FDA approves 5-year use for etonogestrel implant 68 mg contraceptive

The FDA has approved a supplemental New Drug Application extending the duration of use for the etonogestrel implant (Nexplanon) from 3 years to up to 5 years, according to an announcement from Organon. The decision is supported by clinical trial data showing no pregnancies and no new safety concerns during years 4 and 5 of use, broadening access to a highly effective long-acting reversible contraceptive option.

“Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as another advancement in Organon’s women’s health franchise,” said Juan Camilo Arjona Ferreira, MD, in a statement. Ferreira is Organon’s Head of Research and Development and Chief Medical Officer. “The sNDA approval of an extended duration up to five years, along with data about the use of NEXPLANON in women with varying BMIs, including women with overweight or obesity, is a testament to Organon’s commitment to inclusive and comprehensive women’s healthcare.”

Clinical data supporting extended approval of etonogestrel implant

According to Organon, the approval was based on results from a multicenter, single-arm, open-label study evaluating contraceptive efficacy and safety during years 4 and 5 of etonogestrel implant use. The trial (NCT04626596)² enrolled 399 women who had already used the implant for 36 months at the time of enrollment.

Key study findings include¹:

• No pregnancies reported during years 4 and 5 of use
• Pearl Index: 0.0 pregnancies per 100 women-years of use (95% CI: 0.00–0.69)
• No new safety findings identified during extended use
• BMI range: 17.2 to 64.3 kg/m²
• Participants with BMI ≥30 kg/m²: 38.1%, including 10.0% with BMI ≥40 kg/m²

The inclusion of participants across a wide range of body mass index values provides additional reassurance about contraceptive efficacy in women with overweight or obesity, a population often underrepresented in clinical trials.

“The updated label for NEXPLANON reflects the diversity of patients we see every day—women throughout their reproductive ages, those seeking a long-acting option of up to five years, those who prefer birth control that goes in the arm rather than the uterus, and women across a wide range of BMIs,” said Anita Nelson, MD, Professor, Obstetrics and Gynecology at Western University of Health Sciences. “The REMS program builds on existing training requirements to ensure providers maintain the highest standards for insertion and removal, reinforcing confidence and best clinical practice.”

As part of the approval, the FDA is requiring implementation of a new Risk Evaluation and Mitigation Strategy (REMS) program to reduce complications related to improper insertion and removal of the etonogestrel implant. Etonogestrel implant will only be available in the US through the NEXPLANON REMS program, which Organon anticipates will be available beginning on February 23, 2026. Providers will have 6 months to enroll in the program in order to maintain their access to etonogestrel implant for insertion.

The contraceptive is contraindicated for women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumors, benign or malignant, or active liver disease; undiagnosed abnormal uterine bleeding; known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past; and/or allergic reaction to any of the components of NEXPLANON.

References:

1. Organon announces US Food and Drug Administration approval of supplemental new drug application extending duration of use of NEXPLANON (etonogestrel implant) 68 mg Radiopaque. Organon. Press release. January 16, 2026. Accessed January 19, 2026. https://www.organon.com/news/organon-announces-us-food-and-drug-administration-approval-of-supplemental-new-drug-application-extending-duration-of-use-of-nexplanon-etonogestrel-implant-68-mg-radiopaque/

2. A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060). ClinicalTrials.gov. Updated December 30, 2025. Accessed January 19, 2026. https://clinicaltrials.gov/study/NCT04626596