On October 14, 2026, Hungarian drugmaker Gedeon Richter announced that the U.S. FDA had accepted for review its New Drug Application for FYLREVY. FYLREVY is an oral hormone therapy based on estetrol (E4) for moderate to severe vasomotor symptoms (hot flashes and night sweats) due to menopause. The Pharma Letter reports that the FDA is expected to complete its review by Q3 2027. If approved, FYLREVY would be the first menopausal hormone therapy containing E4 on the U.S. market.

Why It Matters

The U.S. menopause market is short of estrogen just as demand has been revived. The FDA removed the boxed warning from menopausal hormone therapy, ACP and ACOG have both now placed hormone therapy first-line, and estradiol patches have been in rolling shortage for months. A new oral estrogen with a distinct molecule would be the first genuinely new HRT option in years. It would give prescribers and telehealth menopause platforms an alternative to a supply chain dominated by a few estradiol makers. Timing is the catch: a Q3 2027 decision means nothing changes on pharmacy shelves for at least a year. Richter has also not said who would commercialize FYLREVY in the U.S., and it is unclear whether it would carry the class's older safety framing. Watch for a U.S. partnering deal, and for whether the oral route raises the same clotting questions the Danish registry data recently put on oral versus transdermal HRT.

The drug is already approved in Europe. The European Commission granted marketing authorization across the European Economic Area in March 2026, according to The Pharma Letter. The label covers estrogen-deficiency symptoms in postmenopausal women with a uterus who are at least 12 months past their last period (14.2 mg and 18.9 mg doses), and in women who have had a hysterectomy. It is sold in Hungary, the Czech Republic, Slovakia, Finland and Sweden. Ad-hoc-news, citing MarketScreener, reports that Richter's market capitalization was about €4.8 billion and that its next earnings release is November 10.

Estetrol is a natural estrogen made by the fetal liver during pregnancy. It is not new to pharmacology: E4 is already used in combined oral contraceptives paired with drospirenone, and those pills are now the subject of comparative trials such as a 2025 Scientific Reports study on delayed-start use. Using it on its own to treat menopause symptoms is a different indication. The safety case on clotting and breast tissue for menopausal use is exactly what the FDA review will test, and we have not seen the U.S. submission data.

Sources

See also: ACP and ACOG put hormone therapy first-line · US estradiol patch shortage · Danish registry on oral vs. transdermal HRT clots.

Update — 2026-10-20

Initial entry — story first created.