Also known as: Korlym, Mifeprex
Mifepristone is a progesterone-blocking medication used with misoprostol for medical termination of intrauterine pregnancy through 70 days gestation. In the U.S., Mifeprex was first approved in 2000 and a generic 200 mg product was approved in 2019. Mifepristone formulations are also marketed for other indications under different brands.
The Fifth Circuit reinstated an in-person dispensing requirement for mifepristone, blocking telemedicine prescriptions. The ruling came after a federal judge paused Louisiana's lawsuit pending the FDA's safety review of the abortion medication.
A federal appeals court affirmed a ruling finding no infringement of two Korlym-related patents by Teva's proposed generic. The decision removes a major legal barrier for generic competition.
The FDA announced major policy changes including requiring only one study for drug approvals instead of two, and offering performance bonuses to reviewers who complete work ahead of schedule while maintaining thoroughness.
Sen. Josh Hawley and Rep. Diana Harshbarger introduced legislation to withdraw FDA approval of mifepristone nationwide, making distribution a federal violation and allowing patients to sue manufacturers.
The Trump administration launched TrumpRx on Feb. 5, a prescription drug website that displays discounted prices on 43 brand-name medications for out-of-pocket purchasers without insurance coverage.
Corcept Therapeutics received an FDA Complete Response Letter denying approval of relacorilant for hypertension secondary to hypercortisolism, triggering a 44.76% stock decline and multiple securities class actions.
The U.S. Court of Appeals for the Federal Circuit ruled that Teva Pharmaceuticals did not infringe Corcept Therapeutics' patents for methods of safely co-administering Korlym with CYP3A4 inhibitors, affirming a 2023 district court verdict.
Twenty-one state attorneys general and 60 members of Congress filed amicus briefs supporting Louisiana's lawsuit challenging the FDA's 2023 policy that removed in-person dispensing requirements for mifepristone, enabling mail-order distribution of abortion drugs.
59 Republican senators filed an amicus brief supporting Louisiana's lawsuit against the FDA, arguing the agency violated federal law by removing in-person dispensing requirements for mifepristone.
Sixty Republican members of Congress filed an amicus brief supporting Louisiana's lawsuit to restore in-person dispensing requirements for mifepristone, challenging Biden-era rules allowing mail-order abortion drugs.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06733727 |
Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage |
NOT_YET_RECRUITING | NA |
| NCT06502158 |
Mifepristone vs Misoprostol |
RECRUITING | PHASE1 |
| NCT06492889 |
Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT06099769 |
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer |
RECRUITING | PHASE2 |
| NCT05341817 |
The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy |
RECRUITING | PHASE4 |
| NCT05322252 |
Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial |
COMPLETED | PHASE4 |
| NCT05304273 |
Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages |
COMPLETED | PHASE3 |
| NCT05217758 |
RESET-medication Glucocorticoid Receptor (GR) Blockade As Disease Modifying Treatment for Depression with Childhood Trauma |
COMPLETED | PHASE2 |
| NCT05177510 |
Mifepristone Outpatient Labour Induction |
RECRUITING | PHASE2 |
| NCT05151016 |
Long-term Use of Mifepristone in the Treatment of Adenomyosis |
UNKNOWN | EARLY_PHASE1 |
