Rabeprazole
Aciphex, Rabeprazole (rabeprazole) is a small molecule pharmaceutical. Rabeprazole was first approved as Aciphex on 1999-08-19. It is used to treat duodenal ulcer, gastroesophageal reflux, heartburn, helicobacter infections, and zollinger-ellison syndrome in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Aciphex, Rabeprazole (discontinued: Aciphex, Rabeprazole)
Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rabeprazole sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACIPHEX | Waylis Therapeutics | N-020973 RX | 1999-08-19 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aciphex | New Drug Application | 2025-01-24 |
| rabeprazole sodium | ANDA | 2025-09-17 |
| rabeprazole sodium delayed-release | NDA authorized generic | 2020-12-29 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
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Patent Expiration
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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
— A02BC04: Rabeprazole
— A02BC54: Rabeprazole, combinations
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD12: Rabeprazole, amoxicillin and clarithromycin
— A02BD13: Rabeprazole, amoxicillin and metronidazole
HCPCS
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Clinical
Clinical Trials
277 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 8 | 10 | 20 | 13 | 14 | 62 |
| Infections | D007239 | EFO_0000544 | — | 4 | 4 | 5 | 35 | 14 | 60 |
| Healthy volunteers/patients | — | — | — | 52 | 1 | 1 | 2 | — | 56 |
| Helicobacter infections | D016481 | EFO_1000961 | — | 2 | 3 | 4 | 16 | 13 | 36 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | 2 | 5 | 12 | 7 | 5 | 30 |
| Communicable diseases | D003141 | — | — | 1 | 1 | 3 | 12 | 6 | 22 |
| Ulcer | D014456 | MPATH_579 | — | — | 6 | 6 | 3 | 4 | 14 |
| Duodenal ulcer | D004381 | EFO_0004607 | K26 | — | 5 | 5 | 1 | 3 | 10 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | — | 1 | 1 | 5 | 3 | 9 |
| Heartburn | D006356 | — | R12 | — | — | 4 | 4 | 1 | 9 |
Show 29 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | — | 3 | 1 | — | — | 3 |
| Small cell lung carcinoma | D055752 | — | — | — | 3 | 1 | — | — | 3 |
| Esophageal diseases | D004935 | EFO_0009544 | K22.9 | — | 1 | 1 | — | — | 2 |
| Non-erosive reflux disease | D000096663 | — | — | — | — | 1 | — | 1 | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | 1 | — | 1 | 2 |
| Deglutition disorders | D003680 | — | R13.1 | — | 2 | 1 | — | — | 2 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | 1 | — | — | 1 |
| Endoscopic mucosal resection | D000069916 | — | — | — | — | 1 | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 1 | — | — | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 7 | 5 | — | — | — | 8 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 3 | — | — | — | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 1 | — | — | — | 1 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 1 | — | — | — | 1 |
| Female genital neoplasms | D005833 | — | — | 1 | 1 | — | — | — | 1 |
| Uterine cervical neoplasms | D002583 | — | — | 1 | 1 | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | — | — | — | 1 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 4 | — | — | — | — | 4 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | 2 | — | — | — | 1 | 3 |
| Covid-19 | D000086382 | — | U07.1 | 1 | — | — | — | 1 | 2 |
| Biological availability | D001682 | — | — | 2 | — | — | — | — | 2 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 2 | — | — | — | — | 2 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 2 | — | — | — | — | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | — | — | — | — | 1 |
Show 12 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Community-acquired pneumonia | D000098968 | — | — | — | — | — | — | 1 | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 1 | 1 |
| Calcium metabolism disorders | D002128 | EFO_0005769 | E83.5 | — | — | — | — | 1 | 1 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | — | — | 1 | 1 |
| Death | D003643 | PATO_0001422 | — | — | — | — | — | 1 | 1 |
| Sudden death | D003645 | — | — | — | — | — | — | 1 | 1 |
| Signs and symptoms | D012816 | EFO_0003765 | R68 | — | — | — | — | 1 | 1 |
| Pharyngeal diseases | D010608 | — | — | — | — | — | — | 1 | 1 |
| Patient compliance | D010349 | — | — | — | — | — | — | 1 | 1 |
Show 13 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rabeprazole |
| INN | rabeprazole |
| Description | Rabeprazole is a member of benzimidazoles, a sulfoxide and a member of pyridines. It has a role as an EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor and an anti-ulcer drug. It is a conjugate acid of a rabeprazole(1-). |
| Classification | Small molecule |
| Drug class | antiulcer agents (benzimidazole derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COCCCOc1ccnc(C[S+]([O-])c2nc3ccccc3[nH]2)c1C |
Identifiers
| PDB | — |
| CAS-ID | 117976-89-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1219 |
| ChEBI ID | 8768 |
| PubChem CID | 5029 |
| DrugBank | DB01129 |
| UNII ID | 32828355LL (ChemIDplus, GSRS) |
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Rabeprazole
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Safety
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14,301 adverse events reported
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