Norgestrel
Lo/ovral, Low-ogestrel, Ogestrel, Opill, Ovral (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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New Drug Application (NDA)
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Ethinyl estradiol
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Norgestrel
Norgestrel
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
OPILL | HRA Pharma | N-017031 DISCN | 1982-01-01 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
cryselle | ANDA | 2023-06-07 |
elinest | ANDA | 2018-11-26 |
low-ogestrel | ANDA | 2023-06-07 |
Indications
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Agency Specific
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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 |
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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
546 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 | — | 154 | 1 | — | 5 | 1 | 161 | ||
Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 5 | 12 | 5 | 1 | — | 19 |
Cataract | D002386 | EFO_0001059 | H26.9 | 1 | — | 1 | 9 | 2 | 13 |
Infections | D007239 | EFO_0000544 | 5 | 1 | 3 | 1 | 1 | 11 | |
Endophthalmitis | D009877 | 2 | 5 | 3 | 4 | — | 11 | ||
Pneumonia | D011014 | EFO_0003106 | J18 | — | 2 | 5 | 2 | 1 | 10 |
Bacterial infections | D001424 | A49 | 3 | — | 1 | 4 | 1 | 9 | |
Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | — | 1 | 4 | 3 | — | 8 |
Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 4 | — | 2 | 1 | — | 7 |
Chronic bronchitis | D029481 | J42 | — | — | 2 | 1 | 4 | 7 |
Show 33 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 11 | 8 | — | 2 | 17 |
Contraception | D003267 | 1 | 4 | 5 | — | 1 | 11 | ||
Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | 7 | 8 | — | — | 9 | |
Community-acquired infections | D017714 | — | 2 | 3 | — | — | 5 | ||
Lung diseases | D008171 | EFO_0003818 | 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 |
Keratitis | D007634 | H16 | — | — | 3 | — | — | 3 | |
Lymphoma | D008223 | C85.9 | 1 | — | 1 | — | 1 | 3 |
Show 36 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pharmacokinetics | D010599 | 8 | 1 | — | — | — | 9 | ||
Neoplasms | D009369 | C80 | 2 | 1 | — | — | 1 | 4 | |
Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | 1 | — | — | — | 4 |
Cholangitis | D002761 | K83.0 | — | 1 | — | — | — | 1 | |
Corneal ulcer | D003320 | H16.0 | — | 1 | — | — | — | 1 | |
Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | 1 | |
Meningeal tuberculosis | D014390 | A17.0 | — | 1 | — | — | — | 1 | |
Graft vs host disease | D006086 | D89.81 | — | 1 | — | — | — | 1 | |
Menorrhagia | D008595 | N92.0 | 1 | 1 | — | — | — | 1 | |
Aplastic anemia | D000741 | HP_0001915 | D61.9 | 1 | 1 | — | — | — | 1 |
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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 | 6 | — | — | — | — | 6 |
Hiv infections | D015658 | EFO_0000764 | B20 | 3 | — | — | — | 1 | 4 |
Schizophrenia | D012559 | EFO_0000692 | F20 | 4 | — | — | — | — | 4 |
Alzheimer disease | D000544 | EFO_0000249 | F03 | 4 | — | — | — | — | 4 |
Asthma | D001249 | EFO_0000270 | J45 | 3 | — | — | — | — | 3 |
Hepatitis c | D006526 | B19.2 | 3 | — | — | — | — | 3 | |
Dyslipidemias | D050171 | HP_0003119 | 3 | — | — | — | — | 3 | |
Therapeutic equivalency | D013810 | 3 | — | — | — | — | 3 | ||
Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 2 | — | — | — | — | 2 |
Hypoglycemia | D007003 | HP_0001943 | E16.2 | 1 | — | — | — | 1 | 2 |
Show 49 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 2 | 2 |
Pathologic dilatation | D004108 | — | — | — | — | 2 | 2 | ||
Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 2 | 2 |
Regeneration | D012038 | — | — | — | — | 2 | 2 | ||
Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 2 | 2 |
Delirium | D003693 | R41.0 | — | — | — | — | 1 | 1 | |
Mycoplasma pneumonia | D011019 | EFO_0007387 | J15.7 | — | — | — | — | 1 | 1 |
Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | — | 1 | 1 |
Chemical and drug induced liver injury | D056486 | — | — | — | — | 1 | 1 | ||
Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | NORGESTREL |
INN | norgestrel |
Description | Norgestrel, sold under the brand name Ovral among others, is a progestin medication which is used in birth control pills and in menopausal hormone therapy. It is available both in combination with an estrogen and alone. It is taken by mouth.
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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 | DB09389 |
UNII ID | 3J8Q1747Z2 (ChemIDplus, GSRS) |
Target
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Safety
Black-box Warning
Black-box warning for: Cryselle, Low-ogestrel
Adverse Events
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873 adverse events reported
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