There is a robust pipeline of male birth control products being tested. Of them, three are relatively close — a few years away — to potential commercialization if the trials are successful. ... This isn’t a product area that is supported by the pharmaceutical industry, said MCI’s Vahdat.

Male Contraceptive Initiative (MCI), a 501(c)(3) non-profit, has provided funding in the amount of $400,000 USD to Sacyl Pharmaceuticals, Inc. to support the development of a novel on-demand, non-hormonal male contraceptive. This most recent grant reaffirms MCI’s continued commitment to the male contraception research and development community and its ongoing efforts to bring new methods of male contraception to market.

The small molecule YCT-529 stops sperm production, and we are developing YCT-529 as a non-hormonal oral contraceptive for men. To study the ...

The hormonal CT regulatory pathway is well established, while non-hormonal and male products have the opportunity to work with regulators to develop new pathways. Since 2018, 30 different funders of contraception R&D have contributed. Just under 90% of all funding between 2018 and 2021 came from three sources: the US NIH, the Gates Foundation and industry.

As of June 2023, two hormonal male contraceptive methods are undergoing phase II clinical trials for safety and efficacy. A large-scale, international phase IIb trial investigating efficacy of transdermal segesterone acetate (Nestorone) plus testosterone gel has enrolled over 460 couples... Today, there are two ongoing trials with DMAU...

The lack of pharmaceutical investment is the most discussed financial barrier for the development of male contraceptives and MPTs. The lack of investment from the pharmaceutical industry, which normally works in concert with public-sector funders, has significantly stymied development in both the contraceptive and STI sectors for decades. The resulting gap in funding has partially been filled by the philanthropic sector.

In the last decade, pharmaceutical companies have largely abandoned their male contraceptive development programs. Large Phase 3 pivotal studies to further demonstrate safety and contraceptive efficacy are needed for regulatory approval and will require involvement of the pharmaceutical industry. Engaging pharmaceutical companies to co-develop products and initiate new pathways to product development is critical to moving the field forward.

Large Phase 3 pivotal studies to further demonstrate safety and contraceptive efficacy are needed for regulatory approval and will require involvement of the pharmaceutical industry. ... A major impediment to moving male contraceptive development forward is a lack of regulatory guidance, inhibiting both scientific and financial investment.

Contraline has closed a $92.5 million Series B financing round to take its topical male contraceptive to late-stage trials. The funding was co-led by RA Capital Management and BVF Partners, with contributions from Google Ventures, Lumira Ventures and others, indicating active private investment in male contraceptive development.

In the early 2000s, multinational pharmaceutical companies (e.g., Wyeth, Schering, Organon, Merck) abandoned their male contraceptive research and development programs. As of now, no pharmaceutical company has brought a novel male contraceptive to market, and development is largely driven by academic groups, nonprofits and small biotechnology companies. Our analysis of survey data suggests substantial demand for male contraceptive methods, which may incentivize renewed industry investment and marketing in the future.

While researchers have been working on new options for men since hormonal birth control for women came to the U.S. market in the 1960s, efforts toward making new male contraceptives have largely hit dead ends. Based on the enormous interest this research generated, Drs. Buck and Levin, along with colleagues, started a new pharmaceutical company called Sacyl Pharmaceuticals to continue developing a sAC-inhibiting male contraceptive.

Perhaps the greatest barrier to the development of male contraceptives has been the lack of interest and involvement from pharmaceutical companies. Today, this work struggles forward with little or no support from the pharmaceutical industry. The costs of scientific discovery and research on the new contraceptive gel, for example, have been borne by the National Institutes of Health and my organization, the nonprofit Population Council, rather than by pharma companies.

Pharmaceutical companies have largely shied away from advancing male contraceptives beyond existing options.[2] A representative from Merck, which acquired Organon’s company in 2009, noted that this area is not a focus of research or interest.[2] Bayer, which took over Schering in 2007, echoed this sentiment, stating that they decided to cease male contraceptive research and have no future plans in this area.[2] Experts say a male birth control method could cut into the thriving global markets for female contraceptives and condoms, valued at $10 billion, which may also make companies cautious.[2]

Contraline unveiled the close of a $92.5 million Series B financing round, co-led by BVF Partners and RA Capital. The round is intended to fund late-stage development of its male birth control candidate, showing that venture financing is being directed toward male contraception.

Learn how YCT-529 qualified as the first hormone-free male birth control pill to enter clinical trials. ... But to market and distribute a drug like YCT-529, “a larger company has to take over. That will be a challenge because none is working in this area.”

MCI is dedicated to advancing non-hormonal, reversible male contraception. We support researchers worldwide by providing funding, advocating for the importance of male contraception, and offering educational resources. Our funding supports young researchers, academic labs, startups, and pharmaceutical companies through grants and equity investments.

Speaking with Univadis Spain, Isabel M. Silva Reus, MD, said, "Drug companies have also shown a sexist bias and have focused on women because if female contraception works, why research male contraception?"[8] To date, no male oral contraceptives or pills are commercially available, despite decades of research and trials.[8] The article highlights that pharmaceutical companies have been slow to invest in male contraceptive development, contributing to the lack of marketed products.[8]

Clinical trials include a Phase 2B combined hormonal gel that men apply daily to the skin of their shoulders. The gel contains both Nestorone® and Testosterone.

Eppin Pharma is an emerging pharmaceutical company focused on the development of a safe, non-hormonal male contraceptive that can be taken orally. The company's product candidate targets the EPPIN protein on the surface of sperm to render them infertile without affecting libido or hormones, positioning it as a potential novel male birth control pill.

Researchers also found that YCT-529 had 'no effect on [men’s] sexual desire or mood,' lead author Nadja Mannowetz explained in a press release. ... In fact, research on male birth control is so far behind that there are only two FDA-approved male birth controls on the market: condoms and vasectomies.

Since there are many safe and effective female contraceptives on the market, developing and marketing a male contraceptive has a higher hurdle.[3] Pharmaceutical companies would need to invest heavily in education and marketing to persuade consumers to adopt a new male method, particularly in the context of existing female-centered products.[3] The article notes that perceived limited profitability and challenging marketing dynamics have contributed to slow industry engagement in male contraceptive development.[3]

However, so far, none have won FDA approval. Why is this? It varies by medication, but the most common reason is due to bothersome side effects. ... Oral pills, such as YCT-529 and dimethandrolone undecanoate (DMAU), are being studied in clinical trials.

According to Dr. Nguyen, there are no pharmaceutical companies currently funding male contraception. Pfizer confirmed they are not currently funding any studies for male contraception. Merck didn't respond to questions. The report adds that federal data show it has been almost 15 years since a major pharmaceutical company funded studies into male birth control.

In 2002 two European drug companies, Schering and Organon, joined forces and developed a hormonal pill for sperm-producing people that seemed to work. The study was halted in 2006 after Schering was bought by the pharmaceutical company Bayer AG, who decided the project was not "financially responsible" and has no plans to pick it back up. The article notes that many researchers say pharmaceutical companies don’t invest in male contraception because they worry that people with sperm won’t want to use it and that the products might not be profitable, leading to limited industry promotion and development of male birth control.

Male Contraceptive Initiative provides research and advocacy support for the development of new methods of non-hormonal, reversible male contraceptives.[4] Its "Marketing One-Pager" emphasizes the need for tailored messaging and campaigns to introduce male contraceptives, but notes that commercial pharmaceutical marketing in this space is currently minimal, necessitating non-profit-led efforts.[4] The organization aims to facilitate collaboration amongst researchers and funders to accelerate time to market in the absence of strong pharmaceutical-company promotion.[4]

Total global funding for contraceptive R&D was approximately $134 million in 2021. Pharma companies typically reinvest around 20% of sales revenue in R&D for new products, whereas in contraception this figure is around 2%. Academic institutions and non-profit product development partners lead much of the basic science, preclinical work, and clinical trials, with the private sector entering R&D at much later stages than in other therapeutic areas.

Current male contraceptive development efforts are thus primarily funded by nonprofit, non-governmental, and government agencies who also act as advocates for the field.

An article reviewing pipelines such as NES/T gel and DMAU notes that the goal is to get novel, reliable, user-friendly, reversible male contraceptives to the market within the next decade.[7] It highlights that, while scientific progress is advancing, commercial pathways, including regulatory guidance and industry investment, remain underdeveloped compared with female contraception.[7] Marketing strategies and public education are identified as future needs once products reach approval, but current industry promotion is limited because no male methods beyond condoms and vasectomy are yet approved.[7]

A DW Stories social media post summarising a video on new male contraceptives states that women endure hormonal side effects because pharmaceutical companies refuse to give men contraceptive options. The post argues that new methods such as thermal rings and hormonal gels exist but are little known and under-promoted, implying that big pharma has not actively marketed male contraceptives compared to female methods.

According to background knowledge from reproductive health reviews, most large, multinational pharmaceutical companies discontinued male contraceptive R&D programs by the late 2000s and currently do not have marketed male hormonal contraceptive products. Development and early-stage promotion of potential male contraceptives is now primarily undertaken by academic groups, nonprofits, and small biotech or specialty pharma firms, rather than by major global pharmaceutical companies.