NDATOPICALEMULSION
Approved
Oct 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
ESTRASORB (estradiol hemihydrate) by Xeltis is relugolix, estradiol (e2), and norethindrone acetate (neta). Approved for heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women [ see clinical studies () ], moderate to severe pain associated with endometriosis in premenopausal women [ see clinical studies () ], premenopausal women for the: management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids). First approved in 2003.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ESTRASORB is a topical estradiol hemihydrate emulsion approved in 2003 for treating heavy menstrual bleeding associated with uterine fibroids and moderate to severe endometriosis pain in premenopausal women. The drug works through a combination mechanism: relugolix suppresses GnRH receptors to reduce FSH/LH and lower estradiol/progesterone; exogenous estradiol is added back to mitigate bone loss; and norethindrone acetate protects the endometrium from unopposed estrogen effects.
LOE Approaching
Product lifecycle is approaching loss of exclusivity, signaling reduced commercial investment and potential team restructuring or transition activities.
Mechanism of Action
relugolix, estradiol (E2), and norethindrone acetate (NETA). Relugolix is a non-peptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors, thereby reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased serum…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.