e-Drug3D

1546

cas 841302-24-7

CLASS

ANTIDIABETIC
DIPEPTIDYL-PEPTIDASE IV INHIBITOR
HYPOGLYCEMIC AGENTS
TYPE 2 DIABETES MELLITUS
METABOLISM
METABOLITE OF SAXAGLIPTIN IS ONE-HALF AS POTENT AS SAXAGLIPTIN AS DPP4 INHIBITOR

ROUTE (list)

-

PK parameters

Cmax 149 NANOMOLAR (5 MILLIGRAM)
Cl 13.8 LITER / HOUR
PPB 0 PERCENT
t1/2 3.1 HOUR

MW 331.41
NB_atoms 24
XLogP 0.27
PSA 98.951
NB_HD 4
NB_HA 6
fsp3 0.89
Lipinski(0=no;1=yes) 1

FDA
-

e-Drug3D

1476

cas 361442-04-8

CLASS

ANTIDIABETIC
DIPEPTIDYL-PEPTIDASE IV INHIBITOR
HYPOGLYCEMIC AGENTS
TYPE 2 DIABETES MELLITUS
METABOLISM
METABOLITE OF SAXAGLIPTIN IS ONE-HALF AS POTENT AS SAXAGLIPTIN AS DPP4 INHIBITOR

ROUTE (list)

ORAL

PK parameters

Cmax 76 NANOMOLAR (5 MILLIGRAM)
Cl 13.8 LITER / HOUR
PPB 0 PERCENT
t1/2 2.5 HOUR

MW 315.41
NB_atoms 23
XLogP 1.16
PSA 79.67
NB_HD 3
NB_HA 5
fsp3 0.89
Lipinski(0=no;1=yes) 1

FDA
NDA 022350 (label) INN (SAXAGLIPTIN HYDROCHLORIDE) ONGLYZA (ASTRAZENECA AB) APPROVAL= AP YEAR= 2009 NEWMOLECULARENTITY DISCONTINUED
NDA 200678 (label) INN (METFORMIN HYDROCHLORIDE ; SAXAGLIPTIN HYDROCHLORIDE) KOMBIGLYZE XR (ASTRAZENECA AB) APPROVAL= AP YEAR= 2010 DISCONTINUED
NDA 205942 (pdf not found) INN (SAXAGLIPTIN ; METFORMIN HYDROCHLORIDE) SAXAGLIPTIN;METFORMIN HYDROCHLORIDE (AMNEAL PHARMS) APPROVAL= TA YEAR= 2016
NDA 205959 (pdf not found) INN (SAXAGLIPTIN) SAXAGLIPTIN (PAR PHARM) APPROVAL= TA YEAR= 2016
NDA 209091 (label) INN (DAPAGLIFLOZIN ; SAXAGLIPTIN HYDROCHLORIDE) QTERN (ASTRAZENECA AB) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 210874 (label) INN (DAPAGLIFLOZIN ; METFORMIN HYDROCHLORIDE ; SAXAGLIPTIN HYDROCHLORIDE) QTERNMET XR (ASTRAZENECA AB) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 205941 (pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (AMNEAL) APPROVAL= AP YEAR= 2023 DISCONTINUED
NDA 205972 (pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023
NDA 205980 (pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (MYLAN) APPROVAL= AP YEAR= 2023
NDA 205994 (pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2023
NDA 205981 (pdf not found) INN (METFORMIN HYDROCHLORIDE ; SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (MYLAN) APPROVAL= AP YEAR= 2023
NDA 206078 (pdf not found) INN (SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN (SUN PHARM) APPROVAL= AP YEAR= 2023 DISCONTINUED
NDA 206081 (pdf not found) INN (METFORMIN HYDROCHLORIDE ; SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (SUN PHARM) APPROVAL= AP YEAR= 2023 DISCONTINUED
NDA 207678 (pdf not found) INN (METFORMIN HYDROCHLORIDE ; SAXAGLIPTIN HYDROCHLORIDE) SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (DR REDDYS LABS SA) APPROVAL= AP YEAR= 2023
NDA 211532 (pdf not found) INN (DAPAGLIFLOZIN ; SAXAGLIPTIN MONOHYDRATE) DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE (LUPIN LTD) APPROVAL= TA YEAR= 2024
NDA 211533 (pdf not found) INN (DAPAGLIFLOZIN ; SAXAGLIPTIN HYDROCHLORIDE) DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE (MSN) APPROVAL= AP YEAR= 2026
NDA 211537 (pdf not found) INN (DAPAGLIFLOZIN ; SAXAGLIPTIN HYDROCHLORIDE) DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE (TORRENT) APPROVAL= AP YEAR= 2026