Lansoprazole
Prevacid, Prevpac (lansoprazole) is a small molecule pharmaceutical. Lansoprazole was first approved as Prevacid on 1995-05-10. It is used to treat duodenal ulcer, esophagitis, gastroesophageal reflux, helicobacter infections, and stomach ulcer amongst others in the USA.
Download report
Favorite
Commercial
Trade Name
FDA
EMA
Prevacid (generic drugs available since 2009-11-10)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
+
Clarithromycin
+
Lansoprazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PREVPAC (COPACKAGED) | Takeda | N-050757 DISCN | 1997-12-02 | 1 products, RLD |
Hide discontinued
Lansoprazole
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lansoprazole | ANDA | 2023-06-21 |
| prevacid 24 hr | New Drug Application | 2023-03-30 |
| prevpac | New Drug Application | 2010-03-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| duodenal ulcer | EFO_0004607 | D004381 | K26 |
| esophagitis | HP_0100633 | D004941 | K20 |
| gastroesophageal reflux | EFO_0003948 | D005764 | K21 |
| helicobacter infections | EFO_1000961 | D016481 | — |
| stomach ulcer | — | D013276 | K25 |
| zollinger-ellison syndrome | — | D015043 | E16.4 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Lansoprazole, Lansoprazole, Dexcel | |||
| 11077055 | 2036-04-21 | DP | |
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
— A02BC03: Lansoprazole
— A02BC53: Lansoprazole, combinations
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD02: Lansoprazole, tetracycline and metronidazole
— A02BD03: Lansoprazole, amoxicillin and metronidazole
— A02BD07: Lansoprazole, amoxicillin and clarithromycin
— A02BD09: Lansoprazole, clarithromycin and tinidazole
— A02BD10: Lansoprazole, amoxicillin and levofloxacin
HCPCS
No data
Clinical
Clinical Trials
111 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | G89.18 | 2 | 4 | 5 | 4 | 1 | 15 | |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | 3 | 5 | 2 | 11 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | — | 2 | 4 | 2 | 8 |
| Macular edema | D008269 | — | 2 | — | 2 | 3 | 7 | ||
| Anesthesia | D000758 | — | — | — | 2 | 1 | 3 | ||
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 1 | 2 | — | 3 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | 1 | 1 | — | 3 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | 2 | — | 2 |
| Rotator cuff injuries | D000070636 | M75.1 | — | — | — | 1 | — | 1 | |
| Osteonecrosis | D010020 | EFO_0004259 | M87 | — | — | — | 1 | — | 1 |
Show 22 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal colic | D056844 | EFO_1001412 | N23 | — | 1 | 2 | — | 1 | 3 |
| Analgesia | D000698 | — | — | 1 | — | 1 | 2 | ||
| Acute pain | D059787 | R52 | — | 1 | 1 | — | — | 2 | |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | — | 2 | — | — | 2 |
| Abdominal pain | D015746 | R10.9 | — | — | 2 | — | — | 2 | |
| Back pain | D001416 | HP_0003418 | M54 | — | — | 2 | — | — | 2 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | — | 1 | — | — | 1 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | — | 1 | — | — | 1 |
| Nephrolithiasis | D053040 | N20.0 | — | — | 1 | — | — | 1 | |
| Emergencies | D004630 | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | 4 | — | — | 1 | 5 |
| Kidney calculi | D007669 | EFO_0004253 | N20.0 | 1 | 1 | — | — | 1 | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Urolithiasis | D052878 | N20-N23 | — | 1 | — | — | — | 1 | |
| Shoulder impingement syndrome | D019534 | EFO_1001178 | M75.4 | — | 1 | — | — | — | 1 |
| Hemiarthroplasty | D062785 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 7 | — | — | — | — | 7 | ||
| Cerebral arterial diseases | D002539 | EFO_1000859 | 1 | — | — | — | — | 1 | |
| Allergic rhinitis | D065631 | J30.9 | 1 | — | — | — | — | 1 | |
| Mammaplasty | D016462 | 1 | — | — | — | — | 1 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Blood pressure | D001794 | EFO_0004325 | 1 | — | — | — | — | 1 | |
| Inflammation | D007249 | 1 | — | — | — | — | 1 | ||
| Pancreatic ductal carcinoma | D021441 | 1 | — | — | — | — | 1 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pathologic dilatation | D004108 | — | — | — | — | 2 | 2 | ||
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 2 | 2 |
| Regeneration | D012038 | — | — | — | — | 2 | 2 | ||
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 2 | 2 |
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | — | — | — | — | 1 | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 1 | 1 |
| Head and neck neoplasms | D006258 | — | — | — | — | 1 | 1 | ||
| Ankle fractures | D064386 | S82.5 | — | — | — | — | 1 | 1 | |
| Bunion | D000071378 | M21.61 | — | — | — | — | 1 | 1 | |
| Hammer toe syndrome | D037801 | EFO_1001336 | M21.53 | — | — | — | — | 1 | 1 |
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | LANSOPRAZOLE |
| INN | lansoprazole |
| Description | Lansoprazole is a member of benzimidazoles, a member of pyridines and a sulfoxide. It has a role as an EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor and an anti-ulcer drug. |
| Classification | Small molecule |
| Drug class | antiulcer agents (benzimidazole derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1c(OCC(F)(F)F)ccnc1C[S+]([O-])c1nc2ccccc2[nH]1 |
Identifiers
| PDB | — |
| CAS-ID | 103577-45-3 |
| RxCUI | 17128 |
| ChEMBL ID | CHEMBL480 |
| ChEBI ID | 6375 |
| PubChem CID | 3883 |
| DrugBank | DB00448 |
| UNII ID | 0K5C5T2QPG (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 7,209 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
6,107 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more