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: C_₁₇H_₁₉N_₃O_₃S

CAS Number: 73590-58-6

Unique Ingredient Identifier: KG60484QX9

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

A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants

Phase 1

Not yet recruiting

Conditions: Healthy Participants

Interventions: Drug: AZD4144
Drug: Omeprazole

First Posted Date: 2025-04-28

Last Posted Date: 2025-04-28

Lead Sponsor: AstraZeneca

Target Recruit Count: 32

Registration Number: NCT06948006

Locations: 🇬🇧
Research Site, Harrow, United Kingdom

Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease

Phase 4

Not yet recruiting

Conditions: Idiopathic Granulomatous Mastitis

Interventions: Drug: Prednisolone
Drug: Methotrexate
Drug: Omeprazole 20 mg
Drug: Folic Acid 5 MG

First Posted Date: 2025-04-24

Last Posted Date: 2025-04-24

Lead Sponsor: National University Hospital, Singapore

Target Recruit Count: 40

Registration Number: NCT06943482

Locations: 🇸🇬
National University Hospital, Singapore, Singapore

Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride

Phase 1

Completed

Conditions: Interaction Drug Food

Interventions: Drug: rifampicin
Drug: Fluconazole
Drug: Omeprazole
Drug: midazolam
Drug: ET-26

First Posted Date: 2025-02-12

Last Posted Date: 2025-02-14

Lead Sponsor: Ahon Pharmaceutical Co., Ltd.

Target Recruit Count: 68

Registration Number: NCT06822166

Locations: 🇨🇳
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province), Jinan, Shandong, China

Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum

Phase 2

Conditions: Crohn Disease (CD)

Interventions: Drug: budesonide
Drug: omeprazole (proton pump inhibitor)

First Posted Date: 2024-12-06

Last Posted Date: 2024-12-06

Lead Sponsor: Medical University of Warsaw

Target Recruit Count: 114

Registration Number: NCT06719622

Locations: 🇵🇱
Jagiellonian University, Kraków, Poland
🇵🇱
Poznań University of Medical Sciences, Poznań, Poland
🇵🇱
Medical University of Warsaw, Warsawa, Poland

Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone

Phase 4

Not yet recruiting

Conditions: Metabolite

Interventions: Drug: Atorvastatin 40mg Tablet
Drug: Omeprazole 20mg Capsule

First Posted Date: 2024-11-15

Last Posted Date: 2024-11-15

Lead Sponsor: National University Hospital, Singapore

Target Recruit Count: 78

Registration Number: NCT06690164

An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates

Phase 1

Recruiting

Conditions: Dermatitis Atopic

Interventions: Drug: Amlitelimab
Drug: Midazolam
Drug: Caffeine
Drug: Metoprolol
Drug: Omeprazole
Drug: Warfarin

First Posted Date: 2024-11-13

Last Posted Date: 2024-12-27

Lead Sponsor: Sanofi

Target Recruit Count: 20

Registration Number: NCT06686628

Locations: 🇩🇪
Investigational Site Number : 2760001, Berlin, Germany

A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants

Phase 1

Recruiting

Conditions: Healthy Volunteers

Interventions: Drug: KarXT
Drug: KarX-EC
Drug: Placebo
Drug: Omeprazole

First Posted Date: 2024-09-20

Last Posted Date: 2025-05-15

Lead Sponsor: Karuna Therapeutics

Target Recruit Count: 78

Registration Number: NCT06605950

Locations: 🇺🇸
Cenexel ACT (Anaheim Clinical Trials), Anaheim, California, United States
🇺🇸
Local Institution - 0002, Anaheim, California, United States