Hydrochlorothiazide
As of the edition of 20 October 2026, Hydrochlorothiazide is a small molecule: marketed, first approved in 1958 (CH); acts on SLC12A3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Esidrix
- First approved
- 22 December 1958 (CH)
- Approvals on record
- 162 in 8 regions
- Holder of the most recent approval
- ANI Pharmaceuticals; 34 holders in all
- Withdrawn from market
- 20 October 2012 (in some regions)
- Registered trials
- 248, 10 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Hormones; Pregnancy and women's health; Urinary and reproductive; Nervous system
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
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Hydrochlorothiazide.
See the 4 companies 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 | 54 | 47 | 4 | 1 |
| Phase 1 | 37 | 34 | 2 | 0 |
| Phase 2 | 10 | 6 | 1 | 3 |
| Phase 3 | 66 | 59 | 1 | 3 |
| Phase 4 | 81 | 67 | 1 | 3 |
| All trials | 248 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Later holder and Lead sponsor of trials | 1991 to now |
| Actavis | Later holder and Lead sponsor of trials | 1996 to now |
| Organon | Applicant and Lead sponsor of trials | 1997 to now |
| Boehringer Ingelheim | Later holder and Lead sponsor of trials | 1998 to now |
| Sanofi | Applicant, Later holder and Lead sponsor of trials | 1998 to now |
| Cheplapharm Arzneimittel | Applicant | 1999 to now |
| Bayer | Later holder and Lead sponsor of trials | 2002 to now |
| AstraZeneca | Later holder and Lead sponsor of trials | 2003 to now |
| Teva | Acquired holder and Lead sponsor of trials | 2003 to now |
| Novartis | Applicant, Later holder and Lead sponsor of trials | 2005 to now |
| Bausch Health | Acquired holder | 2006 to now |
| Takeda | Applicant and Lead sponsor of trials | 2006 to now |
| AbbVie | Acquired holder | 2012 to now |
| ANI Pharmaceuticals | Later holder | 2025 to now |
| Abbott | Later holder |