Vonoprazan
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Also known as TAK-438TakecabVocintiVonoprazan Fumarate (TAK-438)
Summary
Vonoprazan (CHEMBL2079130) is an approved small molecule (ATC A02BC08) targeting ATP4A; indicated across 4 conditions including gastroesophageal reflux disease and peptic ulcer disease.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: A02BC08
- Targets: 1 (ATP4A)
- Indications: 4 conditions
- Clinical trials: 108
- Chemistry: 345.4 Da · C17H16FN3O2S
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL2079130 |
| Name | Vonoprazan |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 15981397 |
| ATC | A02BC08 |
| Molecular formula | C17H16FN3O2S |
| Molecular weight | 345.4 |
| InChIKey | BFDBKMOZYNOTPK-UHFFFAOYSA-N |
SMILES: CNCC1=CN(C(=C1)C2=CC=CC=C2F)S(=O)(=O)C3=CN=CC=C3
IUPAC name: 1-[5-(2-fluorophenyl)-1-pyridin-3-ylsulfonylpyrrol-3-yl]-N-methylmethanamine
Also known as: TAK-438, Takecab, Vocinti, Vonoprazan, VONOPRAZAN, Vonoprazan Fumarate (TAK-438)
Parent form; salt/anhydrous children: CHEMBL2064032
Patent coverage: 259 distinct patent families (464 SureChEMBL compound mentions), from 4 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| ATP4A | ATP4A | Inhibition | 7.72 | 0.2% | P20648 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): ATP4A.
Top Reactome pathways
3 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Transport of small molecules | 1 | ATP4A |
| Ion transport by P-type ATPases | 1 | ATP4A |
| Ion channel transport | 1 | ATP4A |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| intracellular sodium ion homeostasis | 1 |
| response to xenobiotic stimulus | 1 |
| regulation of proton transport | 1 |
| intracellular potassium ion homeostasis | 1 |
| monoatomic ion transmembrane transport | 1 |
| sodium ion export across plasma membrane | 1 |
| pH reduction | 1 |
| potassium ion transmembrane transport | 1 |
| proton transmembrane transport | 1 |
| potassium ion import across plasma membrane | 1 |
| monoatomic ion transport | 1 |
| potassium ion transport | 1 |
| establishment or maintenance of transmembrane electrochemical gradient | 1 |
Indications & clinical
Indications
4 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| gastroesophageal reflux disease | 4 | MONDO:0007186 | EFO:0003948 |
| peptic ulcer disease | 4 | MONDO:0004247 | HP:0004398 |
| Helicobacter pylori infectious disease | 3 | MONDO:0006781 | EFO:1000961 |
| esophagitis | 1 | MONDO:0001409 | MONDO:0001409 |
Clinical trials
Total trials: 108.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 32 |
| PHASE4 | 30 |
| PHASE1 | 21 |
| Not specified | 18 |
| PHASE2 | 4 |
| EARLY_PHASE1 | 2 |
| PHASE2/PHASE3 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05582174 | PHASE4 | RECRUITING | PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers |
| NCT06168214 | PHASE4 | RECRUITING | Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication |
| NCT06526455 | PHASE4 | NOT_YET_RECRUITING | Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection |
| NCT06561698 | PHASE4 | RECRUITING | High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection |
| NCT06720610 | PHASE4 | NOT_YET_RECRUITING | Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis |
| NCT06723197 | PHASE4 | RECRUITING | Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication |
| NCT06929962 | PHASE4 | RECRUITING | VA Dual Sequential Therapy |
| NCT06959368 | PHASE4 | RECRUITING | Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication |
| NCT07040839 | PHASE4 | NOT_YET_RECRUITING | Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection |
| NCT07068607 | PHASE4 | RECRUITING | Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial |
| NCT02679508 | PHASE4 | COMPLETED | Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety |
| NCT03116841 | PHASE4 | COMPLETED | Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation |
| NCT03908619 | PHASE4 | UNKNOWN | A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis |
| NCT04028466 | PHASE4 | TERMINATED | Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features |
| NCT04901663 | PHASE4 | COMPLETED | Vonoprazan in Helicobacter Pylori Treatment an RCT |
| NCT04907747 | PHASE4 | UNKNOWN | Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication |
| NCT05014334 | PHASE4 | COMPLETED | Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication |
| NCT05191888 | PHASE4 | UNKNOWN | 14-day PCAB-based High-dose Dual Therapy and14-day PCAB-based Triple Therapy vs 14-day PPI-based Reverse Hybrid Therapy |
| NCT05419674 | PHASE4 | UNKNOWN | Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection |
| NCT05469685 | PHASE4 | COMPLETED | Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication |
| NCT05590286 | PHASE4 | UNKNOWN | A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection |
| NCT05649540 | PHASE4 | COMPLETED | Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori |
| NCT05658055 | PHASE4 | UNKNOWN | The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication |
| NCT05726734 | PHASE4 | UNKNOWN | Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial |
| NCT05874544 | PHASE4 | COMPLETED | Rescue Therapy for Helicobacter Pylori Infection |
| NCT05901051 | PHASE4 | COMPLETED | High-dose Dual Therapy with Different Administration Frequencies |
| NCT06156085 | PHASE4 | COMPLETED | Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy |
| NCT06168084 | PHASE4 | COMPLETED | Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy |
| NCT06514274 | PHASE4 | COMPLETED | Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication |
| NCT06561711 | PHASE4 | COMPLETED | Optimization of Minocycline for Helicobacter Pylori Rescue Treatment |
| NCT07242456 | PHASE2/PHASE3 | RECRUITING | 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 |
| NCT07275827 | PHASE3 | NOT_YET_RECRUITING | Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection |
| NCT07608536 | PHASE3 | NOT_YET_RECRUITING | Comparison of Rabeprazole and Vonoprazan in the Prevention of Post-endoscopic Variceal Ligation Ulcer in Patients With Cirrhosis |
| NCT01452698 | PHASE3 | COMPLETED | Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis |
| NCT01452711 | PHASE3 | COMPLETED | Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer |
| NCT01452724 | PHASE3 | COMPLETED | Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer |
| NCT01452750 | PHASE3 | COMPLETED | Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID) |
| NCT01452763 | PHASE3 | COMPLETED | Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin |
| NCT01452776 | PHASE3 | COMPLETED | Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis |
| NCT01456247 | PHASE3 | COMPLETED | Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.
Related molecules
Related molecules
Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.
5 molecules share ≥1 primary target. Top 5 by shared-target count:
| Molecule | Source | Status | Shared targets |
|---|---|---|---|
| CIMETIDINE | ChEMBL + PubChem | Phase 4 (approved) | ATP4A |
| LANSOPRAZOLE | ChEMBL + PubChem | Phase 4 (approved) | ATP4A |
| PANTOPRAZOLE | ChEMBL + PubChem | Phase 4 (approved) | ATP4A |
| OMEPRAZOLE | ChEMBL | Phase 4 (approved) | ATP4A |
| RANITIDINE | ChEMBL | Phase 4 (approved) | ATP4A |