Water
As of the edition of 20 October 2026, Water is a small molecule: marketed, first approved in 1951 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Sterile Water In Plastic Container
- First approved
- 31 December 1951 (CA)
- Approvals on record
- 42 in 2 regions
- Holder of the most recent approval
- Pfizer; 13 holders in all
- Registered trials
- 67, 7 stopped early
- Disease areas
- Nutrition and metabolism; Mouth and teeth; Nervous system; Infections; Immune system; Inherited and neonatal
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 28 | 22 | 3 | 2 |
| Phase 1 | 18 | 12 | 2 | 4 |
| Phase 2 | 5 | 3 | 0 | 1 |
| Phase 3 | 4 | 2 | 0 | 0 |
| Phase 4 | 12 | 7 | 3 | 0 |
| All trials | 67 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant, Acquired holder and Lead sponsor of trials | 1952 to now |
| Roche | Later holder | 1996 to now |
| GSK | Later holder and Lead sponsor of trials | 2009 to now |
| Niagara Pharmaceuticals | Later holder | 2011 to now |
| Merck & Co. | Later holder | 2012 to now |
| Octapharma Pharmazeutika Produktionsges.m.b.H | Later holder | 2014 to now |
| Otsuka | Acquired holder | 2025 to now |
| Abbott | Later holder | |
| Baxter Healthcare | Later holder | |
| Bayer | Later holder | |
| B. Braun Medical | Applicant and Later holder |