Norgestimate
Estarylla, Estradiol / Norgestimate, Mili, Mono-linyah, 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.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
No data
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 |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| estarylla | ANDA | 2024-01-10 |
| femynor | ANDA | 2020-12-29 |
| meoly milia remover serum | OTC monograph final | 2023-08-17 |
| mili | ANDA | 2022-03-25 |
| milia remover treatment | C200263 | 2023-11-19 |
| mono-linyah | ANDA | 2023-11-29 |
| mononessa | New Drug Application | 2019-01-09 |
| norgestimate and ethinyl estradiol | ANDA | 2024-01-10 |
| nymyo | ANDA | 2020-12-09 |
| ortho cyclen ortho tri cyclen | New Drug Application | 2019-05-16 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| amenorrhea | — | D000568 | N91.2 |
| female infertility | EFO_0008560 | D007247 | N97 |
| uterine hemorrhage | — | D014592 | — |
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
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Clinical
Clinical Trials
636 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 | — | — | — | 157 | 1 | — | 4 | 2 | 164 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 5 | 12 | 7 | 1 | 3 | 24 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 14 | 11 | 1 | 2 | 23 |
| Cataract | D002386 | HP_0000518 | H26.9 | 1 | 1 | 1 | 12 | 2 | 17 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 7 | 8 | 3 | 3 | 15 |
| Contraception | D003267 | — | — | 4 | 2 | 2 | 2 | 3 | 13 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 2 | 5 | 3 | 2 | 12 |
| Infections | D007239 | EFO_0000544 | — | 5 | 1 | 3 | 1 | 1 | 11 |
| Endophthalmitis | D009877 | — | — | 2 | 5 | 3 | 4 | — | 11 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 4 | — | 3 | 3 | — | 10 |
Show 41 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Keratitis | D007634 | HP_0000491 | H16 | — | 1 | 5 | — | — | 5 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | 1 | 1 | 1 | — | 3 | 5 |
| Community-acquired infections | D017714 | — | — | — | 2 | 3 | — | — | 5 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 2 | 1 | 2 | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | 2 | — | — | 4 |
| Extensively drug-resistant tuberculosis | D054908 | — | — | — | 4 | 4 | — | — | 4 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 3 | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | 1 | — | 1 | 3 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | 2 | — | — | 2 |
| Abdominal abscess | D018784 | EFO_1001753 | — | — | — | 1 | — | 1 | 2 |
Show 37 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 13 | 1 | — | — | — | 14 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | 1 | 4 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | 1 | — | — | — | 4 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | 1 | — | — | — | 2 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | 1 | — | — | — | 2 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | — | 1 | — | — | — | 1 |
| Amenorrhea | D000568 | — | N91.2 | — | 1 | — | — | — | 1 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | — | 1 | — | — | — | 1 |
| Tobacco use disorder | D014029 | — | F17 | — | 1 | — | — | — | 1 |
| Metrorrhagia | D008796 | HP_0100608 | N92.1 | — | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | — | — | — | 2 | 5 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 5 | — | — | — | — | 5 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 5 | — | — | — | — | 5 |
| Hepatitis c | D006526 | — | B19.2 | 4 | — | — | — | — | 4 |
| Asthma | D001249 | EFO_0000270 | J45 | 4 | — | — | — | — | 4 |
| Therapeutic equivalency | D013810 | — | — | 4 | — | — | — | — | 4 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 4 | — | — | — | — | 4 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | 1 | — | — | — | 2 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 3 | — | — | — | — | 3 |
| Dyslipidemias | D050171 | HP_0003119 | — | 3 | — | — | — | — | 3 |
Show 57 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 3 | 3 |
| Regeneration | D012038 | — | — | — | — | — | — | 3 | 3 |
| Retinal detachment | D012163 | EFO_0005773 | H33.2 | — | — | — | — | 2 | 2 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 2 | 2 |
| Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 2 | 2 |
| Pneumococcal pneumonia | D011018 | EFO_1001474 | J13 | — | — | — | — | 1 | 1 |
| Pneumococcal infections | D011008 | EFO_0000772 | J13 | — | — | — | — | 1 | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Bronchitis | D001991 | — | J40 | — | — | — | — | 1 | 1 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 1 | 1 |
Show 16 more
Epidemiology
Epidemiological information for investigational and approved indications
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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
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Alternate
TRPC3
TRPC3
TRPC6
TRPC6
Variants
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Financial
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Estimated US medical usage
Norgestimate
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Estradiol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Price per prescription (USD)
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Norgestimate
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Ethinyl estradiol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Estarylla, Femynor, Mili, Mono-linyah, Mononessa, Norgestimate and ethinyl estradiol, Nymyo, Ortho cyclen ortho tri cyclen, 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
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7,366 adverse events reported
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