All right. I'm excited to talk about Daré Bioscience today. As many of you who follow us know, we are a company focused on really transforming women's health, and our mission is to challenge the status quo by making sure women's health is a priority and giving women the treatment options that they want and deserve. We seek to do that by meeting the increasing demand for evidence-based treatments with both uncompromising scientific rigor and rapid, responsible commercialization. I'm very excited to give a little more perspective on how we're doing that today as a company, and specifically with our dual-path approach that I'll talk a little bit more about. Before I get any further, I should indicate that, obviously, the presentation today will include forward-looking statements, so please do see our SEC filings for a full overview of the risks and uncertainties.
As a company looking to really transform women's health, we have a focus on really cutting through the noise. What I mean when I say that is, first of all, we see gaps where there's research, but solutions are not reaching women. We want to address those gaps and start with meeting those unmet needs. We aim to deliver real science-backed options, and this is really important in terms of meeting women where they are. We understand that different needs are served by different types of products, and this means utilizing all of the eligible pathways to get evidence-based options into the hands of women and not lost in bureaucracy. That's going to be relevant to some of what I talk about today in terms of the dual-path approach. Importantly, we're optimizing for access in a fiscally responsible manner.
What I mean is we leverage strategic collaborations. They can enhance our capabilities and expand our impact. That's a really effective way of bringing new solutions to market. Our product lines are really designed for her, and we have six different areas where we work. Dare to Play are our products designed for her sexual experience. Dare to Thrive are our products designed to help her keep living her best life. Dare to Restore are our products designed to maintain a healthy vaginal microbiome. Dare to Plan are our products designed for her contraceptive needs. Dare to FIGHT are designed to treat vaginal infections. DareE to Support are our products designed to support her pregnancy. I'm going to give a little bit of perspective on all of those.
Before I go forward, I want to talk a little bit about the why, why invest in women's health. Apart from, obviously, the wonderful societal impact, we believe that investment in women's health is disproportionately impactful. Limited R&D investment over the years, where it's only represented about 1% of healthcare spending, has led to large commercial opportunities, where women's health products represent 27% of the blockbuster products out there today. How do we innovate in women's health? One, we listen to what women and doctors want. A great example is around products for arousal disorder. Research into women's sexual health has been overlooked for decades, where the last large studies were 10 to 20 years ago. 64% of women indicate on apps like Rosie that they have low sexual arousal.
They're looking, and their healthcare providers are looking for solutions that they can offer that they can trust. Innovation is recognizing that women's health issues are treatable conditions. Again, great examples in terms of look at the conditions that we treat in men, like erectile dysfunction and some of the unmet needs in women's health that we can similarly treat with pharmacologic solutions. Finally, we really leverage the learnings from existing therapeutics to accelerate our path to market. We believe that's an important way to innovate in women's health. Specifically, we deploy established active pharmaceutical ingredients, or APIs, in potential first-in-category candidates. In some cases, like with sildenafil, which was originally approved for erectile dysfunction as an oral form, we are developing in a topical form to address female sexual arousal disorder.
Some of our product candidates, like sildenafil, may be eligible for a dual-path to market that I'll talk more about. Others, like our tamoxifen for pain associated with sexual pain associated with menopause and lopinavir, which we're developing to prevent cervical cancer, have been approved previously as well. That can really speed our path to market. That's really what allowed us to achieve our track record to date. We've run eight successful clinical trials with six of our assets in the portfolio, including a phase three that led to an FDA approval just over the last few years. In terms of, finally, how we look to move the needle at Daré, it's really around addressing that circle of the three pillars that you have to have there to have really successful healthcare. One is you have to have access. One, you have to have information.
Finally, you need treatments. That is the pillar we are looking to address to truly transform a women's healthcare experience. That final pillar is getting new evidence-based treatment options into the hand of women. In terms of how we seek to challenge the status quo, I am going to talk about a few of the product candidates in the portfolio. I will probably spend the most time today on sildenafil, which is the first one listed here. Sildenafil cream is a product that we are developing as a treatment for female sexual arousal disorder, for which there are no FDA-approved treatments. Our innovative proprietary cream, it is the same active ingredient as an erectile dysfunction drug for men. It seeks to provide that long-overdue solution to bring equity and attention to an overlooked aspect of women's health.
I'm also going to talk about Ovaprene, which is our contraceptive candidate, which is the first once-a-month hormone-free contraceptive candidate, and for which we have a commercialization agreement with Bayer. I will talk a little bit more about that. That's in phase 3 right now. I'm also going to talk a little bit about Dare to Thrive, just briefly, to give some perspective on how we can shift the menopause treatment landscape, both with hormone and non-hormonal approaches. I will talk more about Dare to Fight our revolutionary HPV treatment, Dare HPV, which is designed as an antiviral vaginal capsule that could offer a really proactive solution by treating HPV infection, preventing surgery, stopping the spread, and transforming care for this critical health issue, which is the virus that leads to cervical cancer.
I won't have time today to go into much detail on Dare to Support, our relief for women undergoing IVF, which is a progesterone vaginal ring. Suffice it to say, something like this could be a potential game changer for women who are enduring the grueling process of multiple injections daily during IVF with a vaginal ring solution instead. In terms of arousal in women, I want to take a step back and just give some perspective on when fighting stigma can become a multi-billion dollar industry. I want to take us back to the days before Viagra for erectile dysfunction, when, frankly, that problem in men was dismissed. It was stigmatized and considered a normal part of aging. Fast forward to Viagra coming on the market, peaking at a $2 billion brand in 2012.
ED is now widely recognized as a physiologic medical condition. There are still no FDA-approved treatments for female sexual arousal disorder, which is really her version of erectile dysfunction. It is similarly characterized by the inability to attain or maintain sufficient genital arousal during sexual activity. It is clinically analogous to erectile dysfunction in men. The prevalence of the conditions is quite similar. Without effective treatment options, the condition is often dismissed and stigmatized. That is why we are so excited about our sildenafil cream program. This is part of our dual-path approach that I mentioned upfront. We believe that women should not have to wait for needed medical treatment solutions. We are taking action to accelerate availability of this proprietary formulation for healthcare providers and women, making it available for prescription fulfillment through 503(b) registered outsourcing facility partner.
We look to have this formulation available in the fourth quarter of this year. I do want to stress that, in parallel, we're continuing to pursue FDA approval as a treatment for FSAD, and we have completed phase two. I'll talk more about phase three next steps shortly. As I mentioned, there are no FDA-approved treatments for the condition. We are really breaking new ground in defining what the clinical requirements are for a new indication. That takes time. The dual-path approach that we're taking will ensure that women have access to a solution now that is backed by science, that healthcare providers can have an evidence-based brand that they can trust, while we, in parallel, continue to pursue the FDA approval for the indication.
To give some perspective on the scientific and regulatory standards that exist for our product, toxicology studies have been completed a variety of different routes of exposure, including, importantly, reproductive tox. We've completed pharmacokinetic studies in both men and women, pharmacodynamic studies to show the rapid time to effect of 10-15 minutes, placebo-controlled studies in women using endpoints with FDA input to ensure that the assessment of the product effect is real science and not just marketing. We are manufacturing following good manufacturing practices. You know, clearly, this is a product developed by a pharmaceutical company. It's a product really developed for her. We've invested significantly into making sure that this product candidate hits the target product profile that we are seeking. I'll talk more about that when I talk about the upcoming milestones in terms of what to expect next.
I do want to talk a little bit now about Ovaprene. This program is in phase 3. This is our product for non-hormonal contraception, a once-a-month non-hormonal contraceptive product. You know, as we think about the contraceptive landscape today, huge gaps still exist. Millions of women have not found the contraceptive options that meet their needs. To put that in perspective, there are 18 million women in the U.S. who use hormonal contraceptive and 27 million women who are potential candidates for Ovaprene when you look at the contraceptive method mix. If you think about the percentage of people using GLP-1s today, that's about 20 million women, so 20 million people. That gives you a little bit of perspective on the size of the market and the opportunity.
As I mentioned, this is a program where we are in a commercial relationship with Bayer. They have the right to commercialize the product in the United States. We're in an active phase 3 trial right now. I'll have a little bit more on updates to expect middle of this year related to that study. As I highlighted upfront, I do want to take a second and talk a little bit about menopause, because I'd be remiss if I didn't do so. Menopause is definitely having a moment, which is fantastic. With the rise of digital support platforms and virtual care clinics, menopausal women are looking for solutions. What is challenging today is that there are limited FDA-approved treatment options. Women are turning to the burgeoning industry of supplements and natural remedies, which are not evaluated by the FDA for safety and efficacy.
We're really looking to really change that for women and make sure that we're bringing some evidence-based treatments to market. First of all, I want to talk about hormone therapy, which is really back on the rise again. There was an unfortunate downturn in women getting access to hormone therapy based on the Women's Health Initiative report, which has since been debunked totally. Now the medical societies are actively training their members on the benefits of hormone therapies. We really see that in the availability right now of compounded bioidentical hormone therapies, which is an estimated $4.5 billion market. That really reflects the fact that we're still looking for new solutions for women in that regard. The market is starting to burgeon again, as well as for supplements to address the condition.
As we think about Daré and what we're bringing forward for the hormone therapy, as well as women who cannot take hormones, who I want to talk about as well, we've really got two different programs here. One is a once-a-month vaginal ring that delivers both estradiol and progesterone, very important to have both of those hormones together for women that have a uterus, as a non-oral route and a monthly route to hormone therapy. It's the first product of its kind that combines both of these hormones together in a non-oral monthly form. In addition, we have in development vaginal tamoxifen. Tamoxifen is well known and well understood in the breast cancer community.
In fact, breast cancer survivors are a group of women who are often suffering from sexual pain, dyspareunia, because of the effects that their treatments have on the vaginal epithelium. Tamoxifen, while it's non-hormonal, so women who are survivors and have a contraindication to hormone products would be eligible to take it, has estrogen-like effects on the vaginal epithelium. It can really disrupt that sexual pain that they're experiencing. That product IND is cleared. We are in preparations for phase two on that. Finally, I want to talk a little bit about our human papillomavirus program. If you think about cervical cancer, it's one of the few forms of cancer where we actually know exactly what causes it. It's the human papillomavirus. It's the most commonly sexually transmitted infection in the United States.
It is the cause of 99% of cervical cancer cases. There are 6 million women who are diagnosed each year with high-risk HPV. Those are infections that could lead to cervical cancer. Vaccination is fantastic. Screenings are important. We still do not have safe, effective treatment options for an HPV infection. Instead, we have to wait until that infection leads to precancerous lesions on the cervix, which are then surgically removed. That surgery is associated with increased risk of preterm birth and sexual dysfunction. It is not recommended for patients with fertility concerns. That is the landscape today. We are really looking to change that paradigm by developing a treatment for that high-risk infection that she can take when she has that infection diagnosis.
We are very proud to have received a grant, a $10 million award, in order to support the development of this program through phase two. I'll have a little bit more on upcoming milestones associated with this program as well. Finally, I mentioned upfront, we do have an FDA-approved product. I do want to talk a little bit about this as well. This is our first product to reach FDA approval. It's a great example of how we work to quickly get our innovations to market. In fact, we got this product FDA-approved in three years from InLicense. It is called XACIATO. It is a treatment for bacterial vaginosis. We have a commercialization collaborator in Oregon. This product became available across the United States in 2024. We entered into a monetization royalty financing with Xellia in 2024 as well.
We're really excited about that opportunity that really allowed us to accelerate in some of those future cash flows from Oregon into Daré last year. We remain eligible to receive different milestone-based payments from Xellia as certain revenue thresholds are achieved for Xellia . In terms of a snapshot of the therapeutics portfolio and to give you a visual of where those products are today, as I mentioned upfront, these are really products that are really intended to be some of the most potentially disruptive therapeutic candidates for women in decades, targeting unmet needs with really innovative solutions, often, as I mentioned, leveraging known active pharmaceutical ingredients, which, as I mentioned upfront, gives us a lot of optionality in terms of both how quickly we can get the product advanced through development and also different paths to market.
Ovaprene, as I mentioned, in phase three, actively enrolling. We do have that commercial relationship with Bayer. The NIH has been a supporter of the program, as well as we also have a grant that is supporting, a foundation grant that's also supporting the conduct of that phase three study. I'm going to talk a little bit more on upcoming milestones on that in a moment. I'm going to talk a little bit more about sildenafil cream. Phase two has been completed. In terms of the FDA approval path for this product, phase two has been completed. We have been working with the FDA on phase three preparations. I'll talk a little bit more about that in a moment.
I mentioned upfront hormone therapy, vaginal ring, our vaginal atrophy product for sexual pain associated with menopause, and Dare HPV, where we do have some upcoming milestones. I do not have really time today to go into detail in terms of the earlier stage programs in the portfolio. What I would like to highlight is that across our earlier stage programs, they similarly are addressing unmet needs with very disruptive potential technologies to address those unmet needs with first-in-category products. Really, across those earlier stage programs, we are leveraging grant funding or non-dilutive funding offsets really across that portfolio. It really is a nice means of enhancing the pipeline and ensure we have additional contraceptive options and products for IVF and the like, but without having to rely on equity capital to get those to a real solid proof-of-concept state. Okay.
Now, I want to spend a good bit of my last amount of time here on the upcoming milestones and updates. I want to just give a little more color and perspective on each of those. First of all, I want to talk about sildenafil cream. As I mentioned, we are targeting the availability of what we're referring to as our Dare to Play sildenafil cream by prescription in the fourth quarter of this year via the 503(b) registered outsourcing facility route. I want to give a little more perspective on that in terms of what that means. As I mentioned upfront, women are today not having treatment options because there is no FDA-approved product. There's no formulation of sildenafil available in a topical cream formulation that has gone through that FDA approval process.
What 503(b) does is it's a legal pathway that is available. It really allows us to meet women where they are today and meet the healthcare providers and what they're looking for today in ensuring that the product is available immediately under prescription, so same path as once it would be FDA-approved, a prescription product available for women today. We are targeting having this product available in the fourth quarter. What that means is we would expect to start recording revenue and cash flow in the fourth quarter. In the second quarter, which is this quarter, so keep staying tuned. We will be providing additional updates on the strategic partnerships to achieve these objectives. A little more color on that right now.
First of all, we have guided that we expect that our investment in order to ensure that the product is available this year and to support our 503(b) partner in particular will be about $1 million this year in order to support the availability of the product. In terms of the go-to-market strategy, it's really a multi-pronged approach. Again, it's a prescription product. It's something that the healthcare provider would need to prescribe for the woman. As we all know, in today's world, people and women in particular seek their healthcare solutions in a variety of different ways, in-person, office visits, obviously, as well as telehealth solutions. Our objective in making our cream formulation of sildenafil available is that access will be as broad as possible.
Wherever she's getting her healthcare, we are doing all we can to ensure that sildenafil cream can be available for her, so as broadly available as possible. Also, in terms of strategies, this really accelerates. It doesn't impact the ability to seek an FDA approval. Rather, it's accelerating the time that we will be able to receive revenue and that women will have access to this product and healthcare providers as well. It's really a win for all of those stakeholders in terms of the availability of the product today. That does mean we have to be thoughtful in ensuring continuity of care. Once there is an FDA-approved product, 503(b) would no longer be an option.
As we think about the strategy and a nice transition of making it available today, working with the healthcare providers to educate on the product today, and then making sure that once down the road, hopefully, there is an FDA approval, that it's a very seamless transition. That's also really feasible because of a thoughtful pricing strategy, of course. Under 503(b), products under 503(b) are not eligible for health insurance reimbursement. They are out of pocket. Obviously, health insurance reimbursement could be an option once there's an FDA-approved form of the drug. Really, the vision is to price it such a way that a woman who can start using it today when it becomes available later this year can transition very seamlessly along with her healthcare provider to continue to receive it once there is an FDA-approved form down the road.
More to follow on updates on this. Please stay tuned. We're very excited. The other thing I do want to highlight is that there are other products in our portfolio that are similarly eligible for this dual-path approach in terms of 503(b) compounding, as well as seeking an FDA approval, as well as some products in our portfolio that are eligible for a consumer health path where there's no registration required. Please stay tuned as we continue to provide updates this year on all we're doing to really disrupt the status quo and make sure that women are getting and having access to the innovation and the innovation-based treatments and evidence-based treatments that they're seeking.
In terms of the dual-path approach of the phase three study for sildenafil cream, we are continuing to work on the protocol and the statistical analysis plan reflecting feedback, ongoing feedback from the FDA. We do expect to have that submitted to the FDA in the second quarter. That's obviously an important step towards progressing to phase three. More updates on that as the year progresses. Now, I want to talk a little bit more about Ovaprene. I mentioned that the phase three study is actively ongoing. It is recruiting right now at five sites across the United States. It's actively following subjects across 20 sites across the United States.
Based on the enrollment rates at this time, we anticipate that about half of the number of women that we're targeting to complete the study will have completed six months of product use by the end of the second quarter. The study follows women for up to 12 months of product use. This sort of midpoint is an important place for us to have a Data Safety Monitoring Board meeting. That is planned, therefore, for this summer. We will provide an update of that Data Safety Monitoring Board's review after that meeting is held. We'll also continue to provide updates this year on the enrollment rate for the study and when we expect to complete the study.
Finally, on Dare HPV, which is that product that is intended to really transform the way that cervical cancer risk and human papillomavirus infection is managed today. With that $10 million award we received from ARPA-H, we are having ongoing IND preparations and discussions with the FDA. The objective is to have the phase two study preparations ongoing and commence that study next year. This is all funded with this $10 million non-dilutive funding award that we have received. I thank you for listening in and hearing the updates. I very much look forward to keeping you updated on the plans for sildenafil cream in particular, the revenue opportunities on that, and strategic partnerships around that. Please stay tuned as we progress through this quarter and continue to provide updates. Thank you.