Polyethylene glycol 3350
As of the edition of 20 October 2026, Polyethylene glycol 3350 is a small molecule: marketed, first approved in 1984 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Golytely
- First approved
- 13 July 1984 (US)
- Approvals on record
- 24 in 4 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 10 holders in all
- Registered trials
- 57, 4 stopped early
- Disease areas
- Digestive system; Cancer; Mental health; Injuries; Nervous system; Inherited and neonatal
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 6 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 8 | 5 | 1 | 2 |
| Phase 3 | 9 | 5 | 2 | 1 |
| Phase 4 | 28 | 22 | 3 | 1 |
| All trials | 57 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Schering Plough Healthcare | Earlier holder | 2006 to now |
| Bayer | Applicant, Acquired holder and Lead sponsor of trials | 2009 to now |