Dronabinol

also known as THC · tetrahydrocannabinol · delta-9-THC · Marinol · delta-9-tetrahydrocannabinol · Δ9-THC · BX-1 · SP-104 · +8 more

Other / unclassified

Developed for: cannabis dependence · chronic pain syndrome · obstructive sleep apnea syndrome · HIV infectious disease · post-traumatic stress disorder · osteoarthritis, knee · chemotherapy-induced toxicity · fibromyalgia
+45 more
· schizophrenia · Tourette syndrome · Alzheimer disease · attention deficit-hyperactivity disorder · chronic pancreatitis · dementia · irritable bowel syndrome · neuropathy, painful · opiate dependence · sickle cell disease · amyotrophic lateral sclerosis · anxiety · autism · breast carcinoma · cervical dystonia · chemotherapy-induced neuropathy · chondromalacia · chronic obstructive pulmonary disease · colon carcinoma · dysmenorrhea · endometriosis · esophageal disorder · essential tremor · HIV wasting syndrome · hypoproteinemia, hypercatabolic · intermediate coronary syndrome · malignant pancreatic neoplasm · migraine disorder · migraine with aura · migraine without aura · mood disorder · multiple sclerosis · nervous system injury · nutritional deficiency disease · obsessive-compulsive disorder · radiculopathy · spondylosis, cervical · synovitis · trichotillomania · anorexia nervosa · eating disorder · hypertensive disorder · neurotic excoriation · olfactory nerve disorder · oral sensibility, disturbance of
Investigated by: National Institute on Drug Abuse (NIDA) · Yale University · Johns Hopkins University · Solvay Pharmaceuticals · New York State Psychiatric Institute · Hadassah Medical Organization
+132 more
· Neurothera Labs Inc. · Medical University of South Carolina · Radboud University Medical Center · VA Office of Research and Development · Wayne State University · Bionorica SE · Brain & Behavior Research Foundation · Center for Medicinal Cannabis Research · Central Institute of Mental Health, Mannheim · Charite University, Berlin, Germany · Columbia University · Dartmouth-Hitchcock Medical Center · European Union · INSYS Therapeutics Inc · King's College London · Massachusetts General Hospital · Mayo Clinic · Mclean Hospital · Medical University of Vienna · Montefiore Medical Center · National Cancer Institute (NCI) · National Center for Research Resources (NCRR) · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute on Aging (NIA) · Northwestern University · Oregon Health and Science University · Scilex Pharmaceuticals, Inc. · Substance Abuse and Mental Health Services Administration (SAMHSA) · Tilray · University of California, San Diego · University of Chicago · University of Colorado, Denver · University of Illinois at Chicago · University of Vermont · 3F Clinical Trials LTDA · ALS Association · Alzheimer's Clinical Trials Consortium · Alzheimer's Therapeutic Research Institute · Apnimed · Associação Brasileira de Cannabis Medicinal · Axim Biotechnologies · BASi Clinical Research Unit · Baylor College of Medicine · Bazelet Nehushtan LtD. · Benuvia Therapeutics Inc. · Bionorica Research GmbH · Biopharmaceutical Research Company · Bloom Labs Cannabis Solutions · Brigham and Women's Hospital · Bristol-Myers Squibb · CIHR Canadian HIV Trials Network · Cantonal Hospital of St. Gallen · Centre de Recherche du Centre Hospitalier de l'Université de Montréal · Christopher D. Verrico · City of Hope Medical Center · Colorado Joint Replacement · Colorado State University · CommonSpirit Health · Connecticut Pharmaceutical Solutions · Consortium for Medical Marijuana Clinical Outcomes Research · Daisy Pharma Opioid Venture, LLC · Duke University · Dystonia Medical Research Foundation · FG Brasil LTDA · FGK Clinical Research GmbH · Food and Drug Administration (FDA) · Hamilton Health Sciences Corporation · Harvard Medical School (HMS and HSDM) · Hebrew University of Jerusalem · Hektoen Institute for Medical Research · Hospital for Special Surgery, New York · Icahn School of Medicine at Mount Sinai · Incannex Healthcare Ltd · all 138 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	MARINOL	—	1992-12-22	fda.gov ↗
Approved	US (FDA)	MARINOL	—	1985-05-31	fda.gov ↗

Trials 134 · started per year

today

US approved 1985

198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 08 trials
Phase 0	NCT04099355	Sep 2025 → Aug 2027	arthropathy	New York State Psychiatric Institute	Withdrawn	No outcome recorded Stop: Business
Phase 0	NCT06236815	Jan → Sep 2025	attention deficit-hyperactivity disorder, cognitive impairment with or without cerebellar ataxia	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 0	NCT04231643	Sep 2021 → Nov 2023	bipolar disorder	University of California, San Diego	Terminated	No outcome recorded
Phase 0	NCT03560934	Sep 2018 → Sep 2021	—	Oregon Health and Science University	Completed	No outcome recorded
Phase 0	NCT02335060	May → Sep 2014	—	Yale University	Terminated	No outcome recorded
Phase 0	NCT01591629	Nov 2011 → Jun 2012	—	Yale University	Completed	No outcome recorded
Phase 0	NCT01180374	Feb 2010 → Oct 2014	—	Yale University	Completed	No outcome recorded
Phase 0	NCT00842985	Sep 2008 → Oct 2009	cannabis dependence	Yale University	Completed	No outcome recorded
Phase 132 trials · 1 missed
Phase 1	NCT07176208	Dec 2025 → Jun 2026	cannabis dependence	Food and Drug Administration (FDA)	Completed	No outcome recorded
Phase 1	NCT05865470	Apr 2025 → Oct 2028 expected	poisoning, substance abuse	University of California, Los Angeles	Recruiting	No outcome recorded
Phase 1	NCT06609109	Mar 2025 → Apr 2029 expected	cannabis dependence, nicotine dependence	Johns Hopkins University	Recruiting	No outcome recorded
Phase 1	NCT06378957	Feb 2025 → Jul 2027 expected	—	Johns Hopkins University	Recruiting	No outcome recorded
Phase 1	NCT06772753	Feb 2025 → Jun 2027 expected	—	Johns Hopkins University	Recruiting	No outcome recorded
Phase 1	NCT06609083	Jan 2025 → Apr 2029 expected	—	Johns Hopkins University	Recruiting	No outcome recorded
Phase 1	NCT06218550	Jul 2024 → Sep 2025	cannabis dependence	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT05742724	Jan → Feb 2024 overdue	chronic kidney disease	McMaster University	Active not recruiting	No outcome recorded
Phase 1	NCT06034314	Sep 2023 → Oct 2026 expected	HIV infectious disease	Yale University	Active not recruiting	No outcome recorded
Phase 1	NCT04226690	Nov 2022 → Dec 2023	—	Yale University	Completed	No outcome recorded
Phase 1	NCT05287256	May 2022 → Aug 2024	—	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT04920539	Feb 2022 → Dec 2025	HIV infectious disease	Yale University	Completed	No outcome recorded
Phase 1	NCT05002946	Jan → Apr 2022	—	Scilex Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT04958876	Oct → Dec 2021	—	Scilex Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT04080427	Apr 2021 → May 2025	post-traumatic stress disorder	Wayne State University	Completed	No outcome recorded
Phase 1	NCT04199468	Sep 2019 → Jun 2022	—	Yale University	Completed	No outcome recorded
Phase 1	NCT03978156	Jul 2019 → Jan 2021	sickle cell disease	Yale University	Terminated	No outcome recorded
Phase 1	NCT03936907	Apr → Jul 2019	—	One World Cannabis Ltd.	Completed	No outcome recorded
Phase 1	NCT03098940	Jan → Apr 2018	thrombocytopenia 3	Axim Biotechnologies	Unknown	No outcome recorded
Phase 1	NCT03206463	Aug → Sep 2017	bipolar disorder	Yale University	Terminated	No outcome recorded
Phase 1	NCT02811939	Apr 2016 → Jun 2017	—	Yale University	Completed	No outcome recorded
Phase 1	NCT02710331	Mar 2016 → Dec 2026 expected	alcohol-induced mental disorder	Yale University	Active not recruiting	No outcome recorded
Phase 1	NCT02709954	Mar 2016 → Dec 2026 expected	alcohol-induced mental disorder, cannabis dependence	Yale University	Active not recruiting	No outcome recorded
Phase 1	NCT02404688	Dec 2015 → Dec 2026 expected	alcohol-induced mental disorder	Yale University	Active not recruiting	No outcome recorded
Phase 1	NCT02576912	Feb 2015 → Jun 2019	—	Yale University	Completed	No outcome recorded
Phase 1	NCT01964404	Jul 2014 → Sep 2021	cannabis dependence, schizophrenia	Dartmouth-Hitchcock Medical Center	Completed	Missed primary
Phase 1	NCT02094599	Feb → May 2014	substance abuse	INSYS Therapeutics Inc	Completed	No outcome recorded
Phase 1	NCT00946348	Dec 2009 → Oct 2012	cannabis dependence, schizoaffective disorder, schizophrenia	Dartmouth-Hitchcock Medical Center	Completed	No outcome recorded
Phase 1	NCT00438139	Mar 2007	cannabis dependence	National Institute on Drug Abuse (NIDA)	Terminated	No outcome recorded
Phase 1	NCT00314808	Apr 2006 → Oct 2011	glioma	Duke University	Completed	No outcome recorded
Phase 1	NCT01380457	Jan → Apr 2006	—	Par Pharmaceutical, Inc.	Completed	No outcome recorded
Phase 1	NCT00000737	—	HIV wasting syndrome, hypoproteinemia, hypercatabolic	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 1/28 trials
Phase 1/2	NCT07592390	May → Dec 2026 expected	attention deficit-hyperactivity disorder	University of Southern Santa Catarina	Recruiting	No outcome recorded
Phase 1/2	NCT06381180	Sep 2025 → Dec 2030 expected	cannabis dependence, post-traumatic stress disorder	Wayne State University	Not yet recruiting	No outcome recorded
Phase 1/2	NCT06477952	Aug 2025 → Dec 2026 expected	obstructive sleep apnea syndrome	VA Office of Research and Development	Recruiting	No outcome recorded
Phase 1/2	NCT05272865	Aug 2023 → Feb 2024	chemotherapy-induced toxicity, neoplasm	LaSanta S A S	Unknown	No outcome recorded
Phase 1/2	NCT05101122	Oct 2021 → Apr 2022	obstructive sleep apnea syndrome	Apnimed	Completed	No outcome recorded
Phase 1/2	NCT03805750	Jan 2019 → Sep 2020	essential tremor	University of California, San Diego	Completed	No outcome recorded
Phase 1/2	NCT00893074	Apr 2009 → Oct 2011	cannabis dependence	Johns Hopkins University	Completed	No outcome recorded
Phase 1/2	NCT00079560	Dec 2001 → Aug 2004	HIV infectious disease	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 243 trials · 1 met primary · 2 missed
Phase 2	NCT07815691	Oct 2026 → Jul 2031 expected	cannabis dependence	Medical University of South Carolina	Recruiting	No outcome recorded
Phase 2	NCT07635563	Jul 2026 → Apr 2027 expected	obstructive sleep apnea syndrome	Incannex Healthcare Ltd	Recruiting	No outcome recorded
Phase 2	NCT05126888	Jun 2026 → Oct 2027 expected	Tourette syndrome	Neurothera Labs Inc.	Not yet recruiting	No outcome recorded
Phase 2	NCT07225777	Apr → Aug 2026	cannabis dependence	Medical University of South Carolina	Terminated	No outcome recorded Stop: Business
Phase 2	NCT06834997	Apr 2026 → Mar 2028	endometriosis	Baylor College of Medicine	Withdrawn	No outcome recorded
Phase 2	NCT07199218	Oct 2025 → Dec 2027 expected	autism	Bazelet Nehushtan LtD.	Recruiting	No outcome recorded
Phase 2	NCT06731894	Oct 2025 → Jan 2028 expected	breast carcinoma, chemotherapy-induced neuropathy, colon carcinoma	City of Hope Medical Center	Recruiting	No outcome recorded
Phase 2	NCT06647524	Jul 2025 → Dec 2027 expected	—	Yale University	Recruiting	No outcome recorded
Phase 2	NCT05519111	Apr 2025 → Apr 2027 expected	sickle cell disease	Icahn School of Medicine at Mount Sinai	Recruiting	No outcome recorded
Phase 2	NCT06446479	Jul 2024 → Jun 2026 overdue	cannabis dependence	University of Colorado, Denver	Recruiting	No outcome recorded
Phase 2	NCT06454669	Jun 2024 → Dec 2028 expected	chronic pain syndrome	Christopher D. Verrico	Recruiting	No outcome recorded
Phase 2	NCT05477875	Feb 2024 → Jan 2025	hyperopia, myopia	University of Florida	Completed	No outcome recorded
Phase 2	NCT05644262	Jan 2024 → Nov 2025	dementia	University of Southern California	Completed	No outcome recorded
Phase 2	NCT05612711	Nov 2023 → Nov 2025	dementia	Ralph H. Johnson VA Medical Center	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT04992624	Feb 2022 → Mar 2027 expected	osteoarthritis, knee	Steven E Harte, PhD	Recruiting	No outcome recorded
Phase 2	NCT05239390	Dec 2021 → Jun 2023	Alzheimer disease	The Israeli Medical Center for Alzheimer's	Unknown	No outcome recorded
Phase 2	NCT03550352	Aug 2021 → May 2022	HIV infectious disease	McGill University Health Centre/Research Institute of the McGill University Health Centre	Terminated	No outcome recorded
Phase 2	NCT04596826	Nov 2020 → Oct 2024	retinal vascular disorder	Medical University of Vienna	Completed	Met primary
Phase 2	NCT04448808	Oct 2020 → Jan 2025	post-traumatic stress disorder	Charite University, Berlin, Germany	Completed	No outcome recorded
Phase 2	NCT03928015	Oct 2019 → Jun 2021	—	CommonSpirit Health	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT04091789	Sep 2019 → Mar 2020	dysmenorrhea, migraine disorder, mood disorder	Pure Green	Unknown	No outcome recorded
Phase 2	NCT03635593	Jan 2019 → Jan 2021	chronic pain syndrome	Hamilton Health Sciences Corporation	Unknown	No outcome recorded
Phase 2	NCT03766269	Dec 2018 → Jun 2019	chronic pain syndrome	Daisy Pharma Opioid Venture, LLC	Unknown	No outcome recorded
Phase 2	NCT03651726	Aug 2018 → Nov 2019	Tourette syndrome	Neurothera Labs Inc.	Unknown	No outcome recorded
Phase 2	NCT03646552	Jun 2018 → Apr 2019	obstructive sleep apnea syndrome	Neurothera Labs Inc.	Unknown	No outcome recorded
Phase 2	NCT03005119	Mar → Dec 2018	multiple sclerosis	PhytoTech Therapeutics, Ltd.	Unknown	No outcome recorded
Phase 2	NCT03098563	Nov 2017 → Nov 2023	osteoarthritis, knee	Johns Hopkins University	Completed	No outcome recorded
Phase 2	NCT02792257	Mar 2017 → May 2024	Alzheimer disease	Johns Hopkins University	Completed	Mixed
Phase 2	NCT03066193	Feb 2017 → Jun 2018	Tourette syndrome	Yale University	Completed	No outcome recorded
Phase 2	NCT02901275	Dec 2016 → Mar 2020	—	Johns Hopkins University	Completed	Mixed
Phase 2	NCT02608931	Nov 2015 → Mar 2019	Riley-Day syndrome	NYU Langone Health	Withdrawn	No outcome recorded
Phase 2	NCT01755091	Feb 2013 → Jun 2016	obstructive sleep apnea syndrome	University of Illinois at Chicago	Completed	No outcome recorded
Phase 2	NCT01551511	Oct 2012 → Jun 2014	chronic pain syndrome, chronic pancreatitis	Radboud University Medical Center	Completed	Missed primary
Phase 2	NCT01562483	Oct 2012 → Jun 2014	chronic pain syndrome	Radboud University Medical Center	Completed	Missed primary
Phase 2	NCT01318369	Oct 2011 → May 2013	chronic pancreatitis	Radboud University Medical Center	Completed	No outcome recorded
Phase 2	NCT01093976	Apr 2010 → Jan 2011	obsessive-compulsive disorder, trichotillomania	University of Chicago	Completed	No outcome recorded
Phase 2	NCT01253408	Sep 2009 → Dec 2011	irritable bowel syndrome	Mayo Clinic	Completed	No outcome recorded
Phase 2	NCT01786109	Sep 2009 → Dec 2011	irritable bowel syndrome	Michael Camilleri	Completed	No outcome recorded
Phase 2	NCT00743119	Jun 2008 → Oct 2009	—	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT00418925	Sep 2006 → Nov 2009	cervical dystonia	University Health Network, Toronto	Unknown	No outcome recorded
Phase 2	NCT00123201	Sep 2005 → Mar 2007	migraine with aura, migraine without aura	Solvay Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT00373503	Aug 2005 → Jun 2007	cannabis dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT00642499	Aug 2003 → Apr 2005	HIV infectious disease	Solvay Pharmaceuticals	Completed	No outcome recorded

Phase 2/38 trials
Phase 2/3	NCT07570953	Nov 2026 → Apr 2028 expected	obstructive sleep apnea syndrome	Mayo Clinic	Not yet recruiting	No outcome recorded
Phase 2/3	NCT07422311	May 2026 → May 2028 expected	—	Benuvia Therapeutics Inc.	Not yet recruiting	No outcome recorded
Phase 2/3	NCT05283161	Apr → Aug 2022	fibromyalgia	FG Brasil LTDA	Unknown	No outcome recorded
Phase 2/3	NCT02283281	May 2015 → Dec 2024	anxiety, neuropathy, painful	Hadassah Medical Organization	Unknown	No outcome recorded
Phase 2/3	NCT01598896	May 2012 → Aug 2017	cannabis dependence	Mclean Hospital	Terminated	No outcome recorded Stop: Enrollment
Phase 2/3	NCT01020019	Jan 2010 → Sep 2014	cannabis dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2/3	NCT01024335	Jan 2010 → Dec 2012	opiate dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2/3	NCT00153192	Apr 2001 → Apr 2006	chronic pain syndrome	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 310 trials
Phase 3	NCT07148206	Oct 2026 → May 2028 expected	opiate dependence	Montefiore Medical Center	Not yet recruiting	No outcome recorded
Phase 3	NCT05052541	Jan 2026 → Jun 2027 expected	spondylosis, cervical	University of Colorado, Denver	Recruiting	No outcome recorded
Phase 3	NCT06473701	Feb 2025 → Sep 2026	chronic obstructive pulmonary disease	Vejle Hospital	Completed	No outcome recorded
Phase 3	NCT05335252	Jun 2022 → Dec 2027 expected	chondromalacia, osteoarthritis, knee, synovitis	Northwestern University	Active not recruiting	No outcome recorded
Phase 3	NCT04298528	Feb 2020 → Feb 2024	osteoarthritis, knee	Colorado Joint Replacement	Unknown	No outcome recorded
Phase 3	NCT03756974	Feb 2019 → Mar 2021	—	Bionorica SE	Completed	No outcome recorded
Phase 3	NCT04816994	Jan 2018 → Dec 2025 overdue	radiculopathy	Hadassah Medical Organization	Recruiting	No outcome recorded
Phase 3	NCT00553059	May 2008 → Aug 2014	cancer of unknown primary site, chemotherapy-induced toxicity	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 3	NCT00959218	Jun 2007 → Mar 2010	neuropathy, painful	Bionorica Research GmbH	Completed	No outcome recorded
Phase 3	NCT00642512	Jul 2003 → Jul 2004	chemotherapy-induced toxicity	Solvay Pharmaceuticals	Completed	No outcome recorded
Phase 410 trials · 2 missed
Phase 4	NCT05820685	Jul 2023 → Apr 2024	nervous system injury	The University of Texas Health Science Center, Houston	Terminated	No outcome recorded
Phase 4	NCT04734080	Mar 2021 → Oct 2023	substance-related disorder	Hospital for Special Surgery, New York	Completed	Missed primary
Phase 4	NCT04155008	Mar → Apr 2021	cancer-related condition, head and neck cancer, lung cancer, malignant pancreatic neoplasm +1	Montefiore Medical Center	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT04374773	Oct 2020 → Feb 2026	cannabis dependence, pregnancy disorder	University of Washington	Completed	No outcome recorded
Phase 4	NCT04346407	Sep 2020 → Sep 2023	—	Jeffrey L Gum MD	Unknown	No outcome recorded
Phase 4	NCT03604341	Nov 2018 → May 2019	—	Oregon Health and Science University	Completed	Missed primary
Phase 4	NCT02569073	Jun 2017 → Aug 2019	esophageal disorder	Temple University	Withdrawn	No outcome recorded Stop: Business
Phase 4	NCT03008005	Jun 2017 → Dec 2019	post-traumatic stress disorder	Wayne State University	Completed	No outcome recorded
Phase 4	NCT01598207	Feb 2011 → May 2014	intermediate coronary syndrome	Yehudith Assouline-Dayan	Completed	No outcome recorded
Phase 4	NCT00965809	Oct 2009 → Oct 2012	post-traumatic stress disorder	Hadassah Medical Organization	Unknown	No outcome recorded
Phase not applicable15 trials · 3 missed
—	NCT07656350	Jun 2026 → Dec 2027 expected	—	King's College London	Recruiting	No outcome recorded
—	NCT06967051	May → Aug 2025	drug-induced mental disorder	Sobereye Inc.	Completed	No outcome recorded
—	NCT05644054	Jan 2023 → Apr 2024	fibromyalgia	Tel Aviv Medical Center	Unknown	No outcome recorded
—	NCT04871269	May 2021 → Dec 2023 overdue	—	Charite University, Berlin, Germany	Active not recruiting	No outcome recorded
—	NCT04605393	Jan 2021 → Jul 2023	cannabis dependence, schizophrenia	King's College London	Completed	Missed primary
—	NCT03655717	Nov 2018 → Jan 2021	alcohol-related disorders, poisoning	Massachusetts General Hospital	Completed	Missed primary
—	NCT03907163	Jul → Nov 2018	—	Medical University of Vienna	Completed	No outcome recorded
—	NCT02604992	Nov → Dec 2015	—	INSYS Therapeutics Inc	Completed	No outcome recorded
—	NCT02310347	Dec 2014 → Sep 2016 overdue	—	Universitaire Ziekenhuizen KU Leuven	Active not recruiting	No outcome recorded
—	NCT02291562	Jul → Dec 2014	—	Central Institute of Mental Health, Mannheim	Completed	No outcome recorded
—	NCT02112292	Apr 2014 → Apr 2015	—	Wageningen University	Completed	No outcome recorded
—	NCT02291536	Feb → Dec 2014	—	Central Institute of Mental Health, Mannheim	Completed	No outcome recorded
—	NCT01149018	Jun 2010 → Jul 2012	fibromyalgia	Hadassah Medical Organization	Unknown	No outcome recorded
—	NCT00757822	Dec 2009 → Dec 2013	—	VA Office of Research and Development	Completed	Missed primary
—	NCT00812851	Apr 2005 → Apr 2008	amyotrophic lateral sclerosis	Cantonal Hospital of St. Gallen	Completed	No outcome recorded

Comparator or background therapy33 trials
Phase 0	NCT05906511 Comparator	Oct 2023 → Apr 2026 overdue	substance abuse	Yale University	Recruiting	No outcome recorded
Phase 0	NCT04294966 Comparator	Mar 2020 → May 2021	—	University of Chicago	Completed	No outcome recorded
Phase 0	NCT04025359 Comparator	May 2019 → Dec 2026 expected	—	Yale University	Recruiting	No outcome recorded
Phase 0	NCT03809546 Comparator	Nov 2018 → Jun 2021	—	University of Chicago	Completed	No outcome recorded
Phase 0	NCT03804840 Comparator	Mar 2017 → Dec 2018	—	University of Chicago	Completed	No outcome recorded
Phase 1	NCT06948136 Comparator	Jun 2025 → Nov 2027 expected	cognitive disorder	Yale University	Recruiting	No outcome recorded
Phase 1	NCT06058702 Comparator	Sep 2024 → Dec 2028 expected	cannabis dependence, schizophrenia	Yale University	Recruiting	No outcome recorded
Phase 1	NCT02811510 Comparator	Jun 2016 → Jun 2026 overdue	—	Yale University	Recruiting	No outcome recorded
Phase 1	NCT02781519 Comparator	Jun 2015 → Jun 2026 overdue	—	Yale University	Recruiting	No outcome recorded
Phase 1	NCT01448772 Comparator	Oct → Dec 2011	—	INSYS Therapeutics Inc	Completed	No outcome recorded
Phase 1	NCT01323569 Comparator	Feb → Jun 2008	—	Jazz Pharmaceuticals	Completed	Mixed
Phase 1	NCT00624715 Comparator	Aug 2007 → Jun 2010	alcohol dependence	Yale University	Completed	No outcome recorded
Phase 1	NCT00490269 Comparator	Oct 2006 → Dec 2007	cannabis dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 1/2	NCT07696871 Background	Jun → Dec 2026 expected	major depressive disorder	University of Southern Santa Catarina	Recruiting	No outcome recorded
Phase 1/2	NCT01394185 Comparator	Feb 2011 → Sep 2012	—	Johns Hopkins University	Completed	No outcome recorded
Phase 1/2	NCT01832766 Comparator	Jun 2005 → May 2010	schizophrenia	University of Colorado, Denver	Terminated	No outcome recorded
Phase 1/2	NCT00682929 Comparator	Apr 2004 → Aug 2011	multiple sclerosis	University of California, Davis	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT05269628 Comparator	Mar 2022 → Aug 2027 expected	multiple sclerosis	Tiffany J. Braley, MD, MS	Recruiting	No outcome recorded
Phase 2	NCT02460692 Comparator	Dec 2016 → Mar 2020	neuropathy, painful	University of California, San Diego	Completed	Mixed
Phase 2	NCT00480441 Comparator	Aug 2006 → Jun 2009	cannabis dependence	University of Pennsylvania	Completed	No outcome recorded
Phase 2	NCT00316563 Comparator	Aug 2006 → Nov 2009	cancer, eating disorder, olfactory nerve disorder, oral sensibility, disturbance of	Alberta Health services	Completed	No outcome recorded
Phase 2	NCT00217971 Comparator	Mar 2005 → Dec 2009	cannabis dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2/3	NCT07231965 Comparator	Oct 2026 → Dec 2027 expected	hypertensive disorder	Mayo Clinic	Not yet recruiting	No outcome recorded
Phase 2/3	NCT06146101 Comparator	May 2024 → Dec 2026 expected	obstructive sleep apnea syndrome	Incannex Healthcare Ltd	Active not recruiting	No outcome recorded
Phase 2/3	NCT04989413 Comparator	Oct 2022 → Feb 2025	migraine disorder	Hospital Israelita Albert Einstein	Terminated	No outcome recorded Stop: Enrollment
Phase 2/3	NCT03530800 Comparator	Oct 2018 → Jul 2021	neurotic excoriation, trichotillomania	University of Chicago	Completed	No outcome recorded
Phase 3	NCT03825965 Background	May 2023 → Feb 2025	osteoarthritis, knee	McMaster University	Completed	No outcome recorded
Phase 3	NCT03984214 Comparator	Dec 2019 → Sep 2024	chemotherapy-induced toxicity, malignant pancreatic neoplasm	Study Group of Medical Tumour Therapy (AGMT)	Completed	No outcome recorded
Phase 3	NCT00760695 Comparator	Oct 2008 → Dec 2011	anorexia nervosa	Odense University Hospital	Completed	No outcome recorded
Phase 4	NCT02472847 Comparator	May 2012 → Jul 2014	—	University of Illinois at Chicago	Completed	No outcome recorded
—	NCT05226351 Comparator	Mar 2022 → Aug 2024	post-traumatic stress disorder	Charite University, Berlin, Germany	Completed	No outcome recorded
—	NCT02069366 Comparator	Nov 2014 → Dec 2019	post-traumatic stress disorder	Wayne State University	Completed	No outcome recorded
—	NCT00270803 Comparator	Jul 2004 → Dec 2005	cannabis dependence	Tel-Aviv Sourasky Medical Center	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 2

Date	Issuer	Release
2026-01-12	Benuvia Therapeutics Inc.	Regulatory Benuvia Operations Supports FDA IND Filing by Mandara Biopharma for Dronabinol Oral Solution in Alzheimer’s Agitation benuvia.com ↗ Benuvia Operations, LLC (Benuvia), a U.S.-based pharmaceutical development and manufacturing company specializing in regulated and controlled-substance drug products and active pharmaceutical ingredients (APIs), today announced its role as manufacturing partner supporting Mandara Biopharma Inc.’s (Mandara) filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate clinical development of a dronabinol oral solution formulation for the treatment of agitation associated with Alzheimer’s disease.
2018-05-21	Lannett Company, Inc.	Regulatory Lannett Receives FDA Approval For Dronabinol Capsules investorroom.com ↗ Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg, the therapeutic equivalent to the reference listed drug, Marinol® Capsules 2.5 mg, 5 mg and 10 mg of AbbVie Inc.

All press releases naming this drug 7 releases

Date	Issuer	Release
2026-01-12	Benuvia Therapeutics Inc.	Benuvia Operations Supports FDA IND Filing by Mandara Biopharma for Dronabinol Oral Solution in Alzheimer’s Agitation benuvia.com ↗
2025-05-13	Benuvia Therapeutics Inc.	Benuvia Operations Signs Commercial Supply Agreement with Leading U.S. Pharmaceutical Company for Dronabinol API benuvia.com ↗
2024-12-10	Benuvia Therapeutics Inc.	Benuvia Operations, LLC Enters into Licensing Agreement with Avernus Pharma for SYNDROS® CII (dronabinol) in the Gulf Cooperation Council Region benuvia.com ↗
2023-03-23	Scilex Pharmaceuticals, Inc.	Scilex, a Sorrento Company, Highlights Safety Data From Phase 1 Trial of SP-104, a Proprietary Low Dose Naltrexone for Fibromyalgia gcs-web.com ↗
2021-11-02	Avextra Pharma GmbH	Successful Start of Eurox’s Dronabinol Sales avextra.com ↗
2021-11-02	Avextra Pharma GmbH	Erfolgreicher Start der Dronabinol-Verkäufe von Eurox Pharma avextra.com ↗
2018-05-21	Lannett Company, Inc.	Lannett Receives FDA Approval For Dronabinol Capsules investorroom.com ↗

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 174 sources stand behind the page.

Field	Value	Cited text
Known as	dronabinol	“This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid dronabinol (Marinol; oral) to the FDA-approved opioid hydromorphone (Dilaudid;...” NCT02901275 ↗ 110 “The potential sedative effect of dronabinol and the high expression of cannabinoid receptors on the hypoglossal motor nuclei makes this agent a good candidate for obstructive...” PMID 36805833 ↗ Jul 2023 “SCI-110 - a softgel capsule containing Dronabinol and Palmitoylethanolamide (PEA) in the following doses: 2.5mg Dronabinol+400mg PEA, 5mg Dronabinol+400mg PEA and 10mg Dronabinol+400mg.” NCT05126888 ↗ “Participants (N = 21; 57% women; mean age = 63.4 ± 6.4 yr) with knee osteoarthritis received oral combinations of placebo, hydromorphone (2 mg), and dronabinol (10 mg).” PMID 41481837 ↗ Dec 2025 “Dronabinol (synthetic Δ(9)- tetrahydrocannabinol) is used in patients with nausea and vomiting from chemotherapy and in AIDS patients for appetite stimulation.” PMID 26283236 ↗ Aug 2015 “The primary objective of the study is to examine the efficacy of oral dronabinol (BX-1) versus placebo in reducing nightmares in patients with PTSD.” PMID 37147642 ↗ May 2023 “BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.” NCT03756974 ↗ “dronabinol 20 and 40 mg (synthetic THC: Marinol, Solvay Pharmaceuticals, Brussels, Belgium) and matching placebos” PMID 21671456 ↗ Apr 2011 “Dronabinol - Manufactured by Pharmaceutics International, Inc., Hunt Valley, MD 21031, USA.” NCT05239390 ↗ “Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo” NCT00842985 ↗ “Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)” NCT04992624 ↗ Show 100 more sources
Known as	AXIBAN	“Patients will be administered a one-time dosage of 0.2 mg/kg THC oil (AXIBAN, T10/C2, manufactured by Panaxia Pharmaceuticals, Lod, Israel)” NCT05644054 ↗
Known as	BX-1	“The primary objective of the study is to examine the efficacy of oral dronabinol (BX-1) versus placebo in reducing nightmares in patients with PTSD.” PMID 37147642 ↗ May 2023 1 “BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.” NCT03756974 ↗
Known as	D-9-Tetrahydrocannabinol	“Effects of D-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) on Human Episodic Memory Function” NCT02291562 ↗
Known as	delta-9-tetrahydrocannabinol	“The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e.,...” NCT05226351 ↗ 6 “Delta-9-Tetrahydrocannabinol, Cannabidiol, and Acute Psychotomimetic States: A Balancing Act of the Principal Phyto-Cannabinoids on Human Brain and Behavior.” PMID 35319274 ↗ Mar 2022 “Dronabinol is a synthetic oral formulation of delta-9-tetrahydrocannabinol (THC), a psychoactive constituent of the cannabis plant” NCT02792257 ↗ “Delta-9-tetrahydrocannabinol (THC) is the most abundant cannabinoid from the plant Cannabis sativa.” PMID 27720917 ↗ Oct 2016 “delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis” NCT01591629 ↗ “the cannabinoid, delta-9-tetrahydrocannabinol (THC), in healthy adult subjects” NCT04199468 ↗ “with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol)” NCT04871269 ↗
Known as	delta-9-tetrahydrocannabinol [THC]	“dronabinol (synthetic delta-9-tetrahydrocannabinol [THC])” NCT07148206 ↗
Known as	delta-9-THC	“Active delta-9-THC administered intravenously over 20 minutes.” NCT06058702 ↗ 16 NCT06058702 ↗ NCT02576912 ↗ NCT06378957 ↗ NCT06948136 ↗ NCT04920539 ↗ NCT05287256 ↗ NCT02709954 ↗ NCT04199468 ↗ NCT02404688 ↗ NCT01180374 ↗ Show 6 more sources
Known as	Marinol	“This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid dronabinol (Marinol; oral) to the FDA-approved opioid hydromorphone (Dilaudid;...” NCT02901275 ↗ 12 “This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol...” NCT06834997 ↗ “THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler.” NCT03809546 ↗ “THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler.” NCT03804840 ↗ “Dronabinol (Marinol®) is FDA-approved for the treatment of anorexia/weight loss in AIDS and for nausea/emesis associated with chemotherapy” NCT02792257 ↗ “Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain” NCT00153192 ↗ “dronabinol 20 and 40 mg (synthetic THC: Marinol, Solvay Pharmaceuticals, Brussels, Belgium) and matching placebos” PMID 21671456 ↗ Apr 2011 “oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana)” NCT00682929 ↗ “Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)” NCT04992624 ↗ “dronabinol (also known as THC or by the trade name Marinol)” NCT00079560 ↗ “THC (Marinol® \[dronabinol\]; Solvay Pharmaceuticals)” NCT04294966 ↗ Show 2 more sources
Known as	Namisol	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01318369 ↗
Known as	SP-104	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05002946 ↗ 1 NCT04958876 ↗
Known as	SYNDROS	“Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL)” NCT05272865 ↗
Known as	synthetic THC	“dronabinol (synthetic THC)” NCT04099355 ↗
Known as	synthetic Δ(9)- tetrahydrocannabinol	“Dronabinol (synthetic Δ(9)- tetrahydrocannabinol) is used in patients with nausea and vomiting from chemotherapy and in AIDS patients for appetite stimulation.” PMID 26283236 ↗ Aug 2015
Known as	synthetic Δ9-THC	“THX-110 (Dronabinol (synthetic Δ9-THC) and PEA)” NCT03646552 ↗
Known as	tetrahydrocannabinol	“This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety,...” NCT00490269 ↗ 38 “Aim of this phase III trial is to investigate the efficacy and safety of dronabinol (orally administered tetrahydrocannabinol (THC)) as adjuvant therapy to first-line standard...” NCT03984214 ↗ “A sublingual tablet containing 30 mg of cannabidiol (CBD), 1 mg tetrahydrocannabinol (THC), 97 mg palmitoylethanolamide (PEA), and a 0.2 mg combination of myrcene,...” NCT04091789 ↗ “Full-spectrum Cannabis sativa extract containing cannabigerol (CBG) 30 mg/mL, cannabidiol (CBD) 30 mg/mL, and tetrahydrocannabinol (THC) 3 mg/mL, administered sublingually for...” NCT07592390 ↗ “This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes -...” NCT03936907 ↗ “Full-spectrum Cannabis sativa extract containing cannabidiol (CBD) 100 mg/mL and tetrahydrocannabinol (THC) 3.33 mg/mL, administered sublingually for 12 weeks according to a...” NCT07696871 ↗ “Two piece acid resistance hard capsule filled with seamless gelatin matrix green beads containing tetrahydrocannabinol (THC) and cannabidiol (CBD). Each capsule contain 5 mg...” NCT03005119 ↗ “Oral cannabidiol (CBD; 7.2 mg/kg/day), tetrahydrocannabinol (THC; 0.257 mg/kg/day, equivalent to 1:28 of the CBD dose), and terpenes (0.5 mg/kg/day), administered in two daily doses.” NCT07199218 ↗ “The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes.” NCT06609109 ↗ “The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes.” NCT06609083 ↗ “Cannabidiol (CBD) is the active ingredient of interest because of its anti-inflammatory effects and lack of psychoactive effects seen with tetrahydrocannabinol (THC).” NCT03825965 ↗ Show 28 more sources
Known as	THC	“This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety,...” NCT00490269 ↗ 43 “Aim of this phase III trial is to investigate the efficacy and safety of dronabinol (orally administered tetrahydrocannabinol (THC)) as adjuvant therapy to first-line standard...” NCT03984214 ↗ “A sublingual tablet containing 30 mg of cannabidiol (CBD), 1 mg tetrahydrocannabinol (THC), 97 mg palmitoylethanolamide (PEA), and a 0.2 mg combination of myrcene,...” NCT04091789 ↗ “Full-spectrum Cannabis sativa extract containing cannabigerol (CBG) 30 mg/mL, cannabidiol (CBD) 30 mg/mL, and tetrahydrocannabinol (THC) 3 mg/mL, administered sublingually for...” NCT07592390 ↗ “This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes -...” NCT03936907 ↗ “Full-spectrum Cannabis sativa extract containing cannabidiol (CBD) 100 mg/mL and tetrahydrocannabinol (THC) 3.33 mg/mL, administered sublingually for 12 weeks according to a...” NCT07696871 ↗ “To evaluate the effect of the cannabidiol (CBD) + cannabigerol (CBG) + tetrahydrocannabinol (THC) up to 133/66/4mg daily versus placebo as adjuvant treatment in chronic...” NCT04989413 ↗ “Two piece acid resistance hard capsule filled with seamless gelatin matrix green beads containing tetrahydrocannabinol (THC) and cannabidiol (CBD). Each capsule contain 5 mg...” NCT03005119 ↗ “Oral cannabidiol (CBD; 7.2 mg/kg/day), tetrahydrocannabinol (THC; 0.257 mg/kg/day, equivalent to 1:28 of the CBD dose), and terpenes (0.5 mg/kg/day), administered in two daily doses.” NCT07199218 ↗ “The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC).” NCT02576912 ↗ “Cannabidiol (CBD) is the active ingredient of interest because of its anti-inflammatory effects and lack of psychoactive effects seen with tetrahydrocannabinol (THC).” NCT03825965 ↗ Show 33 more sources
Known as	Δ9-THC	“The development of Namisol®, a tablet containing purified Δ9-THC showing an improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC...” NCT01551511 ↗ 2 “The Safety, Tolerability, and Analgesic Efficacy of Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain” NCT01318369 ↗ “Dronabinol is a licensed form of Δ9-THC.” PMID 32178232 ↗ Mar 2020
Action	Activate	“cannabinoid agonist hypothesized to decrease MJ withdrawal” NCT00373503 ↗
Modality	Other / unclassified	“utilizing Dronabinol, a cannabinoid known to decrease incidence of nausea and vomiting” NCT00314808 ↗
Route	Inhaled	“Oral THC 13mg and 17mg smoked in low nicotine cigarettes” NCT00270803 ↗
Route	Oral	“Oral THC 13mg and 17mg smoked in low nicotine cigarettes” NCT00270803 ↗