Melatonin
As of the edition of 20 October 2026, Melatonin is a small molecule: marketed, first approved in 2007 (EU); acts on MTNR1A and MTNR1B.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Circadin
- First approved
- 29 June 2007 (EU)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- RAD Neurim Pharmaceuticals EEC; 3 holders in all
- Registered trials
- 308, 42 stopped early
- Disease areas
- Nervous system; Mental health; Heart and blood vessels; Cancer; Urinary and reproductive; Lungs and airways
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
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Melatonin.
See the 2 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 | 107 | 46 | 25 | 13 |
| Phase 1 | 33 | 15 | 6 | 7 |
| Phase 2 | 72 | 33 | 10 | 14 |
| Phase 3 | 62 | 25 | 13 | 6 |
| Phase 4 | 34 | 15 | 9 | 2 |
| All trials | 308 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| RAD Neurim Pharmaceuticals EEC | Applicant | 2007 to now |
| Nobelpharma | Applicant and Lead sponsor of trials | 2016 to now |