NDAORALTABLET
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
MYFEMBREE (relugolix, estradiol hemihydrate, and norethindrone acetate) by Sumitomo Dainippon Pharma is gonadotropin releasing hormone receptor antagonists [moa]. First approved in 2021.
Drug data last refreshed 18h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Myfembree is an oral combination tablet containing relugolix (a GnRH receptor antagonist), estradiol hemihydrate, and norethindrone acetate approved in May 2021 for women's health indications. It works by blocking gonadotropin-releasing hormone signaling to modulate reproductive hormones while the estradiol and norethindrone provide hormone replacement. This triplet approach represents a novel non-surgical option addressing moderate-to-severe symptoms in reproductive-age women.
$0.002BPart D
Peak16.0 years to LOEProduct is in peak commercial phase with modest early-stage uptake (~1,153 Part D claims in 2023), suggesting mid-sized brand team focused on market education and patient adoption.
Mechanism of Action
Gonadotropin Releasing Hormone Receptor Antagonists
Pharmacologic Class:
Gonadotropin Releasing Hormone Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on Myfembree offers entry or mid-career pharma professionals the opportunity to build a new-to-market franchise with greenfield brand positioning and zero competitive interference. The modest early uptake (1,153 Part D claims) indicates the market is still maturing, creating roles for physicians educators, patient advocates, and field teams focused on category expansion.
Brand Manager
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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.