolonged release tablets (OXN PR), is the investigational product to be used in this study.” NCT01439100 ↗
Known as	Naloxone hydrochloride dihydrate component of bunavail	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone hydrochloride dihydrate component of cassipa	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxone Hydrochloride Injection	“Drug: Naloxone Hydrochloride Injection” NCT05808881 ↗
Known as	Naloxone: Narcan	“Naloxone = Narcan” NCT01105871 ↗ 1 “Naloxone: Narcan” NCT01068847 ↗
Known as	Naloxoni hydrochloridum anhydrous	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Naloxoni hydrochloridum dihydrate	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Narcan	“This study evaluated effectiveness of 4 mg intranasal naloxone (Narcan; Adapt Pharma Inc., USA) in reversing moderate respiratory depression induced by fentanyl and sufentanil...” PMID 41642634 ↗ Feb 2026 1 “naloxone administration (Narcan, 4 mg)” NCT06089707 ↗
Known as	Narcan (naloxone)	“Narcan® (naloxone)” NCT01218984 ↗
Known as	Narcan neonatal	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Narcanti	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Narconil	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	NIH 7890	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	NLX	“During testing, the following dose combinations of vaped cannabis (V-CB) and intranasal naloxone (IN-NLX) were tested:” PMID 40839512 ↗ Aug 2025
Known as	NSC-70413	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	NSC-757109	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Nyxoid	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Prenoxad	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Rextovy	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Rezenopy	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Rivive	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Known as	Zimhi	ChEMBL registry synonym — accepted as the source's own label CHEMBL80 ↗
Action	Inhibit	“opioid receptor antagonist” NCT00184938 ↗
Modality	Small molecule	— CHEMBL80 ↗
Route	Oral	“Patients receive oral naloxone twice daily.” NCT00020605 ↗