Evicenter
P&T meetings

Saroglitazar

Primary biliary cholangitis

Manufacturer
Zydus Therapeutics
Regulatory submission
NDA submitted by May 2026
81 sources

Section 1 of 6

Terms and abbreviations

1 evidence topic · 0 sources

AbbreviationTerm
1LFirst-line treatment
2L+Second-line or later treatment
5-DFive-dimensional itch scale
AASLDAmerican Association for the Study of Liver Diseases
AHFSAmerican Hospital Formulary Service
AISFAssociazione Italiana per lo Studio del Fegato
ALPAlkaline phosphatase
ALTAlanine aminotransferase
AMAAntimitochondrial antibody
ASPAverage sales price
AUCArea under the concentration-time curve
CASChemical Abstracts Service
CIConfidence interval
CmaxMaximum plasma concentration
DDIDrug-drug interaction
EASLEuropean Association for the Study of the Liver
EC50Half-maximal effective concentration
EMAEuropean Medicines Agency
FDAFood and Drug Administration
GGTGamma-glutamyl transferase
HIHepatic impairment
hPPARHuman peroxisome proliferator-activated receptor
IBATIleal bile acid transporter
IPInpatient
MASHMetabolic dysfunction-associated steatohepatitis
MASLDMetabolic dysfunction-associated steatotic liver disease
MSPModerate-to-severe pruritus
NDANew Drug Application
NHSNational Health System
NMANetwork meta-analysis
NMPNo or mild pruritus
NRSNumerical rating scale
OCAObeticholic acid
PBCPrimary biliary cholangitis
PBC-4040-item primary biliary cholangitis questionnaire
PDUFAPrescription Drug User Fee Act
PKPharmacokinetics
PPARPeroxisome proliferator-activated receptor
QALYQuality-adjusted life-year
RCTRandomized controlled trial
REMSRisk Evaluation and Mitigation Strategy
UDCAUrsodeoxycholic acid
ULNUpper limit of normal
WACWholesale acquisition cost