Spotlight on Women’s Reproductive Health

Women’s health research has long been underfunded. Many reproductive health conditions that impact a significant number of women, such as endometriosis, polycystic ovary syndrome (PCOS), and uterine fibroids, have no treatments and understanding of these conditions is still limited.

While U.S. government funding remains low in this area at 10% or less of the National Institutes of Health (NIH) annual budget, there is increasing interest in the private sector. The number of startups in the region focusing on women’s health has increased from around 40 in 2010 to more than 400 in 2025.

Women’s reproductive health as a field has suffered many setbacks since the thalidomide scandal of the 1950s and 60s. After thousands of women were prescribed thalidomide for morning sickness around the world, over 10,000 children were born with birth defects, making it one of the most devastating adverse drug event scandals known to this generation.

This scandal and others contributed strongly to changes to the U.S. Food and Drug Administration (FDA) guidelines recommending that women of childbearing age not be included in Phase I or II trials of new drugs, even if taking contraceptive pills. Despite protests, it was not until 1993 that the law was changed to mandate the inclusion of women in clinical trials.

The exclusion of women of childbearing age from most clinical trials for decades undoubtedly set back research and development into women’s reproductive health by many years compared with other fields of medicine.

Of course, reproductive health is not limited to a woman’s childbearing years as the menopausal transition—affecting most women between the ages of 45 and 55—has significant adverse impacts on women’s sexual, cardiovascular, musculoskeletal, neurological and mental health.

Despite the fact that millions of women are impacted by the symptoms of menopause every year, very few treatment options exist. Hormone replacement therapy (HRT) remains the main option to help women with menopausal symptoms, but its use dropped 20 years ago after trial results suggested it could be harmful.

In 2002, results from the Women’s Health Initiative trials on the use of HRT for healthy postmenopausal women suggested that the treatment had more risks than benefits, increasing the risk for blood clots, strokes, and breast cancer.

These results caused consternation across the pharma and biotech industries, and in clinics across the country. Prescriptions of HRT dropped dramatically as a result. The results of the trials were later called into question and it has since been shown that many women benefit significantly from HRT, particularly if they are under the age of 60 and within 10 years on the onset of the menopause.

Fallout from both the thalidomide scandal and the Women’s Health Initiative trials have had significant negative effects on the research and development of new treatments for women’s reproductive health conditions. For example, investment in new treatments and in startups focused on women’s health dropped substantially.

In addition to these factors, women’s health research and reproductive rights have historically been marginalized due to social stigma, gender bias, and ongoing political controversies surrounding contraception and abortion.

With so few treatments available for the many conditions affecting women’s reproductive health, it is difficult to apply precision medicine principles to the problem. “In the women’s health field and in the reproductive health field in particular, I would say we are where the cancer field was, maybe in the very early 2000s,” said Piraye Yurttas Beim, PhD, CEO and co-founder of women’s health-focused biotech Celmatix, which is based in New York.

Celmatix’s first product was a genetic test called Fertilome^® that analyzes DNA to identify genetic variants associated with reproductive health conditions that may affect conception or pregnancy. The company is now working on treatments for infertility, ovarian aging, and endometriosis.

“We moved from diagnostics into therapeutics because we realized that there’s a bit of a chicken and egg problem. … I was so focused on diagnostics up until that point, I just assumed there was a lot of innovation on the drug side. As I started to realize there really wasn’t a lot going on on that side, we realized developing therapeutics was the highest impact we could have.”

Although there are many issues that need to be overcome to improve the field of women’s reproductive health, it is definitely moving in an upwards trajectory. There are more companies focusing on women’s health than ever before and investment in the field is also slowly increasing.

DiaMedica Therapeutics is a biotech testing a treatment for preeclampsia, a serious pregnancy-specific disorder characterized by high blood pressure. It is also testing the same treatment for stroke.

“With our recent data, we are positioning our company to become a women’s health company first. … We’re doing it because that’s what we hear from investors,” said Rick Pauls, who is the president and CEO of the Minneapolis-based company. “Our stock prices increased substantially since we announced we were going into preeclampsia last year.”

Reducing the diagnostic odyssey

To give patients the best possible outcomes, it is important to develop both therapeutics and diagnostics. While it is true that some diagnostics without treatments may not significantly change medical outcomes, early diagnosis can be life-changing for dangerous conditions like preeclampsia or cancer.

Although there have been extensive developments in cancer diagnostics over the last decade, some cancers remain hard to treat as they are largely diagnosed at a late stage. Ovarian cancer falls into this group.

Oriana Papin-Zoghbi, CEO and co-founder of Denver-based AOA Diagnostics, and colleagues are aiming to solve the problem of late diagnosis with their early detection test based on lipidomic technology.

“Ovarian cancer is one of the most lethal cancers. It’s the second most expensive cancer to treat in the U.S., second only to brain cancer, with 80% of women diagnosed at stage III and IV and a five-year survival rate of 28%,” said Papin-Zoghbi.

“In 30 years, we haven’t come up with a new biomarker to help solve this problem from a diagnostic perspective.”

Lipids have been known to have a role in cancer since the ‘70s, but until recently it was difficult to reliably quantify the presence or absence of lipids in cancerous versus non-cancerous tissue.

Papin-Zoghbi and team believe they can improve outcomes for women with ovarian cancer by diagnosing it while it is still at stage I using their lipidomics-based test. It’s early days, but so far, they have achieved good results in clinical testing.

“The average time to diagnosis in the U.S. is nine months,” she explained. “But the window of opportunity from when ovarian cancer is still a localized disease [to] before it metastasizes is 4.2 months. If that woman is taking nine months to work herself through the healthcare system because there are no reliable diagnostics, it’s just too late.”

Preeclampsia is another condition where early diagnosis can dramatically improve outcomes. Treatments are available that, if taken early, can help ensure safe pregnancy and improve outcomes for both mother and baby.

Mirvie is a San Francisco diagnostics company that has developed a platform to predict pregnancy complications such as preeclampsia and preterm birth using cell-free RNA.

“RNA is dynamic. It is changing throughout pregnancy, but it’s changing in a predictable manner,” said Maneesh Jain, PhD, CEO and co-founder of the company. “Just looking at the pattern of RNA, we can predict how far along you are. Tracking the development of pregnancy, we can look at deviations from that base pattern. … Whether it’s preeclampsia, fetal growth restriction, preterm birth, or gestational diabetes, we’ve now shown that we have unique molecular signatures for each condition.”

Mirvie’s lead test, Encompass™, detects risk for preeclampsia at an early stage of pregnancy and was commercially launched earlier this year.

Preeclampsia can be predicted using medical history, like an earlier case of preeclampsia or preexisting high blood pressure, in about 10% of cases. However, 90% of cases of preeclampsia are hard to predict using medical history alone.

“They’re apparently healthy pregnancies, but they end up developing preeclampsia and that’s really the unmet need,” emphasized Jain.

“What the guidelines try to do is use these very broad, moderate risk factors, so things like body mass index, race, or age, to assess risk in those pregnancies, and what we show is [that] it’s completely ineffective. Predictive value is little to none because those factors are so generalized.”

Using the Encompass test to assess apparently healthy pregnancies, researchers found that around 25% of those tested are actually at increased risk for placental-driven preeclampsia and can be given early treatment and monitoring.

“We know that, particularly for preventing preterm birth and more severe forms of preeclampsia, the medications are particularly effective,” said Jain. “They may not stop the disease. But I think what’s been widely accepted is that they’re very helpful in delaying the onset of the disease, so baby has more time before delivery and that is just very helpful for everybody.”

Some conditions impacting women’s health, such as endometriosis, commonly take at least four years to diagnose in the U.S., which can result in an enormous physical and mental toll on those affected.

It is still early days, but recent advances in diagnostics have the potential to help women with these conditions get treated faster. For example, Kephera Diagnostics announced the introduction of EndomTest™, a diagnostic blood test for endometriosis, in the U.S. earlier this year. Similarly, anti-Müllerian hormone (AMH) levels were introduced widely as a proxy measure for PCOS during the last two years.

Bringing testing to patients

There is an increasing trend in the women’s reproductive health space of bringing testing into the home. For example, several companies, like Eli Health, Everlywell, and Hertility Health, are now selling tests for hormones linked to reproductive health. The aim is to help improve access to tests that can help women understand their fertility and menstrual cycles, and whether they may be entering the menopause.

London startup Unravel Health is hoping to do something similar. “We’re using a different sensor tech, which was developed to begin with, to measure many different things,” said co-founder Veronika Bridgman. “The reason we want to look at many things simultaneously is so we can finally connect the dots on the interaction of women’s reproductive hormones with other conditions markers, or stress markers, or medication efficacy and side effects.”

Another upcoming area that can shed light on women’s reproductive health is analysis of the vaginal microbiome. “It’s hugely important for women’s health because it really acts as a protective barrier,” said Hana Janebdar, CEO and co-founder of Juno Bio, a London-based biotech focused on direct-to-consumer vaginal microbiome testing. Several other companies such as Evvy and Bio-Me are also providing a similar service.

As highlighted in a review published by the U.K.’s Medicines and Healthcare products Regulatory Agency last month, this is a very new area of research but shows potential to help diagnose and potentially treat conditions such as infertility, miscarriage, preterm birth, gynecological cancers, and menopause-related complications.

Juno carried out a study of more than 1,000 women in the U.S. in 2023 to analyze vaginal microbiome profiles and collect data for potential use in diagnostic testing. “It was to observe what kind of vaginal microbiomes there are, what kind of conditions people complain about, and also it was for us to really understand, technically, what are the best ways of analyzing it,” explained Janebdar.

She admits that while their test can give women a good profile of their vaginal microbiome, there are currently limited therapies available to solve any highlighted problems.

“We’re trying to build a world in which women do have access to precision care, and we’re doing it with the vaginal microbiome. … What’s still limited is the tools that you then have access to for changing the vaginal microbiome. You do have a certain number of antibiotics that you can use and a handful of probiotics and prebiotics … but it is still rather limited when it comes to the therapies that are available.”

Despite this, Janebdar said the test has been popular with women who say it has empowered them to get better responses from their healthcare providers. “We didn’t think that the test would be helpful just as a wellness test, but because 85% of women feel their symptoms are dismissed when they go to their physician, they feel like actually going in there with data is a really powerful tool.”

Papin-Zoghbi says that women are looking for these kinds of tests to help them plan their own healthcare. “Women are taking a lot more control over their own health and are willing to look outside of the traditional system for the care that they don’t feel like they’re getting in the system,” she said.

Improving treatment options for neglected conditions

While it is true that many conditions affecting women’s reproductive health are lacking in effective treatments, this is starting to change.

For example, in the last month, Bayer’s non-hormonal menopause drug elinzanetant, brand name Lynkuet, was approved in both the U.K. and Canada based on three positive Phase III trial results published last year. The FDA is currently reviewing extra data, but a U.S. approval is expected soon.

After switching from diagnostics to treatments, Celmatix is now working on several candidate therapies. It is developing an oral follicle-stimulating hormone (FSH), which would work in the same way as the injections a woman needs to undergo in vitro fertilization (IVF), but in a less invasive way.

“The receptor that FSH binds to is something called a GPCR. … That target is very easy to target with a small molecule,” explained Yurttas Beim.

“The challenge with FSH receptor, and what killed this program for three decades … what makes this GPCR unique compared to other GPCRs targeted by oral medications is that it is very closely related to thyroid-stimulating hormone receptor. And if you have an off-target on thyroid-stimulating hormone, that is a life-threatening side effect.”

Celmatix has used artificial intelligence to help with its search for a new small molecule that will avoid this potentially dangerous side effect. The program is still at an early stage, but Yurttas Beim says she is excited about the progress of the drug candidate.

Another important and historically neglected indication that the company is developing a treatment for is endometriosis. Once endometriosis is diagnosed, there are currently limited treatment options that largely consist of drugs to control hormone levels, surgery, or pain relief medication to control the symptoms.

“Endometriosis was seen as a menstrual disorder. It was seen as a disorder of hormonal imbalances related to estrogen,” said Yurttas Beim, who has the condition herself.

“We are using these big hammers. Women are having hysterectomies because of it, being put on estrogen blockers, and being put into chemical menopause to treat endometriosis. The challenge is those things are a strategy that works for many women for managing pain, but it does not help them with their infertility.”

The work behind the company’s endometriosis program comes from Steve Palmer, PhD, now CSO of Celmatix, who previously discovered with colleagues that Jun N-terminal kinase (JNK) inhibitors could be a good treatment for endometriosis as it can target both the pain and inflammation caused by the condition. These drugs are also being investigated as a potential treatment for cancer, which shares many cellular traits with endometriosis.

“JNK1 and JNK3 are the ones that matter for endometriosis,” explained Yurttas Beim. “JNK3 is how peripheral pain in the peritoneum gets transmitted to the dorsal root ganglion, which is a part of the brain that receives that pain signal, and JNK1 is how endometriosis achieves an immune cloaking mechanism.”

Importantly the company believes these drugs will not impact a woman’s ability to get pregnant, although they are yet to be tested in clinical trials.

Celmatix also has an earlier stage candidate, an AMH receptor agonist to slow the depletion of ovarian reserves. “There’s no way you can preserve eggs. You can preserve your fertility, but there’s no way to get your ovary to function better if you have an ovarian dysfunction condition like PCOS early in life, or through perimenopause and ultimately, menopause,” said Yurttas Beim.

“So that was our goal. To make sure that we have tools in the pipeline being developed, to ensure that women do not have their gonadal function stop working in what is now midlife.”

Developing drugs or other treatments that impact reproductive health is hard enough, but if the treatment is designed for pregnant mothers, then trials and research become exponentially more difficult due to the risks involved.

This is something that DiaMedica Therapeutics is currently navigating. The company started developing a vasodilator, DM199, also known as rinvecalinase alfa, a recombinant form of human tissue kallikrein-1 for treatment of stroke. Last year, it added preeclampsia as an indication after data suggested DM199 could be effective.

“We had to go back to the board a few times to get their blessing to do this,” admitted Pauls. “There was always this concern that treating the pregnant mothers is just fraught with risk, but at the same time, that’s also an opportunity. There’s nothing for these mothers.”

The company is now testing DM199 in Phase II clinical trials for the treatment of preeclampsia after early trials showed good results. “As soon as they’re diagnosed with preeclampsia, we think we’ll be able to improve endothelial health, in addition to controlling blood pressure and dilating the intrauterine arteries so there’s more blood flow to the placenta.”

Pauls also explained that their candidate therapy has the benefit of not passing through the placental barrier, which has helped get the trials to this stage as potential danger to the baby is reduced.

Initially the focus of the research is on getting the mothers to a stage of pregnancy where delivery can occur with minimal or no harm to the baby. But Pauls said that they also want to trial giving DM199 to mothers 6–8 weeks after delivery to help reduce blood pressure and potential long-term side effects from experiencing preeclampsia, which can be significant.

“The longer-term risk factors that these mothers have from having preeclampsia, especially if it’s severe, are not well understood,” he emphasized.

What’s next for women’s reproductive health?

The field of women’s reproductive health is slowly moving forward, but there is still a lot to be done both on the research and the investment side of the table.

“I think currently, there’s a lot of people who agree that the status quo is broken and that we really don’t understand much about women’s bodies in as much detail as we really should,” said Bridgman. “And yet, there’s a lot of debate and skepticism and anxiety around some of the stuff we’re doing and new data.”

Things are moving forward. For example, earlier this year, the Seckin Endometriosis Research Center for Women’s Health launched at Cold Spring Harbor with $20 million in funding.

“What we’re trying to catalyze is this future where we really can understand who’s predisposed for endometriosis and what may make one person’s endometriosis different than another,” said Yurttas Beim, who is involved in the Center through her role as chairperson of the board of directors of the Endometriosis Foundation of America.

Organizations like the Global Alliance for Women’s Health, a multi-stakeholder platform launched in 2024 to address systemic inequities and close the women’s health gap, are also trying to improve funding, research, and political advocacy in this area.

New diagnostics for conditions like preeclampsia and endometriosis are reducing time to diagnosis significantly and new therapeutics like those being developed by Celmatix and DiaMedica are slowly moving towards approval, but there is a lot still to be done. “We’ve come a long way in 15 years, but not as far as we need to,” said Yurttas Beim.

More data about important areas like the vaginal microbiome and its impact on health and disease is also becoming available, which will help progress the field. “When we started, you couldn’t say vagina in an investor meeting. There was no women’s health on the map. But since then, things have changed and we’ve been really happy to be part of that movement,” said Janebdar.

In 2024, U.S. women’s health startups secured $2.6 billion in venture capital funding, up from $1.7 billion in 2023 and around $400 million in 2015. In addition, there are now more than 400 women’s health startups, a significant increase since 2015.

Overall, however, funding remains a challenge, with women’s health companies receiving less than 5% of global venture capital funding. Government funding through sources like the NIH has only increased by a small amount, from around $4.4 billion in 2021 to an estimated $5 billion in 2025, which accounts for 10% or less of the overall annual NIH budget.

“Unfortunately, I would say the hardest part of this is not the science, it is getting funding to actually progress the science,” said Yurttas Beim.

Papin-Zoghbi agrees but thinks this maybe a broader problem at the moment. “I think the venture capital markets are contracted, which is just pretty tough. Similarly, the government funding has contracted, but it’s contracted in everything. Has women’s health been hit a little harder? Perhaps, but I don’t think we’re as much of an outlier as maybe historically we were.”

Women’s health has at least finally become a category for investors in biotech and medtech, which experts in the area believe will help draw more attention to the field.

“What I’d like to see is more money going into the area and it becoming just more normal for women to seek the kind of care that they deserve, but I have to say that we are living in this time where a lot of women’s health and women’s rights are being taken away, and so while that is what I’d like to see, I’m not 100% convinced that we will see it unless we really fight for it,” emphasized Janebdar.

Helen Albert is senior editor at Inside Precision Medicine and a freelance science journalist. Prior to going freelance, she was editor-in-chief at Labiotech, an English-language, digital publication based in Berlin focusing on the European biotech industry. Before moving to Germany, she worked at a range of different science and health-focused publications in London. She was editor of The Biochemist magazine and blog, but also worked as a senior reporter at Springer Nature’s medwireNews for a number of years, as well as freelancing for various international publications. She has written for New Scientist, Chemistry World, Biodesigned, The BMJ, Forbes, Science Business, Cosmos magazine, and GEN. Helen has academic degrees in genetics and anthropology, and also spent some time early in her career working at the Sanger Institute in Cambridge before deciding to move into journalism.