Last reviewed 2026-04-23 · How we verify

Norfloxacin + Synbiotic

Govind Ballabh Pant Hospital · Phase 3 active Small molecule

Norfloxacin + Synbiotic is a Fluoroquinolone antibiotic + synbiotic Small molecule drug developed by Govind Ballabh Pant Hospital. It is currently in Phase 3 development for Bacterial infections (likely urinary tract infections or gastrointestinal infections) with concurrent microbiota restoration.

Norfloxacin kills pathogenic bacteria via DNA gyrase inhibition, while the synbiotic (probiotics + prebiotics) restores and maintains beneficial gut microbiota.

Norfloxacin kills pathogenic bacteria via DNA gyrase inhibition, while the synbiotic (probiotics + prebiotics) restores and maintains beneficial gut microbiota. Used for Bacterial infections (likely urinary tract infections or gastrointestinal infections) with concurrent microbiota restoration.

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	Norfloxacin + Synbiotic
Sponsor	Govind Ballabh Pant Hospital
Drug class	Fluoroquinolone antibiotic + synbiotic
Target	Bacterial DNA gyrase (norfloxacin); gut microbiota restoration (synbiotic)
Modality	Small molecule
Therapeutic area	Infectious Disease / Gastroenterology
Phase	Phase 3

Mechanism of action

Norfloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase, preventing DNA replication and causing bacterial cell death. The synbiotic component provides live beneficial bacteria and their nutritional substrates to restore healthy gut flora, potentially reducing antibiotic-associated dysbiosis and improving treatment outcomes and tolerability.

Approved indications

Bacterial infections (likely urinary tract infections or gastrointestinal infections) with concurrent microbiota restoration

Common side effects

Nausea
Diarrhea
Abdominal discomfort
Headache
Tendinopathy (fluoroquinolone class effect)

Key clinical trials

Evaluation of Safety & Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis (SBP) in Cirrhotics (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:

Norfloxacin + Synbiotic CI brief — competitive landscape report
Norfloxacin + Synbiotic updates RSS · CI watch RSS
Govind Ballabh Pant Hospital portfolio CI

Frequently asked questions about Norfloxacin + Synbiotic

What is Norfloxacin + Synbiotic?

Norfloxacin + Synbiotic is a Fluoroquinolone antibiotic + synbiotic drug developed by Govind Ballabh Pant Hospital, indicated for Bacterial infections (likely urinary tract infections or gastrointestinal infections) with concurrent microbiota restoration.

How does Norfloxacin + Synbiotic work?

Norfloxacin kills pathogenic bacteria via DNA gyrase inhibition, while the synbiotic (probiotics + prebiotics) restores and maintains beneficial gut microbiota.

What is Norfloxacin + Synbiotic used for?

Norfloxacin + Synbiotic is indicated for Bacterial infections (likely urinary tract infections or gastrointestinal infections) with concurrent microbiota restoration.

Who makes Norfloxacin + Synbiotic?

Norfloxacin + Synbiotic is developed by Govind Ballabh Pant Hospital (see full Govind Ballabh Pant Hospital pipeline at /company/govind-ballabh-pant-hospital).

What drug class is Norfloxacin + Synbiotic in?

Norfloxacin + Synbiotic belongs to the Fluoroquinolone antibiotic + synbiotic class. See all Fluoroquinolone antibiotic + synbiotic drugs at /class/fluoroquinolone-antibiotic-synbiotic.

What development phase is Norfloxacin + Synbiotic in?

Norfloxacin + Synbiotic is in Phase 3.

What are the side effects of Norfloxacin + Synbiotic?

Common side effects of Norfloxacin + Synbiotic include Nausea, Diarrhea, Abdominal discomfort, Headache, Tendinopathy (fluoroquinolone class effect).

What does Norfloxacin + Synbiotic target?

Norfloxacin + Synbiotic targets Bacterial DNA gyrase (norfloxacin); gut microbiota restoration (synbiotic) and is a Fluoroquinolone antibiotic + synbiotic.

Drug class: All Fluoroquinolone antibiotic + synbiotic drugs
Target: All drugs targeting Bacterial DNA gyrase (norfloxacin); gut microbiota restoration (synbiotic)
Manufacturer: Govind Ballabh Pant Hospital — full pipeline
Therapeutic area: All drugs in Infectious Disease / Gastroenterology
Indication: Drugs for Bacterial infections (likely urinary tract infections or gastrointestinal infections) with concurrent microbiota restoration

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