A Male Pill Soon? Why the Drug Isn't Expected to Arrive in Pharmacies Anytime Soon

It's a promising step forward. According to a study published in the journal Communications Medicine last July, a particularly effective male pill from the United States could be on the market in the near future. Its name: YCT-529, a method that blocks sperm production.

While there is a lot of talk about the possibility of such a drug hitting the market, it's clear that nothing concrete has yet appeared in French medicine cabinets. What could change soon?

Indeed, this time, the results of phase 2 of the clinical trials, the stage that allows us to confirm the initial results, are very encouraging. Of the 16 people who followed the treatment daily, none of them suffered from side effects, even though this is a regular drawback of this type of oral contraception.

Added to this is the treatment's record efficacy of up to 99%, based on data collected during animal trials. Fully reversible, YCT-529 also offers additional comfort by restoring male fertility within 4 to 6 weeks of stopping the treatment.

But while many see it as an alternative to vasectomy , which is more "definitive", it seems that the arrival on the market of this revolutionary pill is ultimately taking longer than expected.

While around twenty male contraceptive methods are being developed worldwide, one in particular is currently attracting the attention of the scientific community.

The YCT-529 pill from the Californian laboratory YourChoice Therapeutics , a laboratory created in 2018 and specializing in the development of non-hormonal contraceptives, is a source of hope.

However, from the very beginning of its development, the treatment suffered from the negative press of previous failures in the field. And for good reason: for nearly 50 years, global medical research on the subject was completely stagnant.

No "successful" male pill has yet been marketed due to a lack of conclusive clinical results: the side effects then appeared too numerous and dangerous.

This did not prevent the female pill, also widely criticized for its health consequences (weight gain, pain, mood disorders, bleeding, increased risk of breast cancer , etc.), from being sold in France in the 1960s. The contraception market then exploded, placing the burden of daily treatment exclusively on women.

"I had preconceived ideas. And then I saw the results of the very first phases of testing. What's happening is very, very interesting," says Alexandra Alvergne, a researcher at the Montpellier Institute of Evolutionary Sciences (ISEM) and a member of the CNRS .

For her, there is "no doubt that a pill will soon be available" in pharmacies in France.

According to YourChoice Therapeutics, contacted by our colleagues at Le Parisien , YCT-529 should even find a place on the American market by 2029. "In France, and in Europe, the process of putting a drug into circulation involves many stages," explains Alexandra Alvergne, "we will have a pill for men one day or another since researchers are making very good progress on it, but in 10 years. Certainly not before."

Before any marketing of YCT-529, YourChoice Therapeutics will first have to show its credentials to the Food and Drug Administration (FDA) , the American agency responsible for monitoring food and drug products.

Here, it is primarily the FDA that has the power to authorize, or not, the marketing of the contraceptive in the United States. After reviewing the data and results provided directly by the laboratory following the various clinical trials, the FDA will take a position. This review will take place within 10 to 12 months of the filing of the application.

To arrive in France, YCT-529 will need to be approved by the European Medicines Agency (EMA) as well as the French National Agency for the Safety of Medicines and Health Products (ANSM) . These are two additional mandatory steps, a preamble to any industrial production, which last between 1 and 3 years. The conditions for reimbursement of the drug at the national level are also analyzed there. It will therefore be necessary to be all the more patient to see the YCT-529 pill on sale in French pharmacies.

"However," Alexandra Alvergne points out, "men are finally ready to manage taking a daily pill."

According to the researcher, "more than 75% of women say they are ready for a change in the distribution of the mental load" regarding the risks of pregnancy. "It's all a question of cultural and generational evolution. And then men also want to be able to control their reproduction; it's a fundamental freedom."