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Drug ReportsEstradiol
Delestrogen, Zoely(estradiol)
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) is a small molecule pharmaceutical. Estradiol 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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1M
3M
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1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
therapeuticsD013812
reproductive and urinary physiological phenomenaD012101
Trade Name
FDA
EMA
Climara, Delestrogen, Depo-estradiol, Divigel, Elestrin, Estrace, Estradiol, Estring, Estrogel, Evamist, Femring, Imvexxy, Menostar, Minivelle, Vagifem, Vivelle-dot (discontinued: Alora, Delestrogen, Depo-estradiol, Esclim, Estrace, Estraderm, Estradiol, Estradiol cypionate, Estrasorb, Estrogel, Fempatch, Femtrace, Gynodiol, Innofem, Vagifem, Vivelle)
Combinations
Activella, Amabelz, Angeliq, Bijuva, Climara, Combipatch, Estradiol norethindrone, Myfembree, Natazia, Oriahnn (discontinued: Activella, Depo-testadiol, Ditate, Estradiol norethindrone, Estradiol norgestimate, Estradiol progesterone, Etyqa, Lunelle, Prefest, Testosterone cypionate-estradiol cypionate, Testosterone enanthate estradiol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Progesterone
Tradename
Company
Number
Date
Products
BIJUVAMayne GroupN-210132 RX2018-10-28
2 products, RLD, RS
Estradiol
Tradename
Company
Number
Date
Products
ESTROGELAscend TherapeuticsN-021166 RX2004-02-09
1 products, RLD, RS
CLIMARABayerN-020375 RX1994-12-22
6 products, RLD, RS
MENOSTARBayerN-021674 RX2004-06-08
1 products, RLD, RS
IMVEXXYMayne GroupN-208564 RX2018-05-29
2 products, RLD, RS
MINIVELLENoven PharmaceuticalsN-203752 RX2012-10-29
5 products, RLD, RS
VAGIFEMNovo NordiskN-020908 RX2009-11-25
1 products, RLD, RS
EVAMISTPadagisN-022014 RX2007-07-27
1 products, RLD, RS
ESTRINGPfizerN-020472 RX1996-04-26
1 products, RLD, RS
VIVELLE-DOTSandozN-020538 RX1999-01-08
5 products, RLD, RS
DIVIGELVertical PharmaceuticalsN-022038 RX2007-06-04
5 products, RLD, RS
Show 1 marketed
Show 8 discontinued
Estradiol
+
Levonorgestrel
Tradename
Company
Number
Date
Products
CLIMARA PROBayerN-021258 RX2003-11-21
1 products, RLD, RS
Estradiol
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
ACTIVELLAAmneal PharmaceuticalsN-020907 RX1998-11-18
1 products, RLD, RS
COMBIPATCHNoven PharmaceuticalsN-020870 RX1998-08-07
2 products, RLD, RS
Show 1 discontinued
Estradiol valerate
Tradename
Company
Number
Date
Products
DELESTROGENEndoN-009402 RX1982-01-01
2 products, RLD, RS
Show 1 discontinued
Estradiol acetate
Tradename
Company
Number
Date
Products
FEMRINGMillicent PharmaN-021367 RX2003-03-20
2 products, RLD, RS
Show 1 discontinued
Drospirenone
+
Estradiol
Tradename
Company
Number
Date
Products
ANGELIQBayerN-021355 RX2005-09-28
2 products, RLD, RS
Estradiol
+
Norethindrone acetate
+
Relugolix
Tradename
Company
Number
Date
Products
MYFEMBREEMyovant SciencesN-214846 RX2021-05-26
1 products, RLD, RS
Dienogest
+
Estradiol valerate
Tradename
Company
Number
Date
Products
NATAZIABayerN-022252 RX2010-05-06
1 products, RLD, RS
Estradiol
+
Norgestimate
Tradename
Company
Number
Date
Products
PREFESTTevaN-021040 DISCN1999-10-22
1 products, RLD
Hide discontinued
Estradiol hemihydrate
Tradename
Company
Number
Date
Products
ESTRASORBExeltisN-021371 DISCN2003-10-09
1 products, RLD
Hide discontinued
Estradiol cypionate
+
Testosterone cypionate
Tradename
Company
Number
Date
Products
DEPO-TESTADIOLPharmacia & UpjohnN-017968 DISCN1982-01-01
1 products
Hide discontinued
Estradiol cypionate
+
Medroxyprogesterone acetate
Tradename
Company
Number
Date
Products
LUNELLEPharmacia & UpjohnN-020874 DISCN2000-10-05
1 products, RLD
Hide discontinued
Elagolix sodium
+
Elagolix sodium
+
Estradiol
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
ORIAHNN (COPACKAGED)AbbVieN-213388 RX2020-05-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
abigale abigale loANDA2024-09-17
activellaNew Drug Application2023-11-30
afirmelleANDA2024-09-19
altaveraANDA2023-03-02
alyacen 1/35ANDA2024-05-07
alyacen 1/35 alyacen 7/7/7ANDA2017-09-08
alyacen 7/7/7ANDA2023-06-07
amethiaANDA2024-03-01
amethystANDA2022-01-31
angeliqNew Drug Application2023-12-08
Show 276 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
uterine hemorrhage—D014592—
primary ovarian insufficiencyEFO_0004266D016649E28.3
amenorrhea—D000568N91.2
endometrial hyperplasia—D004714N85.0
female infertilityEFO_0008560D007247N97
hot flashes—D019584—
hypogonadism—D007006E23.0
Show 8 more
Agency Specific
FDA
EMA
Expiration
Code
ESTRADIOL / NORETHINDRONE ACETATE / RELUGOLIX, MYFEMBREE, MYOVANT SCIENCES
2026-01-27M-289
2025-12-18NCE
2025-08-05I-898
2024-05-26NP
ESTRADIOL, ESTRADIOL, CHEMO RESEARCH SL
2023-04-08CGT
Patent Expiration
Patent
Expires
Flag
FDA Information
Estradiol / Norethindrone Acetate / Relugolix, Myfembree, Myovant Sciences
110335512037-09-29U-3129
93468222024-02-17U-3129
73009352024-01-28DP
80582802024-01-28DP
Estradiol, Imvexxy, Mayne Pharma
112666612034-02-02U-2316, U-2317
91800912033-12-20DPU-2316, U-2317
102586302033-12-20U-2316, U-2317
103987082033-12-20U-2317, U-2614
104710722033-06-18U-2316, U-2317
105688912033-06-18U-2316, U-2317
106680822033-06-18U-2316, U-2317
108885162033-06-18U-2316, U-2317
110651972033-06-18DP
111167172033-06-18DP
111232832033-06-18DP
92893822032-11-21DP
105375812032-11-21DPU-2316, U-2317
108066972032-11-21DP
108354872032-11-21U-2316, U-2317
112414452032-11-21U-2316, U-2317
112468752032-11-21U-2316, U-2317
113049592032-11-21DP
113511822032-11-21U-2316, U-2317
114977092032-11-21U-2316, U-2317
Estradiol / Progesterone, Bijuva, Mayne Pharma
86331782032-11-21DP
88466482032-11-21U-2439
88466492032-11-21DPU-2439
89330592032-11-21DPU-2439
89872372032-11-21DP
89935482032-11-21DP
89935492032-11-21DP
90062222032-11-21DPU-2439
91141452032-11-21U-2439
91141462032-11-21DPU-2439
93019202032-11-21DPU-2439
100523862032-11-21DP
102069322032-11-21U-2439
106393752032-11-21DP
106752882032-11-21U-2439
108067402032-11-21DPU-2439
110336262032-11-21DPU-2439
111035132032-11-21U-2439
111035162032-11-21DP
111100992032-11-21DP
111669632032-11-21DP
115293602032-11-21DP
Drospirenone / Estradiol, Angeliq, Bayer Hlthcare
89068902031-10-22DP
Estradiol, Minivelle, Noven
82319062030-07-04DS, DP
97243102028-07-10DS, DP
97309002028-07-10U-2086
98334192028-07-10DP
Dienogest / Estradiol Valerate, Natazia, Bayer Hlthcare
81536162028-01-30U-1240
80715772026-05-13DPU-1
Estradiol Acetate, Femtrace, Apil
75727792025-10-02U-904
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03A: Hormonal contraceptives for systemic use
— G03AA: Progestogens and estrogen systemic contraceptives, fixed combinations
— G03AA14: Nomegestrol and estradiol
— G03AA17: Medroxyprogesterone and estradiol
— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations
— G03AB08: Dienogest and estradiol
— G03C: Estrogens, sex hormones and modulators of the genital system
— G03CA: Natural and semisynthetic estrogens, plain
— G03CA03: Estradiol
— G03CA53: Estradiol, combinations
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H01: Pituitary and hypothalamic hormones and analogues
— H01C: Hypothalamic hormones
— H01CC: Anti-gonadotropin-releasing hormones
— H01CC54: Relugolix, estradiol and norethisterone
HCPCS
Code
Description
A9591
Fluoroestradiol f 18, diagnostic, 1 millicurie
J1000
Injection, depo-estradiol cypionate, up to 5 mg
J1380
Injection, estradiol valerate, up to 10 mg
J7294
Segesterone acetate and ethinyl estradiol 0.15mg, 0.013mg per 24 hours; yearly vaginal system, each
J7295
Ethinyl estradiol and etonogestrel 0.015mg, 0.12mg per 24 hours; monthly vaginal ring, each
Clinical
Clinical Trials
1441 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfertilityD007246EFO_0000545—1516153468143
Healthy volunteers/patients———1147665134
ContraceptionD003267——1819462026126
MenopauseD008593EFO_0003922N95131114261979
SyndromeD013577——71113162067
Polycystic ovary syndromeD011085EFO_0000660E28.2638152355
Breast neoplasmsD001943EFO_0003869C50625621551
EndometriosisD004715EFO_0001065N802101611843
Female infertilityD007247EFO_0008560N9794552041
HemorrhageD006470MP_0001914R58171241336
Show 194 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MyofibromaD047708———211—417
Prostatic neoplasmsD011471—C61—84——11
NeoplasmsD009369—C80531—210
AnorexiaD000855—R63.0263——9
Anorexia nervosaD000856EFO_0004215F50.0263——9
InflammationD007249MP_0001845——32—38
Pituitary diseasesD010900—E23.7—13—58
SchizophreniaD012559EFO_0000692F20132——6
Pre-eclampsiaD011225EFO_0000668O14——1—45
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.814—1——5
Show 75 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tissue adhesionsD000267——31——1114
Type 2 diabetes mellitusD003924EFO_0001360E11101——111
Acquired immunodeficiency syndromeD000163EFO_0000765B2081———8
Covid-19D000086382—U07.1—4——48
Male breast neoplasmsD018567——12——13
CarcinomaD002277—C80.0—3———3
VulvodyniaD056650—N94.81—1——23
Gender identityD005783——11——12
Intracranial aneurysmD002532EFO_0003870I67.1—1——12
HemostasisD006487———2———2
Show 43 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——13———114
Therapeutic equivalencyD013810——11———112
PregnancyD011247EFO_0002950Z33.12———68
Diabetes mellitusD003920EFO_0000400E08-E134———37
Drug interactionsD004347——6———17
Hepatitis cD006526—B19.27————7
TransgenesD019076——1———23
PainD010146EFO_0003843R522———13
AsthmaD001249EFO_0000270J453————3
Long qt syndromeD008133HP_0001657I45.811———12
Show 60 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Venous thromboembolismD054556EFO_0004286I74————44
ThromboembolismD013923——————44
Endocrine system diseasesD004700EFO_0001379E34.9————33
Menstrual cycleD008597——————33
Cerebrospinal fluid leakD065634—G96.0————33
Uterine cervical neoplasmsD002583——————22
Traumatic brain injuriesD000070642—S06————22
DiseaseD004194EFO_0000408R69————22
Vascular stiffnessD059289——————22
Kidney diseasesD007674EFO_0003086N08————22
Show 123 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEstradiol
INNestradiol valerate
Description
17beta-estradiol is the 17beta-isomer of estradiol. It has a role as an estrogen, a human metabolite, an EC 1.2.3.1 (aldehyde oxidase) inhibitor, a Daphnia magna metabolite, a mouse metabolite and a geroprotector. It is a 17beta-hydroxy steroid and an estradiol.
Classification
Small molecule
Drug classestrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@]12CC[C@@H]3c4ccc(O)cc4CC[C@H]3[C@@H]1CC[C@@H]2O
Identifiers
PDB—
CAS-ID50-28-2
RxCUI—
ChEMBL IDCHEMBL135
ChEBI ID16469
PubChem CID5757
DrugBankDB00783
UNII ID4TI98Z838E (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
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Myfembree – Myovant Sciences
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Ryeqo – Myovant Sciences
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Bijuva – TherapeuticsMD
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Estradiol – Amneal Pharmaceuticals
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Imvexxy – TherapeuticsMD
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Divigel – RVL Pharmaceuticals
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Estimated US medical usage
Estradiol
+
Dienogest
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Estradiol
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Drospirenone
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Estradiol
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Estradiol
+
Levonorgestrel
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Estradiol
+
Medroxyprogesterone
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Estradiol
+
Norethindrone
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Estradiol
+
Norgestimate
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Estradiol
+
Testosterone
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Abigale abigale lo, Activella, Altavera, Amethia, Angeliq, Annovera, Ashlyna, Aurovela 1.5/30, Aurovela 24 fe, Ayuna, Azurette, Balcoltra, Bekyree, Beyaz, Bijuva, Blisovi 24 fe, Blisovi fe 1.5/30, Blisovi fe 1/20, Camrese, Camrese lo, Camreselo, Charlotte 24fe, Chateal eq, Climara, Climara pro, Climarapro, Combipatch (estradiol/norethindrone acetate transdermal system), Cryselle, Cyclafem 1/35, Cyclafem 7/7/7, Cyonanz, Cyred eq, Dasetta 1/35, Dasetta 7/7/7, Daysee, Delestrogen, Depo-estradiol, Desogestrel and ethinyl estradiol, Divigel, Dotti, Drospirenone and ethinyl estradiol, Drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium, Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, Elestrin, Elinest, Eluryng, Enilloring, Enskyce, Estarylla, Estra-25 estra-50, Estrace, Estradiol / norethindrone acetate, Estradiol and norethindrone acetate, Estradiol and progesterone, Estradiol gel, Estradiol transdermal system, Estradiol vaginal, Estradiol vaginal cream, Estradiol vaginal inserts, Estradiol valerate, Estradiol valerate and estradiol valerate/dienogest, Estring, Estrogel, Etonogestrel and ethinyl estradiol, Etonogestrel and ethinyl estradiol vaginal, Etonogestrel and ethinyl estradiol vaginal ring, Etonogestrel/ethinyl estradiol, Etyqa, Evamist, Feirza 1.5/30 tm, Femhrt, Femlyv, Femring, Femynor, Finzala, Fyavolv, Galbriela, Gemmily, Hailey 1.5/30, Hailey 24 fe, Hailey fe 1.5/30, Hailey fe 1/20, Haloette, Iclevia, Imvexxy, Introvale, Isibloom, Jaimiess, Jasmiel, Jinteli, Jolessa, Joyeaux, Juleber, Junel, Junel fe, Junel fe 1/20, Kaitlib fe, Kalliga, Kariva, Kurvelo, Larin 1.5/30, Larin 1/20, Larin 24 fe, Larin fe 1/20, Layolis fe, Levonorgestrel and ethinyl estradiol and ethinyl estradiol, Levonorgestrel/ethinyl estradiol and ethinyl estradiol, Levora, Lo loestrin fe, Lo simpesse, Lo-zumandimine, Loestrin, Loestrin 24 fe, Lojaimiess, Lopreeza, Loryna, Loseasonique, Low-ogestrel, Lyllana, Marlissa, Melodetta 24 fe, Menostar, Merzee, Mibelas 24 fe, Microgestin 1.5/30, Microgestin 1/20, Microgestin 24 fe, Microgestin fe 1/20, Mili, Mimvey, Mimvey mimvey lo, Minivelle, Minzoya, Mono-linyah, Mononessa, Myfembree, Myzilra, Natazia, Necon, Nexesta fe, Nikki, Norelgestromin and ethinly estradiol, Norelgestromin and ethinyl estradiol, Norethindrone acetate and ethinyl estradiol, Norethindrone acetate and ethinyl estradiol and ferrous fumarate, Norethindrone acetate and ethinyl estradiol, and ferrous fumarate, Norethindrone and ethinyl estradiol, Norethindrone and ethinyl estradiol and ferrous fumarate, Norgestimate and ethinyl estradiol, Nuvaring, Nylia 1/35, Nylia 7/7/7, Nymyo, Ocella, Oriahnn, Ortho tri-cyclen lo, Oshih, Portia, Previfem, Rivelsa, Rosyrah, Safyral, Seasonique, Setlakin, Simliya, Simpesse, Sprintec, Syeda, Tarina 24 fe, Taysofy, Taytulla, Tilia fe, Tri femynor, Tri-estarylla, Tri-legest fe, Tri-linyah, Tri-lo- estarylla, Tri-lo-marzia, Tri-lo-mili, Tri-lo-sprintec, Tri-mili, Tri-nymyo, Tri-sprintec, Tri-vylibra, Tri-vylibra lo, Trinessa, Turqoz, Twirla, Tyblume, Tydemy, Vagifem, Vestura, Viorele, Vivelle dot, Vivelle-dot, Vylibra, Wera, Wymzya fe, Xarah fe, Xelria fe, Xulane, Yasmin, Yaz, Yuvafem, Zafemy, Zarah, Zenchent fe, Zumandimine
Adverse Events
Top Adverse Reactions
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104,985 adverse events reported
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