Breakthroughs Blog: Contraceptives

The Coalition for Epidemic Preparedness Innovations (CEPI) has launched a critical Phase 2/3 clinical trial to evaluate vaccine candidates for the Bundibugyo strain of Ebolavirus, which is responsible for the current outbreak in the Democratic Republic of the Congo and currently has no approved vaccine. The trial will assess the safety, immune response, and efficacy of multiple vaccine candidates in parallel, beginning with Merck’s Ervebo, which is approved for Ebola Zaire, with two Bundibugyo-specific candidates from Moderna and the University of Oxford/Serum Institute of India expected to enter the trial shortly. The organizers hope the trial will help curb transmission and save lives during the current outbreak, while strengthening preparedness for future outbreaks. Weill Cornell Medicine recently announced that it has received a four-year, $8.2 million grant from the National Institute of Child Health and Human Development at the US National Institutes of Health to further development of an experimental on-demand male contraceptive pill that temporarily renders sperm immobile. There is an urgent global need for new contraceptive options for men beyond condoms and vasectomy to enable men to share contraceptive and family planning responsibilities more equally with female partners and reduce the burden that has historically fallen on women. The researchers will now work toward advancing the technology into a Phase 1 trial, developing an oral formulation, setting manufacturing protocols, and establishing safety. A new study from a team of international researchers evaluating experimental methods to improve mRNA vaccine delivery identified a promising needle-free vaccination method, which could offer a new delivery method for mRNA technology, which is continuing to show promise across a range of health areas, as well as reduce unwanted inflammation. The method, which combines a high-pressure liquid jet that delivers mRNA alongside two substances that strengthen the immune response, was able to protect against the viruses that cause COVID-19 and flu in mice. The researchers will now evaluate the method in larger animals and, if it continues to prove successful, in human trials. 

Fatherhood is often framed as a life milestone, but far less attention is paid to men’s role in deciding if or when that milestone occurs. Nearly half of all pregnancies, around 121 million globally each year, are unintended, highlighting major gaps in contraceptive access and limitations in today’s methods. Boosting investment in the research and development (R&D) of new and improved contraceptive options, including for men, offers a critical opportunity to strengthen reproductive autonomy, advance gender equality, and help prevent unintended pregnancy. The gendered burden of pregnancy prevention Without male contraceptive options beyond condoms and vasectomy, the physical, financial, logistical, and emotional burden of pregnancy prevention has long fallen on women.  While a wide range of options exist for women, from pills to injections, patches, and implants, an estimated 257 million women worldwide who want to avoid pregnancy are not using safe, modern methods of contraception due to a combination of social barriers (such as cultural or religious opposition), structural challenges (including limited access to high-quality services or education), and technological limitations (such as unpleasant side effects or short duration of protection). These barriers are especially pronounced in low- and middle-income countries—in sub-Saharan Africa, nearly one in four women has an unmet need for contraception.  Addressing this gap requires expanding options for women, such as methods that are longer acting, more discreet, have fewer side effects, and require fewer health care provider visits, as well as expanding contraceptive choice for men. New male contraceptive options to replace or complement female contraceptives could help rebalance the shared responsibility for family planning, empower men to have greater autonomy over their own reproductive health decision-making, and contribute to reducing unintended pregnancy. The gap in male contraception Limited innovation in male contraception reflects decades of underinvestment—not a lack of demand. Research shows strong interest in male contraceptives among men in diverse settings worldwide, alongside high trust in male partner birth control use among female partners, with preferred product types and attributes varying across contexts. Despite this clear demand, progress in male contraceptive innovation has been slow, in part due to the limited funding landscape. Contraceptive R&D has relied heavily on public and philanthropic funding, with the Gates Foundation playing a lead role. Private-sector engagement has remained limited due to perceived uncertainty about the potential market, unclear regulatory pathways, high development costs, and the broader historical underinvestment in contraception R&D. The continued success of products currently in clinical development has the potential to spark greater engagement in the field from diverse investors. Male contraceptive innovations on the horizon  While the pipeline lags behind demand, several exciting and innovative tools and approaches are advancing through clinical development.  The most advanced product in development is a reversible hormonal gel, NES/T, which can be applied once daily to the upper arms and shoulders. The gel is absorbed through the skin and suppresses sperm production. Originally developed by the Population Council and the US National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development, it is now being advanced by Contraline, which recently announced the launch of Phase 3 trial planning. Nonhormonal male contraceptive options are another promising area of research because they target sperm function directly, avoiding hormone-related side effects. Contraline’s ADAM™ is a nonhormonal injectable device that blocks sperm flow for an extended period before dissolving. It has demonstrated encouraging safety and efficacy data in a first-in-human trial, with Phase 2 planning underway. YourChoice Therapeutics and Columbia University’s YCT529 is a first-in-class nonhormonal daily pill that suppresses sperm production and has shown positive results in a small, early human trial.  The path ahead When the US Food and Drug Administration approved the first oral contraceptive pill for women in 1960, its rapid, widespread adoption transformed reproductive autonomy and expanded economic, education, and career opportunities for women, carrying benefits that reverberated across entire economies and contributed to broader gender equality. Continued innovation in female contraceptives remains essential to ensure options better fit the needs and lifestyles of women worldwide.  But this progress should also be matched by investment in novel male contraceptives. Ensuring that everyone who wants to use contraception can access safe, effective, and acceptable options will expand choice, strengthen reproductive autonomy, and contribute to a more equitable and resilient future for family planning at a time when reproductive health protections are increasingly constrained worldwide. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. The Sabin Vaccine Institute has launched a multi-site Phase 2 clinical trial, supported by the Biomedical Advanced Research and Development Authority, in the United States to test its Marburg vaccine candidate, as outbreaks of the virus, for which there is no approved vaccine, grow in frequency. This trial builds on previous Phase 2 testing in Kenya and Uganda, as well as an open-label Phase 2 trial in Rwanda during the country’s outbreak last year. These trials in the African regions where Marburg and other similar viruses are most common or endemic are key to ensuring the vaccine is effective in the populations currently facing the highest risk of outbreaks. In addition, this new trial in the United States provides key safety and immune response data in non-endemic populations, helping prepare us for the possibility of outbreaks outside of the virus's typical range.Researchers have discovered a small antibody fragment that can block fertilization by targeting a key protein on the egg's surface, potentially paving the way for a nonhormonal contraceptive method. The fragment was found to be effective in mice, and it could potentially have fewer side effects due to its small size. Currently available hormonal contraceptive methods can cause side effects, like mood changes, headaches, or increased risk of blood clots, leading researchers to look for nonhormonal options for people who do not want to or cannot use hormonal methods. The researchers will next develop a similar antibody for human targets and test it in IVF experiments.The Drugs for Neglected Diseases initiative (DNDi) and partners initiated Phase 2 clinical trials in Malawi and Tanzania testing a new, easier-to-administer, and patient-friendly formulation of flucytosine, a medicine used to treat cryptococcal meningitis, which is a major health threat to people with weakened immune systems, including those with advanced HIV disease. Currently, flucytosine can be difficult to administer in resource-limited settings, and many countries face limited supply. As a result, access to timely treatment is limited in Africa, where the disease kills up to 70 percent of those who get it. The new formulation reduces dosing frequency from four times a day to just twice daily, is easier to take with water or through a nasogastric tube, and is suitable for outpatient self-administration.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A research team has discovered an all-new class of antibiotics that could, if it proves successful down the line, improve our ability to address some of the most drug-resistant bacteria in the world, as antimicrobial resistance continues to rise globally. The new molecule, lariocidin, attacks bacteria distinctly from other antibiotics by inhibiting bacteria’s ability to grow and survive. Lariocidin is also not toxic to human cells, not susceptible to existing mechanisms or antibiotic resistance, and it works well in an animal model of infection, underscoring its potential to be a gamechanger in the global fight against antimicrobial resistance, although years of further research are still needed.Scientists from the Institut Pasteur, in collaboration with Kumamoto University, have assessed a new rapid diagnostic test to identify pregnant women at elevated risk of transmitting Hepatitis B to their babies, which could help eliminate mother-to-child transmission of Hepatitis B during childbirth, especially in low- and middle-income countries. Hepatitis B is a leading cause of death globally and particularly affects resource-limited countries. While vaccination is available, available antiviral therapies do not provide a cure and existing tests can be costly and require specialized equipment that is often unavailable in these settings. The new test is highly effective, inexpensive to produce, easy to use, does not require electricity, can be used in higher temperatures, and provides results in 45 minutes, making it ideal for integration into routine antenatal care in decentralized, resource-limited settings.A recently published paper identified a novel method for delivering drugs in higher doses with less pain that could offer a better way to deliver long-lasting contraception or other drugs that need to be given over extended periods. The project, which began as part of a Gates Foundation-funded effort to expand contraceptive options, particularly in low-resource settings, created a new method of injecting drugs formulated into tiny crystals that can last for months or even years in the body. There are similar drug delivery methods that are already in use, but the new method can last longer and can also be injected through a smaller needle that is easier for patients to tolerate.