DELSYM
LOE Approachingdextromethorphan
NDAORALSUSPENSION, EXTENDED RELEASE
Approved
Oct 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
DELSYM (dextromethorphan) is uncompetitive nmda receptor antagonists [moa]. First approved in 1982.
Drug data last refreshed 7h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DELSYM (dextromethorphan) is an oral extended-release suspension that acts as an uncompetitive NMDA receptor antagonist to suppress cough. It has been a standard over-the-counter cough suppressant since 1982, widely used in cold and flu remedies.
LOE Approaching
As a mature OTC product approaching loss of exclusivity, the brand team is likely focused on defensive positioning and operational efficiency rather than growth expansion.
Mechanism of Action
Uncompetitive NMDA Receptor Antagonists
Pharmacologic Class:
Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants
Started Mar 2026
42 enrolled
Healthy Participants
Dextromethorphan-Bupropion on Striatal Activity in Adults With Major Depressive Disorder
Started Nov 2025
30 enrolled
Major Depressive Disorder (MDD)
Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder
Started May 2025
80 enrolled
Major Depressive Disorder (MDD)
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir
Started Mar 2022
48 enrolled
Malaria
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Started Oct 2017
601 enrolled
Agitation in Patients With Dementia of the Alzheimer's Type
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.