Dronabinol

For Acquired Immune Deficiency Syndrome (AIDS). Sold as Marinol, Syndros. Every FDA application for this active ingredient: 2 branded and 5 generic.

As of Nov 13, 2026, FDA lists 7 applications for Dronabinol (sold as Marinol, Syndros), first approved May 31, 1985, with 1 new use approved and 0 published complete response letters.

First approved: May 31, 1985
Applications: 7
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $4.7M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Dronabinol	Part D	$4.7M	-29%	14,323

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

For the stimulation of appetite and prevention of weight loss in patients with a confirmed diagnosis of AIDS.Unimed Pharmaceuticals, Inc. · designated Jan 15, 1991 · approved Dec 22, 1992

Clinical Trials

85 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


An Investigation of Mechanisms That Underly Paranoia in Behaviour and Brain That Can Inform Clinical Diagnoses That Include Paranoid Symptoms.None Volunteer · King's College London	Phase 2	Not yet recruiting	Oct 16, 2026
Effects of Cannabidiol (CBD) on a Fixed Dose of Delta-9-tetrahydrocannabinol (THC)Cannabis Intoxication · Johns Hopkins University	Phase 1	Not yet recruiting	Oct 13, 2026
Oral and Topical Phytocannabinoids for PsoriasisPsoriasis Vulgaris · Federal University of Latin American Integration	Phase 2	Active, not recruiting	Sep 24, 2026
Endocannabinoids in RewardCannabis Use Disorder · Medical University of South Carolina	Phase 2	Recruiting	Sep 11, 2026
Full-Spectrum Cannabis Extract for Chronic Pain and Bone Health Biomarkers in WomenChronic Pain, Fibromyalgia · Associação Pan-Americana Multidisciplinar de Endocanabinologia	Phase 2	Not yet recruiting	Aug 24, 2026
Cannabidiol Oil for Treatment-Resistant Major DepressionMajor Depressive Disorder (MDD), Treatment-resistant Depression (TRD) · Universidade do Sul de Santa Catarina	Phase 1 / Phase 2	Recruiting	Jul 10, 2026
Lung Health and Breath Biomarkers: Acute Effects of Inhaled CannabisCannabis Use, Tobacco · Hannah Harris	Early phase 1	Not yet recruiting	Jul 10, 2026
Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) StudyHealthy Volunteer · King's College London	Not applicable	Recruiting	Jun 18, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


May 31, 1985	MarinolNDA 18651 · New molecular entity	Alkem Labs Ltd	22	Marketed
Jun 27, 2008	DronabinolANDA 78292	Rhodes	2	Discontinued
Aug 19, 2011	DronabinolANDA 78501	Insys Therap	0	Discontinued
Jun 20, 2014	DronabinolANDA 79217	Hikma	0	Discontinued
Jul 1, 2016	SyndrosNDA 205525 · New dosage form	Wellhouse Pharma	7	Discontinued
May 18, 2018	DronabinolANDA 201463	Lannett Co Inc	1	Discontinued
Feb 7, 2020	DronabinolANDA 207421	Ascent Pharms Inc	1	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA