MR-100A-01 Weekly Contraceptive Patch Data Presented at ACOG 2026 Ahead of FDA Decision

Viatris presented 6 abstracts at the 2026 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting on MR-100A-01, an investigational once-weekly combined hormonal contraceptive patch that uses a lower estrogen dose than the company’s marketed transdermal product, Xulane. According to the company, the presentations include phase 3 efficacy and safety results, along with data on adhesion, pharmacokinetics, and cycle control.¹

The update is clinically relevant because the US Food and Drug Administration has already accepted a new drug application for the patch under the 505(b)(2) pathway, with a Prescription Drug User Fee Act target action date of July 30, 2026, according to the company. “The presentations will include positive results from the previously announced Phase 3 study,” Viatris said in the release, although full data were not included in the announcement.¹

MR-100A-01 is being developed for women of childbearing potential with body mass index lower than 30 kg/m² who are candidates for combined hormonal contraception and prefer a nonoral, reversible option.¹ The company described the supporting trial, NCT05139121, as a multicenter, open-label, single-arm phase 3 study evaluating contraceptive efficacy and safety.¹ That design is consistent with prior contraceptive registration programs, which often rely on single-arm Pearl Index analyses rather than active-comparator trials.² However, the press release did not provide numerical efficacy results, adverse-event rates, or discontinuation data, limiting independent interpretation ahead of the conference.

Weekly transdermal contraception is already available in the US, but estrogen exposure has been a longstanding issue in patch development and labeling. The currently approved norelgestromin/ethinyl estradiol patch, marketed as Xulane and previously as Ortho Evra, carries class warnings typical of combined hormonal contraceptives, including thromboembolic risk, and labeling has noted higher steady-state estrogen exposure relative to a 35-µg oral contraceptive in prior FDA reviews.³ A lower-estrogen patch could therefore be of interest if efficacy, bleeding control, and adhesion are maintained, though whether lower systemic estrogen exposure will translate into a clinically meaningful safety advantage would require more complete comparative data.

The ACOG abstracts suggest Viatris is trying to address several practical questions that influence real-world patch use. Two posters focus on adhesion performance, including under “extreme conditions,” and another compares multiple-dose pharmacokinetics of norelgestromin and ethinyl estradiol with those of an oral contraceptive.¹ Adhesion matters because partial or complete detachment can affect hormone delivery, adherence, and patient confidence. Cycle control data may also be important, as unscheduled bleeding remains a common reason for dissatisfaction or discontinuation with hormonal contraception.⁴

The broader contraceptive landscape has shifted toward greater personalization of method choice, with attention to route of administration, contraindications, adherence burden, and patient preference. Combined hormonal methods remain widely used, but they are not appropriate for all patients, particularly those with certain cardiovascular risk factors, migraine with aura, smoking at older reproductive ages, or other contraindications outlined in the US Medical Eligibility Criteria for Contraceptive Use.⁴ For eligible patients who want to avoid daily dosing, nonoral methods such as patches, rings, injections, implants, and intrauterine devices offer varying tradeoffs in convenience, hormone exposure, and efficacy.

Mechanistically, the investigational patch appears to use the same progestin-estrogen combination as Xulane—norelgestromin and ethinyl estradiol—delivered transdermally on a weekly schedule.^1,3 The 505(b)(2) route suggests the application may rely in part on existing findings for approved products while adding new clinical and pharmacokinetic data for the lower-dose formulation.¹

For clinicians, the main unanswered questions are quantitative: Pearl Index by age subgroup, total estrogen exposure, rates of patch detachment, bleeding patterns over time, and the incidence of venous thromboembolism and other estrogen-related adverse events. The phase 3 study’s open-label, single-arm design and the apparent restriction to participants with body mass index below 30 kg/m² may also affect generalizability.¹

References

1. Viatris Announces Several Data Presentations on Investigational Low-Dose Estrogen Combined Hormonal Contraceptive Weekly Patch at the 2026 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting. PR Newswire. May 1, 2026. Accessed May 12, 2026. https://www.prnewswire.com/news-releases/viatris-announces-several-data-presentations-on-investigational-low-dose-estrogen-combined-hormonal-contraceptive-weekly-patch-at-the-2026-american-college-of-obstetricians-and-gynecologists-annual-clinical--scientific-meeting-302759662.html
2. ClinicalTrials.gov. Study to evaluate the efficacy and safety of MR-100A-01 in women of childbearing potential (NCT05139121). Accessed May 12, 2026. https://clinicaltrials.gov/study/NCT05139121
3. US Food and Drug Administration. Xulane (norelgestromin and ethinyl estradiol transdermal system) prescribing information. Accessed May 12, 2026. https://www.accessdata.fda.gov
4. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. medical eligibility criteria for contraceptive use, 2024. MMWR Recomm Rep. 2024;73(4):1-126. doi:10.15585/mmwr.rr7304a1