NDAORALSOLUTION
Approved
Jul 2016
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
7
Data completeness
4/8 — Partial
SYNDROS (dronabinol) by Ascentage Pharma is cns, including central sympathomimetic activity. First approved in 2016.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYNDROS is an oral solution formulation of dronabinol, a synthetic cannabinoid that acts on CNS cannabinoid receptors with central sympathomimetic activity. Approved in 2016, it is indicated for appetite stimulation and anti-emetic effects in specific patient populations. The mechanism involves modulation of neural cannabinoid receptors to produce therapeutic CNS effects.
LOE Approaching2.1 years to LOE
Product approaching loss of exclusivity in 2028 with moderate competitive pressure (15 competitive agents), suggesting potential team restructuring and transition focus toward generic defense or next-generation pipeline support.
Mechanism of Action
CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol.
Pharmacologic Class:
Cannabinoid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Dronabinol for Agitation in Dementia Crossover Trial
Started Nov 2023
0Dementia ModerateDementia SevereAgitation,Psychomotor+1 more
Dronabinol for Post-operative Pain After Lumbar Fusion
Started Sep 2020
90 enrolled
Post-operative Pain
A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty
Started Feb 2020
460 enrolled
Osteoarthritis, Knee
Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain
Started Jun 2017
0Esophageal Diseases
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
Started Sep 2005
Migraine With AuraMigraine Without Aura
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.