FDA · United States
estradiol — FDA regulatory status
estradiol (ESTRADERM MX 50) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- ESTRADERM MX 50
- Originator
- NovoThirteen
- Mechanism
- Estrogen receptor alpha agonist
- Target
- Estrogen receptor
- Structured fields
- 8
Sponsor / originator context: NovoThirteen. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Estrogen receptor alpha agonist. Target: Estrogen receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 37 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 91781 | Phase 3 | Bayer HealthCare Animal | NCT00909857 |
| Active | Phase 3 | Aclaris Therapeutics | NCT03691831 |
| Estradiol | Phase 3 | TherapeuticsMD | NCT02253173 |
| Estradiol | Phase 3 | Teva Pharma | NCT05617820 |
| Estradiol | Phase 3 | TherapeuticsMD | NCT01942668, NCT02449902 |
| Estradiol Vaginal Tablets 10 mcg | Phase 3 | Amneal Pharma Europe | NCT01779947 |
| Generic Estradiol Vaginal Cream USP, 0.01% | Phase 3 | Teva Pharma | NCT03294538 |
| Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg | Phase 3 | Chinese Academy of | NCT02021097 |
| Seasonale (levonorgestrel and ethinyl estradiol) | Phase 3 | Teva Pharma | NCT00117260 |
| Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] | Phase 3 | Teva Pharma | NCT00117273 |
| YOBI/SL79.22 | Phase 3 | Allergon AB | 2023-509833-38-00 |
| oral estradiol 1.0 mg | Phase 3 | TherapeuticsMD | NCT02224313 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12258354 | AhR modulators | US |
| 11957684 | Treatment of heavy menstrual bleeding associated with uterine fibroids | US |
| 11865179 | Progesterone formulations having a desirable PK profile | US |
| 11793812 | Methods of treating endometriosis | US |
| 11793819 | Natural combination hormone replacement formulations and therapies | US |
| 11622933 | Soluble estradiol capsule for vaginal insertion | US |
| 11584755 | Dihydrothieno[3,2-b]pyridine compounds | US |
| 11548867 | Amido compounds as AhR modulators | US |
| 11529360 | Natural combination hormone replacement formulations and therapies | US |
| 11530220 | Substituted imidazo[1,5-a]pyrazines and [1,2,4]triazolo[4,3-a]pyrazines for the modulation of AhR | US |
| 11497709 | Vaginal inserted estradiol pharmaceutical compositions and methods | US |
| 11484591 | Chemoprevention using controlled-release formulations of anti-interleukin 6 agents, synthetic vitamin A analogues or metabolites, and estradiol metabolites | US |
Related hubs
FAQ
What is the FDA approval status of estradiol?
estradiol currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get estradiol regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to estradiol?
This spoke lists 37 published programs associated with estradiol in our pipeline index.