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Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic is a Topical antiseptic combination Small molecule drug developed by Professional Disposables International, Inc.. It is currently in Phase 3 development for Skin antisepsis and disinfection prior to medical procedures, Wound cleansing and antisepsis, Preoperative skin preparation. Also known as: Project X 26ml, Project X 10.5ml, Project X 5.1ml.
Isopropyl alcohol and chlorhexidine gluconate work synergistically as a broad-spectrum antiseptic by disrupting bacterial cell membranes and denaturing proteins to rapidly kill microorganisms on skin.
Isopropyl alcohol and chlorhexidine gluconate work synergistically as a broad-spectrum antiseptic by disrupting bacterial cell membranes and denaturing proteins to rapidly kill microorganisms on skin. Used for Skin antisepsis and disinfection prior to medical procedures, Wound cleansing and antisepsis, Preoperative skin preparation.
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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 | Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic |
|---|---|
| Also known as | Project X 26ml, Project X 10.5ml, Project X 5.1ml |
| Sponsor | Professional Disposables International, Inc. |
| Drug class | Topical antiseptic combination |
| Modality | Small molecule |
| Therapeutic area | Infection Prevention / Dermatology |
| Phase | Phase 3 |
Mechanism of action
Isopropyl alcohol acts as a rapid antimicrobial agent by denaturing proteins and disrupting lipid membranes, while chlorhexidine gluconate provides sustained antimicrobial activity through membrane disruption and nucleic acid interference. Together, they provide both immediate and residual antimicrobial efficacy against a wide range of gram-positive and gram-negative bacteria, fungi, and some viruses, making them effective for skin antisepsis and disinfection.
Approved indications
- Skin antisepsis and disinfection prior to medical procedures
- Wound cleansing and antisepsis
- Preoperative skin preparation
Common side effects
- Skin irritation
- Contact dermatitis
- Drying of skin
Key clinical trials
- CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee (NA)
- Aqueous vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections (PHASE4)
- Skin Preparation for Elective Foot and Ankle Surgery (PHASE4)
- SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty (PHASE4)
- Perioperative Patient Skin Antiseptic Preparation Evaluation (PHASE3)
- Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries (PHASE4)
- ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions (PHASE3)
- Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation (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:
- Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic CI brief — competitive landscape report
- Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic updates RSS · CI watch RSS
- Professional Disposables International, Inc. portfolio CI
Frequently asked questions about Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
What is Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic?
How does Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic work?
What is Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic used for?
Who makes Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic?
Is Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic also known as anything else?
What drug class is Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic in?
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What are the side effects of Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic?
Related
- Drug class: All Topical antiseptic combination drugs
- Manufacturer: Professional Disposables International, Inc. — full pipeline
- Therapeutic area: All drugs in Infection Prevention / Dermatology
- Indication: Drugs for Skin antisepsis and disinfection prior to medical procedures
- Indication: Drugs for Wound cleansing and antisepsis
- Indication: Drugs for Preoperative skin preparation
- Also known as: Project X 26ml, Project X 10.5ml, Project X 5.1ml
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing