Oxymetazoline
As of the edition of 20 October 2026, Oxymetazoline is a small molecule: marketed, first approved in 1965 (ES); acts on ADRA1A, ADRA1B and ADRA1D and 3 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Ocuclear
- First approved
- 1 June 1965 (ES)
- Approvals on record
- 19 in 5 regions
- Holder of the most recent approval
- Santen Pharmaceutical; 8 holders in all
- Registered trials
- 56, 8 stopped early
- Disease areas
- Lungs and airways; Ear, nose and throat; Eye; Skin and connective tissue; Mouth and teeth; Immune system
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
13 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product13 company-target rows are on route B because of Oxymetazoline.
See the 13 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 | 5 | 3 | 1 | 0 |
| Phase 1 | 10 | 9 | 0 | 0 |
| Phase 2 | 18 | 12 | 1 | 5 |
| Phase 3 | 13 | 11 | 1 | 1 |
| Phase 4 | 10 | 6 | 1 | 2 |
| All trials | 56 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant, Acquired holder and Lead sponsor of trials | 1986 to now |
| Pfizer | Acquired holder and Later holder | 1989 to now |
| AbbVie | Later holder and Lead sponsor of trials | 2012 to now |
| RVL Pharmaceuticals | Later holder and Lead sponsor of trials | 2013 to now |
| Kenvue Brands | Acquired holder | 2025 to now |
| Santen Pharmaceutical | Applicant | 2025 to now |
| Merck & Co. | Originator | 1986 to 2015 |