Last reviewed 2026-05-21 · How we verify

Reference: Metronidazole Gel 1%

bioRASI, LLC · Phase 3 active Small molecule Under review Quality 0/100

Reference: Metronidazole Gel 1% is a Nitroimidazole antibiotic Small molecule drug developed by bioRASI, LLC. It is currently in Phase 3 development for Bacterial vaginosis, Rosacea, Anaerobic bacterial infections (topical). Also known as: MetroGel.

Metronidazole is a nitroimidazole antibiotic that disrupts bacterial and protozoal DNA by generating reactive free radicals, leading to cell death.

Metronidazole Gel 1% is used to treat Papulopustular Rosacea and Erythematotelangiectatic Rosacea. It works as a small molecule DNA inhibitor.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Reference: Metronidazole Gel 1%
Also known as	MetroGel
Sponsor	bioRASI, LLC
Drug class	Nitroimidazole antibiotic
Target	Bacterial and protozoal DNA
Modality	Small molecule
Therapeutic area	Infectious Disease / Dermatology
Phase	Phase 3

Mechanism of action

Metronidazole is reduced by anaerobic organisms and protozoa to form reactive intermediates that damage DNA and inhibit nucleic acid synthesis. The drug is selectively toxic to anaerobic microorganisms because it requires anaerobic conditions for activation. It is commonly used topically as a gel formulation for localized treatment of infections and inflammatory conditions.

Approved indications

Bacterial vaginosis
Rosacea
Anaerobic bacterial infections (topical)

Common side effects

Vaginal irritation or burning
Metallic taste (systemic formulations)
Local erythema or pruritus

Key clinical trials

A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea (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:

Reference: Metronidazole Gel 1% CI brief — competitive landscape report
Reference: Metronidazole Gel 1% updates RSS · CI watch RSS
bioRASI, LLC portfolio CI

Frequently asked questions about Reference: Metronidazole Gel 1%

What is Reference: Metronidazole Gel 1%?

Reference: Metronidazole Gel 1% is a Nitroimidazole antibiotic drug developed by bioRASI, LLC, indicated for Bacterial vaginosis, Rosacea, Anaerobic bacterial infections (topical).

How does Reference: Metronidazole Gel 1% work?

Metronidazole is a nitroimidazole antibiotic that disrupts bacterial and protozoal DNA by generating reactive free radicals, leading to cell death.

What is Reference: Metronidazole Gel 1% used for?

Reference: Metronidazole Gel 1% is indicated for Bacterial vaginosis, Rosacea, Anaerobic bacterial infections (topical).

Who makes Reference: Metronidazole Gel 1%?

Reference: Metronidazole Gel 1% is developed by bioRASI, LLC (see full bioRASI, LLC pipeline at /company/biorasi-llc).

Is Reference: Metronidazole Gel 1% also known as anything else?

Reference: Metronidazole Gel 1% is also known as MetroGel.

What drug class is Reference: Metronidazole Gel 1% in?

Reference: Metronidazole Gel 1% belongs to the Nitroimidazole antibiotic class. See all Nitroimidazole antibiotic drugs at /class/nitroimidazole-antibiotic.

What development phase is Reference: Metronidazole Gel 1% in?

Reference: Metronidazole Gel 1% is in Phase 3.

What are the side effects of Reference: Metronidazole Gel 1%?

Common side effects of Reference: Metronidazole Gel 1% include Vaginal irritation or burning, Metallic taste (systemic formulations), Local erythema or pruritus.

What does Reference: Metronidazole Gel 1% target?

Reference: Metronidazole Gel 1% targets Bacterial and protozoal DNA and is a Nitroimidazole antibiotic.

Drug class: All Nitroimidazole antibiotic drugs
Target: All drugs targeting Bacterial and protozoal DNA
Manufacturer: bioRASI, LLC — full pipeline
Therapeutic area: All drugs in Infectious Disease / Dermatology
Indication: Drugs for Bacterial vaginosis
Indication: Drugs for Rosacea
Indication: Drugs for Anaerobic bacterial infections (topical)
Also known as: MetroGel

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