How did Zinereo Pharma come to life, and what sets the company apart in the growing field of microbiome-based healthcare?

Zinereo Pharma was born at the intersection of pharmaceutical heritage and biotechnological innovation. 

Established as one of the companies of the Zendal Group, was founded with a clear and focused mission: to develop microbiome-based solutions that are clinically proven to address specific health challenges and manufactured to the highest pharmaceutical standards. 

Safety, efficacy and quality are the cornerstones of everything we do.

Our journey began with the acquisition of a former AstraZeneca manufacturing site in O Porriño, northern Spain. Within this facility, we constructed a second, fully independent plant — dedicated exclusively to the production of probiotics. This specialized unit operates under GMP certification, with strict segregation protocols designed to prevent cross-contamination, ensuring the highest levels of product quality and safety throughout the entire manufacturing process.

The Zendal Group further strengthened this foundation through the acquisition of two key companies: Bialactis, an expert in probiotics, and Probisearch, a spin-off from the Complutense University of Madrid, operating as a clinical research organisation (CRO). 

Probisearch focuses on the isolation of new probiotic strains and conducts clinical trials on finished products — providing rigorous scientific validation and enabling the development of a product portfolio driven by both innovation and scientific evidence.

What truly sets Zinereo Pharma apart is our commitment to applying the same degree of rigor, traceability and clinical validation to probiotics as one would expect from any pharmaceutical product. 

This is not just a principle; it is part of who we are — embedded in our DNA.

This scientific mindset is also encapsulated in our brand signature: “life for LIFE”. It expresses the idea that something as small as a probiotic — a microscopic, living organism — can profoundly impact human health, animal wellbeing and even planetary balance. 

Could you share some recent scientific insights or breakthroughs regarding probiotics and female fertility? Why is this topic becoming so relevant today?

The relationship between microbiome and fertility has become one of the promising frontiers in reproductive medicine. 

Increasingly, we understand that dysbiosis — a microbial imbalance in the urogenital tract — is associated with repeated implantation failure (RIF), recurrent pregnancy loss (RPL), and low IVF success rates, especially in cases classified as “idiopathic infertility”.

The female reproductive tract, when healthy, is typically dominated by Lactobacillus species, which lower pH and protect against pathogens. But in up to 40% of women undergoing ART, this balance is disrupted, favoring species like Gardnerella vaginalis, Prevotella, and Atopobium vaginae that trigger inflammation and compromise endometrial receptivity.

Meanwhile, the male reproductive tract also plays a crucial role. The absence of Lactobacilli and overrepresentation of pro-inflammatory microbes such as Prevotella have been linked to altered sperm parameters, DNA fragmentation and oxidative stress.

At Zinereo Pharma, these insights have driven the development of Fertibiome®, a probiotic solution based on Ligilactobacillus salivarius PS11610 — a strain with proven antimicrobial and immunomodulatory activity, now supported by both clinical data and a retrospective study.

In the Profec I prospective clinical trial (Iniesta et al., Am J Reprod Immunol, 2022), 17 couples with idiopathic infertility received Fertibiome® over six months. Results included:

  • 88.9% resolution of dysbiosis in couples who completed the intervention
  • 44.4% pregnancy rate, with several spontaneous conceptions
  • Significant immunological shifts from a proinflammatory to an anti-inflammatory profile at both systemic and uterine levels

Complementing this, the 2025 retrospective study (Raimundo et al., Nutrients) evaluated 694 IVF patients at a fertility clinic in Lisbon over a two-year period. The group taking Fertibiome® for at least one month before embryo transfer showed:

  • A significant increase in live births in frozen embryo transfer cycles:
    26.4% with Fertibiome® vs. 17.9% without (p = 0.034)
  • Higher biochemical pregnancy rates:
    42.6% vs. 34% (p = 0.071)
  • Statistically significant benefit particularly in women under 37

Mechanistically, L. salivarius PS11610  its though that it acts by:

  • Re-establishing Lactobacillus dominance in the vaginal and endometrial microbiota
  • Modulating the uterine immune microenvironment
  • Reducing pro-inflammatory cytokines such as IL-12p40 and IFN-λ1
  • Enhancing endometrial receptivity and epithelial integrity

The strain is recognised by EFSA as QPS (Qualified Presumption of Safety), and has demonstrated both safety and stability when administered orally.

The topic of microbiome and fertility is now gaining urgency: not only because over 48 million couples are affected globally, but because conventional treatments are invasive, costly, and often fail to address the root cause. Fertibiome® offers a non-invasive alternative — aligned with the body’s own microbial defences and reproductive physiology.

Currently a second clinical trial is being conducted both in Portugal and Spain, targeting 120 couples, to have deep information. 

At Zinereo, we see this as a new tool in infertility, where microbiome modulation is central to reproductive fertility techniques  success.

What do we currently understand about the relationship between the microbiome and fertility outcomes in women, and how is this shaping product development at Zinereo?

Our understanding of fertility has evolved significantly in recent years. Today, it is well established that the composition and balance of the vaginal and endometrial microbiota plays a role in implantation, pregnancy outcomes, and the success of assisted reproductive technologies.

A healthy reproductive tract is typically dominated by Lactobacillus species, which maintain low pH, reinforce epithelial barrier integrity, and regulate immune responses. 

In contrast, dysbiosis — often characterised by the proliferation of anaerobic bacteria such as Gardnerella, Atopobium, and Prevotella — disrupts this balance. 

It can promote chronic inflammation, impair endometrial receptivity, and contribute to repeated implantation failure (RIF) and recurrent pregnancy loss (RPL).

This connection is especially relevant in cases of idiopathic infertility, where traditional diagnostic methods fail to identify a cause. Thanks to next-generation sequencing and metagenomic analysis, we now understand that many of these cases are in fact microbiome-related — and that modulating the reproductive microbiota can directly improve outcomes.

At Zinereo Pharma, this insight has become a key driver of our product development strategy — particularly in the area of women’s health, which is one of our core commitments and fastest-growing therapeutic domains. 

We see probiotics as new tools for solving complex biological challenges with measurable clinical impact.

This philosophy shaped the development of Fertibiome®, designed to:

  • Restore microbial balance and Lactobacillus dominance
  • Correct dysbiosis
  • Shift the uterine immune profile from pro-inflammatory to receptive

Importantly, Fertibiome® takes a couple-centred approach, recognizing that male urogenital dysbiosis also contributes to infertility. The seminal microbiota, too, affects sperm function, DNA integrity, and oxidative stress. 

Addressing both partners is essential 

The outcomes of our Profec I prospective trial and the recent retrospective study published have confirmed that microbiome modulation improves real-world IVF outcomes. In frozen embryo transfers, for example, women who took Fertibiome® achieved a live birth rate of 26.4%, compared to 17.9% in the control group — a statistically significant increase.

By investing deeply in the science of microbiome and focusing on women’s health as a strategic priority, we aim to deliver transformative, evidence-based solutions for some of life’s most important moments.

What are the key scientific and technical considerations when developing probiotics specifically for women’s health?

Developing probiotics for women’s health involves a targeted, evidence-based approach that reflects the complexity of the female microbiome. 

Key scientific and technical considerations include:

Strain specificity and clinical relevance:

Probiotic effects are strain specific. The selection must be based on clinical evidence showing benefits for uti & vaginal health, such as maintaining a low pH, inhibiting pathogens, modulating local immunity, and promoting mucosal integrity. Strains like Ligilactobacillus salivarius PS11610 are chosen not only for their origin and safety profile, but also for their proven efficacy in restoring microbial balance, as demonstrated by clinical trials

Vaginal tropism and epithelial adhesion:

Strains must demonstrate the ability to reach, colonize, and persist in the vaginal environment. 

Adhesion to vaginal epithelial cells is crucial for competitive exclusion of pathogens and for sustained benefit beyond short-term use.

Synergistic formulation:

Clinically effective probiotic formulations often include complementary compounds—such as specific vitamins, minerals, and bioactive plant extracts—that work synergistically with the probiotic strains. 

By targeting multiple mechanisms simultaneously, these formulations offer broader and more sustained benefits, particularly in the management and prevention of recurrent vaginal and urinary tract infection

Preventive approach to recurrent conditions:

Infections such as bacterial vaginosis, candidiasis, or UTIs are often driven by dysbiosis. A preventive probiotic strategy aims to maintain a resilient, balanced microbiota—minimizing the need for antibiotics and reducing recurrence.

Clinical validation:

Efficacy must be demonstrated through well-designed human clinical trials that are published in peer-reviewed journals and conducted in line with regulatory and ethical standards. These studies should evaluate not only safety and tolerability, but also clinically relevant endpoints—such as recurrence rates of infections, changes in vaginal microbiota composition or reproductive outcomes.

Probiotics use in clinical practice must be supported by robust data to guide personalized, preventive, and long-term strategies in areas like recurrent bacterial vaginosis, candidiasis, urinary tract infections, and fertility support.

What are the most common misconceptions around probiotics you encounter, and how do you educate both healthcare professionals and patients?

Several persistent misconceptions continue to surround the field of probiotics, even among health professionals. One of the most widespread is the idea that “all probiotics are alike” — as though any Lactobacillus species will suffice in any context. This is fundamentally incorrect. The clinical efficacy of a probiotic is strain-dependent, and each strain must be characterised genetically, mechanistically and clinically. 

Another myth is that probiotics are only effective when administered in very high CFU counts — however, a high dose is not a substitute for targeted action. 

Likewise, the belief that probiotics only benefit gut health is outdated. Scientific literature now supports their role in vaginal and urinary tract health, fertility, immunomodulation, skin disorders, and even mental health via the gut–organ axis.

Another common misconception is that “probiotics have no real clinical evidence”. 

This stems from the fact that many products on the market rely on bibliographic data, or generic claims, without supporting trials on the final formulation. 

We also encounter false assumptions around timing and usage — such as the belief that probiotics must be taken indefinitely, or that they are ineffective during antibiotic treatment. In fact, certain strains can support mucosal recovery post-antibiotics, and short, targeted interventions can yield lasting benefits, particularly in reproductive or vaginal health.

To counter these misconceptions, we focus on targeted education: scientific webinars, medical training, and clinician-led content creation. 

For patients, we translate evidence into understandable language.

Our goal is to empower both professionals and individuals with clear, honest, and reliable information — because science without education risks becoming science without impact.

Giniwa has become a flagship brand in women’s health. What was the original vision behind it, and how has the brand evolved since its creation?

Giniwa was born from a powerful metaphor: the female intimate microbiota as a garden — living, evolving, and requiring thoughtful care. Just like a well-tended garden (eubiosis) flourishes with vibrant flora, a balanced vaginal ecosystem supports health and resilience. But when neglected (dysbiosis), imbalances allow opportunistic pathogens to thrive.

The name Giniwa fuses “gynaecology” with niwa — the Japanese word for “garden” — reflecting our commitment to preserving microbial harmony through evidence-based, preventive care.

Rather than waiting for imbalance to manifest as infection or discomfort, we offer scientifically formulated probiotic solutions that work with the body to maintain microbial equilibrium

Giniwa’s formulations are built on the latest understanding of the gut–vagina and gut–urinary tract axes. Disruptions caused by antibiotics, hormonal shifts, stress, or hygiene habits can diminish protective Lactobacillus species, enabling pathogens like Gardnerella, Candida, or E. coli to dominate. Each Giniwa product is tailored to address these vulnerabilities.

For example, Giniwa V combines strains such as L. crispatus, L. acidophilus and L. plantarum with antimicrobial actions of propolis, hibiscus extract, and vitamin A to prevent the recurrency of fungal and bacterial vaginal infections,  regenerating mucosa and support immune resilience — a synergistic formula designed not just to relieve symptoms but to reestablish ecological balance.

Zinereo has expanded globally, especially across Latin America, MENA, and Asia. How do you manage such diverse markets, and what role do local partners play?

Zinereo’s global footprint has grown significantly, with a strong presence across Latin America, the MENA region, and Asia. Managing such diverse markets requires a tailored, partnership-driven approach. Our expansion model is anchored in strategic collaborations with local distributors who actively promote our portfolio within their national medical communities and are deeply integrated into their healthcare systems.

In Latin America, we’ve prioritized women’s health and gastroenterology, two therapeutic areas where unmet needs are substantial and demand for natural, evidence-based solutions is rising. In the MENA region, our efforts are centered on female fertility and intimate health, in alignment with shifting demographics and regional healthcare priorities. In Southeast Asia, where interest in microbiome science is rapidly growing, we’re preparing to launch Fertibiome® in the Philippines. We’re also honored to participate in the country’s first Probiotics & Nutraceuticals Congress—an important milestone for the region.

By building long-term relationships based on education, trust and shared scientific vision, we’re able to expand globally without diluting our values. Our presence in each new market is a reflection of our commitment to evidence, safety and patient impact — not just commercial growth. It is through this model that we translate microbiome innovation into meaningful clinical solutions across borders.

We support our partners them with regulatory documentation, and customized scientific marketing materials, enabling them to engage effectively with healthcare professionals, fertility experts, and regulatory authorities. 

In addition, we provide full launch toolkits, continuous technical training, and opportunities to co-present at global symposia and congresses.

This knowledge-based, collaborative model ensures consistent scientific rigor and brand integrity across all markets. 

By fostering long-term relationships grounded in education, trust, and a shared commitment to science, we’re able to scale globally without compromising our values. 

Finally, what is your personal vision as the leader of this project, and where do you see Zinereo Pharma heading in the years to come?

Leading this project is, above all, a human responsibility. At Zinereo Pharma, we are working at the intersection of science and life — and that comes with the obligation to ensure that our innovation translates into real-world impact. 

My personal vision is to bring microbiome science closer to people — to transform what is often invisible, technical and complex into something deeply human: better health increasing wellbeing by means of a preventive complementary approach.

Our future lies in being a scientific reference in the development of microbiome-based solutions backed by science, clinical proven and to target specific needs.

Equally, our mission is to communicate this science in a way that educates consumers and provides confidence in healthcare professionals.

For me, leadership at Zinereo means ensuring that every decision is anchored in purpose: that our solutions are more than commercial innovations — they are tools for life. 

This is reflected in our signature: “life for LIFE”. A probiotic is a microscopic form of life, but it can improve human life, that’s what drives us every day. And that is where we see Zinereo going: from scientific excellence to meaningful, measurable, human outcomes — across the world.