Protonix, Controloc control(pantoprazole)
Control, Pantoprazole, 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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Pantoprazole, Protonix (discontinued: Pantoprazole)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pantoprazole sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | Baxter | N-217512 RX | 2024-02-14 | 3 products, RLD, RS |
| PANTOPRAZOLE SODIUM | Hikma Pharmaceuticals | N-209463 RX | 2017-06-30 | 1 products, RLD, RS |
| PROTONIX | Wyeth | N-020987 RX | 2000-02-02 | 2 products, RLD, RS |
| PROTONIX IV | Wyeth | N-020988 RX | 2001-03-22 | 1 products, RLD, RS |
| PROTONIX | Wyeth | N-022020 RX | 2007-11-14 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pantoprazole | ANDA | 2025-02-03 |
| pantoprazole sodium | ANDA | 2025-08-22 |
| pantoprazole sodium d/r | ANDA | 2022-10-05 |
| pantoprazole sodium delayed release | ANDA | 2014-06-06 |
| pantoprazole sodium delayed-release | ANDA | 2025-04-01 |
| pantoprazole sodium dr | ANDA | 2025-01-22 |
| protonix | New Drug Application | 2025-08-19 |
| protonix delayed-release | 2009-01-13 |
Indications
FDA
EMA
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
1548 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 17 | 44 | 7 | 1 | 3 | 64 |
| Healthy volunteers/patients | — | — | — | 43 | 2 | — | 5 | 15 | 64 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 6 | 3 | 21 | 14 | 18 | 61 |
| Lung neoplasms | D008175 | — | C34.90 | 13 | 23 | 8 | 1 | 3 | 41 |
| Infections | D007239 | EFO_0000544 | — | 3 | 6 | 8 | 9 | 17 | 40 |
| Covid-19 | D000086382 | — | U07.1 | 2 | 10 | 5 | 6 | 18 | 39 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 2 | 8 | 10 | 17 | 38 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 11 | 16 | 5 | 1 | 1 | 31 |
| Ulcer | D014456 | MPATH_579 | — | 3 | 2 | 5 | 7 | 10 | 27 |
| Tooth discoloration | D014075 | — | K03.6 | — | — | — | 4 | 19 | 23 |
Show 161 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 30 | 66 | 18 | — | 1 | 102 |
| Neoplasms | D009369 | — | C80 | 20 | 17 | 5 | — | 11 | 51 |
| Adenocarcinoma | D000230 | — | — | 11 | 32 | 11 | — | — | 49 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 10 | 27 | 8 | — | — | 41 |
| Non-small-cell lung carcinoma | D002289 | — | — | 12 | 26 | 8 | — | — | 40 |
| Colorectal neoplasms | D015179 | — | — | 9 | 19 | 5 | — | 3 | 34 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 10 | 20 | 6 | — | — | 32 |
| Fallopian tube neoplasms | D005185 | — | — | 8 | 20 | 6 | — | — | 30 |
| Lymphoma | D008223 | — | C85.9 | 10 | 21 | 4 | — | — | 28 |
| Serous cystadenocarcinoma | D018284 | — | — | 6 | 16 | 6 | — | — | 26 |
Show 142 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 7 | 11 | — | — | 5 | 23 |
| Syndrome | D013577 | — | — | 5 | 3 | — | — | 16 | 22 |
| Melanoma | D008545 | — | — | 6 | 12 | — | — | 1 | 17 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 3 | 8 | — | — | 1 | 11 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 5 | — | — | 4 | 9 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 4 | 6 | — | — | — | 9 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 8 | — | — | — | 8 |
| Cutaneous malignant melanoma | D000096142 | — | — | 2 | 7 | — | — | — | 8 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 2 | 6 | — | — | — | 8 |
| Small cell carcinoma | D018288 | — | — | 3 | 8 | — | — | — | 8 |
Show 201 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | D005221 | — | R53.83 | 1 | — | — | — | 6 | 7 |
| Vasodilation | D014664 | — | — | 3 | — | — | — | 3 | 6 |
| Wound healing | D014945 | GO_0042060 | — | 1 | — | — | — | 5 | 6 |
| Vasoconstriction | D014661 | — | — | 3 | — | — | — | 2 | 5 |
| Duodenal ulcer | D004381 | EFO_0004607 | K26 | 2 | — | — | — | 2 | 4 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | 1 | 4 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | 1 | — | — | — | 3 | 4 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 3 | — | — | — | 1 | 4 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | 3 | 4 |
| Plasma cell neoplasms | D054219 | — | — | 3 | — | — | — | — | 3 |
Show 91 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Refractive errors | D012030 | HP_0000483 | H52.7 | — | — | — | — | 25 | 25 |
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | — | 13 | 13 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | — | 9 | 9 |
| Gestational diabetes | D016640 | — | O24.4 | — | — | — | — | 8 | 8 |
| Presbyopia | D011305 | — | H52.4 | — | — | — | — | 7 | 7 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | — | — | — | 7 | 7 |
| Astigmatism | D001251 | EFO_0004222 | H52.2 | — | — | — | — | 7 | 7 |
| Fistula | D005402 | — | — | — | — | — | — | 6 | 6 |
| Hyperopia | D006956 | EFO_0006310 | H52.0 | — | — | — | — | 5 | 5 |
| Rectal fistula | D012003 | — | K60.3 | — | — | — | — | 5 | 5 |
Show 304 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 | — |
| ChEMBL ID | CHEMBL1502 |
| ChEBI ID | 7915 |
| PubChem CID | 4679 |
| DrugBank | DB00213 |
| UNII ID | D8TST4O562 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Pantoprazole
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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91,777 adverse events reported
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