norethindrone

Small moleculeapproved

Approved

Jun 1, 1957

Norethisterone (INN, BAN), also known as Norethindrone (USAN) (brand names Micronor, AYGESTIN, numerous others) is a synthetic progestational hormone (progestin) with actions similar to those of progesterone but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. AYGESTIN® is not intended, recommended or approved to be used with oncomitant estrogen therapy in postmenopausal women for endometrial protection. Progestins diffuse freely into target cells and bind to the progesterone receptor. Target cells include the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progestins slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH surge. Allergic reaction could be: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing. — NCATS

Clinical trial activity

126 trials · 108 clinical orgs · 37 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jan 1, 1993 (NCT00004763)

Timeline

1950s

Jun 1, 1957
Parke-Davis — Earliest FDA Approval
Jun 1, 1957
Parke-Davis — NDA Organization

1960s

May 21, 1962
Johnson and Johnson — Marketing Organization
Mar 5, 1964
Actavis — Marketing Organization
Mar 5, 1964
Actavis — NDA Secondary Org
Nov 6, 1968
G D Searle — Marketing Organization
Nov 6, 1968
G D Searle — NDA Secondary Org

1970s

Jan 2, 1973
Allergan — NDA Secondary Org
Jan 2, 1973
Johnson and Johnson — NDA Secondary Org
Jan 2, 1973
Teva — NDA Secondary Org
Dec 26, 1974
Allergan — Marketing Organization
Aug 28, 1975
Warner Chilcott — Marketing Organization
Aug 28, 1975
Warner Chilcott — NDA Secondary Org

1980s

Apr 21, 1982
Duramed Research — NDA Secondary Org
Apr 11, 1984
Mayne Pharma — Marketing Organization
Apr 11, 1984
Dr. Reddy's Laboratories — NDA Secondary Org
Jul 18, 1986
Pfizer — NDA Secondary Org
Jan 29, 1987
Teva — Marketing Organization
Jan 29, 1987
Watson Pharmaceuticals — Marketing Organization
Jan 29, 1987
Dr. Reddy's Laboratories — Marketing Organization
Dec 14, 1987
Lupin — Marketing Organization
Apr 12, 1988
Heritage Pharma — Marketing Organization

1990s

Feb 28, 1992
Barr Laboratories — Marketing Organization
Jan 1, 1993
Earliest Phase 2 Sponsor(trial)
Oct 9, 1996
SmithKline Beecham — NDA Secondary Org
Jan 1, 1997
Earliest Phase 3 Sponsor(trial)
Jan 1, 1998
Earliest Phase 1 Sponsor(trial)
Aug 7, 1998
Noven Therapeutics — Marketing Organization
Aug 7, 1998
Noven Therapeutics — NDA Secondary Org
Nov 18, 1998
Amneal Pharmaceuticals — NDA Secondary Org

2000s

Apr 11, 2000
Novo Nordisk — Marketing Organization
Apr 11, 2000
Novo Nordisk — NDA Secondary Org
Nov 14, 2003
GlaxoSmithKline — NDA Secondary Org
Apr 17, 2008
Esteve Labs — Marketing Organization
Sep 1, 2009
Amneal Pharmaceuticals — Marketing Organization

2010s

Apr 23, 2010
Glenmark Pharmaceuticals — Marketing Organization
Nov 12, 2010
Apax Partners — Marketing Organization
Nov 6, 2012
Vintage — Marketing Organization
Dec 14, 2012
AbbVie — Marketing Organization
Jun 12, 2013
Mylan — Marketing Organization
Aug 23, 2013
Novast Labs — Marketing Organization
Jan 8, 2016
Aurobindo Pharma — Marketing Organization
Dec 13, 2016
Accord Research — Marketing Organization
Dec 13, 2016
Naari Pte Ltd — Marketing Organization
Mar 21, 2018
Apotex — Marketing Organization
Jul 16, 2018
Exeltis — Marketing Organization
Nov 5, 2018
Pack Pharmaceuticals — Marketing Organization
Nov 5, 2018
Rising Pharmaceuticals — Marketing Organization

2020s

May 29, 2020
AbbVie — NDA Secondary Org
Dec 18, 2020
Slayback Pharma Llc — Marketing Organization
May 26, 2021
Myovant Sciences GmbH — NDA Secondary Org
May 26, 2021
Sumitomo Dainippon — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Progesterone receptorAGONIST
PGR agonist
- Progesterone receptor (PGR) ↗

Combination products

combipatch
with estradiol
Also known as activella, amabelz
loestrin fe
with ethinyl estradiol
Also known as alyacen, aranelle, aurovela, aurovela 24 fe, aurovela fe, balziva, blisovi 24 fe, blisovi fe, brevicon, briellyn, cyclafem, cyonanz, dasetta, estrostep, estrostep fe, femcon fe, femhrt, fyavolv, gencept, gildagia, gildess, gildess 24 fe, gildess fe, hailey, hailey fe, junel, junel fe, kaitlib fe, larin, larin 24 fe, larin fe, leribane, loestrin, loestrin 24 fe, lo larin fe, lo loestrin fe, lo minastrin fe, mibelas 24 fe, microgestin, microgestin fe, minastrin 24 fe, modicon, n.e.e, net/ee, nexesta fe, norcept-e, norethin 1/35e, norethindrone acetate and ethinyl estradiol and ethinyl estradiol and ferrous fumarate, norethindrone acetate and ethinyl estradiol and ferrous fumarate, norethindrone and ethinyl estradiol (10/11), norethindrone and ethinyl estradiol (7/14), norethindrone and ethinyl estradiol and ferrous fumarate, nortrel, nylia, ovcon, philith, pirmella, taytulla, tri-legest, tri-legest fe, tri-norinyl, vyfemla, wera
lupaneta pack
with leuprolide
myfembree
with relugolix, estradiol
Also known as relugolix/e2/neta fdc, ryeqo
norminest fe
with ferrous fumarate, ethinyl estradiol
Also known as lo-blisovi fe, norquest fe
oriahnn (copackaged)
with elagolix, estradiol
ortho-novum
with mestranol
Also known as norethin 1/50m

Approval history

approvedJun 1, 1957

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CC[C@H]3[C@@H](CCC4=CC(=O)CC[C@H]34)[C@@H]1CC[C@@]2(O)C#C

Mol. weight: 298.4192 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Black box warning

Sources

Also known as

(17 alpha)-17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one
(17alpha)-17-ethynyl-17-hydroxyestra-4,8(14),9-trien-3-one
(17alpha)-17-ethynyl-17-hydroxyestra-4,8(14),9-trien-3-one
17alpha-ethinyl-19-nortestosterone
17alpha-ethinyl-19-nortestosterone
17alpha-ethinylestra-4-en-17beta-ol-3-one
17alpha-ethinylestra-4-en-17beta-ol-3-one
17alpha-ethynyl-17beta-hydroxy-19-norandrost-4-en-3-one
17alpha-ethynyl-17beta-hydroxy-19-norandrost-4-en-3-one
17-alpha-ethynyl-17-hydroxy-4-estren-3-one
17-alpha-ethynyl-17-hydroxy-4-estren-3-one
17alpha-ethynyl-17-hydroxy-4-estren-3-one
17alpha-ethynyl-17-hydroxy-4-estren-3-one
17alpha-ethynyl-19-nor-4-androsten-17beta-ol-3-one
17alpha-ethynyl-19-nor-4-androsten-17beta-ol-3-one
17-alpha-ethynyl-19-norandrost-4-en-17-beta-ol-3-one
17-alpha-ethynyl-19-norandrost-4-en-17-beta-ol-3-one
17alpha-ethynyl-19-norandrost-4-en-17beta-ol-3-one
17alpha-ethynyl-19-norandrost-4-en-17beta-ol-3-one
17-alpha-ethynyl-19-nortestosterone
17-alpha-ethynyl-19-nortestosterone
17alpha-ethynyl-19-nortestosterone
17alpha-ethynyl-19-nortestosterone
17-alpha-ethynyl-4-estren-17-ol-3-one
17-alpha-ethynyl-4-estren-17-ol-3-one
17alpha-ethynyl-4-estren-17-ol-3-one
17alpha-ethynyl-4-estren-17-ol-3-one
17-beta-hydroxy-19-norpregn-4-en-20-yn-3-one
17-beta-hydroxy-19-norpregn-4-en-20-yn-3-one
17beta-hydroxy-19-norpregn-4-en-20-yn-3-one
17beta-hydroxy-19-norpregn-4-en-20-yn-3-one
17-ethynyl-19-nortestosterone
17-hydroxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one
17-hydroxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one
17-hydroxy-19-nor-17alpha-pregn-4-en-20-yn-3-one
17-hydroxy-19-nor-17alpha-pregn-4-en-20-yn-3-one
17α-ethinyl-19-nortestosterone
17α-ethinyl-19-nortestosterone
19-nor-17-alpha-ethynyl-17-beta-hydroxy-4-androsten-3-one
19-nor-17-alpha-ethynyl-17-beta-hydroxy-4-androsten-3-one
19-nor-17alpha-ethynyl-17beta-hydroxy-4-androsten-3-one
19-nor-17alpha-ethynyl-17beta-hydroxy-4-androsten-3-one
19-nor-17-alpha-ethynylandrosten-17-beta-ol-3-one
19-nor-17-alpha-ethynylandrosten-17-beta-ol-3-one
19-nor-17alpha-ethynylandrosten-17beta-ol-3-one
19-nor-17alpha-ethynylandrosten-17beta-ol-3-one
19-nor-17-alpha-ethynyltestosterone
19-nor-17-alpha-ethynyltestosterone
19-nor-17alpha-ethynyltestosterone
19-nor-17alpha-ethynyltestosterone
19-nor-17alpha-ethynyltestosterone
19-nor-17-ethynyltestosterone
19-nor-17α-ethynyltestosterone
19-nor-17α-ethynyltestosterone
19-nor-ethindrone
19-nor-ethindrone
19-norethisterone
19-norethisterone
19-norethisterone acetate
4-estren-17alpha-ethynyl-17beta-ol-3-one
4-estren-17alpha-ethynyl-17beta-ol-3-one
activella
activella
aygestin
aygestin
aygestin
aygestin
aygestin
aygestin
camila
camila
combipatch
combipatch
errin
errin
femhrt
heather
loestrin
loestrin
menzol
menzol
micronor
micronor
micronor hrt
noresthisterone
noresthisterone
norethidrone
norethidrone acetate
norethindrone
norethindrone
norethindrone
norethindrone
norethindrone
norethindrone
norethindrone
norethindrone
norethindrone
norethindrone acetate
norethindrone acetate
norethindrone acetate
norethindrone acetate
norethindrone acetate
norethindrone acetate
norethindrone acetate
norethindrone acetate, (17alpha)-isomer
norethindrone acetate, (17alpha)-(+-)-isomer
norethindrone enanthate
norethisteron
norethisteron
norethisteron
norethisterone
norethisterone
norethisterone
norethisterone
norethisterone
norethisterone
norethisterone
norethisterone acetate
norethisterone acetate
norethisterone acetate
norethisterone acetate
norethisteronum
norethisteronum
norethynodrone
noretisterona
noretisterona
noriday
noriday
norlestrin
norlestrin
norlutate
norlutate
norlutate
norlutate
norlutin
norlutin
norlutin
nor-qd
nor-qd
primolut n
primolut n
utovlan
utovlan

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07293728	Phase 4	Jul 31, 2026	Oregon Health and Science University
NCT07173127	N/A	Sep 30, 2025	University of Geneva
NCT07074327	Phase 1	Jul 11, 2025	Vertex
NCT06310616	Phase 1	Mar 6, 2024	ViiV Healthcare
NCT06076486	Phase 3	Sep 14, 2023	Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd, Peking University
NCT05891262	Phase 1	Jun 6, 2023	Bristol-Myers Squibb
NCT05579574	Phase 1	Oct 21, 2022	Bristol-Myers Squibb
NCT05293574	Phase 4	Oct 1, 2022	Assiut University
NCT05648669	Phase 3	Sep 4, 2022	Chinese Academy of Medical Sciences, Qilu Pharmaceutical Co., Ltd.
NCT05294341	Phase 4	Jul 22, 2022	Pennsylvania State University
NCT05586724	Phase 3	Feb 25, 2022	Karolinska Institute
NCT05050357	N/A	Oct 1, 2021	Assiut University
NCT04948489	Phase 2	Sep 1, 2021	Harvard University
NCT05476172	N/A	Apr 1, 2021	Uludag University
NCT04676061	Phase 4	Feb 11, 2021	Baylor University, Merck
NCT04714554	Phase 1	Jan 6, 2021	Myovant Sciences GmbH
NCT04423068	Early Phase 1 (Phase 1)	Jan 1, 2021	University of Kansas
NCT04527003	Phase 3	Dec 4, 2020	Pennsylvania State University
NCT04372121	Phase 3	Mar 23, 2020	ObsEva SA
NCT04335591	Phase 3	Mar 5, 2020	ObsEva SA

Showing 20 of 126 trials

Page 1 / 7

Organizations

Research & Development (108)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
AbbVie	For profit	8	8	2	2011
Bristol-Myers Squibb	For profit	8	8	1	2014
Myovant Sciences GmbH	For profit	8	8	2	2016
Nobel Pharmaceuticals	For profit	7	7	1	2004
University of Southern California	Academic/Hospital	5	5	3	2007
Warner Chilcott	For profit	5	4	3	2004
GlaxoSmithKline	For profit	4	4	1	2007
Harvard University	Academic/Hospital	4	3	2	2004
Novo Nordisk	For profit	4	4	3	2001
Pennsylvania State University	Academic/Hospital	4	4	3	2008
Sponsor GmbH	Academic/Hospital	4	0	2	2004
Teva	For profit	4	4	1	2006
Karolinska Institute	Academic/Hospital	3	2	2	1997
Merck	For profit	3	1	2	2004
National Institutes of Health (NIH)	Government	3	2	2	2004
Nissay Hospital, Osaka	Academic/Hospital	3	0	1	2008
Assiut University	Academic/Hospital	2	2	2	2021
Bayer	For profit	2	2	2	2007
Baylor University	Academic/Hospital	2	1	2	1993
Biovail	For profit	2	0	1	2007

108 organizations

Page 1 / 6

Marketing (69)

Organization	Org type	Relationship	Date
AbbVie	For profit	MKTG	Dec 14, 2012
AbbVie	For profit	NDA2	May 29, 2020
Accord Research	For profit	MKTG	Dec 13, 2016
Actavis	For profit	MKTG	Mar 5, 1964
Actavis	For profit	NDA2	Mar 5, 1964
Allergan	For profit	NDA2	Jan 2, 1973
Allergan	For profit	MKTG	Dec 26, 1974
Allergan	For profit	SYN	Dec 26, 1974
Amneal Pharmaceuticals	For profit	MKTG	Sep 1, 2009
Amneal Pharmaceuticals	For profit	SYN	Nov 18, 1998
Amneal Pharmaceuticals	For profit	MKTG	May 12, 2021
Amneal Pharmaceuticals	For profit	NDA2	Nov 18, 1998
Apax Partners	For profit	MKTG	Nov 12, 2010
Apotex	For profit	MKTG	Mar 21, 2018
Apotex	For profit	SYN	Mar 21, 2018
Aurobindo Pharma	For profit	MKTG	Jan 8, 2016
Aurobindo Pharma	For profit	SYN	Sep 23, 2016
Barr Laboratories	For profit	MKTG	Feb 28, 1992
Barr Laboratories	For profit	SYN	Nov 6, 2009
Dr. Reddy's Laboratories	For profit	NDA2	Apr 11, 1984
Dr. Reddy's Laboratories	For profit	MKTG	Jan 29, 1987
Duramed Research	For profit	NDA2	Apr 21, 1982
Esteve Labs	For profit	MKTG	Apr 17, 2008
Exeltis	For profit	MKTG	Jul 16, 2018
Exeltis	For profit	SYN	Jul 16, 2018
G D Searle	For profit	MKTG	Nov 6, 1968
G D Searle	For profit	NDA2	Nov 6, 1968
GlaxoSmithKline	For profit	NDA2	Nov 14, 2003
Glenmark Pharmaceuticals	For profit	MKTG	Apr 23, 2010
Glenmark Pharmaceuticals	For profit	SYN	Jun 5, 2018
Glenmark Pharmaceuticals	For profit	SYN	Jan 20, 2016
Heritage Pharma	For profit	MKTG	Apr 12, 1988
Johnson and Johnson	For profit	NDA2	Jan 2, 1973
Johnson and Johnson	For profit	MKTG	May 21, 1962
Johnson and Johnson	For profit	SYN	Aug 21, 1968
Lupin	For profit	MKTG	Dec 14, 1987
Lupin	For profit	SYN	May 24, 2016
Lupin	For profit	SYN	Sep 19, 2011
Lupin	For profit	SYN	May 24, 2016
Mayne Pharma	For profit	MKTG	Apr 11, 1984
Mylan	For profit	MKTG	Jun 12, 2013
Mylan	For profit	SYN	Jun 22, 2018
Myovant Sciences GmbH	For profit	NDA2	May 26, 2021
Naari Pte Ltd	For profit	MKTG	Dec 13, 2016
Novast Labs	For profit	MKTG	Aug 23, 2013
Novast Labs	For profit	SYN	Dec 22, 2011
Noven Therapeutics	For profit	MKTG	Aug 7, 1998
Noven Therapeutics	For profit	NDA2	Aug 7, 1998
Novo Nordisk	For profit	MKTG	Apr 11, 2000
Novo Nordisk	For profit	SYN	Dec 29, 2006
Novo Nordisk	For profit	NDA2	Apr 11, 2000
Pack Pharmaceuticals	For profit	MKTG	Nov 5, 2018
Parke-Davis	For profit	NDA	Jun 1, 1957
Pfizer	For profit	NDA2	Jul 18, 1986
Rising Pharmaceuticals	For profit	MKTG	Nov 5, 2018
Slayback Pharma Llc	For profit	MKTG	Dec 18, 2020
SmithKline Beecham	For profit	NDA2	Oct 9, 1996
Sumitomo Dainippon	For profit	NDA2	May 26, 2021
Teva	For profit	MKTG	Jan 29, 1987
Teva	For profit	SYN	Mar 8, 2012
Teva	For profit	NDA2	Jan 2, 1973
Teva	For profit	SYN	Apr 7, 2020
Vintage	For profit	MKTG	Nov 6, 2012
Vintage	For profit	SYN	Apr 28, 2005
Warner Chilcott	For profit	SYN	Jul 5, 1978
Warner Chilcott	For profit	MKTG	Aug 28, 1975
Warner Chilcott	For profit	NDA2	Aug 28, 1975
Watson Pharmaceuticals	For profit	SYN	Jan 29, 1987
Watson Pharmaceuticals	For profit	MKTG	Jan 29, 1987