CLINICAL TRIALS PROFILE FOR ZOLIFLODACIN

All Clinical Trials for ZOLIFLODACIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03404167 ↗	A Study to Evaluate the Safety, Tolerability and Plasma PK of a Single Oral Dose of Zoliflodacin in Healthy Male and Female Volunteers	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2018-02-02	The trial is to evaluate the pharmacokinetics and safety profiles of the single-dose of zoliflodacin in eight healthy male or female subjects ages 18 to 45 years inclusive. All subjects will be dosed in the morning of Day 1 in a staggered fashion with a minimum of several minutes apart. Each subject will receive a single 4g dose of zoliflodacin (2 x 2 g sachets of zoliflodacin) after at least an 8-h fast, which will continue for at least 4 h after dosing. Consumption of water will be permitted during the fasting period. Subjects will be monitored as inpatients in the Clinical Trial Unit (CTU) up to Day 4 and at the Final Visit (Day 8 ± 2). Study duration is approximately 4 weeks with subject participation duration up to 10 days (from dosing to final visit). The primary objective of this study is to evaluate the plasma PK of zoliflodacin after administration of a single 4-g oral dose under fasting conditions.
NCT03613649 ↗	Thorough QT/QTC (TQT) Clinical Trial to Evaluate the Effect of Zoliflodacin on Cardiac Repolarization in Healthy Male and Female Subjects	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2018-09-25	The Phase I Thorough QT/QTc (TQT) study will be performed in a single center, the Vince & Associates Clinical Research, Inc., clinical trials unit (CTU), in 72 healthy male or female subjects, aged 18 to 45 years inclusive, to evaluate the effect of zoliflodacin on the corrected QT interval of the electrocardiogram (ECG) using Fridericia's Formula (QTcF) and other ECG parameters; the correlation of the drug concentrations (and pharmacokinetic (PK) profile) with time-matched, placebo-corrected, baseline-adjusted difference in QTcF interval (delta delta QTcF); and the PK and safety profiles of the new zoliflodacin formulation. Each subject will receive one dose of each of four treatments: zoliflodacin 2 g orally, zoliflodacin 4 g orally, placebo for zoliflodacin 4 g orally, and moxifloxacin 400 mg orally. The study will last approximately 12 weeks with a subject participation duration of up to 55 days. The primary hypothesis to be tested is that following administration of zoliflodacin 2 g and 4 g, the upper bound of the one-sided 95% confidence interval (CI) of treatment effect on delta delta QTcF is > / = 10 msec for at least one of the ECG assessments, against the alternative hypothesis that all mean effects are < 10 msec. The primary objective is to evaluate the effect of zoliflodacin on the corrected QT interval of the ECG using Fridericia's formula (QTcF).
NCT03718806 ↗	Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin	Completed	Quotient Sciences	Phase 1	2018-10-03	This is a phase I, parallel, open-label, randomized, cross-over, single-center study with zoliflodacin administered as granules for oral suspension with or without food. It is planned to enroll 2 cohorts (Cohorts 1 and 2) of 24 subjects each (48 subjects in total), with the target of achieving data in 20 evaluable subjects per cohort. Single doses of zoliflodacin will be assessed within each cohort in a two period cross-over design. Each subject will receive one of the following regimens per period, depending on cohort, in a sequence according to the randomization schedule (per cohort, subjects will be randomized immediately before dosing in Period 1), separated by a minimum 4 day washout between each period. The actual length of washout period may change pending emerging PK data. Cohort 1: - Regimen A: 3 g zoliflodacin oral suspension; oral administration after an overnight fast - Regimen B: 3 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast Cohort 2 - Regimen C: 4 g zoliflodacin oral suspension; oral administration after an overnight fast - Regimen D: 4 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast
NCT03718806 ↗	Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin	Completed	Drugs for Neglected Diseases	Phase 1	2018-10-03	This is a phase I, parallel, open-label, randomized, cross-over, single-center study with zoliflodacin administered as granules for oral suspension with or without food. It is planned to enroll 2 cohorts (Cohorts 1 and 2) of 24 subjects each (48 subjects in total), with the target of achieving data in 20 evaluable subjects per cohort. Single doses of zoliflodacin will be assessed within each cohort in a two period cross-over design. Each subject will receive one of the following regimens per period, depending on cohort, in a sequence according to the randomization schedule (per cohort, subjects will be randomized immediately before dosing in Period 1), separated by a minimum 4 day washout between each period. The actual length of washout period may change pending emerging PK data. Cohort 1: - Regimen A: 3 g zoliflodacin oral suspension; oral administration after an overnight fast - Regimen B: 3 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast Cohort 2 - Regimen C: 4 g zoliflodacin oral suspension; oral administration after an overnight fast - Regimen D: 4 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast

Clinical Trial Conditions for ZOLIFLODACIN

Condition Name

Condition Name for ZOLIFLODACIN
Intervention	Trials
Gonorrhea	2
Gonorrhoea	2
Electrocardiogram Repolarisation Abnormality	1
Gonococcal Infection	1

Condition MeSH

Condition MeSH for ZOLIFLODACIN
Intervention	Trials
Gonorrhea	4

Clinical Trial Locations for ZOLIFLODACIN

Trials by Country

Trials by Country for ZOLIFLODACIN
Location	Trials
United States	9
Netherlands	1
Germany	1
Thailand	1
South Africa	1

Trials by US State

Trials by US State for ZOLIFLODACIN
Location	Trials
Kansas	2
Washington	1
Ohio	1
Louisiana	1
Indiana	1

Clinical Trial Progress for ZOLIFLODACIN

Clinical Trial Phase

Clinical Trial Phase for ZOLIFLODACIN
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for ZOLIFLODACIN
Clinical Trial Phase	Trials
Completed	3
Recruiting	2

Clinical Trial Sponsors for ZOLIFLODACIN

Sponsor Name

Sponsor Name for ZOLIFLODACIN
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	2
Global Antibiotics Research and Development Partnership	2
Quotient Sciences	1

Sponsor Type

Sponsor Type for ZOLIFLODACIN
Sponsor	Trials
Other	4
NIH	2
Industry	2

Last updated: May 9, 2026

Clinical Trials Update, Market Analysis, and Projection: Zoliflodacin

Zoliflodacin (global non-systemic antibacterial program led by a DFI-backed approach) is in late-stage clinical development aimed at treating urogenital and/or sexually transmitted bacterial infections with a single-dose or short-course regimen. Commercial projections depend on (1) the breadth of the label (indication count and geography), (2) unit usage driven by dosing (single-dose vs multi-dose), and (3) competitive intensity from other STI-focused antibacterial candidates and established standard-of-care regimens.

What is the current clinical development status for zoliflodacin?

Zoliflodacin’s clinical program is built around Phase 2/3 efficacy and safety in bacterial urogenital infections, with endpoints that typically include microbiological cure and/or clinical cure at defined post-treatment timepoints, plus safety/tolerability assessments (TEAEs, QTc, GI events, and laboratory parameters).

Clinical development milestone view (high-level, program-structure level)

• Target populations: urogenital bacterial infections with a focus on STI-related pathogens
• Regimen design: short-course or single-dose logic to support adoption and reduce adherence friction
• Key endpoints: microbiological eradication and symptom resolution, measured at prespecified follow-up visits
• Safety profile focus: tolerability with attention to common small-molecule antibacterial adverse events

Practical read-through for decision-makers

• The nearer-to-regulatory programs for zoliflodacin hinge on demonstrating sustained eradication at follow-up, not only early response.
• Label expansion potential increases revenue realism: a narrower indication set compresses addressable market, while a broader label across similar pathogen syndromes supports pull-through across geographies.

Which clinical trial data most matters for commercialization?

For STI and urogenital antibacterial products, investors and commercial leaders screen for four proof points:

1. Efficacy durability
   • Cure rates at the primary endpoint timepoint and at follow-up must remain high.
2. Resistance and microbiological endpoints
   • Evidence that eradication translates to clinically relevant microbiology is central to formulary uptake.
3. Tolerability consistency
   • Single-dose programs rise or fall based on GI tolerability and discontinuation rates.
4. Operational simplicity
   • Trial protocols that mirror real-world patient pathways (clinic testing, index visit treatment) reduce launch friction.

What is the market structure and competitive landscape for zoliflodacin?

The addressable market for zoliflodacin sits inside the global urogenital infection and STI antibacterial segment. Purchase decisions tend to track three drivers:

• Guideline position and stewardship: preferred options for susceptible infections and situations where rapid treatment is needed
• Formulary and procurement pathways: outpatient and sexual health clinics often dictate adoption
• Diagnostic workflow alignment: tests that enable pathogen-directed use increase uptake

Market demand vectors

• Incidence volume: increases create baseline growth for syndromic and test-guided antibacterial usage
• Adherence and single-visit treatment preference: drives uptake when dosing is simplified
• Resistance pressure: supports switching when standard options show reduced effectiveness

Competitive set (commercially relevant categories)

Zoliflodacin’s competitive threats map into three buckets:

• Established antibiotics for STI/urogenital infections with established procurement channels
• New STI antibacterials with claims of improved eradication or shorter regimens
• Alternative modalities (non-antibacterial or combination strategies) used where resistance or safety limits exist

How should zoliflodacin revenue be projected?

A robust projection model for zoliflodacin uses a “units-first” approach.

Revenue build: unit sales mechanics

Unit sales (core formula)

• Units per patient = regimen dose count (single-dose = 1; short-course = >1)
• Treated patients = (incidence or diagnosed population) × (tested share if test-guided) × (eligible share) × (target penetration share)
• ASP = geography-weighted net price, reflecting tendering and contracting

Because label scope controls penetration

• Narrow label caps eligibility and depresses penetration.
• Broad label increases treatable syndromes and expands clinic use cases.

Projection scenarios (framework)

Create three scenarios that capture launch uncertainty:

• Base case: limited initial geography plus 1 main indication; steady penetration in sexual health clinics
• Upside case: broader label and faster adoption in test-guided care pathways
• Downside case: slower label expansion, higher payer friction, and strong displacement by existing standard therapies

Parameter ranges to anchor planning

• Launch timing risk: impacts adoption ramp
• Penetration ramp speed: depends on guideline adoption and procurement cycles
• Price realization: influenced by tender dynamics and competitor pricing

What are the key commercial KPIs after approval?

Commercial traction for a STI/urogenital antibacterial product should be tracked on:

1. Diagnosed eligible patient volume share
2. Share of prescription within target syndrome
3. Persistence of uptake across quarters
4. Real-world microbiological outcomes through post-marketing studies
5. Adverse event signal management (pharmacovigilance metrics and discontinuation trends)

What timing and regulatory pathway considerations drive value?

For zoliflodacin, value sensitivity is tied to the regulatory readout sequence and the probability-weighted path to approvals in major markets.

• Phase 3 success is the primary determinant of market access speed
• Label breadth in the initial authorization drives the first-year revenue ceiling
• Geography scope determines the fastest way to reach scale and stabilize ASP

Key Takeaways

• Zoliflodacin’s commercialization outcome depends on late-stage efficacy durability, safety tolerability, and label breadth across urogenital/STI syndromes.
• The market is structured around STI antibacterial prescribing in outpatient and sexual health clinics, where adoption follows guideline fit, diagnostic workflow alignment, and procurement simplicity.
• Revenue projection should be modeled as units-first with scenario-based penetration and label expansion assumptions; the strongest upside comes from broader indication coverage and faster adoption in test-guided pathways.

FAQs

1) What endpoints most influence whether zoliflodacin gains uptake?
Microbiological cure at the primary endpoint timepoint, durability at follow-up, and tolerability metrics that support single-dose or short-course adoption.

2) Does zoliflodacin pricing rely more on ASP or on volume penetration?
Both matter; for regimen-driven products, volume penetration and label breadth usually dominate the long-run revenue trajectory, while ASP reflects payer and tender dynamics.

3) What market access friction is most likely post-approval?
Formulary inclusion tied to stewardship policies, procurement tender timelines, and the degree to which the product aligns with clinic diagnostic workflows.

4) What would most likely expand zoliflodacin’s addressable market?
Additional indications and broader label coverage across urogenital/STI syndromes that match real-world testing and treatment pathways.

5) What KPIs should define launch success within the first 12 months?
Eligible patient treated share, prescription share within the target syndrome, quarter-over-quarter persistence, and real-world tolerability and effectiveness confirmation through post-marketing monitoring.

References

1. ClinicalTrials.gov. (n.d.). Search results for zoliflodacin trials. https://clinicaltrials.gov
2. European Medicines Agency. (n.d.). Zoliflodacin procedure and assessment documents (if available). https://www.ema.europa.eu
3. U.S. Food and Drug Administration. (n.d.). Zoliflodacin information (if available). https://www.fda.gov