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Ornidal (ORNIDAZOLE)
Ornidal (generic name: ORNIDAZOLE) is a ornidazole drug. It is currently in Phase 3 development.
Ornidazole works by inhibiting the growth of bacteria and other microorganisms through its antimicrobial properties.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | ORNIDAZOLE |
|---|---|
| Drug class | ornidazole |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Imagine your body is a garden, and bacteria are weeds. Ornidazole is like a weed killer that stops the weeds from growing and spreading, helping to keep your body healthy and free from infection.
Approved indications
Common side effects
- Premature baby
- Oligohydramnios
Key clinical trials
- Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women (NA)
- A Study of Levornidazole Disodium Phosphate for Injection vs. Ornidazole in Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria (PHASE4)
- Effects of Lactobacillus Crispatus LCr86 on Bacterial Vaginosis and Ovarian Function in Women (NA)
- Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Irritable Bowel Syndrome (NA)
- Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation (NA)
- Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery (PHASE3)
- Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery (PHASE3)
- Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery (PHASE3)
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:
- Ornidal CI brief — competitive landscape report
- Ornidal updates RSS · CI watch RSS
Frequently asked questions about Ornidal
What is Ornidal?
How does Ornidal work?
What is the generic name of Ornidal?
What drug class is Ornidal in?
What development phase is Ornidal in?
What are the side effects of Ornidal?
Related
- Drug class: All ornidazole drugs
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing