Depo-testadiol, Zoely(estradiol valerate)
Activella, Angeliq, Bijuva, Climara, Combipatch, Delestrogen, Depo-testadiol, Ditate, Divigel, Elestrin, Estrasorb, Estring, Estrogel, 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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Commercial
Trade Name
FDA
EMA
Climara, Delestrogen, Divigel, Elestrin, Estring, Estrogel, Evamist, Femring, Imvexxy, Menostar, Minivelle, Vagifem, Vivelle-dot (generic drugs available since 1982-01-01, discontinued: Alora, Esclim, Estrace, Estraderm, Estrasorb, Fempatch, Femtrace, Gynodiol, Innofem, Vivelle)
CombinationsActivella, Angeliq, Bijuva, Climara, Combipatch, Myfembree, Natazia (generic drugs available since 1982-01-01, discontinued: Depo-testadiol, Ditate, Lunelle, Prefest)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dienogest
+
Estradiol valerate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
NATAZIA | Bayer | N-022252 RX | 2010-05-06 | 1 products, RLD, RS |
Drospirenone
+
Estradiol
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ANGELIQ | Bayer | N-021355 RX | 2005-09-28 | 2 products, RLD, RS |
Estradiol
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ESTROGEL | Ascend Therapeutics | N-021166 RX | 2004-02-09 | 1 products, RLD, RS |
CLIMARA | Bayer | N-020375 RX | 1994-12-22 | 6 products, RLD, RS |
MENOSTAR | Bayer | N-021674 RX | 2004-06-08 | 1 products, RLD, RS |
IMVEXXY | Mayne Group | N-208564 RX | 2018-05-29 | 2 products, RLD, RS |
ELESTRIN | Mylan | N-021813 RX | 2006-12-15 | 1 products, RLD, RS |
MINIVELLE | Noven Pharmaceuticals | N-203752 RX | 2012-10-29 | 5 products, RLD, RS |
VAGIFEM | Novo Nordisk | N-020908 RX | 2009-11-25 | 1 products, RLD, RS |
EVAMIST | Padagis | N-022014 RX | 2007-07-27 | 1 products, RLD, RS |
ESTRING | Mylan | N-020472 RX | 1996-04-26 | 1 products, RLD, RS |
VIVELLE-DOT | Sandoz | N-020538 RX | 1999-01-08 | 5 products, RLD, RS |
Show 1 marketed
Show 8 discontinued
Estradiol
+
Levonorgestrel
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
CLIMARA PRO | Bayer | N-021258 RX | 2003-11-21 | 1 products, RLD, RS |
Estradiol
+
Norethindrone acetate
Estradiol
+
Norethindrone acetate
+
Relugolix
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
MYFEMBREE | Myovant Sciences | N-214846 RX | 2021-05-26 | 1 products, RLD, RS |
Estradiol
+
Norgestimate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
PREFEST | Teva | N-021040 DISCN | 1999-10-22 | 1 products, RLD |
Hide discontinued
Estradiol
+
Progesterone
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
BIJUVA | Mayne Group | N-210132 RX | 2018-10-28 | 2 products, RLD, RS |
Estradiol acetate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
FEMRING | Millicent Pharma | N-021367 RX | 2003-03-20 | 2 products, RLD, RS |
Show 1 discontinued
Estradiol cypionate
+
Medroxyprogesterone acetate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
LUNELLE | Pharmacia & Upjohn | N-020874 DISCN | 2000-10-05 | 1 products |
Hide discontinued
Estradiol cypionate
+
Testosterone cypionate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
DEPO-TESTADIOL | Pharmacia & Upjohn | N-017968 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Estradiol hemihydrate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ESTRASORB | Exeltis | N-021371 DISCN | 2003-10-09 | 1 products, RLD |
Hide discontinued
Estradiol valerate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
DELESTROGEN | Par Pharmaceutical | N-009402 RX | 1982-01-01 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
activella | New Drug Application | 2021-08-27 |
alora | OTC monograph not final | 2022-01-07 |
amabelz | ANDA | 2022-12-30 |
angeliq | New Drug Application | 2017-11-14 |
bijuva | New Drug Application | 2021-06-30 |
climara pro | New Drug Application | 2023-03-29 |
combipatch (estradiol/norethindrone acetate transdermal system) | New Drug Application | 2022-12-05 |
delestrogen | New Drug Application | 2022-02-23 |
divigel | New Drug Application | 2022-04-10 |
elestrin | New Drug Application | 2020-10-15 |
Show 15 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
breast neoplasms | EFO_0003869 | D001943 | C50 |
hot flashes | — | D019584 | — |
hypogonadism | HP_0000815 | D007006 | E23.0 |
menorrhagia | HP_0000132 | D008595 | N92.0 |
premature menopause | HP_0008209 | D008594 | E28.31 |
primary ovarian insufficiency | EFO_0004266 | D016649 | E28.3 |
prostatic neoplasms | — | D011471 | C61 |
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 | |||
11033551 | 2037-09-29 | U-3129 | |
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 | |
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
591 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Contraception | D003267 | 12 | 5 | 22 | 14 | 10 | 63 | ||
Menopause | D008593 | EFO_0003922 | N95 | 9 | 7 | 13 | 14 | 6 | 47 |
Infertility | D007246 | EFO_0000545 | 2 | 2 | 4 | 12 | 19 | 38 | |
Healthy volunteers/patients | — | 28 | 4 | 2 | 3 | — | 34 | ||
Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 4 | — | 2 | 7 | 12 | 25 |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 12 | 2 | 1 | 5 | 20 |
Hot flashes | D019584 | — | 3 | 9 | 3 | 3 | 18 | ||
Postmenopause | D017698 | 2 | 3 | 6 | 4 | 3 | 16 | ||
Endometriosis | D004715 | EFO_0001065 | N80 | — | 3 | 7 | 3 | 2 | 14 |
Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | 1 | 3 | 5 | 10 |
Show 69 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Premenstrual syndrome | D011293 | N94.3 | 1 | 1 | 4 | — | 2 | 8 | |
Prostatic neoplasms | D011471 | C61 | — | 5 | 2 | — | — | 6 | |
Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | 2 | 2 | 1 | — | — | 5 |
Schizophrenia | D012559 | EFO_0000692 | F20 | — | 3 | 2 | — | — | 5 |
Atrophy | D001284 | — | 2 | 2 | — | — | 4 | ||
Adenomyosis | D062788 | EFO_1001757 | N80.0 | 1 | — | 1 | — | 1 | 3 |
Metabolic bone diseases | D001851 | HP_0000938 | — | 1 | 2 | — | — | 3 | |
Premenstrual dysphoric disorder | D065446 | F32.81 | — | 2 | 1 | — | — | 3 | |
Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 2 | 1 | — | — | 3 |
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | 1 | — | 1 | 2 |
Show 17 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Covid-19 | D000086382 | U07.1 | — | 3 | — | — | — | 3 | |
Neoplasms | D009369 | C80 | 1 | 1 | — | — | — | 2 | |
Feeding and eating disorders | D001068 | F50 | — | 2 | — | — | — | 2 | |
Bulimia nervosa | D052018 | EFO_0005204 | F50.2 | — | 2 | — | — | — | 2 |
Temporomandibular joint disorders | D013705 | M26.6 | — | 1 | — | — | 1 | 2 | |
Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | — | — | 1 | 2 |
Endometrial neoplasms | D016889 | EFO_0004230 | — | 2 | — | — | — | 2 | |
Orthostatic intolerance | D054971 | — | 1 | — | — | — | 1 | ||
Ovarian diseases | D010049 | — | 1 | — | — | — | 1 | ||
Hemostasis | D006487 | — | 1 | — | — | — | 1 |
Show 20 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Therapeutic equivalency | D013810 | 10 | — | — | — | 1 | 11 | ||
Pharmacokinetics | D010599 | 5 | — | — | — | — | 5 | ||
Drug interactions | D004347 | 3 | — | — | — | 1 | 4 | ||
Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | 1 | 2 |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 2 | — | — | — | — | 2 |
Hepatitis c | D006526 | B19.2 | 2 | — | — | — | — | 2 | |
Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | — | — | — | 1 | 2 |
Transgenes | D019076 | 1 | — | — | — | — | 1 | ||
Cerebral arterial diseases | D002539 | EFO_1000859 | 1 | — | — | — | — | 1 | |
Infections | D007239 | EFO_0000544 | 1 | — | — | — | — | 1 |
Show 10 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Psychological sexual dysfunctions | D020018 | F52.0 | — | — | — | — | 2 | 2 | |
Heart disease risk factors | D000082742 | — | — | — | — | 1 | 1 | ||
Premature menopause | D008594 | HP_0008209 | E28.31 | — | — | — | — | 1 | 1 |
Breast density | D000071060 | — | — | — | — | 1 | 1 | ||
Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 1 | 1 | |
Blood pressure | D001794 | EFO_0004325 | — | — | — | — | 1 | 1 | |
Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | — | — | 1 | 1 |
Intracranial sinus thrombosis | D012851 | — | — | — | — | 1 | 1 | ||
Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | — | — | 1 | 1 | |
Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
Show 11 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
Agency Approved
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Alternate
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Variants
Clinical Variant
No data
Financial
Myfembree - Myovant Sciences
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Ryeqo - Myovant Sciences
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Bijuva - TherapeuticsMD
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Trends
PubMed Central
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Additional graphs summarizing 119,122 documents
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Safety
Black-box Warning
Black-box warning for: Activella, Amabelz, Angeliq, Bijuva, Climara pro, Combipatch (estradiol/norethindrone acetate transdermal system), Delestrogen, Divigel, Elestrin, Estrace, Estradiol valerate, Estring, Estrogel, Evamist, Femring, Imvexxy, Menostar, Minivelle, Myfembree, Natazia, Vagifem, Vivelle-dot, Yaz
Adverse Events
Top Adverse Reactions
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85,982 adverse events reported
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