Estradiol valerate
Activella, Amabelz, Angeliq, Bijuva, Climara, Combipatch, Delestrogen, Depo-testadiol, Ditate, Divigel, Elestrin, Estrace, Estradiol, Estrasorb, Estring, Estrogel, Etyqa, Evamist, Femring, Imvexxy, Ioa, Lunelle, Menostar, Minivelle, Myfembree, Natazia, Prefest, Ryeqo, Vagifem, Vivelle-dot, Zoely (estradiol valerate) is a small molecule pharmaceutical. Estradiol valerate was first approved as Estrace on 1982-01-01. It is used to treat breast neoplasms, hot flashes, hypogonadism, menorrhagia, and premature menopause amongst others in the USA. It has been approved in Europe to treat contraception and leiomyoma.
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alora | OTC monograph not final | 2019-09-18 |
| bijuva | New Drug Application | 2025-01-28 |
| climara | New Drug Application | 2023-12-06 |
| climara pro | New Drug Application | 2023-12-06 |
| climarapro | 2009-01-20 | |
| delestrogen | New Drug Application | 2024-07-08 |
| divigel | New Drug Application | 2023-11-21 |
| elestrin | New Drug Application | 2024-02-27 |
| estrace | ANDA | 2024-08-12 |
| estradiol valerate | ANDA | 2024-10-25 |
Show 12 more
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ESTRADIOL / NORETHINDRONE ACETATE / RELUGOLIX, MYFEMBREE, MYOVANT SCIENCES | |||
| 2026-01-27 | M-289 | ||
| 2025-12-18 | NCE | ||
| 2025-08-05 | I-898 | ||
| 2024-05-26 | NP | ||
ESTRADIOL, ESTRADIOL, CHEMO RESEARCH SL | |||
| 2023-04-08 | CGT | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Estradiol / Norethindrone Acetate / Relugolix, Myfembree, Myovant Sciences | |||
| 11793812 | 2038-05-03 | U-2360 | |
| 11033551 | 2037-09-29 | U-3129 | |
| 11795178 | 2033-09-27 | DS, DP | |
| 9346822 | 2024-02-17 | U-3129 | |
| 7300935 | 2024-01-28 | DP | |
| 8058280 | 2024-01-28 | DP | |
| Estradiol, Imvexxy, Mayne Pharma | |||
| 11266661 | 2034-02-02 | U-2316, U-2317 | |
| 9180091 | 2033-12-20 | DP | U-2316, U-2317 |
| 10258630 | 2033-12-20 | U-2316, U-2317 | |
| 10398708 | 2033-12-20 | U-2317, U-2614 | |
| 10471072 | 2033-06-18 | U-2316, U-2317 | |
| 10568891 | 2033-06-18 | U-2316, U-2317 | |
| 10668082 | 2033-06-18 | U-2316, U-2317 | |
| 10888516 | 2033-06-18 | U-2316, U-2317 | |
| 11065197 | 2033-06-18 | DP | |
| 11116717 | 2033-06-18 | DP | |
| 11123283 | 2033-06-18 | DP | |
| 9289382 | 2032-11-21 | DP | |
| 10537581 | 2032-11-21 | DP | U-2316, U-2317 |
| 10806697 | 2032-11-21 | DP | |
| 10835487 | 2032-11-21 | U-2316, U-2317 | |
| 11241445 | 2032-11-21 | U-2316, U-2317 | |
| 11246875 | 2032-11-21 | U-2316, U-2317 | |
| 11304959 | 2032-11-21 | DP | |
| 11351182 | 2032-11-21 | U-2316, U-2317 | |
| 11497709 | 2032-11-21 | U-2316, U-2317 | |
| Estradiol / Progesterone, Bijuva, Mayne Pharma | |||
| 8633178 | 2032-11-21 | DP | |
| 8846648 | 2032-11-21 | U-2439 | |
| 8846649 | 2032-11-21 | DP | U-2439 |
| 8933059 | 2032-11-21 | DP | U-2439 |
| 8987237 | 2032-11-21 | DP | |
| 8993548 | 2032-11-21 | DP | |
| 8993549 | 2032-11-21 | DP | |
| 9006222 | 2032-11-21 | DP | U-2439 |
| 9114145 | 2032-11-21 | U-2439 | |
| 9114146 | 2032-11-21 | DP | U-2439 |
| 9301920 | 2032-11-21 | DP | U-2439 |
| 10052386 | 2032-11-21 | DP | |
| 10206932 | 2032-11-21 | U-2439 | |
| 10639375 | 2032-11-21 | DP | |
| 10675288 | 2032-11-21 | U-2439 | |
| 10806740 | 2032-11-21 | DP | U-2439 |
| 11033626 | 2032-11-21 | DP | U-2439 |
| 11103513 | 2032-11-21 | U-2439 | |
| 11103516 | 2032-11-21 | DP | |
| 11110099 | 2032-11-21 | DP | |
| 11166963 | 2032-11-21 | DP | |
| 11529360 | 2032-11-21 | DP | |
| 11793819 | 2032-11-21 | U-2439 | |
| Drospirenone / Estradiol, Angeliq, Bayer Hlthcare | |||
| 8906890 | 2031-10-22 | DP | |
| Estradiol, Minivelle, Noven | |||
| 8231906 | 2030-07-04 | DS, DP | |
| 9724310 | 2028-07-10 | DS, DP | |
| 9730900 | 2028-07-10 | U-2086 | |
| 9833419 | 2028-07-10 | DP | |
| Dienogest / Estradiol Valerate, Natazia, Bayer Hlthcare | |||
| 8153616 | 2028-01-30 | U-1240 | |
| 8071577 | 2026-05-13 | DP | U-1 |
| Estradiol Acetate, Femtrace, Apil | |||
| 7572779 | 2025-10-02 | U-904 | |
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J1380 | Injection, estradiol valerate, up to 10 mg |
Clinical
Clinical Trials
1457 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | 15 | 16 | 15 | 34 | 70 | 145 |
| Healthy volunteers/patients | — | — | — | 115 | 7 | 6 | 6 | 5 | 135 |
| Contraception | D003267 | — | — | 18 | 19 | 46 | 20 | 26 | 126 |
| Menopause | D008593 | EFO_0003922 | N95 | 13 | 11 | 16 | 26 | 19 | 81 |
| Syndrome | D013577 | — | — | 7 | 12 | 13 | 16 | 21 | 69 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 6 | 3 | 8 | 15 | 24 | 56 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 25 | 6 | 2 | 15 | 51 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 2 | 10 | 16 | 11 | 8 | 43 |
| Female infertility | D007247 | EFO_0008560 | N97 | 9 | 4 | 5 | 5 | 21 | 42 |
| Atrophy | D001284 | — | — | 4 | 7 | 18 | 6 | 4 | 38 |
Show 192 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myofibroma | D047708 | — | — | — | 2 | 11 | — | 4 | 17 |
| Neoplasms | D009369 | — | C80 | 5 | 3 | 1 | — | 2 | 10 |
| Anorexia | D000855 | — | R63.0 | 2 | 6 | 3 | — | — | 9 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | 2 | 6 | 3 | — | — | 9 |
| Inflammation | D007249 | MP_0001845 | — | — | 3 | 2 | — | 3 | 8 |
| Prostatic neoplasms | D011471 | — | C61 | — | 7 | 2 | — | — | 8 |
| Pituitary diseases | D010900 | — | E23.7 | — | 1 | 3 | — | 5 | 8 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 3 | 2 | — | — | 6 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 4 | — | 1 | — | 1 | 6 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | 1 | — | 4 | 5 |
Show 79 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tissue adhesions | D000267 | — | — | 3 | 1 | — | — | 12 | 15 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 10 | 1 | — | — | 1 | 11 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 8 | 1 | — | — | — | 8 |
| Covid-19 | D000086382 | — | U07.1 | — | 4 | — | — | 4 | 8 |
| Male breast neoplasms | D018567 | — | — | 1 | 2 | — | — | 1 | 3 |
| Carcinoma | D002277 | — | C80.0 | — | 3 | — | — | — | 3 |
| Vulvodynia | D056650 | — | N94.81 | — | 1 | — | — | 2 | 3 |
| Gender identity | D005783 | — | — | 1 | 1 | — | — | 1 | 2 |
| Intracranial aneurysm | D002532 | EFO_0003870 | I67.1 | — | 1 | — | — | 1 | 2 |
| Hemostasis | D006487 | — | — | — | 2 | — | — | — | 2 |
Show 44 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 13 | — | — | — | 1 | 14 |
| Therapeutic equivalency | D013810 | — | — | 11 | — | — | — | 1 | 12 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 2 | — | — | — | 6 | 8 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 4 | — | — | — | 3 | 7 |
| Drug interactions | D004347 | — | — | 6 | — | — | — | 1 | 7 |
| Hepatitis c | D006526 | — | B19.2 | 7 | — | — | — | — | 7 |
| Transgenes | D019076 | — | — | 1 | — | — | — | 2 | 3 |
| Pain | D010146 | EFO_0003843 | R52 | 2 | — | — | — | 1 | 3 |
| Asthma | D001249 | EFO_0000270 | J45 | 3 | — | — | — | — | 3 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | 1 | — | — | — | 1 | 2 |
Show 60 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 4 | 4 |
| Thromboembolism | D013923 | — | — | — | — | — | — | 4 | 4 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | — | — | 3 | 3 |
| Menstrual cycle | D008597 | — | — | — | — | — | — | 3 | 3 |
| Cerebrospinal fluid leak | D065634 | — | G96.0 | — | — | — | — | 3 | 3 |
| Uterine cervical neoplasms | D002583 | — | — | — | — | — | — | 2 | 2 |
| Traumatic brain injuries | D000070642 | — | S06 | — | — | — | — | 2 | 2 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 2 | 2 |
| Vascular stiffness | D059289 | — | — | — | — | — | — | 2 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 2 | 2 |
Show 126 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Estradiol valerate |
| INN | estradiol valerate |
| Description | Estradiol valerate is a steroid ester. |
| Classification | Small molecule |
| Drug class | estrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCC(=O)O[C@H]1CC[C@H]2[C@@H]3CCc4cc(O)ccc4[C@H]3CC[C@]12C |
Identifiers
| PDB | — |
| CAS-ID | 979-32-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1511 |
| ChEBI ID | 31561 |
| PubChem CID | 13791 |
| DrugBank | DB13956 |
| UNII ID | OKG364O896 (ChemIDplus, GSRS) |
Target
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Myfembree – Myovant Sciences
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Imvexxy – TherapeuticsMD
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Ryeqo – Myovant Sciences
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Divigel – RVL Pharmaceuticals
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Bijuva – TherapeuticsMD
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Estradiol – Amneal Pharmaceuticals
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 4,275 documents
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Safety
Black-box Warning
Black-box warning for: Bijuva, Climara, Climara pro, Climarapro, Delestrogen, Divigel, Elestrin, Estrace, Estradiol valerate, Estradiol valerate and estradiol valerate/dienogest, Estring, Estrogel, Evamist, Femring, Imvexxy, Menostar, Minivelle, Natazia, Vagifem, Vivelle dot, Vivelle-dot
Adverse Events
Top Adverse Reactions
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108,338 adverse events reported
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