Vonoprazan
Voquezna (vonoprazan) is a small molecule pharmaceutical. Vonoprazan was first approved as Voquezna triple pak on 2022-05-03. It is used to treat helicobacter pylori in the USA.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Combinations
Voquezna dual, Voquezna triple
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
+
Clarithromycin
+
Vonoprazan fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VOQUEZNA TRIPLE PAK | Phathom Pharmaceuticals | N-215152 PEND | 2022-05-03 | 1 products, RLD |
Amoxicillin
+
Vonoprazan fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VOQUEZNA DUAL PAK | Phathom Pharmaceuticals | N-215153 PEND | 2022-05-03 | 1 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| voquezna dual pak voquezna triple pak | New Drug Application | 2022-06-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| helicobacter pylori | NCBITaxon_210 | D016480 | B96.81 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMOXICILLIN / CLARITHROMYCIN / VONOPRAZAN FUMARATE, VOQUEZNA TRIPLE PAK, PHATHOM | |||
| 2032-05-03 | GAIN | ||
| 2027-05-03 | NCE | ||
AMOXICILLIN / VONOPRAZAN FUMARATE, VOQUEZNA DUAL PAK, PHATHOM | |||
| 2032-05-03 | GAIN | ||
| 2027-05-03 | NCE | ||
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
— A02BC08: Vonoprazan
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD14: Vonoprazan, amoxicillin and clarithromycin
— A02BD15: Vonoprazan, amoxicillin and metronidazole
HCPCS
No data
Clinical
Clinical Trials
448 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | 24 | 66 | 21 | 5 | 30 | 138 | ||
| Neoplasms | D009369 | C80 | 28 | 15 | 2 | 1 | 10 | 54 | |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 6 | 7 | 8 | 2 | 7 | 28 |
| Non-small-cell lung carcinoma | D002289 | 4 | 11 | 2 | 1 | 1 | 18 | ||
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 1 | 6 | 1 | 1 | 3 | 12 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 7 | 20 | 3 | — | 8 | 37 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 12 | 19 | 4 | — | 2 | 31 |
| Prostatic neoplasms | D011471 | C61 | 5 | 12 | 1 | — | — | 16 | |
| Colorectal neoplasms | D015179 | 4 | 9 | 2 | — | — | 13 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | 9 | 2 | — | 1 | 12 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | 7 | 1 | — | — | 11 |
| Glioblastoma | D005909 | EFO_0000515 | 4 | 7 | 1 | — | — | 11 | |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 1 | — | 1 | 4 | |
| Urologic neoplasms | D014571 | C64-C68 | 1 | 1 | 1 | — | — | 3 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 1 | 1 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | C67 | 1 | 12 | — | — | — | 12 | |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 4 | 5 | — | — | 1 | 10 |
| Lung neoplasms | D008175 | C34.90 | — | 7 | — | — | — | 7 | |
| Melanoma | D008545 | 3 | 6 | — | — | — | 7 | ||
| Myeloid leukemia acute | D015470 | C92.0 | 4 | 3 | — | — | — | 6 | |
| Multiple myeloma | D009101 | C90.0 | 2 | 4 | — | — | — | 6 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 6 | — | — | — | 6 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 5 | — | — | 1 | 6 | |
| Esophageal neoplasms | D004938 | C15 | 1 | 5 | — | — | — | 6 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 3 | 2 | — | — | — | 5 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | 1 | 2 | ||
| Hodgkin disease | D006689 | C81 | 2 | — | — | — | — | 2 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 1 | — | — | — | 1 | 2 | |
| Osteosarcoma | D012516 | 1 | — | — | — | — | 1 | ||
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
| Thrombocytosis | D013922 | D75.83 | 1 | — | — | — | — | 1 | |
| Tongue neoplasms | D014062 | EFO_0003871 | C02.9 | 1 | — | — | — | — | 1 |
| Verrucous carcinoma | D018289 | 1 | — | — | — | — | 1 | ||
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | VONOPRAZAN |
| INN | vonoprazan |
| Description | Vonoprazan is a member of pyrroles. |
| Classification | Small molecule |
| Drug class | proton pump inhibitors, not dependent on acid activation |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 881681-00-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2079130 |
| ChEBI ID | — |
| PubChem CID | 15981397 |
| DrugBank | DB11739 |
| UNII ID | 1R5L3J156G (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
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Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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47,045 adverse events reported
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