Last reviewed · How we verify
Immediate-release metronidazole
Immediate-release metronidazole is a Small molecule drug developed by Gateway Pharmaceutical LLC. It is currently in Phase 1 development. Also known as: Flagyl®.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Immediate-release metronidazole |
|---|---|
| Also known as | Flagyl® |
| Sponsor | Gateway Pharmaceutical LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- International Care Bundle Evaluation in Cerebral Hemorrhage Research (PHASE4)
- Study of Metronidazole Delayed-Release Capsules in Comparison With Immediate-Release Tablets (Flagyl) for Safety and Pharmacokinetics (PHASE1)
- Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo (PHASE4)
- Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis
- A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Immediate-release metronidazole CI brief — competitive landscape report
- Immediate-release metronidazole updates RSS · CI watch RSS
- Gateway Pharmaceutical LLC portfolio CI
Frequently asked questions about Immediate-release metronidazole
What is Immediate-release metronidazole?
Who makes Immediate-release metronidazole?
Is Immediate-release metronidazole also known as anything else?
What development phase is Immediate-release metronidazole in?
Related
- Manufacturer: Gateway Pharmaceutical LLC — full pipeline
- Also known as: Flagyl®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing