Norethindrone
Activella, Alyacen, Amabelz, Aranelle, Aurovela, Balziva, Blisovi, Briellyn, Camila, Combipatch, Cyonanz, Dasetta, Emzahh, Errin, Estradiol / Norethindrone, Etyqa, Fe, Finzala, Fyavolv, Gemmily, Gildagia, Gildess, Hailey, Heather, Incassia, Jencycla, Junel, Larin, Leribane, Lupaneta Pack, Merzee, Mibelas, Nor-qd, Norethindrone, Norinyl, Norlestrin, Nortrel, Nylia, Ortho-novum, Oshih, Philith, Taytulla, Wera (norethindrone) is a small molecule pharmaceutical. Norethindrone was first approved as Norlestrin fe 1/50 on 1982-01-01. It is used to treat acne vulgaris, endometrial hyperplasia, endometriosis, hypogonadism, and menorrhagia in the USA. The pharmaceutical is active against progesterone receptor.
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| activella | New Drug Application | 2023-11-30 |
| affodel | ANDA | 2024-04-22 |
| alyacen 1/35 | ANDA | 2024-05-07 |
| alyacen 1/35 alyacen 7/7/7 | ANDA | 2017-09-08 |
| alyacen 7/7/7 | ANDA | 2023-06-07 |
| aranelle | ANDA | 2023-01-31 |
| aurovela 1.5/30 | ANDA | 2023-11-21 |
| aurovela 1/20 | ANDA | 2023-11-21 |
| aurovela 24 fe | ANDA | 2023-11-21 |
| aurovela fe | ANDA | 2023-11-21 |
Show 110 more
Indications
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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 | ||
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
— G03AA05: Norethisterone and ethinylestradiol
— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations
— G03AB04: Norethisterone and ethinylestradiol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC01: Norethisterone
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DC: Estren derivatives, sex hormones and modulators of the genital system
— G03DC02: Norethisterone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA01: Norethisterone and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB05: Norethisterone and estrogen
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
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Clinical
Clinical Trials
173 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 17 | — | 2 | 1 | 1 | 21 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | 4 | 13 | 1 | 2 | 20 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | 10 | 3 | 5 | 20 |
| Leiomyoma | D007889 | HP_0000131 | D25 | — | 2 | 13 | 1 | 4 | 20 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | 2 | 9 | 2 | 6 | 19 |
| Contraception | D003267 | — | — | 1 | 1 | 5 | 4 | 5 | 16 |
| Menopause | D008593 | EFO_0003922 | N95 | 2 | — | 1 | 4 | 2 | 9 |
| Dysmenorrhea | D004412 | HP_0100607 | N94.6 | — | — | 6 | 1 | 1 | 8 |
| Pelvic pain | D017699 | — | — | — | 1 | 2 | 2 | 2 | 7 |
| Uterine hemorrhage | D014592 | — | — | — | 2 | 1 | 2 | 2 | 7 |
Show 27 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 |
| Contraception behavior | D003268 | — | — | 1 | — | 1 | — | 2 | 4 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | 2 | — | 1 | — | — | 3 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | 1 | — | 1 | — | 1 | 3 |
| Postmenopause | D017698 | — | — | — | 1 | 1 | — | — | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | 1 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | 1 | 2 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | 1 | — | — | 1 |
| Fertility preservation | D059247 | — | — | — | 1 | 1 | — | — | 1 |
| Ovulation | D010060 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 1 | — | — | 1 | 5 |
| Benign familial pemphigus | D016506 | — | Q82.8 | 1 | 1 | — | — | 3 | 5 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | — | — | 1 | 3 |
| Endometrial hyperplasia | D004714 | — | N85.0 | — | 2 | — | — | 1 | 3 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | 2 | — | — | 1 | 3 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | 1 | — | — | — | 2 |
| Syndrome | D013577 | — | — | — | 1 | — | — | 1 | 2 |
| Hyperandrogenism | D017588 | — | — | — | 2 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | — | — | — | 1 | 3 |
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | 2 | 3 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Hepatitis c | D006526 | — | B19.2 | 2 | — | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 2 | — | — | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 2 | — | — | — | — | 2 |
| Darier disease | D007644 | Orphanet_218 | E50.8 | 1 | — | — | — | 1 | 2 |
| Bacterial infections | D001424 | — | A49 | 1 | — | — | — | — | 1 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | — | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
Show 15 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 2 | 2 |
| Hemostatic disorders | D020141 | — | — | — | — | — | — | 2 | 2 |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 2 | 2 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 2 | 2 |
| High-risk pregnancy | D018566 | — | — | — | — | — | — | 2 | 2 |
| Pituitary diseases | D010900 | — | E23.7 | — | — | — | — | 1 | 1 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | — | — | — | — | 1 | 1 |
| Microbiota | D064307 | — | — | — | — | — | — | 1 | 1 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 1 | 1 |
| Pulmonary embolism | D011655 | HP_0002204 | I26 | — | — | — | — | 1 | 1 |
Show 24 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Norethindrone |
| INN | norethisterone |
| Description | Norethisterone is a 17beta-hydroxy steroid that is testosterone in which the hydrogen at position 17 is replaced by an ethynyl group and in which the methyl group attached to position 10 is replaced by hydrogen. It has a role as a synthetic oral contraceptive and a progestin. It is a 17beta-hydroxy steroid, a terminal acetylenic compound, a tertiary alcohol and a 3-oxo-Delta(4) steroid. It derives from a hydride of an estrane. |
| Classification | Small molecule |
| Drug class | Progestogen (medication); Progestin |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 68-22-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1162 |
| ChEBI ID | 7627 |
| PubChem CID | 6230 |
| DrugBank | DB00717 |
| UNII ID | T18F433X4S (ChemIDplus, GSRS) |
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Myfembree – Myovant Sciences
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Loestrin – Allergan
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Loestrin – Warner Chilcott
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Loestrin – AbbVie
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Tabular view
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Trends
PubMed Central
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Additional graphs summarizing 20,622 documents
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Safety
Black-box Warning
Black-box warning for: Activella, Aurovela 1.5/30, Aurovela 24 fe, Blisovi 24 fe, Blisovi fe 1.5/30, Blisovi fe 1/20, Charlotte 24fe, Combipatch (estradiol/norethindrone acetate transdermal system), Cyclafem 1/35, Cyclafem 7/7/7, Cyonanz, Dasetta 1/35, Dasetta 7/7/7, Estradiol / norethindrone acetate, Estradiol and norethindrone acetate, Etyqa, Femhrt, Femlyv, Finzala, Fyavolv, Gemmily, Hailey 1.5/30, Hailey 24 fe, Hailey fe 1.5/30, Hailey fe 1/20, Jinteli, Junel, Junel fe, Junel fe 1/20, Kaitlib fe, Larin 1.5/30, Larin 1/20, Larin 24 fe, Larin fe 1/20, Layolis fe, Lo loestrin fe, Loestrin, Loestrin 24 fe, Melodetta 24 fe, Merzee, Mibelas 24 fe, Microgestin 1.5/30, Microgestin 1/20, Microgestin 24 fe, Microgestin fe 1/20, Mimvey, Mimvey mimvey lo, Myfembree, Necon, Nexesta fe, 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, Nylia 1/35, Nylia 7/7/7, Oriahnn, Oshih, Tarina 24 fe, Taysofy, Taytulla, Tilia fe, Tri-legest fe, Wera, Wymzya fe, Zenchent fe
Adverse Events
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17,881 adverse events reported
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