Dronabinol
As of the edition of 20 October 2026, Dronabinol is a small molecule: marketed, first approved in 1985 (US); acts on CNR1; no US protection of its own 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
- Marinol
- First approved
- 31 May 1985 (US)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Wellhouse Pharma; 3 holders in all
- Registered trials
- 157, 18 stopped early
- Disease areas
- Mental health; Chemically induced; Nervous system; Bones, joints and muscles; Digestive system; Immune system
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Wellhouse Pharma holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CNR1 | Cannabinoid receptor 1 | P21554 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 21 | 12 | 6 | 0 |
| Phase 1 | 61 | 37 | 15 | 8 |
| Phase 2 | 47 | 20 | 14 | 5 |
| Phase 3 | 17 | 7 | 6 | 1 |
| Phase 4 | 11 | 5 | 0 | 4 |
| All trials | 157 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Unimed Pharmaceuticals | Earlier holder | 1985 to now |
| CNX Therapeutics | Applicant | 2005 to now |
| Alkem | Acquired holder | 2020 to now |
| Wellhouse Pharma | Acquired holder | 2026 to now |