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Delsym (dextromethorphan)
Dextromethorphan is the most widely used OTC cough suppressant, available since 1958. Originally from Roche, it is a non-opioid antitussive found in hundreds of cold/cough products. Recent combinations (Nuedexta, Auvelity) have expanded its prescription use.
At a glance
| Generic name | dextromethorphan |
|---|---|
| Also known as | Delsym, DXM, Robitussin DM (component) |
| Sponsor | Generic (originally Roche) |
| Drug class | Antitussive (non-opioid) |
| Target | Taste receptor type 2 member 46, Solute carrier family 22 member 1, Cytochrome P450 2D6 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1958-01-01 (United States) |
Approved indications
- Allergic rhinitis
- Common cold
- Cough
- Fever
- Headache disorder
- Influenza-like symptoms
- Major depressive disorder
- Mouth Irritation
- Nasal congestion
- Nasal discharge
- Pseudobulbar affect
- Rhinitis
- Sneezing
- Sore throat symptom
- Vasomotor rhinitis
Common side effects
Key clinical trials
- A Randomized, Double-Blind 4-Week Study to Evaluate the Impact of AXS-05 on Smoking Behavior (Phase 2)
- A Prospective Phase Ib/IIa, Active-controlled, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of Multiple Oral Doses of BT (Phase 1)
- Exogenous and Endogenous Biomarkers of CYP2D6 and CYP3A4 Variability in Pediatrics (N/A)
- A Drug-Drug Interaction Study to Investigate the Effect of Givosiran on the Pharmacokinetics (PK) of Midazolam, Caffeine, Losartan, Omeprazole, and Dextromethorphan in Patients With Acute Intermittent (Phase 1)
- Impact of Nuedexta on Bulbar Physiology and Function in ALS (Phase 1)
- Licorice Botanical Dietary Supplements - Metabolism and Safety in Women (Phase 1)
- Developmental Regulation of CYPs 1A2, 2D6, 3A4 (N/A)
- Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia: A Randomized, Group Sequential Adaptive Design, Controlled Clinical Trial (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Delsym CI brief — competitive landscape report
- Delsym updates RSS · CI watch RSS
- Generic (originally Roche) portfolio CI