Ramelteon
As of the edition of 20 October 2026, Ramelteon is a small molecule: marketed, first approved in 2005 (US); acts on MTNR1A and MTNR1B; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Rozerem
- First approved
- 22 July 2005 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Takeda
- Registered trials
- 61, 10 stopped early
- Disease areas
- Mental health; Nervous system; Lungs and airways; Chemically induced; Injuries; Occupational diseases
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
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 Ramelteon.
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 | 5 | 4 | 0 | 1 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 12 | 11 | 0 | 0 |
| Phase 3 | 17 | 11 | 1 | 5 |
| Phase 4 | 24 | 17 | 1 | 4 |
| All trials | 61 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Acquired holder and Lead sponsor of trials | 2002 to now |