Norgestrel
Cryselle, Elinest, Low-ogestrel, Opill, Prefest, Previfem, Sprintec, Tri-sprintec, Turqoz (norgestrel) is a small molecule pharmaceutical. Norgestrel was first approved as Lo/ovral on 1982-01-01. The pharmaceutical is active against progesterone receptor.
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Commercial
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Trade Name
FDA
EMA
Opill
CombinationsCryselle, Elinest, Low-ogestrel, Turqoz (discontinued: Lo/ovral, Low-ogestrel, Norgestrel ethinyl estradiol, Ogestrel, Ovral)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Norgestrel
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OPILL | HRA Pharma | N-017031 OTC | 1982-01-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cryselle | ANDA | 2024-05-07 |
| elinest | ANDA | 2023-01-31 |
| low-ogestrel | ANDA | 2024-10-10 |
| norgestimate and ethinyl estradiol | ANDA | 2025-04-08 |
| opill | New Drug Application | 2025-03-13 |
| previfem | ANDA | 2016-12-02 |
| sprintec | ANDA | 2024-12-19 |
| tri-lo-sprintec | ANDA | 2023-02-01 |
| tri-sprintec | ANDA | 2025-03-12 |
| turqoz | ANDA | 2025-05-15 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NORGESTREL, OPILL, LABORATOIRE HRA | |||
| 2026-07-13 | RTO | ||
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
— G03AA06: Norgestrel and ethinylestradiol
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA10: Norgestrel and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB01: Norgestrel and estrogen
HCPCS
Code | Description |
|---|---|
| J7296 | Levonorgestrel-releasing intrauterine contraceptive system, (kyleena), 19.5 mg |
| J7297 | Levonorgestrel-releasing intrauterine contraceptive system (liletta), 52 mg |
| J7298 | Levonorgestrel-releasing intrauterine contraceptive system (mirena), 52 mg |
| J7301 | Levonorgestrel-releasing intrauterine contraceptive system (skyla), 13.5 mg |
| J7306 | Levonorgestrel (contraceptive) implant system, including implants and supplies |
| S4981 | Insertion of levonorgestrel-releasing intrauterine system |
Clinical
Clinical Trials
704 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 | — | — | — | 193 | 1 | — | 5 | 2 | 201 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 7 | 30 | 22 | 6 | 9 | 64 |
| Infections | D007239 | EFO_0000544 | — | 6 | 2 | 14 | 6 | 6 | 34 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 1 | 20 | 17 | 1 | 2 | 33 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 5 | 14 | 5 | 7 | 31 |
| Cataract | D002386 | EFO_0001059 | H26.9 | 3 | 3 | 3 | 20 | 4 | 31 |
| Communicable diseases | D003141 | — | — | — | 2 | 13 | 6 | 1 | 22 |
| Contraception | D003267 | — | — | 4 | 5 | 6 | 1 | 3 | 19 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 7 | 9 | 3 | 4 | 17 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 5 | 1 | 4 | 4 | — | 13 |
Show 75 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 8 | — | 1 | — | 2 | 11 |
| Keratitis | D007634 | — | H16 | — | 1 | 7 | — | 2 | 9 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 2 | 6 | — | — | 8 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 5 | — | 1 | — | — | 6 |
| Community-acquired infections | D017714 | — | — | — | 2 | 4 | — | — | 6 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | 1 | — | 1 | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | 3 | — | — | 5 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | 1 | 1 | 1 | — | 3 | 5 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | 1 | 2 | — | 1 | 4 |
| Mycobacterium infections | D009164 | — | A31.9 | 1 | 1 | 3 | — | — | 4 |
Show 66 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 14 | 1 | — | — | — | 15 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | 1 | — | — | — | 4 |
| Pharmacological phenomena | D000069437 | — | — | 2 | 1 | — | — | — | 3 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | 1 | — | — | — | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 1 | — | — | — | 2 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | — | 1 | — | — | — | 1 |
| Amenorrhea | D000568 | — | N91.2 | — | 1 | — | — | — | 1 |
| Hypoxia | D000860 | — | R09.02 | — | 1 | — | — | — | 1 |
| H1n1 subtype influenza a virus | D053118 | — | — | — | 1 | — | — | — | 1 |
| Tobacco use disorder | D014029 | — | F17 | — | 1 | — | — | — | 1 |
Show 8 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 7 | — | — | — | 1 | 8 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | 4 | — | — | — | 3 | 7 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 6 | — | — | — | — | 6 |
| Hepatitis c | D006526 | — | B19.2 | 6 | — | — | — | — | 6 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 5 | — | — | — | — | 5 |
| Therapeutic equivalency | D013810 | — | — | 5 | — | — | — | — | 5 |
| Hypertension | D006973 | EFO_0000537 | I10 | 4 | — | — | — | — | 4 |
| Asthma | D001249 | EFO_0000270 | J45 | 4 | — | — | — | — | 4 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 4 | — | — | — | — | 4 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | 1 | — | — | — | 2 | 3 |
Show 87 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | — | 4 | 4 |
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 3 | 3 |
| Regeneration | D012038 | — | — | — | — | — | — | 3 | 3 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 2 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 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 |
| Aortic dissection | D000784 | — | I71.0 | — | — | — | — | 1 | 1 |
Show 27 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Norgestrel |
| INN | norgestrel |
| Description | Norgestrel is a progestin which is used in birth control pills sold under the brand name Ovral in combination with the estrogen ethinylestradiol and Opill by itself. It is also used in menopausal hormone therapy. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | estrogens; progestins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C#CC1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@@]21CC |
Identifiers
| PDB | — |
| CAS-ID | 6533-00-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2107797 |
| ChEBI ID | — |
| PubChem CID | 16051930 |
| DrugBank | DB00506 |
| UNII ID | 3J8Q1747Z2 (ChemIDplus, GSRS) |
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Estimated US medical usage
Norgestrel
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Ethinyl estradiol
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Norgestrel
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Cryselle, Elinest, Low-ogestrel, Norgestimate and ethinyl estradiol, Previfem, Sprintec, Tri-lo-sprintec, Tri-sprintec, Turqoz
Adverse Events
Top Adverse Reactions
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121,506 adverse events reported
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