Norgestimate
Estarylla, Ethinyl Estradiol / Norgestimate, Mili, Mono-linyah, Prefest, Previfem, Sprintec, Tri-estarylla, Tri-linyah, Tri-lo-estarylla, Tri-lo-linyah, Tri-lo-mili, Tri-mili (norgestimate) is a small molecule pharmaceutical. Norgestimate was first approved as Ortho cyclen-21 on 1989-12-29. It is used to treat amenorrhea, female infertility, and uterine hemorrhage in the USA. It is known to target short transient receptor potential channel 3 and short transient receptor potential channel 6.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Combinations
Estarylla, Mili, Mono-linyah, Norgestimate ethinyl estradiol, Previfem, Sprintec, Tri lo sprintec, Tri-estarylla, Tri-linyah, Tri-lo-estarylla, Tri-lo-linyah, Tri-lo-mili, Tri-mili, Tri-sprintec (discontinued: Estradiol norgestimate, Norgestimate ethinyl estradiol, Ortho cyclen, Ortho tri-cyclen, Ortho tri-cyclen lo, Prefest, Tri-previfem)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Norgestimate
Ethinyl estradiol
+
Norgestimate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORTHO CYCLEN-21 | Johnson & Johnson | N-019653 DISCN | 1989-12-29 | 1 products |
| ORTHO CYCLEN-28 | Johnson & Johnson | N-019653 DISCN | 1989-12-29 | 1 products, RLD |
| ORTHO TRI-CYCLEN | Johnson & Johnson | N-019697 DISCN | 1992-07-03 | 2 products |
| ORTHO TRI-CYCLEN LO | Johnson & Johnson | N-021241 DISCN | 2002-08-22 | 1 products, RLD |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| estarylla | ANDA | 2024-10-01 |
| femynor | ANDA | 2020-12-29 |
| mili | ANDA | 2024-12-07 |
| mono-linyah | ANDA | 2025-01-20 |
| mononessa | New Drug Application | 2019-01-09 |
| norgestimate and ethinyl estradiol | ANDA | 2025-05-28 |
| nymyo | ANDA | 2022-12-08 |
| ortho tri cyclen | New Drug Application | 2012-02-27 |
| ortho tri cyclen lo | New Drug Application | 2011-02-03 |
| ortho tri-cyclen lo | New Drug Application | 2009-12-31 |
Show 16 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
— G03AA11: Norgestimate and ethinylestradiol
— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations
— G03AB09: Norgestimate and ethinylestradiol
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA13: Norgestimate and estrogen
HCPCS
No data
Clinical
Clinical Trials
45 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | — | — | 3 | 1 | 2 | 2 | 2 | 10 |
| Contraception behavior | D003268 | — | — | 1 | — | — | 1 | 1 | 3 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | 1 | — | 1 | — | 2 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | 2 | — | 2 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | 1 | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | 1 | — | 1 |
| Perimenopause | D047648 | — | — | — | — | — | 1 | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | — | 1 | — | — | 1 |
| Premature menopause | D008594 | — | E28.31 | — | — | 1 | — | — | 1 |
| Ovarian cysts | D010048 | — | N83.1 | — | 1 | 1 | — | — | 1 |
| Cysts | D003560 | — | — | — | 1 | 1 | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | 1 | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 1 | — | — | 1 |
| Hereditary congenital and neonatal diseases and abnormalities | D009358 | — | — | — | — | 1 | — | — | 1 |
| Neural tube defects | D009436 | — | Q00.0 | — | — | 1 | — | — | 1 |
| Nervous system malformations | D009421 | — | Q00-Q07 | — | — | 1 | — | — | 1 |
| Spinal dysraphism | D016135 | EFO_1001210 | Q05 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombosis | D013927 | — | — | — | 1 | — | — | 1 | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | — | 1 |
| Metrorrhagia | D008796 | — | N92.1 | — | 1 | — | — | — | 1 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 1 | — | — | — | 1 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | — | 8 |
| Pharmacokinetics | D010599 | — | — | 6 | — | — | — | — | 6 |
| Hepatitis c | D006526 | — | B19.2 | 3 | — | — | — | — | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | — | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | — | — | — | 2 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | — | — | — | — | 2 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | — | — | — | 1 |
Show 10 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thrombosis | D020246 | — | I82.40 | — | — | — | — | 1 | 1 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 1 | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
| Thromboembolism | D013923 | — | — | — | — | — | — | 1 | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 1 | 1 |
| Overweight | D050177 | — | E66.3 | — | — | — | — | 1 | 1 |
| Body weight changes | D001836 | — | — | — | — | — | — | 1 | 1 |
| Appetitive behavior | D001070 | — | — | — | — | — | — | 1 | 1 |
Show 1 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Norgestimate |
| INN | norgestimate |
| Description | Norgestimate is a steroid ester, a ketoxime and a terminal acetylenic compound. It has a role as a contraceptive drug, a progestin and a synthetic oral contraceptive. |
| Classification | Small molecule |
| Drug class | progestins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C#C[C@]1(OC(C)=O)CC[C@H]2[C@@H]3CCC4=C/C(=N/O)CC[C@@H]4[C@H]3CC[C@@]21CC |
Identifiers
| PDB | — |
| CAS-ID | 35189-28-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200934 |
| ChEBI ID | 50815 |
| PubChem CID | 6540478 |
| DrugBank | DB00957 |
| UNII ID | C291HFX4DY (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
TRPC3
TRPC3
TRPC6
TRPC6
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Norgestimate
+
Estradiol
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Norgestimate
+
Ethinyl estradiol
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 988 documents
View more details
Safety
Black-box Warning
Black-box warning for: Estarylla, Femynor, Mili, Mono-linyah, Mononessa, Norgestimate and ethinyl estradiol, Nymyo, Ortho tri-cyclen lo, Previfem, Sprintec, Tri femynor, Tri-estarylla, 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, Vylibra
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
5,360 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use