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Auriclosene Irrigation Solution, 0.2%

NovaBay Pharmaceuticals, Inc. · Phase 2 active Small molecule

Auriclosene Irrigation Solution, 0.2% is a Antimicrobial Small molecule drug developed by NovaBay Pharmaceuticals, Inc.. It is currently in Phase 2 development for Treatment of mild to moderate diabetic foot ulcers.

Auriclosene Irrigation Solution is a topical antimicrobial agent that kills bacteria and fungi by disrupting their cell membranes.

Auriclosene Irrigation Solution is a topical antimicrobial agent that kills bacteria and fungi by disrupting their cell membranes. Used for Treatment of mild to moderate diabetic foot ulcers.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameAuriclosene Irrigation Solution, 0.2%
SponsorNovaBay Pharmaceuticals, Inc.
Drug classAntimicrobial
ModalitySmall molecule
Therapeutic areaDermatology
PhasePhase 2

Mechanism of action

Auriclosene works by binding to the bacterial cell membrane, causing leakage of essential ions and ultimately leading to cell death. This mechanism of action is effective against a broad spectrum of microorganisms, including bacteria and fungi. The solution is designed for irrigation and cleansing of wounds and other infected areas.

Approved indications

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Auriclosene Irrigation Solution, 0.2%

What is Auriclosene Irrigation Solution, 0.2%?

Auriclosene Irrigation Solution, 0.2% is a Antimicrobial drug developed by NovaBay Pharmaceuticals, Inc., indicated for Treatment of mild to moderate diabetic foot ulcers.

How does Auriclosene Irrigation Solution, 0.2% work?

Auriclosene Irrigation Solution is a topical antimicrobial agent that kills bacteria and fungi by disrupting their cell membranes.

What is Auriclosene Irrigation Solution, 0.2% used for?

Auriclosene Irrigation Solution, 0.2% is indicated for Treatment of mild to moderate diabetic foot ulcers.

Who makes Auriclosene Irrigation Solution, 0.2%?

Auriclosene Irrigation Solution, 0.2% is developed by NovaBay Pharmaceuticals, Inc. (see full NovaBay Pharmaceuticals, Inc. pipeline at /company/novabay-pharmaceuticals-inc).

What drug class is Auriclosene Irrigation Solution, 0.2% in?

Auriclosene Irrigation Solution, 0.2% belongs to the Antimicrobial class. See all Antimicrobial drugs at /class/antimicrobial.

What development phase is Auriclosene Irrigation Solution, 0.2% in?

Auriclosene Irrigation Solution, 0.2% is in Phase 2.

What are the side effects of Auriclosene Irrigation Solution, 0.2%?

Common side effects of Auriclosene Irrigation Solution, 0.2% include Skin irritation.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing