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Drug ReportsVonoprazan
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
Voquezna
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 PAKPhathom PharmaceuticalsN-215152 PEND2022-05-03
1 products, RLD
Amoxicillin
+
Vonoprazan fumarate
Tradename
Company
Number
Date
Products
VOQUEZNA DUAL PAKPhathom PharmaceuticalsN-215153 PEND2022-05-03
1 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
voqueznaNew Drug Application2024-07-22
voquezna dual pak voquezna triple pakNew Drug Application2024-08-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
urinary tract infectionsEFO_0003103D014552N39.0
sinusitisEFO_0007486D012852J32
otitis mediaEFO_0004992D010033H66.9
bacterial infections—D001424A49
bacterial skin diseases—D017192—
soft tissue infections—D018461—
chlamydia infectionsEFO_0007205D002690A74.9
helicobacter infectionsEFO_1000961D016481—
duodenal ulcerEFO_0004607D004381K26
streptococcal infectionsEFO_1001476D013290—
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Agency Specific
FDA
EMA
Expiration
Code
AMOXICILLIN / CLARITHROMYCIN / VONOPRAZAN FUMARATE, VOQUEZNA TRIPLE PAK, PHATHOM
2032-05-03GAIN
2027-05-03NCE
AMOXICILLIN / VONOPRAZAN FUMARATE, VOQUEZNA DUAL PAK, PHATHOM
2032-05-03GAIN
2027-05-03NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Amoxicillin / Clarithromycin / Vonoprazan Fumarate, Voquezna Triple Pak, Phathom
91864112030-08-11DP
79774882028-08-11DP
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
121 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—325241447
Helicobacter infectionsD016481EFO_1000961—23381126
UlcerD014456MPATH_579—1—111316
Gastroesophageal refluxD005764EFO_0003948K215233316
GastritisD005756EFO_0000217K29.72—37214
EsophagitisD004941HP_0100633K202—72314
Stomach ulcerD013276—K25——81211
Communicable diseasesD003141————15410
Peptic esophagitisD004942EFO_1001095—2—2239
HemorrhageD006470MP_0001914R581—11—3
Show 7 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Duodenal ulcerD004381EFO_0004607K26——8—412
Healthy volunteers/patients———8—1——9
HeartburnD006356—R12111——3
HypertensionD006973EFO_0000537I10——1——1
Portal hypertensionD006975EFO_0000666K76.6——1——1
Treatment outcomeD016896————1——1
Adolescent developmentD041923————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——————22
B-cell lymphoma marginal zoneD018442—C88.4————11
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3————11
Thrombocytopenic purpuraD011696——————11
PurpuraD011693HP_0000979D69.2————11
Patient participationD010358——————11
Gastrointestinal microbiomeD000069196——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVonoprazan
INNvonoprazan
Description
Vonoprazan is a member of pyrroles.
Classification
Small molecule
Drug classproton pump inhibitors, not dependent on acid activation
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1
Identifiers
PDB—
CAS-ID881681-00-1
RxCUI—
ChEMBL IDCHEMBL2079130
ChEBI ID—
PubChem CID15981397
DrugBankDB11739
UNII ID1R5L3J156G (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Voquezna – Phathom Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,162 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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609 adverse events reported
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