Chlorhexidine
As of the edition of 20 October 2026, Chlorhexidine is a small molecule: marketed, first approved in 1949 (ES); 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 1982
- Kind
- Small molecule
- Brand name
- Hibiclens
- First approved
- 1 May 1949 (ES)
- Approvals on record
- 35 in 3 regions
- Holder of the most recent approval
- Medline Industries; 15 holders in all
- Withdrawn from market
- 1 January 1984 (in some regions)
- Registered trials
- 217, 12 stopped early
- Disease areas
- Infections; Mouth and teeth; Lungs and airways; Urinary and reproductive; Cancer; Pregnancy and women's health
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.
Solventum holds a later exclusivity on its own new formulation or combination product, which ended in 2026; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 67 | 45 | 11 | 2 |
| Phase 1 | 10 | 8 | 0 | 1 |
| Phase 2 | 35 | 23 | 6 | 2 |
| Phase 3 | 44 | 31 | 6 | 3 |
| Phase 4 | 61 | 39 | 5 | 4 |
| All trials | 217 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Xttrium | Later holder | 1984 to now |
| Huntington | Later holder | 1986 to now |
| Procter And Gamble | Later holder and Lead sponsor of trials | 1986 to now |
| Kendall | Later holder | 1987 to now |
| Baxter Healthcare | Later holder | 1988 to now |
| Dexcel Pharma Technologies | Acquired holder and Lead sponsor of trials | 2003 to now |
| Ecolab | Acquired holder | 2003 to now |
| Kw Griffen | Acquired holder | 2003 to now |
| Sage | Later holder | 2005 to now |
| Solventum | Acquired holder and Lead sponsor of trials | 2007 to now |
| Molnlycke Health Care | Acquired holder and Lead sponsor of trials | 2011 to now |
| Medline Industries | Later holder and Lead sponsor of trials | 2014 to now |
| Carefusion 2200 | Acquired holder | 2017 to now |
| Bajaj Medical | Acquired holder | 2019 to now |
| Stuart Therapeutics | Earlier holder |