Metolazone
As of the edition of 20 October 2026, Metolazone is a small molecule: marketed, first approved in 1974 (CA); acts on SLC12A3.
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
- Diulo
- First approved
- 31 December 1974 (CA)
- Approvals on record
- 8 in 2 regions
- Holder of the most recent approval
- Chartwell Molecular; 4 holders in all
- Registered trials
- 12, 1 stopped early
- Disease areas
- Heart and blood vessels; Infections; Lungs and airways; Injuries
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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Metolazone.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC12A3 | Solute carrier family 12 member 3 | P55017 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 1 | 1 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 2 | 0 | 1 | 0 |
| Phase 3 | 2 | 0 | 0 | 0 |
| Phase 4 | 2 | 0 | 0 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant | 1974 to now |
| Pfizer | Acquired holder | 2002 to now |
| I3 Pharmaceuticals | Acquired holder | 2023 to now |
| Chartwell Molecular | Acquired holder | 2023 to now |
| Fisons | Applicant |