Dextromethorphan
As of the edition of 20 October 2026, Dextromethorphan is a small molecule: marketed, first approved in 1950 (CH); acts on GRIN2A and SIGMAR1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2005
- Kind
- Small molecule
- Brand name
- Delsym
- First approved
- 8 November 1950 (CH)
- Approvals on record
- 31 in 5 regions
- Holder of the most recent approval
- Axsome Therapeutics; 10 holders in all
- Withdrawn from market
- 15 February 2016 (in some regions)
- Registered trials
- 121, 13 stopped early
- Disease areas
- Mental health; Nervous system; Infections; Lungs and airways; Nutrition and metabolism; Cancer
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Dextromethorphan.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 9 | 1 | 3 |
| Phase 1 | 49 | 40 | 6 | 1 |
| Phase 2 | 29 | 23 | 4 | 2 |
| Phase 3 | 14 | 8 | 1 | 1 |
| Phase 4 | 15 | 9 | 0 | 6 |
| All trials | 121 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Fisons | Earlier holder | 1982 to now |
| Bayer | Applicant | 1987 to now |
| GSK | Applicant and Lead sponsor of trials | 2005 to now |
| Johnson & Johnson | Later holder and Lead sponsor of trials | 2006 to now |
| Reckitt Benckiser | Acquired holder | 2026 to now |