Dextromethorphan

also known as Dextromethorphan hydrobromide · DXM · Dextromethorphan HBr · Dextromethorphan Hydrobromide Monohydrate · Dextromethorphan, Ratiopharm GmbH · Dextrométhorphane bromhydrate · DMO · Drill Pierre FABRE MEDICAMENT · +1 more

Developed for: major depressive disorder · Alzheimer disease · neuropathy, painful · common cold · pseudobulbar palsy · stroke disorder · amyotrophic lateral sclerosis · Parkinson disease
+43 more
· Rett syndrome · type 2 diabetes mellitus · allesthesia · chemotherapy-induced toxicity · multiple sclerosis · substance-related disorder · amphetamine abuse · atherosclerosis · attention deficit-hyperactivity disorder · autism · autism spectrum disorder · bipolar disorder · bipolar II disorder · body dysmorphic disorder · chemotherapy-induced neuropathy · diabetic macular edema · diabetic neuropathy · diabetic polyneuropathy · facial neuralgia · fibromyalgia · hypochondriasis · idiopathic pulmonary fibrosis · movement disorder · neuralgia · neurodegenerative disease · neurological pain disorder · nicotine dependence · obsessive-compulsive disorder · opiate dependence · opioid abuse · respiratory tract infectious disorder · rheumatoid arthritis · schizophrenia · somatization disorder · treatment-refractory schizophrenia · trigeminal neuralgia · voice disorders · bronchitis · migraine disorder · mood disorder · persian gulf syndrome · proteinuria · sickle cell disease
Investigated by: Avanir Pharmaceuticals · Axsome Therapeutics, Inc. · Boehringer Ingelheim · GlaxoSmithKline · National Cheng-Kung University Hospital · Eli Lilly and Company
+151 more
· Johns Hopkins University · Pfizer · Janssen Research & Development, LLC · Jules Desmeules · National Institute of Neurological Disorders and Stroke (NINDS) · National Center for Complementary and Integrative Health (NCCIH) · National Institute on Drug Abuse (NIDA) · University Hospital, Clermont-Ferrand · Washington State University · ALS Association · All India Institute of Medical Sciences, Bhubaneswar · Brigham and Women's Hospital · Bristol-Myers Squibb · Emalex Biosciences Inc. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Hoffmann-La Roche · Medivation, Inc. · Ministry of Science and Technology, Taiwan · National Cancer Institute (NCI) · National Institute of Dental and Craniofacial Research (NIDCR) · National Institute of General Medical Sciences (NIGMS) · Nuventra, Inc. · Profil Institute for Metabolic Research GmbH · Radboud University Medical Center · Syneos Health · University of Florida · University of Medicine and Dentistry of New Jersey · University of Washington · Virginia Commonwealth University · Abliva AB · Academy of Finland · AccuDial Pharmaceutical, Inc. · Aegerion Pharmaceuticals, Inc. · Allyx Therapeutics · Alnylam Pharmaceuticals · Asad Ullah Jan · Assistance Publique - Hôpitaux de Paris · Astellas Pharma Europe B.V. · Astellas Pharma Global Development, Inc. · AstraZeneca · Avy L. & Roberta L. Miller Foundation · Basilea Pharmaceutica International Ltd · BioCryst Pharmaceuticals · Biogen · Blade Therapeutics · CSPC Ouyi Pharmaceutical Co., Ltd. · Canadian Institutes of Health Research (CIHR) · Celgene Corporation · Center for Neurologic Study, La Jolla, California, · Chonbuk National University Hospital · Cognition Therapeutics · Combined Military Hospital Nowshera · Diabetes Research Foundation, Finland · Dr Anne-Margot Duclot, Pain Clinic, Paris Rotschild Hospital · Dr Dominique JOLY / Dr Christine VILLATTE · Dr Gisèle PICKERING · Dr Géraldine Brumauld de Montgazon, Pain Clinic, La Rochelle Hospital · Dr Malou Navez, Pain Clinic, Saint-Etienne Hopital · Dr Marc Sorel, Pain Clinic, Nemours Hospital · Dr Marie-Christine Crosmary/Dr Renato Colamarino, Pain Clinic, Vichy Hospital · Dr Mohamed El Ayadi, Pain Clinic, Issoire Hospital · Dr Monique Belon, Pain Clinic, Aurillac Hospital · Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD · Dr. Rachel Rooney · Drugs for Neglected Diseases · Duke University · Estella S. Poloni · European and Developing Countries Clinical Trials Partnership (EDCTP) · Finnish Cultural Foundation · First Affiliated Hospital of Wenzhou Medical University · French National Institute of Health and Medical Research · Galera Therapeutics, Inc. · Genentech, Inc. · German Federal Ministry of Education and Research · all 157 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Withdrawn	EU (EMA)	Nuedexta	—	2016-02-15	europa.eu ↗
Approved	EU (EMA)	Nuedexta	—	2013-06-24	europa.eu ↗
Approved	US (FDA)	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	—	1957-12-03	fda.gov ↗

Trials 160 · started per year

today

US approved 1957

EU approved 2013

19561957195819591960196119621963196419651966196719681969197019711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 03 trials
Phase 0	NCT06693960	Sep 2024 → Dec 2026 expected	—	Washington State University	Recruiting	No outcome recorded
Phase 0	NCT04923659	May 2021 → Jul 2022 overdue	—	University Health Network, Toronto	Active not recruiting	No outcome recorded
Phase 0	NCT04392011	Oct 2019 → Aug 2021	—	Washington State University	Completed	No outcome recorded
Phase 169 trials
Phase 1	NCT07665723	Jun 2026 → Jul 2027 expected	ulcerative colitis	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 1	NCT07386730	Jun 2026 → Feb 2030 expected	—	Jennifer Mitchell	Recruiting	No outcome recorded
Phase 1	NCT07241065	Mar → Jun 2026 overdue	—	AstraZeneca	Recruiting	No outcome recorded
Phase 1	NCT06383338	Jul 2025 → Jul 2026 overdue	Hodgkins lymphoma, non-Hodgkin lymphoma	Murdoch Childrens Research Institute	Recruiting	No outcome recorded
Phase 1	NCT06930872	Jun → Oct 2025	—	Harmony Biosciences Management, Inc.	Completed	No outcome recorded
Phase 1	NCT06772753	Feb 2025 → Jun 2027 expected	—	Johns Hopkins University	Recruiting	No outcome recorded
Phase 1	NCT06632990	Nov 2024 → Apr 2025 overdue	—	Allyx Therapeutics	Active not recruiting	No outcome recorded
Phase 1	NCT06348290	Apr → May 2024	cancer	Jemincare	Unknown	No outcome recorded
Phase 1	NCT05699993	Mar → Oct 2023	—	Innovent Biologics (Suzhou) Co. Ltd.	Completed	No outcome recorded
Phase 1	NCT05947604	Feb → May 2023	human African trypanosomiasis	Drugs for Neglected Diseases	Completed	No outcome recorded
Phase 1	NCT05602675	Nov 2022 → Mar 2023	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT05444556	Jul → Nov 2022	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT05334108	Apr → Aug 2022	—	Emalex Biosciences Inc.	Completed	No outcome recorded
Phase 1	NCT05236530	Mar → Oct 2022	malaria	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT04814498	May → Sep 2021	—	Blade Therapeutics	Completed	No outcome recorded
Phase 1	NCT04887194	Apr 2021 → Dec 2022	—	Mirati Therapeutics Inc.	Completed	No outcome recorded
Phase 1	NCT04764851	Feb → Apr 2021	—	Emalex Biosciences Inc.	Terminated	No outcome recorded
Phase 1	NCT04525235	Jan → Aug 2021	tuberculosis	Radboud University Medical Center	Completed	No outcome recorded
Phase 1	NCT04201197	Nov 2020 → Mar 2022	—	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT04643249	Nov → Dec 2020	mitochondrial disease	Abliva AB	Completed	No outcome recorded
Phase 1	NCT04226352	Mar 2020 → Dec 2021	major depressive disorder	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT04233437	Feb → May 2020	stroke disorder	Moleac Pte Ltd.	Completed	No outcome recorded
Phase 1	NCT03948243	Apr 2019 → Jul 2020	—	University of Illinois at Chicago	Completed	No outcome recorded
Phase 1	NCT03792971	Feb 2019	—	Galera Therapeutics, Inc.	Completed	No outcome recorded
Phase 1	NCT03718884	Oct 2018 → Oct 2019	psoriasis	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT03720366	Oct 2018 → Sep 2023	acute myeloid leukemia	Celgene Corporation	Completed	No outcome recorded
Phase 1	NCT03547024	Jun → Aug 2018	—	Janssen-Cilag International NV	Completed	No outcome recorded
Phase 1	NCT03505853	Apr → Nov 2018	acute intermittent porphyria	Alnylam Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT03415243	Mar 2018	common cold	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT03358706	Feb 2018 → Nov 2021	Crohn disease, ulcerative colitis	Janssen Research & Development, LLC	Terminated	No outcome recorded
Phase 1	NCT03864042	Jan 2018 → Jul 2022	cancer, metastatic melanoma	Pfizer	Completed	No outcome recorded
Phase 1	NCT03381664	Nov 2017 → Jan 2018	—	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT03195946	Jun 2017 → Jan 2018	hypersensitivity reaction disease	H. Lundbeck A/S	Completed	No outcome recorded
Phase 1	NCT03058419	Mar → May 2017	—	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT02993471	Dec 2016 → Nov 2017	psoriasis	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT03716427	Nov → Dec 2016	—	Cognition Therapeutics	Completed	No outcome recorded
Phase 1	NCT02775240	Jul → Sep 2016	cytomegalovirus infection	Shire	Completed	No outcome recorded
Phase 1	NCT02688088	Mar 2016 → Feb 2018	metastatic neoplasm	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT02819102	Mar → Jun 2016	hereditary angioedema	BioCryst Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT02596360	Nov 2015 → Mar 2016	—	University Hospital, Clermont-Ferrand	Completed	No outcome recorded
Phase 1	NCT02397382	Jun 2015 → Aug 2016	psoriasis	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT02434861	May → Jul 2015	chemotherapy-induced toxicity	Tesaro, Inc.	Completed	No outcome recorded
Phase 1	NCT02391688	Nov 2014 → Apr 2015	—	Jules Desmeules	Completed	No outcome recorded
Phase 1	NCT02033707	Apr 2014 → Feb 2019	—	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT02225093	Oct 2013 → Feb 2014	prostate cancer	Astellas Pharma Europe B.V.	Completed	No outcome recorded
Phase 1	NCT02056743	Sep → Oct 2013	—	Chonbuk National University Hospital	Completed	No outcome recorded
Phase 1	NCT01731067	Nov 2012 → May 2013	—	Jules Desmeules	Completed	No outcome recorded
Phase 1	NCT01651325	May 2012	—	Astellas Pharma Global Development, Inc.	Completed	No outcome recorded
Phase 1	NCT01218620	Sep 2010 → Jul 2012	neoplasm	National Cancer Institute (NCI)	Completed	No outcome recorded
Phase 1	NCT01188525	Aug 2010 → Jul 2011	—	French National Institute of Health and Medical Research	Completed	No outcome recorded
Phase 1	NCT01017939	Jan → Jun 2010	prostate cancer	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT01001299	Nov 2009 → Feb 2012	melanoma	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT00999817	Nov → Dec 2009	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00964106	Aug 2009 → Aug 2011	—	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00950586	Aug → Dec 2009	cognitive disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02191176	Jun → Jul 2009	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00920088	Jun → Nov 2009	HIV infectious disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02191709	Jan → Feb 2009	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00788047	Nov 2008 → Jan 2009	Alzheimer disease, Huntington disease	Pfizer	Completed	No outcome recorded
Phase 1	NCT00726726	Aug → Oct 2008	Alzheimer disease	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT00741468	Jul → Sep 2008	—	Repros Therapeutics Inc.	Completed	No outcome recorded
Phase 1	NCT02182336	Jun → Sep 2008	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00467779	May 2007 → Apr 2014	cancer	Genentech, Inc.	Completed	No outcome recorded
Phase 1	NCT00401583	Jul 2006 → Feb 2008	renal cell carcinoma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02243553	Jan → Jul 2006	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00127686	Sep 2005 → Dec 2006	respiratory tract infectious disorder	Penn State University	Completed	No outcome recorded
Phase 1	NCT02256813	Sep → Dec 2005	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00055549	Mar 2003 → Nov 2009	voice disorders	National Institute of Neurological Disorders and Stroke (NINDS)	Completed	No outcome recorded
Phase 1	NCT00333242	Sep 2002 → Aug 2006	—	National Institute on Drug Abuse (NIDA)	Unknown	No outcome recorded

Phase 1/27 trials
Phase 1/2	NCT07593222	Jul 2026 → Dec 2030 expected	major depressive disorder	Mclean Hospital	Not yet recruiting	No outcome recorded
Phase 1/2	NCT05976646	Sep 2023 → Jul 2025	opiate dependence	Virginia Commonwealth University	Completed	No outcome recorded
Phase 1/2	NCT04044001	Nov 2019 → Mar 2022	pulmonary tuberculosis	Michael Hoelscher	Completed	No outcome recorded
Phase 1/2	NCT03883581	Jul 2019 → Sep 2021	amyotrophic lateral sclerosis	University of Florida	Completed	No outcome recorded
Phase 1/2	NCT03729128	Jul 2018 → Aug 2020	substance-related disorder	Tzu-Yun Wang	Completed	No outcome recorded
Phase 1/2	NCT01441102	Aug 2011 → Jun 2014	diabetic macular edema	National Eye Institute (NEI)	Completed	No outcome recorded
Phase 1/2	NCT01086722	Feb 2010 → Feb 2013	morbid obesity	Hospital del Mar Medical Research Institute (IMIM)	Completed	No outcome recorded
Phase 229 trials
Phase 2	NCT07583589	May 2026 → Mar 2027 expected	idiopathic pulmonary fibrosis	First Affiliated Hospital of Wenzhou Medical University	Not yet recruiting	No outcome recorded
Phase 2	NCT07523048	Nov 2025 → Jul 2026 overdue	major depressive disorder	Roger McIntyre	Recruiting	No outcome recorded
Phase 2	NCT06731335	Mar 2025 → Aug 2026 overdue	neuropathy, painful	Unity Health Toronto	Recruiting	No outcome recorded
Phase 2	NCT04899687	Jan 2022 → Apr 2027 expected	body dysmorphic disorder, hypochondriasis, obsessive-compulsive disorder, somatization disorder	Stanford University	Recruiting	No outcome recorded
Phase 2	NCT04971291	Apr → Jul 2021	major depressive disorder	Axsome Therapeutics, Inc.	Unknown	No outcome recorded
Phase 2	NCT04634669	Sep 2020 → Feb 2022	major depressive disorder	Axsome Therapeutics, Inc.	Terminated	No outcome recorded
Phase 2	NCT03538054	Jun 2018 → Mar 2020	fibromyalgia	University of Alabama at Birmingham	Completed	No outcome recorded
Phase 2	NCT03595579	May 2018 → Jan 2019	major depressive disorder	Axsome Therapeutics, Inc.	Completed	No outcome recorded
Phase 2	NCT03471767	Mar 2018 → Mar 2019	nicotine dependence	James Davis	Completed	No outcome recorded
Phase 2	NCT02142712	Dec 2014	brain edema, stroke disorder	University of Florida	Completed	No outcome recorded
Phase 2	NCT02271893	Nov 2014 → Oct 2017	chemotherapy-induced neuropathy	University Hospital, Clermont-Ferrand	Terminated	No outcome recorded
Phase 2	NCT01767129	Oct 2013 → Feb 2015	Parkinson disease, movement disorder	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01936025	Oct 2013 → Apr 2014	type 2 diabetes mellitus	Profil Institute for Metabolic Research GmbH	Completed	No outcome recorded
Phase 2	NCT01882829	Jul 2013 → Mar 2016	major depressive disorder	James Murrough	Completed	No outcome recorded
Phase 2	NCT01806857	Apr 2013 → Mar 2015	amyotrophic lateral sclerosis	Center for Neurologic Study, La Jolla, California,	Completed	No outcome recorded
Phase 2	NCT01584440	Aug 2012 → Jul 2014	Alzheimer disease	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01602185	May 2012 → Jun 2014	neuropathy, painful	University Hospital, Clermont-Ferrand	Completed	No outcome recorded
Phase 2	NCT01630811	Jan 2012 → Dec 2015	autism	Sutter Health	Completed	No outcome recorded
Phase 2	NCT01324232	Sep 2011 → Sep 2013	multiple sclerosis, neuropathy, painful	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01441986	Sep 2011 → May 2012	type 2 diabetes mellitus	Profil Institute for Metabolic Research GmbH	Completed	No outcome recorded
Phase 2	NCT00359281	Mar 2006 → Nov 2007	—	Aegerion Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 2	NCT00593957	Aug 2004 → Apr 2010	Rett syndrome	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Terminated	No outcome recorded
Phase 2	NCT00108446	Oct 2003 → Mar 2006	irritable bowel syndrome	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 2	NCT02218203	Apr 2003 → Jan 2008	allesthesia, neuropathy, painful, spinal cord injury	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 2	NCT01435798	Apr 2003 → Jan 2008	allesthesia, neurological pain disorder, spinal cord injury	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 2	NCT00001725	Dec 1997 → Jan 2002	facial neuralgia, trigeminal neuralgia	National Institute of Dental and Craniofacial Research (NIDCR)	Completed	No outcome recorded
Phase 2	NCT00000352	Dec 1996 → Feb 1998	substance-related disorder	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2	NCT00001365	Jul 1993 → Jun 2001	Parkinson disease, neurodegenerative disease	National Institute of Neurological Disorders and Stroke (NINDS)	Completed	No outcome recorded
Phase 2	NCT00001344	Mar 1993 → Feb 2001	diabetic neuropathy, herpes zoster, neuralgia	National Institute of Dental and Craniofacial Research (NIDCR)	Completed	No outcome recorded

Phase 2/33 trials
Phase 2/3	NCT04687566	Aug 2020 → Jul 2024	amphetamine abuse	National Cheng-Kung University Hospital	Unknown	No outcome recorded
Phase 2/3	NCT02212275	Aug 2015 → Jul 2016	autism spectrum disorder	Duke University	Withdrawn	No outcome recorded
Phase 2/3	NCT01189006	Jan 2005 → Dec 2008	schizophrenia	National Cheng-Kung University Hospital	Completed	No outcome recorded
Phase 316 trials
Phase 3	NCT06958692	Apr 2025 → Sep 2026 expected	major depressive disorder	CSPC Ouyi Pharmaceutical Co., Ltd.	Recruiting	No outcome recorded
Phase 3	NCT04947553	Jun 2021 → Dec 2024	Alzheimer disease	Axsome Therapeutics, Inc.	Completed	No outcome recorded
Phase 3	NCT04039022	Jul 2019 → Oct 2020	major depressive disorder	Axsome Therapeutics, Inc.	Completed	No outcome recorded
Phase 3	NCT04019704	Jun → Nov 2019	major depressive disorder	Axsome Therapeutics, Inc.	Completed	No outcome recorded
Phase 3	NCT03480009	Jul 2018 → Jun 2019	—	Study Investigator-Sponsor	Completed	No outcome recorded
Phase 3	NCT03039842	Jan 2013 → Dec 2016	bipolar II disorder	National Cheng-Kung University Hospital	Unknown	No outcome recorded
Phase 3	NCT01462318	Nov 2011 → Jan 2016	relapsing-remitting multiple sclerosis	Biogen	Completed	No outcome recorded
Phase 3	NCT01189097	Apr 2008 → Mar 2011	opioid abuse	National Cheng-Kung University Hospital	Unknown	No outcome recorded
Phase 3	NCT00573443	Dec 2007 → Jun 2009	pseudobulbar palsy	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01188265	Jun 2007 → Dec 2010	bipolar disorder	National Cheng-Kung University Hospital	Completed	No outcome recorded
Phase 3	NCT00113620	Jul 2005 → Feb 2007	diabetic polyneuropathy	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00069550	Sep 2004 → Jun 2008	Rett syndrome	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Unknown	No outcome recorded
Phase 3	NCT00056524	Feb 2003 → Jun 2007	Alzheimer disease, Parkinson disease, stroke disorder, traumatic brain injury	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00050232	Dec 2002 → Jun 2004	multiple sclerosis	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00021697	Jan 2001 → Apr 2002	amyotrophic lateral sclerosis	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00003687	Jun 1998 → Sep 2001	cancer of unknown primary site, leukemia, myelodysplastic syndrome, myeloproliferative neoplasm +3	NCIC Clinical Trials Group	Completed	No outcome recorded

Phase 417 trials
Phase 4	NCT06716645	Dec 2024 → Feb 2025	common cold	HALEON	Completed	No outcome recorded
Phase 4	NCT05944510	Aug 2023 → Oct 2024	treatment-refractory schizophrenia	All India Institute of Medical Sciences, Bhubaneswar	Completed	No outcome recorded
Phase 4	NCT05181527	Feb 2022 → Sep 2023	major depressive disorder	All India Institute of Medical Sciences, Bhubaneswar	Completed	No outcome recorded
Phase 4	NCT02987920	Jan 2017 → Jan 2018	—	University of Southern California	Terminated	No outcome recorded
Phase 4	NCT02760615	Nov 2016 → Aug 2020	Crohn disease, ulcerative colitis	Takeda	Withdrawn	No outcome recorded
Phase 4	NCT03076021	Jul 2016 → Nov 2023	—	University of Washington	Completed	No outcome recorded
Phase 4	NCT02651116	Feb 2016 → Mar 2020	—	Pfizer	Terminated	No outcome recorded
Phase 4	NCT02496039	Sep 2015 → May 2016	pseudobulbar palsy	Avanir Pharmaceuticals	Terminated	No outcome recorded
Phase 4	NCT02291666	Apr 2015 → Jul 2019	type 2 diabetes mellitus	University of Montreal Hospital Centre (CHUM)	Completed	No outcome recorded
Phase 4	NCT02246166	Jan → Feb 2015	common cold	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT02062710	Jan → Jun 2014	—	Montefiore Medical Center	Completed	No outcome recorded
Phase 4	NCT01799941	Feb 2013 → May 2015	dementia, pseudobulbar palsy, stroke disorder, traumatic brain injury	Avanir Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01766050	Jan → Apr 2013	transplant rejection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 4	NCT01832350	Aug 2012 → Dec 2015	Alzheimer disease, pseudobulbar palsy	St. Joseph's Hospital and Medical Center, Phoenix	Terminated	No outcome recorded
Phase 4	NCT02727491	Mar 2012 → Sep 2014	neuropathy, painful	Dr. Rachel Rooney	Completed	No outcome recorded
Phase 4	NCT01257542	Dec 2010 → Mar 2011	common cold	Pfizer	Terminated	No outcome recorded
Phase 4	NCT00605605	Mar → Dec 2005	atherosclerosis	National Cheng-Kung University Hospital	Completed	No outcome recorded

Phase not applicable15 trials
—	NCT06957223	May → Nov 2025	major depressive disorder	Asad Ullah Jan	Completed	No outcome recorded
—	NCT05278494	Sep 2022 → Dec 2026 expected	—	University of Southern California	Recruiting	No outcome recorded
—	NCT04188028	Jan → Jul 2019	—	Jules Desmeules	Completed	No outcome recorded
—	NCT03054220	Jul 2016 → Dec 2018	—	Jules Desmeules	Completed	No outcome recorded
—	NCT02590185	Dec 2015 → Dec 2019	major depressive disorder	Assistance Publique - Hôpitaux de Paris	Unknown	No outcome recorded
—	NCT02789527	Nov 2015 → Apr 2017	—	Estella S. Poloni	Completed	No outcome recorded
—	NCT02438072	Dec 2014 → Dec 2015	depressive disorder	University Hospital, Geneva	Unknown	No outcome recorded
—	NCT03563287	Jan 2012 → Dec 2014	morbid obesity	University of Eastern Finland	Completed	No outcome recorded
—	NCT01361217	Sep 2011 → Jun 2012	—	University of Washington	Completed	No outcome recorded
—	NCT02368093	Jan 2010 → Sep 2012	rheumatoid arthritis	Taichung Veterans General Hospital	Completed	No outcome recorded
—	NCT00176540	Oct 2003 → Aug 2007	cancer of unknown primary site, childhood malignant neoplasm	University of Medicine and Dentistry of New Jersey	Terminated	No outcome recorded
—	NCT00176553	Mar 2003 → May 2007	chemotherapy-induced toxicity	University of Medicine and Dentistry of New Jersey	Terminated	No outcome recorded
—	NCT00310323	Jan 2003 → Feb 2006	obstructive sleep apnea syndrome	Virginia Commonwealth University	Completed	No outcome recorded
—	NCT00199303	Dec 2002 → Dec 2003	—	Khon Kaen University	Completed	No outcome recorded
—	NCT00004807	Jan 1995 → ?	Rett syndrome	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Completed	No outcome recorded

Phase not stated1 trial
—	NCT01787136	—	attention deficit-hyperactivity disorder	Tri-Service General Hospital (TSGH)	No longer available	No outcome recorded

Also used as a comparator or background therapy in 17 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 13 trials
Phase 1	NCT02860962 Comparator	Aug 2016 → Jun 2017	major depressive disorder	Medical University of South Carolina	Completed	No outcome recorded
Phase 1	NCT01570569 Comparator	Jan → Mar 2011	—	Inje University	Completed	No outcome recorded
Phase 1	NCT00934466 Comparator	Jul → Dec 2009	schizophrenia	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT02426983 Comparator	Apr → Sep 2015	schizophrenia	University of Ottawa	Unknown	No outcome recorded
Phase 24 trials
Phase 2	NCT03714919 Background	Aug → Nov 2019	adenoid hypertrophy	Arlyne Thung	Completed	No outcome recorded
Phase 2	NCT02176018 Comparator	Aug 2014 → Feb 2017	migraine disorder	Cady, Roger, M.D.	Completed	No outcome recorded
Phase 2	NCT01520363 Comparator	Mar 2012 → Oct 2016	Rett syndrome	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Completed	No outcome recorded
Phase 2	NCT02206490 Comparator	Jan 2012 → Jan 2016	persian gulf syndrome	East Carolina University	Completed	No outcome recorded
Phase 31 trial
Phase 3	NCT01091324 Comparator	Jan → Jun 2010	proteinuria	National Cheng-Kung University Hospital	Unknown	No outcome recorded
Phase 45 trials
Phase 4	NCT05043805 Comparator	May 2021 → Apr 2024	mood disorder	Tri-Service General Hospital (TSGH)	Unknown	No outcome recorded
Phase 4	NCT03738917 Comparator	Feb 2019 → Nov 2021	bronchitis	Jordi Gol Institute for Primary Care Research	Completed	No outcome recorded
Phase 4	NCT00513864 Comparator	Nov 2006 → Mar 2012	sickle cell disease	Children's National Research Institute	Withdrawn	No outcome recorded
Phase 4	NCT00377403 Background	Oct 2006 → May 2009	respiratory tract infectious disorder, sinusitis	Washington University School of Medicine	Completed	No outcome recorded
Phase 4	NCT00164112 Background	Nov 2004 → Jun 2005	—	Bassett Healthcare	Completed	No outcome recorded
Phase not applicable3 trials
—	NCT06566794 Comparator	Aug 2024 → Jan 2025	—	Helsinki University Central Hospital	Completed	No outcome recorded
—	NCT02515526 Comparator	Jun → Aug 2015	—	University of Cologne	Completed	No outcome recorded
—	NCT01553435 Comparator	Jan 2011 → Jan 2015	substance-related disorder	King Abdullah International Medical Research Center	Unknown	No outcome recorded

Press releases naming this drug 2 releases

Date	Issuer	Release
2019-02-13	Otsuka Pharmaceutical Development & Commercialization, Inc.	Avanir Pharmaceuticals, Inc. Reaches Agreement in Principle with U.S. Department of Justice Regarding NUEDEXTA (dextromethorphan HBr and quinidine sulfate) 20 mg/10 mg capsule otsuka.co.jp ↗
2015-08-13	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical's Subsidiary Avanir Pharmaceuticals Prevails in NUEDEXTA Patent Appeal Maintaining Exclusivity Through 2026 in the U.S.® otsuka.co.jp ↗

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 179 sources stand behind the page.

Field	Value	Cited text
Known as	Dextromethorphan	“Ten healthy Caucasian subjects were orally dosed with the CIME combination (caffeine-CYP1A2, repaglinide-CYP2C8, tolbutamide-CYP2C9, omeprazole-CYP2C19,...” PMID 25465228 ↗ Dec 2014 171 “OBJECTIVE: The aim of this study was to further understand how the phenomenological and health-promoting effects of high-dose dextromethorphan (DXM) compared to psilocybin in...” PMID 38152462 ↗ Dec 2023 “Two equally loaded capsules containing: Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone...” NCT03563287 ↗ “Ten volunteers received an oral cocktail capsule containing low doses of the probes bupropion (CYP2B6), flurbiprofen (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6),...” PMID 24722393 ↗ Apr 2014 “The BTZ-043 groups also received oral dolutegravir (a third of participants) or a probe drug cocktail (caffeine [probe for CYP1A2], tolbutamide [CYP2C9], dextromethorphan...” PMID 39793592 ↗ Jan 2025 “The authors conducted a multicenter, randomized, double-blind, controlled, parallel, three-arm study to test a defined combination of dextromethorphan hydrobromide (DM) and...” PMID 15505150 ↗ Oct 2004 “Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg,...” NCT02246166 ↗ “A single dose of selective substrates (probe drugs) was administered orally on days 15 and 30: caffeine (CYP1A2), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan...” PMID 37768317 ↗ Sep 2023 “Patients with a DSM-5 diagnosis of MDD were randomized in a 1:1 ratio to receive dextromethorphan-bupropion (45 mg-105 mg tablet) or placebo, orally (once daily for days 1-3,...” PMID 35649167 ↗ May 2022 “Dextromethorphan 20 mg / quinidine 10 mg (DM/Q) was approved to treat pseudobulbar affect (PBA) based on phase 3 trials conducted in participants with amyotrophic lateral...” PMID 29477412 ↗ Feb 2018 “capsules containing dextromethorphan [DM] and quinidine [Q]) compared with placebo, taken twice daily, for the treatment of pseudobulbar affect over a 12-week period in...” PMID 16634036 ↗ May 2006 “the sigma-1 receptor-agonist and glutamatergic/monoaminergic modulator, dextromethorphan plus quinidine (to inhibit rapid dextromethorphan metabolism), for treating...” PMID 28370447 ↗ Mar 2017 “AVP-923-45 (dextromethorphan 45 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of...” NCT01324232 ↗ “Clinical trials establishing dextromethorphan and quinidine (DM/Q) as PBA treatment were conducted in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).” PMID 25062507 ↗ Jul 2014 “Dextromethorphan at 150 mg acts as an NMDA receptor antagonist, blocking NMDAR-mediated synaptic transmission at brain concentrations consistent with in vitro receptor blockade.” NCT07593222 ↗ “Dextromethorphan Immediate Release + Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.” NCT03471767 ↗ “AXS-05 (dextromethorphan-bupropion) is an oral NMDA receptor antagonist and sigma-1 receptor agonist, which utilizes inhibition of CYP2D6 to increase its bioavailability.” PMID 35582785 ↗ May 2022 “Single dose of drug cocktail: 100 milligram (mg) caffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.” NCT02688088 ↗ “Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease” NCT01584440 ↗ “ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)” NCT06930872 ↗ “The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.” NCT00113620 ↗ “Following the oral absorption of low doses of omeprazole, midazolam, dextromethorphan, and fexofenadine, drug metabolizing enzymes activity is assessed” PMID 29115994 ↗ Nov 2017 “Oral drug cocktail consisting of caffeine (100 mg), dextromethorphan (30 mg), losartan (25 mg), midazolam syrup (2 mg), and omeprazole (20 mg).” NCT06693960 ↗ “Group DEX was given 30 mg tablets of oral dextromethorphan with their pre-medication and three more times in the first 24 hours after surgery.” NCT00199303 ↗ “probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg).” NCT00401583 ↗ “Single oral administration of caffeine (100mg), omeprazole (20mg), losartan (25mg), dextromethorphan (30mg), and midazolam (1mg)” NCT04201197 ↗ “The Geneva cocktail is composed of caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam, and fexofenadine.” PMID 32851583 ↗ Nov 2020 “Repaglinide 0.25 mg, caffeine 100 mg, warfarin 10 mg (with vitamin K), omeprazole 40 mg, dextromethorphan 30 mg, midazolam 2 mg” NCT04233437 ↗ “The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.” NCT02596360 ↗ “Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally” NCT03718884 ↗ “Drug cocktail (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) orally once daily, day 1 and day 20” NCT01001299 ↗ “modified "karolinska cocktail" (dextromethorphan, caffeine, losartan, omeprazole and paracetamol) before bariatric surgery” NCT01086722 ↗ “Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days.” NCT01630811 ↗ “AVP-923-20/10 (dextromethorphan hydrobromide \[DM\] 20 milligram \[mg\]/quinidine sulfate \[Q\] 10 mg) capsule” NCT03381664 ↗ “acute exposure to dextromethorphan (DXM), which transiently blocks one type of excitatory neurotransmission” NCT02212275 ↗ “oral dose of the Cooperstown Cocktail (midazolam, omeprazole, warfarin, caffeine, and dextromethorphan)” NCT02434861 ↗ “Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity).” NCT05976646 ↗ “Caffeine + Warfarin (plus vitamin K) + Omeprazole + Dextromethorphan + Midazolam” NCT02993471 ↗ “includes midazolam, caffeine, losartan, omeprazole, and dextromethorphan” NCT03505853 ↗ “500 mg tolbutamide, 40 mg omeprazole, and 30 mg dextromethorphan orally.” NCT02819102 ↗ “caffeine, dextromethorphan, flurbiprofen, midazolam, and omeprazole” NCT03720366 ↗ “Dextromethorphan (30 mg orally) with collection of a 12-hour urine.” NCT00164112 ↗ “NUEDEXTA® (Dextromethorphan Hydrobromide and Quinidine Sulfate)” NCT02496039 ↗ “* dextromethorphan: 1.6mL (containing ~10 mg) oral solution” NCT04764851 ↗ “dextromethorphan, caffeine, omeprazole, and midazolam” NCT05334108 ↗ “Dextromethorphan tablets for oral use, 30 mg/day” NCT03195946 ↗ “45 mg dextromethorphan-105 mg bupropion” NCT04971291 ↗ “Dextromethorphan 400 mg PO single dose” NCT06731335 ↗ “Dextromethorphan (10 mg, R05DA09)” NCT02438072 ↗ “30 mg dextromethorphan (CYP2D6)” PMID 31099895 ↗ Jul 2019 “dextromethorphan (30 mg) syrup” NCT02062710 ↗ “CYP2D6 Dextromethorphan 10 mg” NCT04814498 ↗ “Dextromethorphan/Quinidine” NCT01832350 ↗ “Dextromethorphan (30 mg)” NCT00741468 ↗ “Dextromethorphan 30mg” NCT02056743 ↗ NCT01936025 ↗ NCT01257542 ↗ NCT00069550 ↗ NCT02225093 ↗ NCT03716427 ↗ NCT05236530 ↗ NCT05699993 ↗ NCT00359281 ↗ NCT02860962 ↗ NCT05444556 ↗ NCT04039022 ↗ NCT01189097 ↗ NCT01189006 ↗ NCT03729128 ↗ NCT05043805 ↗ NCT03714919 ↗ NCT01218620 ↗ NCT00999817 ↗ NCT03058419 ↗ NCT02651116 ↗ NCT01787136 ↗ NCT05602675 ↗ NCT07386730 ↗ NCT01188265 ↗ NCT04947553 ↗ NCT02775240 ↗ NCT00467779 ↗ NCT02206490 ↗ NCT01441102 ↗ NCT06566794 ↗ NCT03864042 ↗ NCT04188028 ↗ NCT03792971 ↗ NCT05181527 ↗ NCT01766050 ↗ NCT03054220 ↗ NCT00333242 ↗ NCT05947604 ↗ NCT00573443 ↗ NCT01091324 ↗ NCT06957223 ↗ NCT01651325 ↗ NCT07523048 ↗ NCT00934466 ↗ NCT02191709 ↗ NCT00377403 ↗ NCT00108446 ↗ NCT01361217 ↗ NCT05944510 ↗ NCT02515526 ↗ NCT03547024 ↗ NCT04643249 ↗ NCT00593957 ↗ NCT00964106 ↗ NCT04887194 ↗ NCT02368093 ↗ NCT02271893 ↗ NCT03538054 ↗ NCT02182336 ↗ NCT00003687 ↗ NCT06383338 ↗ NCT00001365 ↗ NCT00920088 ↗ NCT02218203 ↗ NCT03358706 ↗ NCT00127686 ↗ NCT04634669 ↗ NCT03883581 ↗ NCT06632990 ↗ NCT01553435 ↗ NCT02397382 ↗ NCT00788047 ↗ NCT02243553 ↗ NCT02727491 ↗ NCT02142712 ↗ NCT06772753 ↗ NCT06958692 ↗ NCT06348290 ↗ NCT03948243 ↗ NCT05278494 ↗ NCT00001725 ↗ NCT01882829 ↗ NCT04923659 ↗ NCT07665723 ↗ NCT01435798 ↗ NCT07583589 ↗ NCT02191176 ↗ NCT02176018 ↗ NCT01520363 ↗ NCT03738917 ↗ NCT04899687 ↗ NCT00513864 ↗ NCT00001344 ↗ NCT03039842 ↗ NCT00605605 ↗ NCT01570569 ↗ NCT00176553 ↗ NCT01462318 ↗ NCT01441986 ↗ NCT00726726 ↗ NCT02426983 ↗ NCT00176540 ↗ NCT04392011 ↗ NCT04687566 ↗ NCT01602185 ↗ NCT02391688 ↗ NCT04226352 ↗ NCT00055549 ↗ NCT00950586 ↗ NCT02987920 ↗ NCT02760615 ↗ NCT07241065 ↗ NCT03076021 ↗ NCT00310323 ↗ NCT03415243 ↗ NCT00000352 ↗ NCT00004807 ↗
Known as	Dextromethorphan HBr	“Drug: Dextromethorphan HBr” NCT03792971 ↗
Known as	Dextromethorphan hydrobromide	“The authors conducted a multicenter, randomized, double-blind, controlled, parallel, three-arm study to test a defined combination of dextromethorphan hydrobromide (DM) and...” PMID 15505150 ↗ Oct 2004 8 “In this study, the investigators will be using Dextromethorphan Hydrobromide Monohydrate powder supplied by the MUSC Investigational Drug Service that will be compounded as a...” NCT02860962 ↗ “NUEDEXTA capsules (20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate) administered orally, once a day from Days 1 to 7 and twice a day from Days 8 to 180” NCT02496039 ↗ “Dextromethorphan Hydrobromide, United States Pharmacopeia (USP) 20 milligram (mg) and Guaifenesin, USP 400 mg” NCT06716645 ↗ “Dextromethorphan hydrobromide•1 H2O; 30 mg; hard capsules; single, oral dose.” NCT01441986 ↗ “oral DXM \[dextromethorphan hydrobromide; Detosiv Slow Release®” NCT02368093 ↗ NCT02256813 ↗ NCT03480009 ↗ NCT01017939 ↗
Known as	Dextromethorphan Hydrobromide Monohydrate	“In this study, the investigators will be using Dextromethorphan Hydrobromide Monohydrate powder supplied by the MUSC Investigational Drug Service that will be compounded as a...” NCT02860962 ↗
Known as	Dextromethorphan, Ratiopharm GmbH	“Dextromethorphan, Ratiopharm GmbH” NCT01441986 ↗
Known as	Dextrométhorphane bromhydrate	“10 mg of an oral liquid formulation of Dextrométhorphane bromhydrate (Drill Pierre FABRE MEDICAMENT® 5mg/5mL, syrup)” NCT02590185 ↗
Known as	DMO	“Dextromethorphan (DMO), a non-competitive NMDA antagonist, will be delivered in the form of generic Life Brand Clear Cough Syrup DM (Trillium Healthcare Products Inc,...” NCT02426983 ↗
Known as	Drill Pierre FABRE MEDICAMENT	“10 mg of an oral liquid formulation of Dextrométhorphane bromhydrate (Drill Pierre FABRE MEDICAMENT® 5mg/5mL, syrup)” NCT02590185 ↗
Known as	DXM	“OBJECTIVE: The aim of this study was to further understand how the phenomenological and health-promoting effects of high-dose dextromethorphan (DXM) compared to psilocybin in...” PMID 38152462 ↗ Dec 2023 7 “30, 60 and 90 mg dextromethorphan (DXM) as well as 100 mg sitagliptin alone versus combinations of DXM and sitagliptin during an oral glucose tolerance test (OGTT) in 20 men with T2DM.” PMID 26362564 ↗ Oct 2015 “acute exposure to dextromethorphan (DXM), which transiently blocks one type of excitatory neurotransmission” NCT02212275 ↗ “The objective of this protocol is to evaluate if Dextromethorphan (DXM) reduces Fibromyalgia (FM) pain.” NCT03538054 ↗ “dextromethorphan (DXM) and amantadine compared to placebo exert blood glucose (BG) lowering effects” NCT01441986 ↗ “oral DXM \[dextromethorphan hydrobromide; Detosiv Slow Release®” NCT02368093 ↗ “Drug: Dextromethorphan (DXM)” NCT06772753 ↗ “Dextromethorphan (DXM)” NCT07386730 ↗
Known as	Nuedexta	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01806857 ↗
Action	Inhibit	“The ability of the putative excitatory amino acid receptor antagonist, dextromethorphan, to modify psychomotor function safely in patients with neurodegenerative disease will...” NCT00001365 ↗
Route	Oral	“receive dose escalated oral dextromethorphan capsules or placebo every 4 hours” NCT00003687 ↗