Metronidazole clinical trials
Metronidazole is named as an intervention in 18 current clinical trials in our Taiwan, China, Switzerland, France, Egypt, Germany, Canada, Brazil and Australia registers. 9 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Assistance Publique - Hôpitaux de Paris (2). The most-studied condition is Helicobacter Pylori Infection. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials.
Where Metronidazole is approved
All regulators →Of the three regulators tracked here, the first to approve Metronidazole was the US, on 18 Jul 1963. It is approved in 2 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of pouchitis (21 Jun 2011, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Metronidazole patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Metronidazole, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 9 listed patents; the last listed expires 4 Oct 2039 (US 11541035).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Metronidazole
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Metronidazole works
All drug targets →- Crohn diseasePhase 3
- Helicobacter pylori infectious diseasePhase 3
- Abdominal abscessPhase 3
- AppendicitisPhase 3
- BlepharitisPhase 3
- Chronic periodontitisPhase 3
- Clostridium difficile infectionPhase 3
- GingivitisPhase 3
- Hidradenitis suppurativaPhase 3
- Infectious peritonitisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL137, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10914, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Metronidazole
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 6 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Metronidazole
- ChEMBL
- CHEMBL137
- DrugBank
- DB00916
- PubChem CID
- 4173
- CAS number
- 443-48-1
- FDA UNII
- 140QMO216E
- Wikidata
- Q169569
- Wikipedia
- Metronidazole
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Metronidazole
18 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Metronidazole in the EU trials register (CTIS)
4 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Metronidazole. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Metronidazole across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
6 single-substance products containing Metronidazole on the HPRA medicines list.
- Flagyl 400mg TabletsFidia Farmaceutici S.p.A. · PA0814/003/002 · Marketed
- Flagyl-S 200mg/5ml Oral SuspensionFidia Farmaceutici S.p.A. · PA0814/003/001 · Marketed
- Metronidazole 5 mg/ml solution for infusionB. Braun Melsungen AG · PA0736/002/001 · Marketed
- Metronidazole 5 mg/mL solution for infusionNoridem Enterprises Limited · PA1122/041/001 · Not marketed
- Rozex 7.5 mg/g CreamGalderma International · PA22743/013/002 · Not marketed
Supply shortages
- Metronidazole InjectionUS (FDA) · Current · updated 3 Nov 2026
Conditions studied with Metronidazole
22 conditionsAll 22 conditions
| Condition (as registered) | Trials |
|---|---|
| Helicobacter Pylori Infection | 5 |
| HELICOBACTER PYLORI INFECTIONS | 1 |
| Intra-abdominal Infections | 1 |
| Bacterial Vaginosis (BV) | 1 |
| Previable Labour With Intact Membranes | 1 |
| Acute Mesenteric Ischemia | 1 |
| Surgical Site Infection | 1 |
| Colon Surgery | 1 |
| Surgical Site Infections | 1 |
| Metastatic Castration-Resistant Prostate Cancer (mCRPC) | 1 |
| Colorectal Cancer | 1 |
| Elective Colon Surgery | 1 |
| Rectal Cancer, Adenocarcinoma | 1 |
| Helicobatcer Pylori | 1 |
| First-Line Eradication | 1 |
| Sex | 1 |
| Bismuth Quadruple Therapy | 1 |
| Dysbiosis | 1 |
| Probiotics | 1 |
| Bacterial Vaginosis | 1 |
| Pulp Necrosis | 1 |
| Apical Periodontitis | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Assistance Publique - Hôpitaux de Paris | 2 |
| National Cheng-Kung University Hospital | 2 |
| Shanghai Jiao Tong University School of Medicine | 1 |
| Xiuli Zuo | 1 |
| Qilu Pharmaceutical Co., Ltd | 1 |
| Freya Biosciences ApS | 1 |
| Universität Luzern | 1 |
| Institute of Cancer Research, United Kingdom | 1 |
| Oncology Institute of Southern Switzerland | 1 |
| Ottawa Hospital Research Institute | 1 |
| AC Camargo Cancer Center | 1 |
| Chih-An Shih, MD | 1 |
| National Taiwan University Hospital | 1 |
| Massachusetts General Hospital | 1 |
| Tanta University | 1 |
+ 1 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Metronidazole trials
How many clinical trials are testing Metronidazole?
18 current trials in our Taiwan, China, Switzerland, France, Egypt, Germany, Canada, Brazil and Australia registers name Metronidazole as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Metronidazole trials recruiting patients?
Yes. 9 of the 18 trials are recruiting: 1 with sites in Taiwan, 1 with sites in China, 2 with sites in Switzerland, 1 with sites in France, 2 with sites in Egypt, 1 with sites in Germany and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Metronidazole clinical trials?
Assistance Publique - Hôpitaux de Paris (2), National Cheng-Kung University Hospital (2), Shanghai Jiao Tong University School of Medicine (1) and Xiuli Zuo (1), among 16 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Metronidazole licensed in Ireland?
Yes. The HPRA medicines list includes 6 single-substance products containing Metronidazole, for example Flagyl 400mg Tablets (Fidia Farmaceutici S.p.A.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Metronidazole shortage?
The registers we track list 1 entry for Metronidazole: US FDA: current. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Metronidazole works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Metronidazole works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Metronidazole (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.