Xulane Lo
Low-Dose Weekly Dermal Patch
- User: Female
- Hormonal: Hormonal
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Delivery type:
- Transdermal
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Intended Duration:
- Short-Acting
- Development Stage: Phase III
- Developer(s)/researcher(s): Viatris
Details
- API: Norelgestromin, Ethinyl Estradiol
- Target: Progesterone Receptor, Estrogen Receptor
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Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Regimen: 1 Patch/Week
- MPT: Not Potential MPT
- Promising Attributes: Developers indicate that the Xulane Lo patch delivers a lower dose of estrogen than other short-acting options, which may lead to lower risk of blood clots and other estrogen-linked side effects.
Product Status
Active Clinical Evaluation
History
Xulane, a weekly contraceptive patch, was first approved as a generic in 2014. Xulane's estrogen dose requires a black box warning for potential cardiovascular risk, particularly for users with high BMI or users who smoke. In 2021, Viatris initiated an open label Phase III trial to evaluate a lower-dose patch, Xulane Lo, for efficacy, cycle control, safety, and tolerability.
Preliminary trial results were made public in 2025, indicating high safety and efficacy, a favorable user tolerability profile, minimal unscheduled bleeding, and high patch adhesion. Viatris announced their intent to submit a new drug application to the US FDA in 2025.