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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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Trade Name
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EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ethinyl estradiol
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Norgestrel
Tradename
Company
Number
Date
Products
LO/OVRALCadence PharmaceuticalsN-017612 DISCN1982-01-01
1 products, RLD
OVRALWYETH PHARMSN-016672 DISCN1982-01-01
1 products
OVRAL-28WYETH PHARMSN-016806 DISCN1982-01-01
1 products
LO/OVRAL-28WYETH PHARMSN-017802 DISCN1982-01-01
1 products, RLD
Hide discontinued
Norgestrel
Tradename
Company
Number
Date
Products
OPILLHRA PharmaN-017031 DISCN1982-01-01
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cryselleANDA2023-06-07
elinest ANDA2018-11-26
low-ogestrelANDA2023-06-07
Indications
FDA
EMA
No data
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
— 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
546 clinical trials
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Mock data
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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—1541—51161
TuberculosisD014376EFO_0000774A15-A1951251—19
CataractD002386EFO_0001059H26.91—19213
InfectionsD007239EFO_00005445131111
EndophthalmitisD0098772534—11
PneumoniaD011014EFO_0003106J18—252110
Bacterial infectionsD001424A493—1419
Bacterial conjunctivitisD003234EFO_1000829H10.0—143—8
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.94—21—7
Chronic bronchitisD029481J42——2147
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary tuberculosisD014397EFO_1000049A15—118—217
ContraceptionD003267145—111
Multidrug-resistant tuberculosisD018088EFO_0007381—78——9
Community-acquired infectionsD017714—23——5
Lung diseasesD008171EFO_0003818J98.4212——4
Breast neoplasmsD001943EFO_0003869C50112——4
Extensively drug-resistant tuberculosisD054908—44——4
Bacterial pneumoniaD018410EFO_1001272J15.9——3——3
KeratitisD007634H16——3——3
LymphomaD008223C85.91—1—13
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059981———9
NeoplasmsD009369C8021——14
Parkinson diseaseD010300EFO_0002508G2031———4
CholangitisD002761K83.0—1———1
Corneal ulcerD003320H16.0—1———1
Endometrial neoplasmsD016889EFO_0004230—1———1
Meningeal tuberculosisD014390A17.0—1———1
Graft vs host diseaseD006086D89.81—1———1
MenorrhagiaD008595N92.011———1
Aplastic anemiaD000741HP_0001915D61.911———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 mellitusD003924EFO_0001360E116————6
Hiv infectionsD015658EFO_0000764B203———14
SchizophreniaD012559EFO_0000692F204————4
Alzheimer diseaseD000544EFO_0000249F034————4
AsthmaD001249EFO_0000270J453————3
Hepatitis cD006526B19.23————3
DyslipidemiasD050171HP_00031193————3
Therapeutic equivalencyD0138103————3
Rheumatoid arthritisD001172EFO_0000685M06.92————2
HypoglycemiaD007003HP_0001943E16.21———12
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Long qt syndromeD008133HP_0001657I45.81————22
Pathologic dilatationD004108————22
KeratoconusD007640EFO_0004223H18.6————22
RegenerationD012038————22
PeritonitisD010538EFO_0008588K65————22
DeliriumD003693R41.0————11
Mycoplasma pneumoniaD011019EFO_0007387J15.7————11
AppendicitisD001064EFO_0007149K37————11
Chemical and drug induced liver injuryD056486————11
Macular degenerationD008268EFO_0001365H35.30————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNORGESTREL
INNnorgestrel
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.
Classification
Small molecule
Drug classestrogens; 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-ID6533-00-2
RxCUI—
ChEMBL IDCHEMBL2107797
ChEBI ID—
PubChem CID16051930
DrugBankDB09389
UNII ID3J8Q1747Z2 (ChemIDplus, GSRS)
Target
Agency Approved
PGR
PGR
Organism
Homo sapiens
Gene name
PGR
Gene synonyms
NR3C3
NCBI Gene ID
Protein name
progesterone receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 3
Uniprot ID
Mouse ortholog
Pgr (18667)
progesterone receptor (Q00175)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,093 documents
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Safety
Black-box Warning
Black-box warning for: Cryselle, Low-ogestrel
Adverse Events
Top Adverse Reactions
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873 adverse events reported
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