Takecab

(Vonoprazan)

ApprovedSmall molecule

Vonoprazan is used to treat acid reflux and ulcers by reducing the amount of acid your stomach produces, helping to relieve heartburn and allow ulcers to heal.[2] Takecab is currently approved and in use across 13 indications[4].[1]

Takecab is one of 131 small molecule programs targeting Helicobacter pylori infectious disease. It is currently in Approved.

Indications

Total Trials

Active Trials

130

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Helicobacter Pylori Infectious DiseaseUnknown

Peptic EsophagitisActive, not recruiting

Duodenal UlcerActive, not recruiting

Functioanl DyspepsiaRecruiting

Non-Erosive Gastroesophageal Reflux DiseaseNot yet recruiting

Randomized Controlled TrialRecruiting

Eosinophilic EsophagitisActive, not recruiting

Peptic UlcerRecruiting

GastritisUnknown status

Helicobacter Pylori InfectionRecruiting

Helicobacter Pylori Infectious DiseasePreclinical

Unknown

Peptic EsophagitisPreclinical

Active, not recruiting

Duodenal UlcerPreclinical

Active, not recruiting

Functioanl DyspepsiaPreclinical

Recruiting

Non-Erosive Gastroesophageal Reflux DiseasePhase 3

Not yet recruiting

Randomized Controlled TrialPhase 2

Recruiting

Eosinophilic EsophagitisPhase 2

Active, not recruiting

Peptic UlcerApproved

Recruiting

GastritisApproved

Unknown status

Helicobacter Pylori InfectionApproved

Recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Takecab

PPhathom Pharmaceuticals, Inc.

Approved

3 2

Rinvoq

AbbVie

Phase 3

4 3

Savaysa

Daiichi Sankyo

Phase 3

3 4

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

7 5

Rapamune

PPrism Pharmaceuticals

Phase 3

5 6

Rilutek

AAzurity Pharmaceuticals

Phase 3

3 7

Kineret

SSwedish Orphan Biovitrum

Phase 3

2 8

UPLIZNA

HHorizon Therapeutics Ireland DAC

Phase 3

1 9

Becotatug Vedotin

FFudan University

Phase 3

1 10

Apatinib Mesylate

BBukwang Pharmaceutical

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Not yet recruiting

Helicobacter Pylori Infection

NCT06731023

Q1 2027

Phase 2Active, not recruiting

Eosinophilic Esophagitis

NCT06851559

PreclinicalRecruiting

Functioanl Dyspepsia

NCT07731542

Q4 2027

N/ARecruiting

Esophagitis

NCT06953986

Q1 2028

Phase 3Not yet recruiting

Non-Erosive Gastroesophageal Reflux Disease

NCT07752407

Clinical

Trials by Indication[1]

Esophagitis9 trials

Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation

Completed· Takeda logo

Takeda·Phase 4·NCT03116841·3 enrolled

A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

Recruiting·—·N/A·NCT06953986·414 enrolled

Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety

Completed· Takeda logo

Takeda·Phase 4·NCT02679508·208 enrolled

Show 6 more trials

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

Completed·PPhathom Pharmaceuticals, Inc.·Phase 3·NCT04124926·1,027 enrolled

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 3·NCT02388737·703 enrolled

Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM

Recruiting·—·N/A·NCT06955520·300 enrolled

Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

Not yet recruiting·IIndonesia University·Phase 4·NCT06720610·216 enrolled

Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 3·NCT02388724·481 enrolled

Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"

Completed· Takeda logo

Takeda··NCT03214081·1,237 enrolled

Helicobacter Pylori Eradication7 trials

The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication

Unknown status·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT05658055·100 enrolled

Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04907747·234 enrolled

Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

Completed·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT05469685·914 enrolled

Show 4 more trials

Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication

Unknown status·—·Phase 3·NCT06811207·300 enrolled

Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial

Recruiting·YYongquan Shi·Phase 4·NCT07068607·400 enrolled

Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Completed·—·Phase 3·NCT06162949·242 enrolled

Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

Completed· Takeda logo

Takeda··NCT03219723·560 enrolled

Helicobacter Pylori Infection5 trials

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

Completed·PPhathom Pharmaceuticals, Inc.·Phase 3·NCT04167670·1,046 enrolled

High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection

Recruiting·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT06561698·200 enrolled

Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study

Not yet recruiting·XXiuli Zuo··NCT06731023·30 enrolled

Show 2 more trials

A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection

Unknown status·FFirst People's Hospital of Hangzhou·Phase 4·NCT05590286·100 enrolled

A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

Completed· Takeda logo

Takeda·Phase 3·NCT04198363·510 enrolled

Gastroesophageal Reflux Disease5 trials

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease

Completed·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT05343364·24 enrolled

A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease

Completed·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT06106022·22 enrolled

A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)

Completed·PPhathom Pharmaceuticals, Inc.·Phase 3·NCT05195528·776 enrolled

Show 2 more trials

A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

Completed·PPhathom Pharmaceuticals, Inc.·Phase 2·NCT04799158·458 enrolled

Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features

Terminated·—·Phase 4·NCT04028466·82 enrolled

Helicobacter Pylori4 trials

A Study of Vonoprazan in Adults With Helicobacter Pylori

Completed· Takeda logo

Takeda·Phase 1·NCT04753437·44 enrolled

Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Completed·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT05649540·900 enrolled

Optimization of Minocycline for Helicobacter Pylori Rescue Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT06561711·480 enrolled

Show 1 more trial

The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

Unknown status·HHuazhong University of Science and Technology·N/A·NCT05189444·672 enrolled

24 more indications

Tics3 trials

Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers

Completed·SSeoul National University Hospital·Phase 1·NCT04568772·19 enrolled

Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants

Withdrawn·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT04558216

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants

Completed·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT04729101·44 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection

Not yet recruiting·SShicai Ye·Phase 4·NCT06526455·196 enrolled

Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05014334·300 enrolled

Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT06514274·558 enrolled

Duodenal Ulcer3 trials

Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

Completed· Takeda logo

Takeda··NCT03214094·1,119 enrolled

Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"

Completed· Takeda logo

Takeda··NCT03214198·1,304 enrolled

Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"

Completed· Takeda logo

Takeda··NCT03214952·3,183 enrolled

Oral2 trials

A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants

Completed·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT06831344·25 enrolled

Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)

Completed· Takeda logo

Takeda·Phase 3·NCT02037477·20 enrolled

Peptic ulcer2 trials

PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

Recruiting·—·Phase 4·NCT05582174·594 enrolled

Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

Completed·UUayporn Kaosombatwattana·Phase 1·NCT05005910·194 enrolled

High-dose Dual Therapy2 trials

The Effects of High-dose Dual Therapy With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment

Completed·ZZhongshan Hospital (Xiamen), Fudan University·N/A·NCT06292546·72 enrolled

High-dose Dual Therapy with Different Administration Frequencies

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05901051·327 enrolled

Efficacy1 trial

Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

Completed·—·Phase 3·NCT06101420·232 enrolled

Helicobacter1 trial

Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Completed·YYongquan Shi·Phase 4·NCT06168084·688 enrolled

First-line Treatment1 trial

Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT05419674·393 enrolled

ART1 trial

A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants

Completed·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT05366738·27 enrolled

Rescue Therapy for Helicobacter Pylori1 trial

Rescue Therapy for Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05874544·360 enrolled

GERD1 trial

Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI)

Completed· Takeda logo

Takeda·Phase 2·NCT02743949·256 enrolled

Randomized Controlled Trial1 trial

Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial

Recruiting·KKing Edward Medical University·Phase 2·NCT07267260·154 enrolled

H Pylori Infection1 trial

Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

Not yet recruiting·RRehman Medical Institute - RMI·Phase 4·NCT07040839·128 enrolled

TED1 trial

Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT07278349·28 enrolled

Concentration1 trial

A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily

Completed·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT06391177·15 enrolled

Bismuth Quadruple Therapy1 trial

Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial

Unknown status·SShanghai East Hospital·Phase 4·NCT05726734·100 enrolled

Midazolam1 trial

Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants

Completed·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT04545944·20 enrolled

Gastritis1 trial

A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis

Unknown status·—·Phase 4·NCT03908619·252 enrolled

Erosive Esophagitis1 trial

Vonoprazan Pregnancy Registry: An Observational Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Recruiting·PPhathom Pharmaceuticals, Inc.··NCT06660342·728 enrolled

Non-erosive Gastroesophageal Reflux Disease1 trial

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks

Not yet recruiting·PPhathom Pharmaceuticals, Inc.·Phase 3·NCT07752407·500 enrolled

Functioanl Dyspepsia1 trial

A Randomized Controlled Trial of Vonoprazan Monotherapy Versus Vonoprazan-Itopride Combination Therapy in Functional Dyspepsia (VIVA Trial)

Recruiting·AAsian Institute of Gastroenterology, India·Preclinical·NCT07731542·192 enrolled

Eosinophilic Esophagitis1 trial

A Phase 2, Randomized, Double-Blind, Multi-Center Study in Adult Subjects With Eosinophilic Esophagitis (EoE) to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Up to 24 Weeks

Active, not recruiting·PPhathom Pharmaceuticals, Inc.·Phase 2·NCT06851559·95 enrolled

Unspecified5 trials

Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication

Completed·NNanjing First Hospital, Nanjing Medical University·Phase 3·NCT06340724·104 enrolled

Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication

Recruiting·FFirst People's Hospital of Hangzhou·Phase 2/3·NCT07242456·240 enrolled

The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole

Completed·SShowa Inan General Hospital·N/A·NCT04720781·300 enrolled

Show 2 more trials

7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication

Completed·—·Phase 3·NCT06576882·326 enrolled

Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication

Not yet recruiting·NNanjing First Hospital, Nanjing Medical University·Phase 1·NCT06901375·136 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 1, 2023

VOQUEZNA

NDA NDA215151

Sources

References

[1]
ClinicalTrials.gov — 67 trial records for Vonoprazan. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Takecab drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Vonoprazan compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Vonoprazan. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215151). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Takecab. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Phathom Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Potassium-Transporting Atpase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPhathom Pharmaceuticals, Inc.

Patent Landscape[6]

Patent Cliff

Aug 11, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9186411Aug 11, 2030

Takecab

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Esophagitis9 trials

Helicobacter Pylori Eradication7 trials

Helicobacter Pylori Infection5 trials

Gastroesophageal Reflux Disease5 trials

Helicobacter Pylori4 trials

Tics3 trials

Efficacy and Safety3 trials

Duodenal Ulcer3 trials

Oral2 trials

Peptic ulcer2 trials

High-dose Dual Therapy2 trials

Efficacy1 trial

Helicobacter1 trial

First-line Treatment1 trial

ART1 trial

Rescue Therapy for Helicobacter Pylori1 trial

GERD1 trial

Randomized Controlled Trial1 trial

H Pylori Infection1 trial

TED1 trial

Concentration1 trial

Bismuth Quadruple Therapy1 trial

Midazolam1 trial

Gastritis1 trial

Erosive Esophagitis1 trial

Non-erosive Gastroesophageal Reflux Disease1 trial

Functioanl Dyspepsia1 trial

Eosinophilic Esophagitis1 trial

Unspecified5 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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