Gynuity Responds to Court Decision Restricting Mifepristone Access & Provides Information on Ulipristal Acetate for Medication Abortion

On May 1, 2026, a federal appeal court issued a ruling ordering the U.S. Food & Drug Administration (FDA) to temporarily reinstate a nationwide in-person dispensing requirement for mifepristone—a medication that was approved by the FDA for abortion care in 2000. The U.S. Supreme Court paused the ruling after companies that make mifepristone filed an emergency application with the high court.

The ruling is the result of Louisiana’s legal challenge to the FDA’s 2023 modifications to the risk evaluation and mitigation strategy for mifepristone, which included allowing providers and patients to use telehealth to prescribe and receive mifepristone by mail.

Gynuity strongly condemns the decision to restrict access to essential medical care. Decades of scientific evidence and real-world experiences leave no doubt as to the safety and effectiveness of mifepristone when combined with misoprostol for medication abortion.

Solutions are needed to help fill unmet need for safe abortion products.

Gynuity Continues Investigation into Ulipristal Acetate for Medication Abortion 

Gynuity launched a new study to continue investigating ulipristal acetate as an alternative to mifepristone for early medication abortion.

The double-blind, placebo-controlled randomized trial is underway at two clinical sites in Mexico to identify an appropriate dose for ulipristal acetate in a combined regimen with misoprostol. We anticipate completing enrolment of 426 participants later this year.

This latest study follows on from our initial proof-of-concept study, also conducted in Mexico, which provided positive evidence supporting the potential of pairing ulipristal acetate with misoprostol for early pregnancy termination (Winikoff 2025).

Ulipristal acetate has a similar chemical compound and mechanism of action to mifepristone, acting as a selective progesterone receptor modulator, and is rapidly absorbed when taken orally. As an existing medication, it is widely available either by prescription or over the counter in many countries.

Outcomes from this early-stage clinical research will help determine the design of future studies that could have far-reaching implications for service delivery both in the U.S. and globally.

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