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Prontosan
Prontosan is a Small molecule drug developed by Consorci Sanitari de l'Alt Penedès i Garraf. It is currently in Phase 3 development. Also known as: 0,1 % Undecilenamidopropil betaine, 0,1 % Polyhexanide.
Prontosan is a wound care product used to treat various conditions, including venous leg ulcers, surgical site infections, and pressure ulcers. It is available in the form of a wound irrigation solution and a wound gel, which are used for wound care and treatment.
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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).
| 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 | Prontosan |
|---|---|
| Also known as | 0,1 % Undecilenamidopropil betaine, 0,1 % Polyhexanide |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Reduction of Bacterial Seeding in Total Shoulder Arthroplasty (NA)
- Efficacy of a Polyhexanide Biguanide-Based Gel in the Prevention of Biofilm Formation in Pressure Ulcers (EARLY_PHASE1)
- Impact of Prontosan Wound Gel X on Surgical Site Infections in Cardiac Surgery
- Acetic Acid 2% Solution for Skin Ulcers (PHASE3)
- Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure (PHASE4)
- SALACIA: SALvesAn vs Conventional Management of dIAbetic Foot Wounds (NA)
- Honey as A Wound Care Modality in Treating Deep Neck Space Abscess (NA)
- A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement (NA)
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:
- Prontosan CI brief — competitive landscape report
- Prontosan updates RSS · CI watch RSS
- Consorci Sanitari de l'Alt Penedès i Garraf portfolio CI
Frequently asked questions about Prontosan
What is Prontosan?
Who makes Prontosan?
Is Prontosan also known as anything else?
What development phase is Prontosan in?
Related
- Manufacturer: Consorci Sanitari de l'Alt Penedès i Garraf — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: 0,1 % Undecilenamidopropil betaine, 0,1 % Polyhexanide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing