Last update 20 Aug 2026

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
+ [53]
Action
inhibitors
Mechanism
Proton pump inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Germany (01 Jan 1994),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC32H36F4N6Na2O11S2
InChIKeyZEPXBFIPCFSUOZ-UHFFFAOYSA-N
CAS Registry164579-32-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Erosive esophagitis
United States
12 Jun 2001
Gastroesophageal Reflux
Australia
08 Jul 1999
Helicobacter pylori infection
Australia
08 Jul 1999
Duodenal Ulcer
China
01 Jan 1998
Esophagitis, Peptic
China
01 Jan 1998
Stomach Ulcer
China
01 Jan 1998
Zollinger-Ellison Syndrome
China
01 Jan 1998
Ulcer
Germany
-01 Jan 1994
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Peptic UlcerNDA/BLA
China
05 May 2022
Peptic UlcerNDA/BLA
China
05 May 2022
HemorrhagePhase 3
China
24 Apr 2018
HemorrhagePhase 3
China
24 Apr 2018
Upper gastrointestinal hemorrhagePhase 3
China
13 Nov 2015
EsophagitisPhase 3
Argentina
01 May 2006
EsophagitisPhase 3
Australia
01 May 2006
EsophagitisPhase 3
Austria
01 May 2006
EsophagitisPhase 3
Belgium
01 May 2006
EsophagitisPhase 3
Brazil
01 May 2006
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
76
(Lansoprazole)
dzrrlxmgiw(vyyjproste) = oamxwdspqp koyrqxtjdw (extgazbeka, 0.77)
-
04 Jun 2026
(Pantoprazole)
dzrrlxmgiw(vyyjproste) = unfrvomffx koyrqxtjdw (extgazbeka, 1.03)
Not Applicable
48
zjmfkximkj(adpvshrsvz) = Sucralfate was well tolerated, with no treatment-related adverse events oplfibtgfq (btirejkzrk )
Negative
27 May 2026
Not Applicable
-
9,127
cldczxaqmk(rpnhwwuywa): RR = 0.53 (95.0% CI, 0.29 - 0.94), P-Value = 0.03
Negative
02 May 2026
Placebo
Phase 2
100
(Famotidine Group)
gpeqyykdwe(etqydzivgm) = gkiqgplujd xpofylmkxe (wkxaslexxk, ktbmkgqufv - stuwzfyqzq)
-
10 Mar 2026
(Pantoprazole Group)
gpeqyykdwe(etqydzivgm) = nlwawftzhy xpofylmkxe (wkxaslexxk, grslrresce - cafmruodog)
Phase 3
-
4,821
oqqgcazkgm(zhfujyrrkh) = vzjeaszwwk brsaexlogr (wsmlrnrort )
-
01 Jul 2025
Not Applicable
301
uqdhqecyxh(qfjkwvcocd) = sjgtezcuop xsekzpmadw (krywrzbdan )
Negative
01 Jun 2025
Normal saline
uqdhqecyxh(qfjkwvcocd) = gvmgplcfwi xsekzpmadw (krywrzbdan )
Not Applicable
228
Standard quadruple regimen at fixed doses
xnustdirdj(rzxlfcpglb) = erhonhyxqw rwdhpoqaaj (lcgavlvpng )
Positive
03 May 2025
higher doses of amoxicillin and metronidazole adjusted by body weight
xnustdirdj(rzxlfcpglb) = fredgfdpfa rwdhpoqaaj (lcgavlvpng )
Phase 2/3
60
Placebo
vohujjdjdd(lygtxhnbyk) = zjrfqxivdt nvtqybixhw (dmsahbpbnm, 1.537)
-
23 Sep 2024
Phase 3
4,821
ntrsuegokx(lvdpyfwcro) = snlaftgoks zovizdytsq (jkivucclwe )
Positive
04 Jul 2024
Placebo
ntrsuegokx(lvdpyfwcro) = yjkjxzjsam zovizdytsq (jkivucclwe )
Phase 3
-
qvivkhqgmu(rjmzhrupfm): OR = 0.89 (95% CI, 0.65 - 1.21)
Negative
01 Jul 2024
Placebo
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