Rabeprazole
Aciphex (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
Trade Name
FDA
EMA
Aciphex (generic drugs available since 2013-11-08)
Drug Products
FDA
EMA
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 | Woodward Pharma Services | 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 | 2022-05-18 |
| rabeprazole sodium | ANDA | 2023-05-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| duodenal ulcer | EFO_0004607 | D004381 | K26 |
| gastroesophageal reflux | EFO_0003948 | D005764 | K21 |
| heartburn | — | D006356 | R12 |
| helicobacter infections | EFO_1000961 | D016481 | — |
| zollinger-ellison syndrome | — | D015043 | E16.4 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
No data
Clinical
Clinical Trials
184 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 | 6 | 14 | 8 | 9 | 44 |
| Healthy volunteers/patients | — | 39 | 1 | 1 | 1 | — | 42 | ||
| Infections | D007239 | EFO_0000544 | — | — | 1 | 19 | 4 | 24 | |
| Duodenal ulcer | D004381 | EFO_0004607 | K26 | — | 5 | 5 | 1 | 2 | 9 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | 3 | 1 | 2 | 1 | 6 | |
| Heartburn | D006356 | R12 | — | — | 4 | 1 | 1 | 6 | |
| Gastritis | D005756 | EFO_0000217 | K29.7 | — | 1 | 1 | 2 | 2 | 5 |
| Stomach ulcer | D013276 | K25 | — | 1 | 1 | 1 | 2 | 4 | |
| Gastrointestinal diseases | D005767 | — | 1 | — | 2 | — | 3 | ||
| Helicobacter infections | D016481 | EFO_1000961 | — | 1 | 1 | 2 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Esophageal diseases | D004935 | EFO_0009544 | K22.9 | — | 1 | 1 | — | — | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | 1 | — | 1 | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 1 | — | — | 1 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 1 | — | — | 1 |
| Laryngopharyngeal reflux | D057045 | EFO_1001355 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 6 | 4 | — | — | — | 7 | |
| Non-small-cell lung carcinoma | D002289 | 1 | 2 | — | — | — | 2 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | — | 2 |
| Female genital neoplasms | D005833 | 1 | 1 | — | — | — | 1 | ||
| Urologic neoplasms | D014571 | C64-C68 | 1 | 1 | — | — | — | 1 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | 1 | 1 | — | — | — | 1 | ||
| Lung neoplasms | D008175 | C34.90 | — | 1 | — | — | — | 1 | |
| Small cell lung carcinoma | D055752 | — | 1 | — | — | — | 1 | ||
| Esophageal motility disorders | D015154 | K22.4 | — | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | 3 | — | — | — | — | 3 | ||
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 2 | — | — | — | — | 2 |
| Pharmacokinetics | D010599 | 2 | — | — | — | — | 2 | ||
| Lymphoma | D008223 | C85.9 | 2 | — | — | — | — | 2 | |
| Communicable diseases | D003141 | 1 | — | — | — | — | 1 | ||
| Food-drug interactions | D018565 | 1 | — | — | — | — | 1 | ||
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peptic ulcer | D010437 | HP_0004398 | K27 | — | — | — | — | 2 | 2 |
| Calcium metabolism disorders | D002128 | EFO_0005769 | E83.5 | — | — | — | — | 1 | 1 |
| Signs and symptoms | D012816 | EFO_0003765 | R68 | — | — | — | — | 1 | 1 |
| Pharyngeal diseases | D010608 | — | — | — | — | 1 | 1 | ||
| B-cell lymphoma marginal zone | D018442 | C88.4 | — | — | — | — | 1 | 1 | |
| Chest pain | D002637 | HP_0100749 | R07.9 | — | — | — | — | 1 | 1 |
| Laryngitis | D007827 | — | — | — | — | 1 | 1 |
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) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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110,359 adverse events reported
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