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ZuraPrep without 70% IPA
ZuraPrep without 70% IPA is a Topical antiseptic Small molecule drug developed by Zurex Pharma, Inc.. It is currently in Phase 3 development for Prevention of surgical site infections. Also known as: ZuraPrep Vehicle.
ZuraPrep without 70% IPA is a topical antiseptic solution that helps prevent surgical site infections by reducing microbial load.
ZuraPrep is a topical antimicrobial agent used for surgical skin preparation to reduce the risk of surgical site infections. It has been clinically evaluated for its efficacy in in-vivo studies, with results from the study "In-vivo Efficacy of Patient Preoperative Prep" (NCT02831998) indicating its effectiveness in this application.
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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 | ZuraPrep without 70% IPA |
|---|---|
| Also known as | ZuraPrep Vehicle |
| Sponsor | Zurex Pharma, Inc. |
| Drug class | Topical antiseptic |
| Modality | Small molecule |
| Therapeutic area | Surgical site infection prevention |
| Phase | Phase 3 |
Mechanism of action
It achieves this by denaturing proteins and disrupting cell membranes of microorganisms, thereby inhibiting their growth and replication. This mechanism is effective against a broad spectrum of bacteria, viruses, and fungi.
Approved indications
- Prevention of surgical site infections
Common side effects
- Skin irritation
Key clinical trials
- In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP) (PHASE3)
- In-vivo Efficacy of Patient Preoperative Prep (PHASE3)
- Clinical Evaluation of Patient Preoperative Prep (PHASE3)
- Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle (PHASE3)
- Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™ (PHASE2)
- Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA (PHASE1)
- Safety Study to Evaluate the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA (PHASE1)
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:
- ZuraPrep without 70% IPA CI brief — competitive landscape report
- ZuraPrep without 70% IPA updates RSS · CI watch RSS
- Zurex Pharma, Inc. portfolio CI
Frequently asked questions about ZuraPrep without 70% IPA
What is ZuraPrep without 70% IPA?
How does ZuraPrep without 70% IPA work?
What is ZuraPrep without 70% IPA used for?
Who makes ZuraPrep without 70% IPA?
Is ZuraPrep without 70% IPA also known as anything else?
What drug class is ZuraPrep without 70% IPA in?
What development phase is ZuraPrep without 70% IPA in?
What are the side effects of ZuraPrep without 70% IPA?
Related
- Drug class: All Topical antiseptic drugs
- Manufacturer: Zurex Pharma, Inc. — full pipeline
- Therapeutic area: All drugs in Surgical site infection prevention
- Indication: Drugs for Prevention of surgical site infections
- Also known as: ZuraPrep Vehicle
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing