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Propamidine 0.1%
Propamidine 0.1% is a Antiprotozoal Small molecule drug developed by SIFI SpA. It is currently in Phase 3 development for Acanthamoeba keratitis, Naegleria fowleri infection. Also known as: Brolene eye drops.
Propamidine is an antiprotozoal agent that works by inhibiting the growth of protozoa.
Propamidine 0.1% is a small molecule used in ophthalmic solutions. It has been studied in a clinical trial for the treatment of Acanthamoeba Keratitis.
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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 | Propamidine 0.1% |
|---|---|
| Also known as | Brolene eye drops |
| Sponsor | SIFI SpA |
| Drug class | Antiprotozoal |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
Propamidine acts by interfering with the protozoa's ability to synthesize proteins, ultimately leading to cell death. This mechanism is effective against a range of protozoal infections, including those caused by Acanthamoeba and Naegleria. By inhibiting the growth of these pathogens, propamidine helps to prevent the spread of infection and promote healing.
Approved indications
- Acanthamoeba keratitis
- Naegleria fowleri infection
Common side effects
- Eye irritation
- Headache
- Eye pain
Key clinical trials
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:
- Propamidine 0.1% CI brief — competitive landscape report
- Propamidine 0.1% updates RSS · CI watch RSS
- SIFI SpA portfolio CI
Frequently asked questions about Propamidine 0.1%
What is Propamidine 0.1%?
How does Propamidine 0.1% work?
What is Propamidine 0.1% used for?
Who makes Propamidine 0.1%?
Is Propamidine 0.1% also known as anything else?
What drug class is Propamidine 0.1% in?
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Related
- Drug class: All Antiprotozoal drugs
- Manufacturer: SIFI SpA — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Acanthamoeba keratitis
- Indication: Drugs for Naegleria fowleri infection
- Also known as: Brolene eye drops
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing