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vonoprazan

Trade name: Voquezna

Small moleculeapprovedFast Track FDA

Approved

May 3, 2022

Vonoprazan, sold under the brand name Voquezna among others, is a first-in-class potassium-competitive acid blocker medication. Vonoprazan is used in form of the fumarate for the treatment of gastroduodenal ulcer and reflux esophagitis, and can be combined with antibiotics for the eradication of Helicobacter pylori. — Wikipedia

Clinical trial activity

129 trials · 79 clinical orgs · 1 marketing orgs

Phase 1
27
Phase 2
44
Phase 3
34
Phase 4
42

Earliest trial started Sep 1, 2007 (NCT02123927)

Timeline

2000s

  1. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

2020s

  1. May 3, 2022

    Phathom Pharmaceuticals, Inc. — Earliest FDA Approval

  2. May 3, 2022

    Phathom Pharmaceuticals, Inc. — NDA Secondary Org

  3. May 3, 2022

    Phathom Pharmaceuticals, Inc. — NDA Organization

  4. Jul 17, 2024

    Phathom Pharmaceuticals, Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • voquezna dual pak

    with amoxicillin

  • voquezna triple pak

    with amoxicillin, clarithromycin

    Also known as vonoprazan, amoxicillin, and clarithromycin, vonoprazan+amoxicillin+clarithromycin 14 days, vonoprazan+amoxicillin+clarithromycin 7 days

Approval history

  • approvedPriority reviewFast trackMay 3, 2022

Chemistry & pharmacology

Loading structure…

SMILES

CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1.O=C(O)/C=C/C(=O)O
Mol. weight
461.47 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1h-pyrrol-3-yl)-n-methylmethanamine
  • tak438
  • tak 438
  • tak-438
  • tak-438
  • tak-438
  • tak-438
  • takecab
  • vonoprazan
  • vonoprazan
  • vonoprazan
  • vonoprazan
  • vonoprazan
  • vonoprazan
  • vonoprazan
  • vonoprazan fumarate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07293910Phase 2Dec 20, 2025Tanta University
NCT07267260Phase 2Dec 16, 2025King Edward Medical University
NCT07275632Phase 1/Phase 2 (Phase 2)Dec 1, 2025Chongqing Medical University, Sun Yat-Sen University
NCT07278349Phase 1Sep 21, 2025Humanis Saglık Anonim Sirketi
NCT07179159N/ASep 9, 2025Qilu Hospital of Shandong University, Shandong University, Shandong University of Traditional Chinese Medicine, Zibo Maternal and Child Health Hospital
NCT07159412N/AAug 31, 2025Nanjing Medical University
NCT07130253N/AAug 18, 2025National Taiwan University
NCT07040839Phase 4Jul 31, 2025Rehman Medical Institute - RMI
NCT06953986N/AJun 7, 2025Asian Institute of Gastroenterology
NCT06901375Early Phase 1 (Phase 1)May 31, 2025Nanjing Medical University
NCT07045688N/AMay 13, 2025Sohag University
NCT06955520N/AApr 30, 2025Asian Institute of Gastroenterology
NCT06929962Phase 4Apr 24, 2025Nanjing Medical University
NCT07306988Phase 4Apr 17, 2025Nanjing Medical University
NCT07068607Phase 4Apr 1, 2025People's Liberation Army of China
NCT06851559Phase 2Mar 31, 2025Phathom Pharmaceuticals, Inc.
NCT06959368Phase 4Mar 25, 2025Asian Institute of Gastroenterology
NCT06783257Phase 2Feb 28, 2025Shandong New Time Pharmaceutical Co., LTD
NCT07242456Phase 2/Phase 3 (Phase 3)Feb 17, 2025First People's Hospital of Hangzhou
NCT06831344Phase 1Feb 14, 2025Phathom Pharmaceuticals, Inc.
Showing 20 of 129 trials
Page 1 / 7

Organizations

Research & Development (79)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TakedaFor profit343442007
Phathom Pharmaceuticals, Inc.For profit131332019
Nanjing Medical UniversityAcademic/Hospital121142021
Shandong UniversityAcademic/Hospital7722021
People's Liberation Army of ChinaGovernment6612021
Alexandria UniversityAcademic/Hospital4422022
Jiao Tong UniversityAcademic/Hospital4412021
Ain Shams UniversityAcademic/Hospital3322022
Asian Institute of GastroenterologyAcademic/Hospital3322025
Sun Yat-Sen UniversityAcademic/Hospital3232022
Zhejiang UniversityAcademic/Hospital3212021
Zibo Maternal and Child Health HospitalAcademic/Hospital3022024
Central South UniversityAcademic/Hospital2212021
Feicheng Municipal People's HospitalAcademic/Hospital2022024
First People's Hospital of HangzhouAcademic/Hospital2222022
Fu Jen Catholic UniversityAcademic/Hospital2212021
Hamamatsu UniversityAcademic/Hospital2222016
Heze Municipal 3rd people's hospitalAcademic/Hospital2012021
Huazhong University of Science and TechnologyAcademic/Hospital2222022
Kaohsiung Medical UniversityAcademic/Hospital2222021
79 organizations
Page 1 / 4

Marketing (3)

OrganizationOrg typeRelationshipDate
Phathom Pharmaceuticals, Inc.For profitMKTGJul 17, 2024
Phathom Pharmaceuticals, Inc.For profitNDA2May 3, 2022
Phathom Pharmaceuticals, Inc.For profitNDAMay 3, 2022