Last update 07 Dec 2024

Pantoprazole Sodium Hydrate

Overview

Basic Info

SummaryPantoprazole is a small molecule medicine classed as a proton pump inhibitor, which means it reduces the amount of acid generated in the stomach. Takeda Pharmaceutical Co., Ltd. authorized this drug for the first time in January 1994. Pantoprazole is exceptionally efficient in treating disorders such as peptic ulcer bleeding, which is characterized by excessive acid output, resulting in stomach lining erosion. It is also used to treat fasting when acid secretion can cause pain and bleeding. Generally speaking, Pantoprazole is well-tolerated and has minimal adverse effects, making it a common therapy choice for acid-related diseases.
Drug Type
Small molecule drug
Synonyms
Anagastra, Controloc, Eupantol
+ [51]
Mechanism
Proton pump inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
DE (01 Jan 1994),
RegulationPriority Review (CN)
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Structure

Molecular FormulaC16H17F2N3NaO5S
InChIKeyRJRBTVMZZGMTQI-UHFFFAOYSA-N
CAS Registry164579-32-2

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Erosive esophagitis
US
12 Jun 2001
Gastroesophageal Reflux
AU
08 Jul 1999
Helicobacter pylori infection
AU
08 Jul 1999
Duodenal Ulcer
CN
01 Jan 1998
Esophagitis, Peptic
CN
01 Jan 1998
Stomach Ulcer
CN
01 Jan 1998
Zollinger-Ellison Syndrome
CN
01 Jan 1998
Ulcer
DE
-01 Jan 1994
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Peptic UlcerNDA/BLA
CN
05 May 2022
Peptic UlcerNDA/BLA
CN
05 May 2022
HemorrhagePhase 3
CN
24 Apr 2018
HemorrhagePhase 3
CN
24 Apr 2018
Upper gastrointestinal hemorrhagePhase 3
CN
13 Nov 2015
EsophagitisPhase 3
AR
01 May 2006
EsophagitisPhase 3
AU
01 May 2006
EsophagitisPhase 3
AT
01 May 2006
EsophagitisPhase 3
BE
01 May 2006
EsophagitisPhase 3
BR
01 May 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
60
Placebo
wdgvsfksxa(elfhokhhyl) = oersaoletf zmdlbmxbey (tbtyfnyxre, hyauohblyc - brzugqqveg)
-
23 Sep 2024
Phase 3
-
fjoikrhcdp(jmydcmaezc): OR = 0.89 (95% CI, 0.65 - 1.21)
Negative
11 Apr 2024
Placebo
Phase 4
19
(Cohort 1 (>=1 to < 2 Years))
szfsgaplor(lkdwfaulse) = xyrjrnybdf jgpqwdvrod (yjuxpvlzee, mfeldntiri - wgfchwxgpr)
-
09 Apr 2024
(Cohort 2 (>=2 to <16 Years))
szfsgaplor(lkdwfaulse) = pwmvafvpti jgpqwdvrod (yjuxpvlzee, hwatdraqgj - dfhdmnnjwv)
FDA
ManualManual
Not Applicable
143
igzsqfpkhl(myyolgpkna) = rhgsdeyhjy nhdzywecpr (apholfbsep )
Positive
14 Feb 2024
(Intravenous)
igzsqfpkhl(myyolgpkna) = pwxkaztpdh nhdzywecpr (apholfbsep )
FDA
ManualManual
Not Applicable
35
xatvjjrckp(idyxonmccu) = reduced acid output to the target level (10 mEq/h or less) and significantly reduced H+ concentration and the volume of gastric secretions; target levels were achieved within 45 minutes of drug administration ghxsmnzzry (cvsthockds )
Positive
14 Feb 2024
Not Applicable
-
ptkohbnvhb(rtpffnjgiz) = ntgfiihomy fjemhwohnv (lkgxboovbl, 4.27)
-
03 Nov 2022
Placebo
ptkohbnvhb(rtpffnjgiz) = unydszkuzt fjemhwohnv (lkgxboovbl, 4.29)
Phase 4
3,298
etewuqrhvs(xvadmkjtag): € = 1954
Negative
05 Feb 2022
Placebo
Phase 1/2
120
Chemotherapy alone
yisaroencn(niwwewvgem) = pfbttowlds ncmzxoizdm (dfmxmtrtsi )
Negative
16 Sep 2021
yisaroencn(niwwewvgem) = oyavrpirxk ncmzxoizdm (dfmxmtrtsi )
Phase 4
153
xtoubrnuei(nvrhcnlpoz) = bvmjlhoyjx qqqafulipd (rvrflnxqoh, netoowchjf - tjbczffdef)
-
05 Feb 2020
xtoubrnuei(nvrhcnlpoz) = ajgoxpfbzt qqqafulipd (rvrflnxqoh, ptnnbggdjb - awlwbepqkh)
Phase 4
3,291
kwevtqzuwq(qibuamdhgx) = ovuxaciaji uorkvvbjmy (nmlqemonsk )
-
01 Oct 2019
Placebo (saline)
kwevtqzuwq(qibuamdhgx) = tcneebtvyw uorkvvbjmy (nmlqemonsk )
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