The US Food and Drug Administration has approved an extended duration of use for Nexplanon, Organon’s contraceptive implant, from three years to five years. The approval is based on a clinical trial in which no pregnancies were reported during years four and five of use.
The trial evaluated 399 women aged 18 to 35 who had been using Nexplanon for three years at enrollment. The study included participants across a range of body mass index values, with 38.1% having a BMI of 30 or higher. The resulting Pearl Index was 0.0 pregnancies per 100 women-years of use.
“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, 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.”
“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, Professor of Obstetrics and Gynecology at Western University of Health Sciences.
The approval also includes a new Risk Evaluation and Mitigation Strategy (REMS) program requiring healthcare providers to complete training on proper insertion and removal before prescribing Nexplanon. The REMS program is planned to be available starting February 23, 2026.
