Protonix, Pantozol control(pantoprazole)
Control, Protonix (pantoprazole) is a small molecule pharmaceutical. Pantoprazole was first approved as Protonix on 2000-02-02. It is used to treat esophagitis, gastroesophageal reflux, heartburn, helicobacter infections, and zollinger-ellison syndrome in the USA. It has been approved in Europe to treat gastroesophageal reflux.
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Protonix (generic drugs available since 2011-01-19)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pantoprazole sodium
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pantoprazole sodium | ANDA | 2023-06-20 |
| protonix | New Drug Application | 2023-03-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| esophagitis | HP_0100633 | D004941 | K20 |
| gastroesophageal reflux | EFO_0003948 | D005764 | K21 |
| heartburn | — | D006356 | R12 |
| helicobacter infections | EFO_1000961 | D016481 | — |
| zollinger-ellison syndrome | — | D015043 | E16.4 |
Agency Specific
FDA
EMA
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BC: Proton pump inhibitors for peptic ulcer and gord
— A02BC02: Pantoprazole
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD04: Pantoprazole, amoxicillin and clarithromycin
— A02BD11: Pantoprazole, amoxicillin, clarithromycin and metronidazole
Clinical
Clinical Trials
503 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Human influenza | D007251 | EFO_0007328 | J11.1 | 13 | 32 | 5 | 9 | 8 | 62 |
| Healthy volunteers/patients | — | 29 | 2 | — | 2 | 11 | 43 | ||
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 3 | 1 | 18 | 11 | 8 | 40 |
| H1n1 subtype influenza a virus | D053118 | — | 8 | 4 | 2 | 1 | 14 | ||
| Covid-19 | D000086382 | U07.1 | — | 1 | — | 3 | 8 | 12 | |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | 3 | 6 | 11 | |
| Peptic ulcer | D010437 | HP_0004398 | K27 | — | — | 5 | 1 | 1 | 7 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 4 | — | 2 | — | 6 |
| Peptic ulcer hemorrhage | D010438 | — | 1 | 2 | 2 | 1 | 6 | ||
| Coronary artery disease | D003324 | I25.1 | — | — | — | 5 | — | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | C85.9 | — | 3 | 1 | — | 2 | 6 | |
| Chronic urticaria | D000080223 | L50.8 | — | 1 | 3 | — | — | 4 | |
| Myelodysplastic syndromes | D009190 | D46 | — | 3 | 1 | — | — | 4 | |
| Multiple myeloma | D009101 | C90.0 | 1 | 2 | 1 | — | 1 | 4 | |
| Aplastic anemia | D000741 | HP_0001915 | D61.9 | 1 | 4 | 1 | — | — | 4 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 2 | 2 | — | 1 | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | — | 1 | — | 1 | 3 |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | 1 | 1 | — | — | 3 | |
| Gingivitis | D005891 | K05.10 | — | — | 1 | — | 2 | 3 | |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | 1 | — | 2 | 3 |
Show 21 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 3 | — | — | 2 | 6 | |
| Leukemia | D007938 | C95 | 2 | 3 | — | — | 2 | 6 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 4 | — | — | — | 5 |
| Hodgkin disease | D006689 | C81 | 1 | 2 | — | — | 1 | 4 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 2 | 2 | — | — | 1 | 4 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | — | 3 | — | — | 1 | 4 | |
| Myeloproliferative disorders | D009196 | D47.1 | — | 2 | — | — | 1 | 3 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | 1 | 3 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | 3 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | C61 | 1 | 1 | — | — | — | 2 |
Show 58 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | 2 | 3 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | 1 | — | — | — | 1 | 2 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | 2 | — | — | — | — | 2 |
| Invasive pulmonary aspergillosis | D055744 | B44.0 | 1 | — | — | — | — | 1 | |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | — | — | — | — | 1 |
| Vasculitis | D014657 | EFO_0006803 | M31 | 1 | — | — | — | — | 1 |
| Dental caries | D003731 | EFO_0003819 | K02 | 1 | — | — | — | — | 1 |
| Cocaine-related disorders | D019970 | F14 | 1 | — | — | — | — | 1 | |
| Bacterial infections | D001424 | A49 | 1 | — | — | — | — | 1 |
Show 25 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Refractive errors | D012030 | EFO_0003908 | H52.7 | — | — | — | — | 5 | 5 |
| Tooth discoloration | D014075 | K03.6 | — | — | — | — | 3 | 3 | |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 3 | 3 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 2 | 2 |
| Glucose metabolism disorders | D044882 | — | — | — | — | 2 | 2 | ||
| Presbyopia | D011305 | H52.4 | — | — | — | — | 2 | 2 | |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | 2 | 2 | |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 2 | 2 |
| Gastrointestinal diseases | D005767 | — | — | — | — | 2 | 2 | ||
| Fatty liver | D005234 | — | — | — | — | 2 | 2 |
Show 58 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PANTOPRAZOLE |
| INN | pantoprazole |
| Description | Pantoprazole is a member of the class of benzimidazoles that is 1H-benzimidazole substituted by a difluoromethoxy group at position 5 and a [(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl group at position 2. It has a role as an anti-ulcer drug, an EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor, a xenobiotic and an environmental contaminant. It is a member of benzimidazoles, a member of pyridines, an aromatic ether, an organofluorine compound and a sulfoxide. It is a conjugate acid of a pantoprazole(1-). |
| Classification | Small molecule |
| Drug class | antiulcer agents (benzimidazole derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccnc(C[S+]([O-])c2nc3cc(OC(F)F)ccc3[nH]2)c1OC |
Identifiers
| PDB | — |
| CAS-ID | 102625-70-7 |
| RxCUI | 40790 |
| ChEMBL ID | CHEMBL1502 |
| ChEBI ID | 7915 |
| PubChem CID | 4679 |
| DrugBank | DB00213 |
| UNII ID | D8TST4O562 (ChemIDplus, GSRS) |
Target
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Alternate
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Variants
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Financial
Pantoprazole - Takeda
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Protonix - Pfizer
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Trends
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Safety
Black-box Warning
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Adverse Events
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1,736 adverse events reported
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