Drugs / Dextromethorphan
Dextromethorphan
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| Withdrawn | EU (EMA) | Nuedexta | — | 2016-02-15 | europa.eu ↗ |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 ↗ |
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| 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 | NCT00920088 | Jun → Nov 2009 | HIV infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02191176 | Jun → Jul 2009 | — | Boehringer Ingelheim | 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 | NCT02256813 | Sep → Dec 2005 | — | 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 | 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 | Mixed |
| 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 · 4 met primary · 3 missed | ||||||
| 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 | Missed primary |
| Phase 2 | NCT03595579 | May 2018 → Jan 2019 | major depressive disorder | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT03471767 | Mar 2018 → Mar 2019 | nicotine dependence | James Davis | Completed | Missed primary |
| 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 Stop: Enrollment |
| Phase 2 | NCT01767129 | Oct 2013 → Feb 2015 | Parkinson disease, movement disorder | Avanir Pharmaceuticals | Completed | Missed primary |
| 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 | Met primary |
| Phase 2 | NCT01584440 | Aug 2012 → Jul 2014 | Alzheimer disease | Avanir Pharmaceuticals | Completed | Met primary |
| 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 | Met primary |
| 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 Stop: Business |
| Phase 2/3 | NCT01189006 | Jan 2005 → Dec 2008 | schizophrenia | National Cheng-Kung University Hospital | Completed | No outcome recorded |
| Phase 316 trials · 6 met primary · 2 missed | ||||||
| Phase 3 | NCT06958692 | Apr 2025 → Sep 2026 overdue | 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT03480009 | Jul 2018 → Jun 2019 | — | Study Investigator-Sponsor | Completed | Missed primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00021697 | Jan 2001 → Apr 2002 | amyotrophic lateral sclerosis | Avanir Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00003687 | Jun 1998 → Sep 2001 | cancer of unknown primary site, leukemia, myelodysplastic syndrome, myeloproliferative neoplasm +3 | NCIC Clinical Trials Group | Completed | Missed primary |
| Phase 417 trials · 5 met primary · 2 missed | ||||||
| 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 | Met primary |
| Phase 4 | NCT05181527 | Feb 2022 → Sep 2023 | major depressive disorder | All India Institute of Medical Sciences, Bhubaneswar | Completed | Met primary |
| Phase 4 | NCT02987920 | Jan 2017 → Jan 2018 | — | University of Southern California | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02760615 | Nov 2016 → Aug 2020 | Crohn disease, ulcerative colitis | Takeda | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03076021 | Jul 2016 → Nov 2023 | — | University of Washington | Completed | No outcome recorded |
| Phase 4 | NCT02651116 | Feb 2016 → Mar 2020 | — | Pfizer | Terminated | Met primary Stop: Enrollment |
| Phase 4 | NCT02496039 | Sep 2015 → May 2016 | pseudobulbar palsy | Avanir Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Missed primary |
| Phase 4 | NCT02062710 | Jan → Jun 2014 | — | Montefiore Medical Center | Completed | Met primary |
| Phase 4 | NCT01799941 | Feb 2013 → May 2015 | dementia, pseudobulbar palsy, stroke disorder, traumatic brain injury | Avanir Pharmaceuticals | Completed | Met primary |
| 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 | Missed primary |
| Phase 4 | NCT00605605 | Mar → Dec 2005 | atherosclerosis | National Cheng-Kung University Hospital | Completed | No outcome recorded |
| Phase not applicable15 trials · 1 missed | ||||||
| — | 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 | Missed primary |
| — | 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 Stop: Enrollment |
| — | NCT00176553 | Mar 2003 → May 2007 | chemotherapy-induced toxicity | University of Medicine and Dentistry of New Jersey | Terminated | No outcome recorded Stop: Enrollment |
| — | 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 · 1 missed | ||||||
| — | NCT01787136 | — | attention deficit-hyperactivity disorder | Tri-Service General Hospital (TSGH) | No longer available | Missed primary |
| Comparator or background therapy17 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 1/2 | NCT02426983 Comparator | Apr → Sep 2015 | schizophrenia | University of Ottawa | Unknown | No outcome recorded |
| 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 3 | NCT01091324 Comparator | Jan → Jun 2010 | proteinuria | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05043805 Comparator | May 2021 → Apr 2024 | mood disorder | Tri-Service General Hospital (TSGH) | Completed | 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 Stop: Business |
| Phase 4 | NCT00377403 Background | Oct 2006 → May 2009 | respiratory tract infectious disorder, sinusitis | Washington University School of Medicine | Completed | Missed primary |
| Phase 4 | NCT00164112 Background | Nov 2004 → Jun 2005 | — | Bassett Healthcare | Completed | No outcome recorded |
| — | 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 |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-05-04 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update gcs-web.com ↗
AUVELITY approved for the treatment of agitation associated with dementia due to Alzheimer’s disease |
| 2026-04-30 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Approval of AUVELITY® (dextromethorphan HBr and bupropion HCl) for the Treatment of Agitation Associated with Dementia due to Alzheimer’s Disease gcs-web.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITY ® (dextromethorphan HBr and bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease. |
| 2024-05-28 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents Data from Multiple Programs at the 2024 American Society of Clinical Psychopharmacology Annual (ASCP) Meeting gcs-web.com ↗
Effects of AXS-05 (Dextromethorphan-Bupropion) in Improving Anhedonia and Interest-Activity Symptoms of MDD and the Associated Improvements in Functional Impairment |
| 2023-12-12 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE ORALLY DISINTEGRATING TABLETS OBTAINS CLINICAL TRIAL APPROVAL irasia.com ↗ |
| 2023-12-11 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents New Data and Post-Hoc Analyses of Auvelity® in Patients with Major Depressive Disorder at the American College of Neuropsychopharmacology (ACNP) 2023 Annual Meeting gcs-web.com ↗
today announced new data that treatment with Auvelity ® (dextromethorphan-bupropion) was associated with improvement in quality of life outcomes in broad populations of depression patients in the EVOLVE open-label trial in major depressive disorder (MDD). |
| 2023-09-07 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Highlights Commitment to Innovating Treatments for Mental Health Conditions with Presentations at Psych Congress 2023 gcs-web.com ↗
AXS-05 (Dextromethorphan-Bupropion) Significantly Improved Functioning in Major Depressive Disorder: Analysis of the Domains of the Sheehan Disability Scale |
| 2023-05-30 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics to Present Data and Post-Hoc Analyses on Auvelity® and Sunosi® at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting gcs-web.com ↗
The presentations on Auvelity incorporate new data and post-hoc analyses including demonstration of functional improvement in patients with major depressive disorder (MDD). |
| 2022-12-07 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents New Data from the EVOLVE Open-Label Trial Demonstrating Effects of AUVELITY® on Cognitive and Physical Functioning in Patients with Major Depressive Disorder at the American College of Neuropsychopharmacology (ACNP) 2022 Annua gcs-web.com ↗
In the trial, AUVELITY rapidly, durably, and substantially improved symptoms of depression including cognitive and physical functioning, and reduced disability in patients with MDD who had received one or more prior antidepressants. |
| 2022-08-19 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Approval of AUVELITY™, the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults gcs-web.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITY TM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. |
| 2022-06-01 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Late-Breaking Presentations of Positive Results of the EVOLVE Trial of AXS-05 in Major Depressive Disorder After Prior Treatment Failures at the American Society of Clinical Psychopharmacology (ASCP) 2022 Annual Meeting gcs-web.com ↗
today announced positive results from the long-term, open-label EVOLVE trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD). |
| 2022-05-31 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Publication of Pivotal GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder in The Journal of Clinical Psychiatry gcs-web.com ↗
AXS-05 (dextromethorphan-bupropion) demonstrated rapid, substantial, and statistically significant antidepressant efficacy compared to placebo starting 1 week after treatment |
| 2022-05-18 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Publication of Pivotal ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder in The American Journal of Psychiatry gcs-web.com ↗
today announced the publication of the results from the pivotal ASCEND Phase 2 clinical trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD). |
| 2018-03-07 | Perrigo Company | Regulatory Perrigo Announces Final FDA Approval and Planned Launch for the Store Brand OTC Equivalent of Mucinex® DM Maximum Strength Extended Release Tablets perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced that it has received final approval from the U.S. Food & Drug administration for the store brand OTC equivalent of Mucinex ® DM Maximum Strength (Guaifenesin and Dextromethorphan Hydrobromide Extended-Release Tablets, 1200 mg/60 mg). |
| 2018-02-26 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Primary Endpoint Met in Phase 1 Trial of Next Generation Product Candidate AXS-09 Containing Chirally Pure Esbupropion and Dextromethorphan gcs-web.com ↗
Results of the Phase 1 trial demonstrated that AXS-09 resulted in substantial increases in dextromethorphan plasma concentrations, the trial’s primary endpoint, into a potentially therapeutic range with repeated dosing (p<0.0001 day 1 versus day 8). |
| 2012-05-30 | Perrigo Company | Regulatory Perrigo Announces FDA Final Approval Of Tris Pharma's Dextromethorphan Polistirex Extended-Release Oral Suspension perrigo.com ↗
Perrigo Company (Nasdaq: PRGO;TASE) today announced that the U.S. Food and Drug Administration has granted final approval to Tris Pharma for its abbreviated new drug application (ANDA) for Dextromethorphan Polistirex Extended-Release Oral Suspension |
All press releases naming this drug 19 releases
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 2014171“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 |
| 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 20048“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 ↗ |
| 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 20237“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 ↗ |