pantoprazole

Trade name: protonix

Small moleculeapproved

Approved

Feb 2, 2000

Pantoprazole is a proton pump inhibitor that inhibits gastric acid secretion and used for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease. Pantoprazole suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours. Pantoprazole is used for short-term treatment of erosion and ulceration of the esophagus for adults and pediatric patients 5 years of age and older caused by gastroesophageal reflux disease. It can be used as a maintenance therapy for long-term use after initial response is obtained, but there have not been any controlled studies about the use of pantoprazole past a duration of 12 months. Pantoprazole may also be used in combination with antibiotics to treat ulcers caused by Helicobacter pylori. Use of pantoprazole may increase the chance of developing infections such as pneumonia, particularly in hospitalized patients. — NCATS

Clinical trial activity

205 trials · 195 clinical orgs · 51 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Feb 3, 1983 (NCT00001191)

Timeline

1980s

Jan 1, 1983
Earliest Phase 2 Sponsor(trial)

1990s

Jan 1, 1998
Earliest Phase 1 Sponsor(trial)

2000s

Jan 1, 2000
Earliest Phase 3 Sponsor(trial)
Feb 2, 2000
Earliest FDA Approval
Feb 2, 2000
Wyeth — NDA Secondary Org
Aug 2, 2007
Teva — Marketing Organization
Sep 10, 2007
Sun Pharmaceuticals — Marketing Organization
Oct 20, 2008
Teva — NDA Secondary Org

2010s

Jan 19, 2011
Atlantide Pharmaceuticals — Marketing Organization
Jan 19, 2011
Dr. Reddy's Laboratories — Marketing Organization
Jan 19, 2011
Torrent Pharmaceuticals Limited — Marketing Organization
Jan 19, 2011
Wockhardt — Marketing Organization
Jan 20, 2011
Lannett Company, Inc. — Marketing Organization
Feb 7, 2011
Actavis — Marketing Organization
Aug 30, 2011
Jubilant Innovation Ltd. — Marketing Organization
Feb 16, 2012
Macleods Pharmaceuticals, Ltd — Marketing Organization
May 2, 2012
Apotex — Marketing Organization
May 2, 2012
Rubicon Research — Marketing Organization
Sep 28, 2012
Aurobindo Pharma — Marketing Organization
Nov 8, 2012
Akorn, Inc. — Marketing Organization
Nov 8, 2012
Epic Pharma Llc — Marketing Organization
May 7, 2014
Perrigo — Marketing Organization
Sep 10, 2014
Hetero Labs Ltd — Marketing Organization
Dec 2, 2014
Orbion Pharms — Marketing Organization
Dec 2, 2014
Orchid Pharma — Marketing Organization
Jul 14, 2015
Sandoz — Marketing Organization
Jul 14, 2015
Novartis — Marketing Organization
Jan 26, 2016
Amneal Pharmaceuticals — Marketing Organization
Mar 30, 2016
Eugia Pharma — Marketing Organization
Mar 8, 2017
Hospira — Marketing Organization
Jun 30, 2017
Exela Pharma Sciences, LLC. — NDA Secondary Org
Jun 30, 2017
Hikma — NDA Secondary Org
May 4, 2018
Mylan — Marketing Organization
May 4, 2018
PHARMOBEDIENT — Marketing Organization
Mar 1, 2019
Ingenus Pharmaceuticals — Marketing Organization

2020s

Aug 30, 2021
Acic Pharmaceuticals — Marketing Organization
Aug 30, 2021
Hangzhou Zhongmei — Marketing Organization
May 18, 2022
Aspiro — Marketing Organization
May 18, 2022
BE Pharmaceuticals — Marketing Organization
May 18, 2022
Gland Pharma Ltd — Marketing Organization
May 18, 2022
Fosun — Marketing Organization
May 19, 2022
KNACK — Marketing Organization
Jul 26, 2022
Mankind Pharma — Marketing Organization
Aug 29, 2022
Meitheal — Marketing Organization
Feb 9, 2023
Ajanta Pharma Ltd — Marketing Organization
Jun 16, 2023
Dexcel Pharma Technologies Ltd. — Marketing Organization
Oct 27, 2023
Annora Pharma — Marketing Organization
Dec 11, 2023
Granules India — Marketing Organization
Feb 14, 2024
Baxalta — Marketing Organization
Aug 1, 2024
Fresenius — Marketing Organization
Jan 16, 2025
Graviti Pharmaceuticals — Marketing Organization
Mar 31, 2025
Alembic — Marketing Organization
Mar 31, 2025
Cipla — Marketing Organization
May 16, 2025
Deva Holding A.S. — Marketing Organization
Apr 22, 2026
Shuangcheng — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Potassium-transporting ATPaseINHIBITOR
Potassium-transporting ATPase inhibitor
Alpha subunit is likely binding site
- Potassium-transporting ATPase alpha chain 1 (ATP4A) ↗
- Potassium-transporting ATPase subunit beta (ATP4B) ↗

Approval history

approvedFeb 2, 2000

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccnc(C[S+]([O-])c2nc3cc(OC(F)F)ccc3[n-]2)c1OC.O.[Na+]

Mol. weight: 423.37 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral
Availability: Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Sources

Also known as

1h-benzimidazole, 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-
agspt201
by 1023
by-1023
by-1023
by-1023
controloc control
l-pantoprazole
l-pantoprazole
pantoline
pantoloc
pantoloc
pantoloc control
pantoloc control
pantoprazol
pantoprazol
pantoprazole
pantoprazole
pantoprazole
pantoprazole
pantoprazole
pantoprazole
pantoprazole
pantoprazole
pantoprazole
pantoprazole
pantoprazole
pantoprazole magnesium
pantoprazole sodium
pantoprazole sodium
pantoprazole sodium
pantoprazole sodium
pantoprazole sodium
pantoprazole sodium
pantoprazole sodium hydrate
pantoprazole sodium hydrate
pantoprazole sodium sesquihydrate
pantoprazolum
pantoprazolum
pantozol
protium
protium
protium i.v.
protonix
protonix
protonix
protonix
protonix
protonix iv
protonix iv
sk-96022
sk-96022
sk&f 96022
sk&f-96022
sk&f-96022
sk&f-96022
skf-96022
s-pantoprazole
s-pantoprazole

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06861387	N/A	May 1, 2025	St. Antonius Hospital, Nieuwegein
NCT06564246	Phase 4	Sep 18, 2024	Tanta University
NCT06991348	Phase 4	Jul 30, 2024	Carnot Laboratories
NCT06856447	Phase 1	Jun 1, 2024	Tanta University
NCT06154226	Phase 4	Dec 1, 2023	Society of Cardiovascular Anesthesiologists, University of Texas at Houston
NCT06414707	Phase 3	Oct 12, 2023	Ain Shams University
NCT05915520	N/A	Jul 20, 2023	Cairo University
NCT05604261	Phase 2	Dec 31, 2022	Xuanzhu Biopharmaceutical Co., Ltd.
NCT05624229	Phase 4	Dec 1, 2022	Sichuan University
NCT06488001	Phase 2	Aug 26, 2022	United States Navy
NCT05353933	N/A	May 4, 2022	Ho Chi Minh City University of Medicine and Pharmacy
NCT05251233	Phase 2	Apr 21, 2022	Washington University in St. Louis
NCT05227833	Phase 3	Feb 15, 2022	Alexandria University
NCT04821310	Phase 2	Nov 29, 2021	Pfizer
NCT05005910	Early Phase 1 (Phase 1)	Sep 30, 2021	Mahidol University
NCT04728516	Phase 4	Aug 10, 2021	Shandong University
NCT04935112	Phase 1	Jul 7, 2021	Mirati Therapeutics Inc.
NCT04713969	Phase 4	Mar 31, 2021	Katholieke Universiteit Leuven
NCT07262736	Phase 1	Feb 6, 2021	Univerisiti Sains Malaysia
NCT04566250	N/A	Jan 4, 2021	Hamilton Health Sciences Corporation, McMaster University

Showing 20 of 205 trials

Page 1 / 11

Organizations

Research & Development (195)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Wyeth	For profit	14	0	4	2000
Boehringer Ingelheim	For profit	13	13	2	1998
Pfizer	For profit	13	13	4	2000
Takeda	For profit	11	10	2	2000
Seoul National University	Academic/Hospital	8	5	4	2009
McMaster University	Academic/Hospital	6	5	2	2000
Taichung Veterans General Hospital	Academic/Hospital	6	6	2	2010
National Taiwan University	Academic/Hospital	5	5	3	2006
University of Copenhagen	Academic/Hospital	5	2	2	2011
Ahn-Gook Pharmaceuticals Co.,Ltd	For profit	4	4	2	2009
Inje University	Academic/Hospital	4	0	3	2008
Sihuan Pharmaceutical Holdings Group Ltd.	For profit	4	4	3	2014
Sungkyunkwan University	Academic/Hospital	4	2	3	2009
AstraZeneca	For profit	3	3	1	2004
Catholic University of Korea	Academic/Hospital	3	1	2	2009
Government of Taiwan	Government	3	2	1	2006
Johnson and Johnson	For profit	3	1	2	2004
Kaohsiung Medical University	Academic/Hospital	3	2	1	2012
Nycomed	For profit	3	1	1	2005
Tanta University	Academic/Hospital	3	3	3	2019

195 organizations

Page 1 / 10

Marketing (61)

Organization	Org type	Relationship	Date
Acic Pharmaceuticals	For profit	MKTG	Aug 30, 2021
Actavis	For profit	MKTG	Feb 7, 2011
Ajanta Pharma Ltd	For profit	MKTG	Feb 9, 2023
Akorn, Inc.	For profit	MKTG	Nov 8, 2012
Akorn, Inc.	For profit	SYN	Nov 8, 2012
Alembic	For profit	MKTG	Mar 31, 2025
American Home Products	For profit	NDA	—
Amneal Pharmaceuticals	For profit	MKTG	Jan 26, 2016
Annora Pharma	For profit	MKTG	Oct 27, 2023
Apotex	For profit	MKTG	May 2, 2012
Apotex	For profit	SYN	Jan 19, 2011
Aspiro	For profit	MKTG	May 18, 2022
Atlantide Pharmaceuticals	For profit	MKTG	Jan 19, 2011
Aurobindo Pharma	For profit	MKTG	Sep 28, 2012
BE Pharmaceuticals	For profit	MKTG	May 18, 2022
Baxalta	For profit	MKTG	Feb 14, 2024
Cipla	For profit	MKTG	Mar 31, 2025
Deva Holding A.S.	For profit	MKTG	May 16, 2025
Dexcel Pharma Technologies Ltd.	For profit	MKTG	Jun 16, 2023
Dr. Reddy's Laboratories	For profit	MKTG	Jan 19, 2011
Epic Pharma Llc	For profit	MKTG	Nov 8, 2012
Eugia Pharma	For profit	MKTG	Mar 30, 2016
Exela Pharma Sciences, LLC.	For profit	NDA2	Jun 30, 2017
Fosun	For profit	MKTG	May 18, 2022
Fresenius	For profit	MKTG	Aug 1, 2024
Gland Pharma Ltd	For profit	MKTG	May 18, 2022
Gland Pharma Ltd	For profit	SYN	May 18, 2022
Granules India	For profit	MKTG	Dec 11, 2023
Graviti Pharmaceuticals	For profit	MKTG	Jan 16, 2025
Hangzhou Zhongmei	For profit	MKTG	Aug 30, 2021
Hetero Labs Ltd	For profit	MKTG	Sep 10, 2014
Hikma	For profit	NDA2	Jun 30, 2017
Hospira	For profit	MKTG	Mar 8, 2017
Ingenus Pharmaceuticals	For profit	MKTG	Mar 1, 2019
Jubilant Innovation Ltd.	For profit	MKTG	Aug 30, 2011
KNACK	For profit	MKTG	May 19, 2022
Lannett Company, Inc.	For profit	MKTG	Jan 20, 2011
Macleods Pharmaceuticals, Ltd	For profit	MKTG	Feb 16, 2012
Mankind Pharma	For profit	MKTG	Jul 26, 2022
Meitheal	For profit	MKTG	Aug 29, 2022
Mylan	For profit	MKTG	May 4, 2018
Mylan	For profit	SYN	Jan 19, 2011
Novartis	For profit	MKTG	Jul 14, 2015
Orbion Pharms	For profit	MKTG	Dec 2, 2014
Orchid Pharma	For profit	MKTG	Dec 2, 2014
PHARMOBEDIENT	For profit	MKTG	May 4, 2018
Perrigo	For profit	MKTG	May 7, 2014
Perrigo	For profit	SYN	May 7, 2014
Rubicon Research	For profit	MKTG	May 2, 2012
Rubicon Research	For profit	SYN	May 2, 2012
Sandoz	For profit	MKTG	Jul 14, 2015
Sandoz	For profit	SYN	Jul 14, 2015
Shuangcheng	For profit	MKTG	Apr 22, 2026
Sun Pharmaceuticals	For profit	MKTG	Sep 10, 2007
Sun Pharmaceuticals	For profit	SYN	Sep 10, 2007
Teva	For profit	NDA2	Oct 20, 2008
Teva	For profit	MKTG	Aug 2, 2007
Torrent Pharmaceuticals Limited	For profit	MKTG	Jan 19, 2011
Wockhardt	For profit	MKTG	Jan 19, 2011
Wockhardt	For profit	SYN	Jan 19, 2011
Wyeth	For profit	NDA2	Feb 2, 2000