Metronidazole
As of the edition of 20 October 2026, Metronidazole is a small molecule: marketed, first approved in 1960 (CH).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Flagyl
- First approved
- 14 May 1960 (CH)
- Approvals on record
- 70 in 7 regions
- Holder of the most recent approval
- HEMAFARMA COM E IND FARMACEUTICA LTDA; 38 holders in all
- Registered trials
- 247, 14 stopped early
- Disease areas
- Infections; Digestive system; Urinary and reproductive; Pregnancy and women's health; Mouth and teeth; Cancer
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 | 56 | 32 | 7 | 3 |
| Phase 1 | 25 | 21 | 0 | 1 |
| Phase 2 | 41 | 20 | 14 | 2 |
| Phase 3 | 41 | 30 | 2 | 1 |
| Phase 4 | 84 | 47 | 9 | 7 |
| All trials | 247 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Labatec Pharma | Applicant | 1960 to now |
| Sanofi | Applicant | 1979 to now |
| Vitarine Pharmaceuticals | Later holder | 1982 to now |
| B. Braun Medical | Later holder | 1982 to now |
| Lundbeck | Later holder | 1982 to now |
| Teva | Later holder and Lead sponsor of trials | 1983 to now |
| Johnson & Johnson | Later holder and Lead sponsor of trials | 1983 to now |
| Endo | Later holder and Lead sponsor of trials | 1983 to now |
| Abbott | Acquired holder and Later holder | 1983 to now |
| Lnk | Later holder | 1984 to now |
| Curatek Pharmaceuticals | Later holder | 1988 to now |
| Baxter Healthcare | Acquired holder and Later holder | 1990 to now |
| Galderma Brasil Ltda | Applicant | 2000 to now |
| Actavis | Acquired holder | 2003 to now |
| Galderma | Acquired holder | 2003 to now |
| Mutual Pharmaceutical | Acquired holder | 2005 to now |
| Pfizer | Acquired holder and Lead sponsor of trials | 2005 to now |
| Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals | Acquired holder | 2009 to now |
| Galderma | Applicant | 2014 to now |
| Takeda | Later holder and Lead sponsor of trials | 2015 to now |
| Chartwell Molecules | Acquired holder | 2017 to now |
| Fosun Pharma | Acquired holder | 2018 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Hikma Pharmaceuticals | Acquired holder | 2022 to now |
| Saptalis Pharmaceuticals | Later holder and Lead sponsor of trials | 2023 to now |
| Alembic Pharmaceuticals | Acquired holder | 2026 to now |
| Astellas | Later holder | |
| AstraZeneca | Later holder | |
| Eisai | Later holder | |
| Maruho | Later holder | |
| Mitsubishi Tanabe Pharma | Later holder | |
| Shionogi | Later holder | |
| Taisho Pharmaceutical | Later holder |