Responsible compounding could close the innovation gap

You’ve probably seen compounding making headlines recently, and not for the right reasons. From so-called “personalized” GLP-1s flooding the market to telehealth startups touting hormone “rebalancing” kits, compounding has become a buzzword for companies looking to shortcut regulation. Much of the scrutiny is justified; some companies exploit compounding to bypass evidence standards or chase fast revenue.

But when compounding is grounded in rigorous data, fills a real market gap, and meets a clinical need, it can meaningfully accelerate access to therapies that would otherwise take years to reach patients. In women’s health, especially, it can bridge the gap between urgent unmet needs and slow regulatory timelines in a market overlooked for far too long.

WHAT IS COMPOUNDING?

When a physician prescribes a compounded medication, a licensed pharmacist prepares it by adjusting an FDA-approved drug to create a tailored formulation when no commercial option meets the patient’s needs. Simply put, compounding exists to fill gaps in care.

This plays a critical role, for example, with oncology patients who require custom dosages not offered in commercial products, or those who need medications reformulated without allergens. In limited circumstances, compounding can also allow companies to deliver new formulations to underserved populations using proven pharmaceutical ingredients while continuing toward FDA approval.

Responsible compounding is always:

• Anchored in evidence
• Only used when no FDA-approved option exists, and patients would otherwise have no access
• And part of a defined regulatory plan

When aligned with these standards, compounding can bring scientific advancements into real‑world use years sooner—without compromising rigor—especially in areas where investment and approvals lag. 

WOMEN’S HEALTH AS A CASE STUDY

Women’s health is decades behind other therapeutic categories when it comes to FDA-approved options. A recent WEF-BCG report found that women’s health receives only 6% of private healthcare capital,and companies focused exclusively on women’s health capture less than 1%. Meanwhile, drug development averages 10–12 years and can exceed $2 billion per approved product. Costs and timelines can be further compounded by gender bias in clinical research, regulatory standards based on male physiology, or inconsistent definitions of women‑specific conditions. The result is an even wider gap between what science can deliver and what women can actually access.

Compounding offers one way to close that gap responsibly. When my company, Daré, evaluated sildenafil—the same active ingredient in Viagra—for female arousal disorder, decades of data and controlled studies supported its potential. Yet, 30 years after Viagra’s approval for men, no one had put in the hard work to do the research, develop the right formulation, and definitively demonstrate sildenafil’s effect on women.

After extensive FDA engagement and rigorous development, we made our proprietary formulation for DARE to PLAY, the first topical sildenafil cream for women, supported by published, peer-reviewed clinical data, available via compounding. We did so because the evidence we generated was compelling, the need was urgent, and millions of women were living without options.

WHY SHOULD YOU CARE?

Compounding allowed us to give women access to a formulation that has been rigorously studied and clinically tested, where no FDA-approved option exists. We’re committed to FDA approval of the first treatment for arousal disorder in women, but we won’t let women wait unnecessarily for a solution that we’ve demonstrated the science already supports.

RAISE THE BAR, WIDEN THE PATH

Compounding is not a shortcut, nor a replacement for FDA approval. It can be a catalyst for innovation when used exactly as designed, to get credible, science-backed solutions to people who need them and should not have to wait.

It allows innovators to widen access in a controlled, science-first way while continuing the work toward FDA approval. For founders working in historically underfunded areas like women’s health, including sexual health, menopause, fertility, and pelvic pain, compounding offers a model where patient need, scientific rigor, and market-building move in the same direction.

The future of responsible innovation isn’t about choosing between speed and rigor. We can and should deliver both.

Sabrina Martucci Johnson is founder and CEO of Daré Bioscience.

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