Pharma eyes male birth control pill for Gen Z

• Early stage trials have identified mechanisms for inhibiting or blocking sperm that don't involve hormones and could create a $200 billion market built around the belief that contraception is a shared responsibility.
• "Even if you only get 10% or 20% of the market, you're still talking about tens of millions of men around the world. I think the market is there," John Amory, a University of Washington professor who studies male contraceptive options.

Driving the news: Last week, California-based YourChoice Therapeutics announced the launch of an early phase human trial of an experimental birth control pill for men that could be an alternative to condoms or vasectomies.

• The once-a-day pill inhibits a receptor for vitamin A, or retinol, in the testes, a well-known pathway for sperm cell production. It's based on research out of the University of Minnesota.
• The science was inspired by findings that men with vitamin deficiencies during the Dust Bowl were less fertile — a problem that resolved when their diets improved, YourChoice Therapeutics' CEO Akash Bakshi told Axios.

Between the lines: While the approach may seem straightforward, it's difficult to make male contraception foolproof.

• "Part of it is the underlying physiology," Amory said. "Men make 1,000 sperm every second. Women make one egg month. And in practice, it's turned out easier to suppress the production of one egg a month."
• Conventional birth control pills for women disrupt the menstrual cycle by elevating levels of the hormone progesterone to mimic pregnancy, when women don't produce new eggs. There's nothing equivalent for men.

Reality check: The roadmap for approving a male birth control pill also is untested.

• The Food and Drug Administration has stricter standards than when the first forms of birth control for women were approved decades ago, said Heather Vahdat, executive director of the Male Contraceptive Initiative, which has provided funding to YourChoice.
• Regulators consider risks versus benefits. In the case of a woman, the benefits of avoiding a pregnancy outweigh certain risks around the contraceptive. The calculus is expected to be different for a pill for men.
• "They are going to be a little bit more conservative because it's like, OK, if this person does not take this pill, what is the risk? And you could argue, biologically, nothing," Vahdat said.
• It's not clear how the pill would dovetail with the Affordable Care Act's requirement for full coverage of female-controlled contraception as well as condoms. Researchers and advocates say the pills need to be affordable to compete with alternative methods.
• The FDA declined to comment, saying it "cannot discuss ongoing clinical trials or products in development."

Then there's the human factor. It's still unclear whether women will trust their partners to take these drugs.

• There are inexpensive products already on the market to allow men to check their sperm count following vasectomies, which makes it straightforward to verify their status to their partners.
• This could be particularly important to gain trust from women who, Bakshi said, may be thinking: "'How can I go from living in a world where I have taken on responsibility? I know that I'm compliant. The risk is all with me. Now, do I really trust my husband or my boyfriend?'"

State of play: Other male contraception techniques under development involve gels, ultrasound devices and implants.

• Contraline has a long-acting hydrogel injected into the scrotum in an outpatient setting that's undergoing an early phrase safety trial in Australia.
• A hormonal method in phase 2 trials from researchers at the National Institutes of Health is delivered in the form of a gel that's rubbed daily on the shoulders.
• Researchers are also working on creating an on-demand option, taken only as needed shortly before sex, that's still being tested on animals.

What to watch: The best-case scenario for YourChoice Therapeutics is still years away: If all trials go according to plan, it could be approved in 2030, its executives say.

• There's also a lingering question about whether big drug companies will get interested in taking the lead on research and taking on the risk of developing new products. For now, "it's a win-win for them to just sit back and wait," Vahdat said.