Long-Lasting Male Contraceptive Vasalgel Enters Human Trials
Plan A by NEXT Life Sciences offers a reversible, non-hormonal male contraceptive using Vasalgel.
The notion that today’s contraceptives grant genuine reproductive autonomy, for men or women, contradicts the reality of their limitations. With over 40% of unintended pregnancies resulting from inconsistent or incorrect contraceptive use, it is time to recognize that existing methods are insufficient.
Incorrect contraceptive use includes condom mishaps, with real-world failure rates of over 13% observed. Men are left with just two additional options: vasectomy, an invasive procedure with variable reversal success, and withdrawal, which is equally risky with regard to efficacy. These partial solutions leave reproductive autonomy out of reach.
With demand for novel male contraceptives on the rise, pioneers are working on various forms to provide a wider range of options, from oral tablets to topical creams and long-lasting injectables.
Technology Networks spoke with Dr. Darlene Walley, chief executive officer at NEXT Life Sciences. The company is taking an innovative approach in developing a non-hormonal, long-acting, reversible hydrogel, able to filter sperm from semen to prevent pregnancy and provide a novel family planning solution.
You have over 3 decades of life science business experience. After completing a PhD in organic chemistry, how did your career evolve, and what sparked your interest in Plan A®?
Darlene R. Walley, PhD (DRW):
For more than three decades, I’ve focused on guiding complex health technologies through development, regulatory strategy, and commercialization as chief executive officer for over a half-dozen start-up companies. Plan A by NEXT Life Sciences is a rare opportunity to apply this experience to a market with a profound unmet need and to a product that will have a major impact on society.
IH:
DRW:
Plan A prevents pregnancy by blocking sperm in the vas deferens of a man. Vasalgel is placed in the center of the vas deferens, preventing the flow of sperm while still allowing normal flow of other fluids.
The vas deferens
The vas deferens is a fibromuscular tube in the male reproductive system that transports sperm from the epididymis, which is connected to the testicle, to the ejaculatory duct. The male reproductive tract has two vas deferens, one for each testis; these are referred to as the vasa deferentia.
We observed in animal studies with rhesus monkeys and rabbits that accurate delivery into the center of the vas deferens was critical to success. Plan A’s delivery system consists of patented devices that accurately deliver Vasalgel, with a feedback mechanism for the doctor carrying out the procedure. This patented delivery system allows medical professionals to accurately enter the small center of the vas deferens and deposit the Vasalgel.
IH:
DRW:
Our animal and laboratory data informed the design of our human feasibility studies, and we are in close communication with the Food and Drug Administration (FDA) and regulatory groups around the world. We have previously demonstrated 100% technical success with our delivery device across new and experienced physicians on two continents.
As we move forward, our focus remains on safety, precision, and demonstrating consistent performance in a controlled clinical setting, including within our first-in-human clinical trials, which commenced in October 2025. We are advancing Plan A’s clinical program using a very purposeful and highly structured stepwise approach.
IH:
DRW:
Plan A is a long-acting, non-hormonal, reversible on-demand option. Those three characteristics are central. Many men and couples want reliability without daily adherence, and they want the ability to restore fertility when they are ready.
We like to say that Plan A offers men the opportunity to “set it and forget it” until they are ready to be fertile again. The “on-demand” reversibility of Plan A, in which men can have the Vasalgel dissolved in a simple procedure, is one of the greatest features of Plan A.
We are also developing NLS-133, an on-demand oral option, to expand the range of choices available to men. Our broader goal is to provide multiple solutions that support shared responsibility in family planning.
IH:
DRW:
I believe that our understanding of science and of how technology works, such as that used in Plan A, has progressed over the past few decades to a point that puts us close to commercialization today. For example, scientific understanding of polymer chemistry, hydrogel behavior, and medical device precision has advanced significantly.
Earlier work laid the foundation, but we now have improved analytical tools, refined formulations, and FDA-regulated manufacturing capabilities that enable greater consistency and quality control. Importantly, we have deeper insight into the mechanism and reversibility s
IH:
What do you think is driving the demand for alternative male contraceptives, and when might these needs realistically be met?
DRW:
Alongside the science and technology being ready for commercialization, the attitudes of young men and our understanding of current contraceptives make this a perfect time for male contraceptives.
Young men want to play a part in family planning but are frustrated with the limited options: condoms and vasectomies. Men and couples, as well as physicians, are embracing Plan A as a solution to a long-unmet need. Several technologies are progressing through clinical pathways to finally meet this need and should be available in the next 3 to 5 years. The time is right for male contraceptives.
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