MedPath

Omeprazole

Generic Name
Omeprazole
Brand Names
Konvomep, Losec, Omeclamox, Omesec, Previdolrx Analgesic Pak, Prilosec, Talicia, Yosprala, Zegerid, Zegerid Reformulated Aug 2006, Zegerid With Magnesium Hydroxide
Drug Type
Small Molecule
Chemical Formula
C17H19N3O3S
CAS Number
73590-58-6
Unique Ingredient Identifier
KG60484QX9

Overview

Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .

Background

Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .

Indication

Omeprazole, according to the FDA label is a proton pump inhibitor (PPI) used for the following purposes: • Treatment of active duodenal ulcer in adults • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults • Treatment of active benign gastric ulcer in adults • Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients. • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older • Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older • Pathologic hypersecretory conditions in adults

Associated Conditions

  • Ankylosing Spondylitis (AS)
  • Duodenal Ulcer
  • Erosive Esophagitis
  • Gastric Ulcer
  • Gastro-esophageal Reflux Disease (GERD)
  • Healing
  • Heartburn
  • Helicobacter Pylori Infection
  • Osteoarthritis (OA)
  • Rheumatoid Arthritis
  • Upper GI Bleeding
  • Zollinger-Ellison Syndrome
  • Benign, active Gastric Ulcer
  • Develop NSAID-induced gastric ulcers
  • Hypersecretory conditions
  • Multiple endocrine adenomas

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis
2017/03/22
NCT03086070
Phase 4
Completed
Children's Hospital Srebrnjak
Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)
2017/02/23
NCT03059303
Phase 1
Terminated
Janssen Research & Development, LLC
A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy Subjects
2017/02/20
NCT03058419
Phase 1
Completed
Janssen Research & Development, LLC
Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients
2017/01/23
NCT03028103
Phase 1
Completed
Epizyme, Inc.
Placebo In Chronic Back Pain (Phase 2)
2016/12/08
NCT02986334
Phase 4
Completed
Apkar Apkarian
A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects
2016/11/06
NCT02957474
Phase 1
Completed
Celgene
Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
2016/11/01
NCT02950259
Phase 1
Active, not recruiting
Providence Health & Services
Factors Influencing the Human Gut Microbiome Profile in Multi-ethnic Groups of the Singapore Community (FAMES)
2016/09/08
NCT02893709
Not Applicable
Completed
Changi General Hospital
Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation in Older Adults
2016/07/26
NCT02844621
Early Phase 1
Completed
The University of Texas Health Science Center at San Antonio
A Multiple-Dose Pharmacokinetics Study of Three Gefapixant (AF-219/MK-7264) Formulations
2016/06/06
NCT02790840
Phase 1
Completed
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
Omeprazole
NuCare Pharmaceuticals,Inc.
ORAL
40 mg in 1 1
2022/12/07
68071-2893
Omeprazole
Apotex Corp
ORAL
10 mg in 1 1
2023/05/25
60505-0145
Omeprazole
ReadyMeds
ORAL
40 mg in 1 1
2014/06/30
64205-640
Omeprazole
Preferred Pharmaceuticals Inc.
ORAL
20 mg in 1 1
2023/08/21
68788-6881
OMEPRAZOLE
Lupin Pharmaceuticals, Inc.
ORAL
40 mg in 1 1
2019/01/15
68180-784
Omeprazole
Zydus Lifesciences Limited
ORAL
20 mg in 1 1
2023/09/27
65841-760
Omeprazole
medsource pharmaceuticals
ORAL
40 mg in 1 1
2019/12/30
45865-966
Omeprazole
Unit Dose Services
ORAL
40 mg in 1 1
2017/02/28
50436-0146
Omeprazole
Golden State Medical Supply, Inc.
ORAL
20 mg in 1 1
2023/04/03
51407-287
Omeprazole and Sodium Bicarbonate
Oceanside Pharmaceuticals
ORAL
40 mg in 1 1
2023/10/11
68682-104

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

Singapore Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
Online

No Singapore products found

No Singapore products found for this drug

China Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
Omeprazole Enteric Capsules
国药准字H20084453
万邦德制药集团有限公司
胶囊剂
N/A
20mg
Chemical Drug
Approved
2023/09/25
Domestic
Omeprazole Enteric-coated Capsules
国药准字H20123057
江苏福邦药业有限公司;寿光富康制药有限公司
胶囊剂
N/A
20mg
Chemical Drug
Approved
2022/02/16
Domestic
Omeprazole Enteric Capsules
国药准字H20059247
哈尔滨松鹤制药有限公司
胶囊剂
N/A
20mg
Chemical Drug
Approved
2020/10/13
Domestic
Omeprazole Enteric Capsules
国药准字H20033510
海南海力制药有限公司
胶囊剂
N/A
20mg
Chemical Drug
Approved
2020/08/10
Domestic
Omeprazole Enteric-coated Capsules
国药准字H20094063
苏州二叶制药有限公司
胶囊剂
N/A
20mg
Chemical Drug
Approved
2019/11/05
Domestic
Omeprazole Enteric-coated Capsules
国药准字H20033444
山东罗欣药业集团股份有限公司
胶囊剂
N/A
20mg
Chemical Drug
Approved
2020/01/16
Domestic
Omeprazole Enteric Capsules
国药准字H10980308
汕头经济特区鮀滨制药厂
胶囊剂
奥斯坦
20mg
Chemical Drug
Approved
2019/11/15
Domestic
Omeprazole Enteric Capsules
国药准字H43021416
湖南迪诺制药股份有限公司
胶囊剂
N/A
20mg
Chemical Drug
Approved
2024/08/14
Domestic
Omeprazole Enteric Capsules
国药准字H20083763
悦康药业集团股份有限公司
胶囊剂
N/A
10mg
Chemical Drug
Approved
2022/12/27
Domestic
Omeprazole Enteric Capsules
国药准字H20033476
烟台鲁银药业有限公司
胶囊剂
N/A
20mg
Chemical Drug
Approved
2020/04/20
Domestic

Australia Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient

No Australia products found

No Australia products found for this drug

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy