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ELAGOLIX
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac electrophysiology
- The effect of elagolix on the QTc interval was evaluated in a randomized, placebo- and positive-controlled, open-label, single-dose, crossover thorough QTc study in 48 healthy adult premenopausal women. Elagolix concentrations in subjects given a single dose of 1200 mg was 17-times higher than the concentration in subjects given elagolix 200 mg twice daily. There was no clinically relevant prolongation of the QTc interval.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
5054
38376533
Odds Ratio = 0.0
Drug Property Information
ATC Code(s):
- H01CC03 - elagolix
- H01CC - Anti-gonadotropin-releasing hormones
- H01C - HYPOTHALAMIC HORMONES
- H01 - PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
- H - "SYSTEMIC HORMONAL PREPARATIONS, EXCL. "
Active Ingredient:ELAGOLIX SODIUM
Active Ingredient UNII:5948VUI423
Drugbank ID:DB11979
PubChem Compound:11250647
CTD ID: C539351
CAS Number:834153-87-6
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
COC1=CC=CC(=C1F)C1=C(C)N(CC2=C(C=CC=C2F)C(F)(F)F)C(=O)N(C[C@H](NCCCC(O)=O)C2=CC=CC=C2)C1=O
COC1=CC=CC(=C1F)C1=C(C)N(CC2=C(C=CC=C2F)C(F)(F)F)C(=O)N(C[C@H](NCCCC(O)=O)C2=CC=CC=C2)C1=O
Reference
N/A
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