The 60-Year Wait May Be Ending: Two Non-Hormonal Male Contraceptives Enter Phase II Trials

For decades, male contraception has been a punchline more than a clinical reality: condoms or vasectomy, take your pick. That dynamic is finally changing.

NEXT Life Sciences has advanced two non-hormonal male contraceptives into Phase II clinical trials simultaneously — a first in reproductive medicine that could reshape how the world thinks about family planning.

Plan A™ is a long-acting, reversible-on-demand injectable that proved 100% effective in early trials. It works without hormones, avoiding the side effects — mood changes, weight gain, reduced libido — that have derailed every previous hormonal male contraceptive candidate. The injectable provides sustained contraception but can be reversed when the user decides they want to conceive.

NLS-133 is an on-demand non-hormonal pill that provides a 24-hour window of contraceptive protection. It's designed for a fundamentally different use case: situational rather than sustained, offering flexibility that mirrors how many people actually live their lives.

The dual approach matters enormously. Different men in different circumstances need different options — just as women have pills, IUDs, implants, patches, and rings. The lack of male options has placed a disproportionate contraceptive burden on women, more than 20% of whom cannot tolerate hormonal methods due to side effects ranging from mood disorders to blood clot risks.

The history of male contraception research is a study in frustration. Hormonal approaches — testosterone-based injections and gels — showed efficacy in trials but were repeatedly abandoned due to side effects that, ironically, women's contraception has normalised for decades. Non-hormonal approaches like Vasalgel, a polymer injection, showed promise but never reached advanced clinical trials.

What's different now is that NEXT Life Sciences has two candidates in parallel Phase II trials across Australia, Canada, and the United States. If Phase II results hold, Phase III trials could begin by 2028, with potential market availability in the early 2030s.

The market opportunity is substantial. Surveys consistently show that 50 to 80% of men express willingness to use new contraceptive methods. Male contraception is estimated to be a billion-dollar-plus annual market if effective options reach pharmacies.

Key Facts

• Two non-hormonal male contraceptives in Phase II trials simultaneously — a first
• Plan A™: long-acting, reversible-on-demand injectable; 100% effective in early trials
• NLS-133: on-demand non-hormonal pill providing 24-hour protection
• Over 20% of women cannot tolerate hormonal birth control
• The last major innovation in male contraception was in the 1970s

Why This Matters

Contraception is one of the most important public health tools ever developed — but for half a century, almost all of the innovation, side effects, and responsibility have fallen on women. Two effective, non-hormonal options for men wouldn't just expand choice; they would fundamentally redistribute the burden of family planning.

This has implications beyond individual relationships. In countries where access to women's healthcare is restricted or stigmatised, male contraception could provide an alternative pathway to reduced unintended pregnancies. Globally, unintended pregnancies account for nearly half of all pregnancies — a statistic that better male options could meaningfully change.

What We Don't Know Yet

Phase II trials test safety and dosing, not definitive efficacy. Phase III is the real test, and many promising drug candidates fail at that stage.

The "100% effective in early trials" claim for Plan A™ likely reflects a small sample size. Real-world effectiveness will almost certainly be lower, as it is for virtually all contraceptive methods.

The timeline to market availability is five to eight years at minimum, assuming no setbacks. Regulatory pathways for male contraceptives are less established than for female methods, which could introduce delays.

NEXT Life Sciences is a relatively small biotech company. Funding stability and potential partnership requirements are relevant risk factors in any drug development programme of this scale.

User adherence for on-demand options is historically challenging across all medications. Whether men will reliably take a pill before sexual activity — and whether partners will trust that they have — are practical questions that clinical trials alone cannot fully answer.

Sources: PRNewswire · Plan A for Men
Published 21 February 2026 · Category: Health & Medicine