FDA
FDA OKs Nexplanon for pregnancy prevention for up to 5 years
FDA has approved a supplemental New Drug Application (sNDA) for Nexplanon (etonogestrel implant), a contraceptive for women of reproductive age. This approval extends Nexplanon’s approved duration of effectiveness from three years to up to five years.
Efficacy
Contraceptive efficacy of Nexplanon during use from 3 to 5 years was evaluated in a multicenter, single-arm, open-label study (NCT04626596). A total of 399 women were evaluated, having a mean age of 27 years, ranging from 18 to 35 years, and having been using Nexplanon for 36 months (± 2 weeks) from the date of insertion at the time of enrollment. The primary efficacy endpoint was the Pearl Index (PI) at years 4 and 5. No pregnancies were reported during this period, resulting in a PI of 0.0 (95% confidence interval, 0.00-0.69) pregnancies per 100 women-years of use, and there were no new safety findings.
Safety
The adverse‑event profile during years 4 and 5 was similar to that seen in the first three years. Intermenstrual bleeding was the most common Nexplanon‑related adverse event (5.4%), and changes in bleeding patterns were the leading cause of discontinuation, occurring in 4% of participants.
Sources:
Nexplanon (etonogestrel implant) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021529s027lbl.pdf Revised January 2026. Accessed January 22, 2026.
Organon announces US Food and Drug Administration approval of supplemental New Drug Application extending duration of use of Nexplanon® (etonogestrel implant) 68 mg radiopaque. [News release]. 2025. 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/