- The disease
- Oral contraception refers to hormone-based tablets taken daily to prevent pregnancy. Combined oral contraceptive pills (COCs) typically contain a synthetic estrogen and a progestin. They are among the most widely used prescription contraceptive methods globally. In the United States, the contraceptive market includes a large number of generic and branded COC options.
- What the asset is trying to do
- NEXTSTELLIS contains estetrol (E4), a naturally occurring estrogen produced by the human fetal liver during pregnancy, combined with the progestin drospirenone. Estetrol acts as a selective estrogen receptor modulator, meaning its activity differs depending on the tissue type (per the European Medicines Agency assessment report for Nextstellis, EMA/CHMP/787327/2021). This mechanism distinguishes it from the synthetic ethinylestradiol used in most approved COCs.
- Efficacy benchmarks in this setting
- Approved COCs containing ethinylestradiol and drospirenone (e.g., Yasmin) have demonstrated a Pearl Index (a measure of contraceptive failure rate per 100 woman-years of use) of approximately 0.3 to 1.0 in clinical trials, though the specific figures vary by study population and methodology (per respective US prescribing information). The pivotal Phase 3 trial supporting NEXTSTELLIS approval reported a Pearl Index figure that is cited in the US prescribing information for NEXTSTELLIS; analysts should consult that document directly for the specific value. Early-phase or single-arm figures from different study designs are not statistically comparable across products.
- Commercial context
- NEXTSTELLIS received US Food and Drug Administration (FDA) approval in April 2021 and is indicated for use by women of reproductive age as a combined oral contraceptive (per FDA approval records). The product is also approved in Canada under the brand name NEXTSTELLIS and in Europe under the brand name Lydisilka (per EMA records). Mayne Pharma holds commercial rights to NEXTSTELLIS in the United States and has disclosed a DistributeRx partnership with Resilia Pharmaceuticals (per ASX announcement, 26 May 2026). NEXTSTELLIS is described as a key commercial asset for Mayne Pharma in company investor presentations (per MYX ASX presentation, 6 May 2026).