CLINICAL TRIALS PROFILE FOR SECNIDAZOLE

All Clinical Trials for SECNIDAZOLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01019083 ↗	Studies of Immune Responses to Orally Administered Vaccines in Developing Country	Completed	Göteborg University	Phase 1/Phase 2	2008-02-01	The efficacy and immunogenicity of enteric vaccines have generally been found to be lower in children in the developed than in the developing countries. This has been observed with vaccines against cholera rotavirus, ETEC and typhoid vaccines. There are a number of factors that may contribute to such differences in vaccine "take rates" in children, e.g. breast feeding and nutritional status of the children might influence their immunogenicity and efficacy. Thus, breast feeding of newborn and young infants may adversely influence the immune response to vaccination, which might have more pronounced effect in developing than in developed countries. Breastfeeding has also been shown to interfere with the serum immune responses to rotavirus vaccine although this effect could be overcome by administering three rather than one dose of the oral rotavirus vaccine. Our recent study of Dukoral in Bangladeshi children aged 18 months or younger has shown that the response rates and the magnitude of responses improved when breast milk was temporarily withheld . Thus, administration of vaccines may have to be adjusted when given to breast fed children. Another factor that may affect the immunogenicity is the effect of zinc. Previous studies have shown that zinc enhances the immune response to cholera vaccine in participants > 2 years of age , a recent study also observed a similar effect in infants. In this research project, we plan to study a number of different factors that might influence the immunogenicity of the two licensed oral model vaccines, specifically the inactivated killed oral cholera vaccine, Dukoral, and the live oral typhoid vaccine, Ty21a. We will also identify strategies that might improve the immunogenicity of the vaccines. The main objective of our study is to identify immunization regimens that may improve the immunogenicity of the vaccines in young children, which could be subsequently in field trials in Bangladesh and other developing countries. Specifically, we will determine if: (i) interventions identified to enhance immune responses to Dukoral, including zinc supplementation, could also enhance the immune responses to Ty21a; (ii) these two vaccines are able to induce both acute and memory B and T cell responses, (iii) treatment with antiparasitic drugs prior to immunization could modulate the immune responses to cholera and typhoid vaccines; and (iv) examine if arsenic exerts a suppressive effect on the immunogenicity of these vaccines.
NCT01019083 ↗	Studies of Immune Responses to Orally Administered Vaccines in Developing Country	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 1/Phase 2	2008-02-01	The efficacy and immunogenicity of enteric vaccines have generally been found to be lower in children in the developed than in the developing countries. This has been observed with vaccines against cholera rotavirus, ETEC and typhoid vaccines. There are a number of factors that may contribute to such differences in vaccine "take rates" in children, e.g. breast feeding and nutritional status of the children might influence their immunogenicity and efficacy. Thus, breast feeding of newborn and young infants may adversely influence the immune response to vaccination, which might have more pronounced effect in developing than in developed countries. Breastfeeding has also been shown to interfere with the serum immune responses to rotavirus vaccine although this effect could be overcome by administering three rather than one dose of the oral rotavirus vaccine. Our recent study of Dukoral in Bangladeshi children aged 18 months or younger has shown that the response rates and the magnitude of responses improved when breast milk was temporarily withheld . Thus, administration of vaccines may have to be adjusted when given to breast fed children. Another factor that may affect the immunogenicity is the effect of zinc. Previous studies have shown that zinc enhances the immune response to cholera vaccine in participants > 2 years of age , a recent study also observed a similar effect in infants. In this research project, we plan to study a number of different factors that might influence the immunogenicity of the two licensed oral model vaccines, specifically the inactivated killed oral cholera vaccine, Dukoral, and the live oral typhoid vaccine, Ty21a. We will also identify strategies that might improve the immunogenicity of the vaccines. The main objective of our study is to identify immunization regimens that may improve the immunogenicity of the vaccines in young children, which could be subsequently in field trials in Bangladesh and other developing countries. Specifically, we will determine if: (i) interventions identified to enhance immune responses to Dukoral, including zinc supplementation, could also enhance the immune responses to Ty21a; (ii) these two vaccines are able to induce both acute and memory B and T cell responses, (iii) treatment with antiparasitic drugs prior to immunization could modulate the immune responses to cholera and typhoid vaccines; and (iv) examine if arsenic exerts a suppressive effect on the immunogenicity of these vaccines.
NCT02111629 ↗	Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge	Completed	Universidad Nacional de Colombia	Phase 3	2012-05-01	Genital tract infections (GTIs) have increased in the past decade and there is an association between sexually transmitted infections (STIs) and other infections like bacterial vaginosis (BV), with the HIV transmission. BV and Candida are the most common causes of vaginal infections in symptomatic women, the prevalence of BV being 22-50% and the prevalence of Candida 17-39%. In an effort to reduce the transmission of GTIs, the World Health Organization (WHO) proposed a syndromic diagnostic approach as a low cost alternative in places with no access to laboratory diagnostic tests. Justification. In patients with syndrome of vaginal discharge, an effective treatment against Candida albicans, Trichomonas vaginalis, and bacterial vaginosis is adviced, therefore, for syndromic management of symptomatic vaginal discharge the combination of fluconazole and secnidazole could be used. No studies evaluating this combination were found in the literature reviewed. Objectives: To describe the safety and the clinical and microbiological efficacy of a single oral dose of a combined treatment with secnidazole + fluconazole for the syndromic management of symptomatic vaginal discharge. Methods: Design: open label, uncontrolled clinical trial to estimate clinical efficacy and safety of the combination of fluconazole and secnidazole for the treatment of symptomatic vaginal discharge. The participants will be sexually active women with lower genital tract symptoms (leukorrhea, itching, burning, pain, foul-smelling vaginal discharge, or urethral symptoms) compatible with symptomatic vaginal discharge syndrome. The study will be conducted in an outpatient service of a hospital in Bogota, Colombia. Given the descriptive character of the study, no a priori hypothesis is considered. A consecutive convenience sample size of 100 symptomatic patients is calculated. The statistical analysis will be performed with STATA 11.0 software (College Station, Texas, USA). Simple and relative frequencies and measures of central tendency and dispersion appropriate for the distribution of the variables will be calculated. The study has been submitted and approved by the Ethics Committee of the Faculty of Medicine of the National University of Colombia and the Institutional Review Board of the participating institution. All women must sign a written informed consent form agreeing to voluntarily participate in the study.
NCT02147899 ↗	A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis	Completed	Symbiomix Therapeutics	Phase 2	2014-05-01	The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

Clinical Trial Conditions for SECNIDAZOLE

Condition Name

Condition Name for SECNIDAZOLE
Intervention	Trials
Bacterial Vaginosis	2
Vaginal Discharge	1
Bacterial Vaginitis	1
Bacterial Vaginoses	1

Condition MeSH

Condition MeSH for SECNIDAZOLE
Intervention	Trials
Vaginosis, Bacterial	5
Vaginal Diseases	4
Typhoid Fever	1
Cholera	1

Clinical Trial Locations for SECNIDAZOLE

Trials by Country

Trials by Country for SECNIDAZOLE
Location	Trials
United States	54
Bangladesh	1
Colombia	1

Trials by US State

Trials by US State for SECNIDAZOLE
Location	Trials
Florida	5
Tennessee	4
Alabama	4
Texas	3
Pennsylvania	3

Clinical Trial Progress for SECNIDAZOLE

Clinical Trial Phase

Clinical Trial Phase for SECNIDAZOLE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for SECNIDAZOLE
Clinical Trial Phase	Trials
Completed	6
Recruiting	2

Clinical Trial Sponsors for SECNIDAZOLE

Sponsor Name

Sponsor Name for SECNIDAZOLE
Sponsor	Trials
Symbiomix Therapeutics	2
Lupin Research Inc	2
Segal Trials Healthcare Clinical Data, Inc	1

Sponsor Type

Sponsor Type for SECNIDAZOLE
Sponsor	Trials
Other	7
Industry	5
UNKNOWN	1

Secnidazole: Clinical Trials Update and Market Outlook

Last updated: April 28, 2026

What is the current clinical-trials footprint for secnidazole?

Se-nidazole (secnidazole) has an established treatment role in parasitic and protozoal infections and is marketed in multiple geographies. Public trial activity in the modern era is dominated by (1) small-to-moderate randomized studies evaluating formulation performance (often single-dose regimens) and (2) comparative studies versus metronidazole or tinidazole for bacterial vaginosis and related indications.

Observed trial pattern in the public record

• Indexing suggests ongoing or recently completed activity is concentrated in women’s health indications, with study designs focused on cure rates at defined timepoints after single-dose therapy.
• Studies commonly compare against metronidazole-based standards, typically with symptom resolution and microbiologic endpoints.
• Formulation optimization and pharmacokinetic bridging appears frequently because secnidazole is an older molecule; trial activity tends to support label expansions, generics, or improved regimens rather than wholly new targets.

Practical implication for development strategy

• For investment-grade R&D, the highest-probability near-term value creation lies in label-relevant repositions and lifecycle extensions (new combinations, new dosage forms, or country-by-country labeling that hinges on bridging or comparator trials).
• If the goal is a new regulatory pathway, the trial record supports that the bar is not discovery biology, but endpoint selection and non-inferiority/ superiority design in existing clinical settings.

Note: No specific, up-to-date trial identifiers (e.g., NCT numbers) were provided in the source material available in this workspace. Without those identifiers, a precise line-by-line “last updated” clinical trials table cannot be produced while maintaining accuracy.

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Where does secnidazole sit in the competitive landscape?

Secnidazole competes within the nitroimidazole class, where primary reference comparators include metronidazole and tinidazole, plus alternative regimens depending on indication.

Competitive positioning by indication (commercial logic)

• Bacterial vaginosis (BV): secnidazole is commercially attractive in markets that reward single-dose adherence and faster patient experience.
• Trichomoniasis and related protozoal infections: clinical value depends on equivalent or improved cure rates versus multi-day nitroimidazole regimens.
• Amoebiasis and giardiasis: the commercial strength is linked to single-dose convenience where local standards permit.

Competitive levers that drive uptake

1. Dosing convenience
   • Single-dose or short-course regimens materially improve adherence versus longer regimens.
2. Safety and tolerability
   • The class tolerability profile is well characterized; the commercial differentiator is often tolerability in real-world usage and comparative adverse event rates in trials.
3. Formulary and reimbursement
   • Uptake rises when generics maintain low price and when clinicians perceive consistent cure rates.

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What does the market structure look like?

Secnidazole markets are shaped by two forces: mature demand and generics-driven price compression.

Market structure drivers

• Patent maturity and generic penetration: secnidazole is an established molecule, which shifts the market toward generics and lifecycle defense rather than monopoly pricing.
• Guideline alignment: adoption tracks national guidance for BV/protozoal treatment and whether single-dose options are positioned as preferred.
• Healthcare access and adherence constraints: health systems that emphasize outpatient simplicity favor single-dose regimens.

Commercial segmentation by geography

• High-structure maturity markets (EU/US-type formularies, where available) generally show:
  • Lower pricing power,
  • Greater reliance on differentiation via regimen convenience, and
  • Strong generics competition.
• Emerging or high-volume markets typically show:
  • Larger absolute demand for nitroimidazoles,
  • Greater sensitivity to procurement pricing, and
  • Faster uptake of branded single-dose where physician preference is established.

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How should investors and R&D leaders project secnidazole revenue potential?

Without molecule-specific, source-backed figures in this workspace, the only defensible projection is a framework tied to industry mechanics: dose form, uptake drivers, competitive pricing, and guideline adherence. The projection below is a scenario-based model that uses market mechanics rather than numeric claims.

Revenue projection mechanics (what moves the curve)

1) Volume growth (units)

• Driven by:
  • guideline inclusion for BV/protozoal infections,
  • prescribing patterns toward single-dose regimens,
  • and generics availability that expands access.

2) Price erosion

• Driven by:
  • generic entry timing,
  • procurement contracting,
  • and substitution to lowest-cost nitroimidazole options where clinical equivalence is accepted.

3) Lifecycle extensions

• Driven by:
  • new dosage forms (where registration supports),
  • combination products (where available),
  • and label extensions to additional indications or sub-populations.

Projection scenarios (directional)

• Base case: modest volume growth with steady price erosion, resulting in flat-to-slightly growing revenue in many mature geographies.
• Upside case: stronger guideline adoption for single-dose convenience and fewer aggressive competitors in key tenders, supporting above-market volume growth.
• Downside case: aggressive generic price undercutting and substitution to metronidazole/tinidazole where single-dose is not preferred, causing revenue contraction.

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What are the highest-probability clinical and regulatory pathways?

Given secnidazole’s maturity, the most credible development routes emphasize regulatory efficiency and market access.

Pathways with strongest alignment to existing evidence

• Bridging studies for new formulations or dosage forms
  • Focus: bioequivalence, tolerability, and consistent microbiologic endpoints in indication-specific trials.
• Comparative clinical trials anchored on standard-of-care
  • Focus: non-inferiority on cure rates and symptom endpoints.
• Lifecycle extensions tied to label language
  • Focus: aligning trial endpoints with guideline definitions to accelerate uptake.

Endpoint selection that typically matters commercially

• Symptom resolution by pre-specified day windows
• Microbiologic eradication at post-treatment timepoints
• Recurrence or persistence measures where defined
• Adverse event rates with attention to nitroimidazole class effects

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Key implications for business decisions

• Secnidazole is a mature nitroimidazole where market share is governed by single-dose advantage and tender pricing, not by brand-new mechanism innovation.
• Clinical activity in the modern era typically supports product lifecycle and access, so ROI depends on speed-to-market and registration strategy rather than discovery.
• For investors, the risk is not clinical failure probability alone; it is price erosion and substitution after competitor entry.

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Key Takeaways

• Secnidazole’s clinical program profile is consistent with lifecycle and formulation-supported evidence rather than new biology.
• Market outcomes are primarily driven by single-dose adherence value and generic price competition.
• Revenue projections should be built around volume uptake plus price erosion, not monopoly pricing assumptions.
• Best-aligned pathways are bridging and comparator trials designed to match guideline endpoint language.

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FAQs

1. Is secnidazole still being studied in randomized clinical trials?
   Yes, public trial activity tends to cluster around comparative and regimen-focused designs that support labels, formulation changes, and guideline-aligned endpoints.

2. What drugs most often compete with secnidazole in clinical comparisons?
   Metronidazole and tinidazole are the most common comparators within the nitroimidazole class, with regimen length and adherence as major differentiators.

3. What is the commercial differentiator for secnidazole?
   Single-dose or short-course dosing convenience in indications such as bacterial vaginosis and certain protozoal infections.

4. Why does generic entry matter so much for secnidazole revenue?
   Generic substitution and tender pricing typically compress net realized prices, shifting growth dependence to volume and market access.

5. What should R&D prioritize for secnidazole lifecycle projects?
   Bioequivalence/bridging for formulation changes and comparator trials that map endpoints directly to how guidelines define cure and tolerability.

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References

[1] ClinicalTrials.gov. Secnidazole (search results and listings). https://clinicaltrials.gov/
[2] WHO Model Formulary / nitroimidazole class guidance (general therapeutic context). https://www.who.int/
[3] EMA and FDA public labeling databases (bacterial vaginosis and nitroimidazole therapeutic context). https://www.ema.europa.eu/ and https://www.fda.gov/