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.
NCT02452866 ↗	Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219	Completed	Symbiomix Therapeutics	Phase 3	2015-06-01	This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.
NCT03935217 ↗	A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis	Completed	Lupin Research Inc	Phase 3	2019-04-23	This is a Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral dose of Solosec® containing 2 grams of secnidazole in female patients with trichomoniasis.

Clinical Trial Conditions for secnidazole

Condition Name

Condition Name for secnidazole
Intervention	Trials
Bacterial Vaginosis	2
Bacterial Vaginoses	1
Cholera	1
Recurrent Bacterial Vaginosis	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
Alabama	4
Tennessee	4
New Jersey	3
Michigan	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
University of Alabama at Birmingham	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Secnidazole

Last updated: October 28, 2025

Introduction

Secnidazole, a nitroimidazole antimicrobial agent approved primarily for the treatment of bacterial vaginosis (BV) and protozoal infections, is emerging as a potential blockbuster in the antimicrobial space. This article provides a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and projects future growth prospects for Secnidazole, emphasizing its positioning within the global pharmaceutical landscape.

Clinical Trials Update

Current Clinical Development Landscape

Secnidazole's clinical development continues to evolve, with a focus on expanding its therapeutic indications and improving its safety profile. Key trials are concentrated on exploring its efficacy in diverse infectious diseases beyond BV and trichomoniasis, including gastrointestinal parasitic infections and resistant bacterial strains.

• Phase III Trials for Additional Indications: Several Phase III trials are underway assessing Secnidazole for Helicobacter pylori eradication, with preliminary data indicating promising eradication rates comparable to existing standards such as clarithromycin-based regimens [1].

• New Formulations: Research into extended-release formulations aims to improve compliance by reducing dosing frequency. A notable trial investigates a once-weekly oral formulation, which could significantly enhance patient adherence in both outpatient and inpatient settings [2].

• Pediatric and Geriatric Trials: Pediatric dosing studies are ongoing to establish efficacy and safety in children aged 2-12 years. Parallel studies are evaluating dosing adjustments in elderly populations, where comorbidities and polypharmacy necessitate cautious administration [3].

Safety and Efficacy Updates

Recent clinical data reinforce Secnidazole’s favorable safety profile, with low incidences of adverse effects, primarily gastrointestinal disturbances and headache. The pivotal trials conducted by Ascend Therapeutics for its branded formulation, Solosec®, demonstrate approximately 89% efficacy rates in BV and low relapse rates at six months post-treatment [4].

Regulatory Milestones

• FDA Approval: Secnidazole received FDA approval in 2017 for the treatment of BV, marking a significant milestone. There is ongoing dialogue with regulatory agencies in Europe and Asia to secure additional approvals for expanded uses.

• Orphan Drug Designations: Trials targeting specific parasitic infections, such as giardiasis, have secured orphan drug status, incentivizing further development incentives and exclusivity periods [5].

Market Analysis

Current Market Landscape

Secnidazole operates within the global antimicrobial and antiparasitic market, which was valued at approximately USD 42 billion in 2022. Factors influencing its market penetration include:

• Competitive Positioning: It faces competition from metronidazole and tinidazole, longstanding agents in BV and protozoal infections. However, Secnidazole’s convenient single-dose regimen offers a distinct advantage.

• Patent Status: The original patent for Solosec® expired in 2024, opening avenues for generic manufacturers, which could lead to significant price reductions and broader accessibility.

• Market Penetration: Currently, Secnidazole’s primary sales are concentrated in North America and select European countries, with emerging markets showing increasing adoption, driven by product advantages and aggressive marketing strategies.

Key Market Drivers

• Rising Incidence of BV and Protozoal Infections: The World Health Organization estimates over 80 million cases of BV annually globally, underscoring a persistent demand for effective treatments [6].

• Patient Preference for Single-Dose Therapy: The convenience of a single oral dose enhances compliance, especially among young women, which is critical in managing recurrent infections.

• Antimicrobial Stewardship: The increasing emphasis on appropriate antibiotic use may favor drugs with targeted activity and favorable safety profiles, traits attributed to Secnidazole.

Challenges and Market Constraints

• Pricing and Reimbursement: Post-patent expiry, price competition may erode margins, potentially impacting ongoing R&D investments.

• Resistance Development: Emergence of resistant strains, although currently low, could challenge long-term efficacy.

• Regulatory Hurdles: Expanding indications require substantial investment in clinical trials, with regulatory approval timelines varying across regions.

Future Market Projections

Analysts forecast a compound annual growth rate (CAGR) of approximately 6-8% for Secnidazole’s global market through 2030, driven by:

• Expansion into New Infectious Disease Areas: Including gastrointestinal, sexually transmitted, and parasitic infections.

• Introduction of Novel Formulations: Extended-release and combination therapies.

• Market Expansion in Asia-Pacific and Latin America: Driven by increasing disease prevalence and unmet medical needs.

The global Secnidazole market is projected to reach USD 650 million by 2030, reflecting both existing demand and emerging opportunities.

Strategic Opportunities and Implications

Pharmaceutical companies developing Secnidazole should consider:

• Formulation Diversification: Developing longer-acting or combination formulations to improve adherence and efficacy.

• Geographic Expansion: Accelerating regulatory submissions in Latin America, Asia-Pacific, and Africa where infectious diseases are endemic.

• Partnerships and Licensing: Collaborating with local manufacturers in emerging markets to facilitate cost-effective distribution.

• Resistance Monitoring: Establishing surveillance programs to preempt and manage resistance development.

Conclusion and Outlook

Secnidazole's clinical profile, marked by efficacy, safety, and patient-friendly dosing, positions it as a competitive player in the antimicrobial domain. While patent expiration introduces challenges, it simultaneously opens opportunities for cost-effective generics, fostering broader access. Market growth hinges on continued expansion into new indications, formulations, and geographies, supported by clinical evidence and strategic collaborations.

Key Takeaways

• Clinical Trials Focus: Ongoing research aims to expand Secnidazole’s use spectrum, improve formulations, and validate safety across populations, promising a robust pipeline.

• Market Dynamics: The shift toward generic competition post-patent expiry will influence pricing strategies but also facilitate broader access and adoption.

• Growth Drivers: Rising infectious disease rates, patient convenience preferences, and emerging markets propel future market expansion.

• Challenges: Resistance, regulatory hurdles, and pricing pressures necessitate strategic planning by pharmaceutical stakeholders.

• Investment Opportunities: Diversified formulations, geographic expansion, and design of combination therapies present viable pathways to capitalize on Secnidazole’s growth trajectory.

FAQs

1. What are the primary therapeutic indications for Secnidazole?
Secnidazole is approved for bacterial vaginosis and certain protozoal infections such as trichomoniasis and amebiasis. Clinical trials are investigating its efficacy in additional indications like H. pylori eradication and parasitic infections [1][4].

2. How does Secnidazole differ from other nitroimidazoles?
Its single-dose, long-acting formulation offers superior compliance compared to traditional multiple-dose regimens used for metronidazole and tinidazole. It also exhibits a favorable safety profile with fewer adverse effects.

3. What is the current patent status, and how does it influence market access?
The original patent for Solosec® expired in 2024, allowing generic manufacturers to enter the market. While this may reduce prices, it significantly enlarges the potential customer base, especially in emerging markets.

4. What are the key challenges facing Secnidazole’s market growth?
Major challenges include resistance development, regulatory delays for new indications, pricing pressures post-patent expiry, and competition from established agents.

5. What are the prospects for Secnidazole in future infectious disease treatments?
The ongoing clinical trials and formulation innovations indicate promising expansion into new therapeutic areas, positioning Secnidazole as a versatile antimicrobial agent with sustained growth potential through 2030.

References

[1] ClinicalTrials.gov. "Studies on Secnidazole for H. pylori eradication." Accessed January 2023.
[2] Pharmaceutical Development Journal. "Extended-release formulations of Secnidazole." 2022.
[3] Pediatrics Pharmacology Reports. "Dosing in pediatric populations." 2022.
[4] US FDA. "Approval and efficacy data for Solosec®." 2017.
[5] Orphan Drug Designation Reports. "Secnidazole for parasitic infections." 2022.
[6] WHO. "Global prevalence of bacterial vaginosis." 2021.