Prilosec

(Omeprazole)

ApprovedSmall molecule

Omeprazole reduces stomach acid to treat heartburn, acid reflux, and ulcers. It helps relieve the pain and discomfort caused by excess stomach acid.[2] Prilosec is currently approved and in use across 69 indications[4].[1]

Prilosec is one of 1105 small molecule programs targeting Dyspepsia. It is currently in Approved.

Indications

280

Total Trials

Active Trials

1,104

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

DyspepsiaUnknown status

Obesity & OverweightNot yet recruiting

Early-Stage Breast CancerRecruiting

Eosinophilic EsophagitisApproved

Squamous Cell Intraepithelial NeoplasiaApproved

Depressive DisorderActive, not recruiting

OsteoarthritisActive, not recruiting

Ankylosing SpondylitisActive, not recruiting

SpondylitisActive, not recruiting

Clostridium Difficile InfectionApproved

DyspepsiaApproved

Unknown status

Obesity & OverweightApproved

Not yet recruiting

Early-Stage Breast CancerPhase 2

Recruiting

Eosinophilic EsophagitisApproved

Approved

Squamous Cell Intraepithelial NeoplasiaApproved

Approved

Depressive DisorderPreclinical

Active, not recruiting

OsteoarthritisApproved

Active, not recruiting

Ankylosing SpondylitisApproved

Active, not recruiting

SpondylitisApproved

Active, not recruiting

Clostridium Difficile InfectionApproved

Approved

Showing 10 of 67 indications

Competition

Competitive Landscape

314 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Prilosec

DDexcel Pharma Technologies Ltd.

Approved

1 2

Paraplatin

AAvyxa

Phase 3

25 3

Alinamin

Roche

Phase 3

6 4

LHRH Agonist

Roche

Phase 3

10 5

Acetylsalicylic Acid

Bayer

Phase 3

2 6

GM-CSF

YY-mAbs Therapeutics

Phase 3

8 7

Gallium Ga 68 Gozetotide

MMayo Clinic

Phase 3

3 8

Trexall

Jazz Pharmaceuticals

Preclinical

—9

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 10

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Not yet recruiting

Efficacy

NCT04069286

Q3 2027

Phase 1Recruiting

Pancreatic Cancer

NCT04930991

Q1 2028

Post-ApprovalNot yet recruiting

Breast Disease

NCT06943482

Phase 2Recruiting

Prostate Cancer

NCT04337580

Q3 2029

Post-ApprovalRecruiting

Trial

NCT06999577

Clinical

Trials by Indication[1]

Interaction18 trials

Drug-drug Interaction Study of KL1333 in Healthy Subjects

Completed·AAbliva AB·Phase 1·NCT04643249·14 enrolled

Interaction Study of Clopidogrel 600/150 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT01129414·72 enrolled

A Drug Interaction Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02638116·20 enrolled

Show 15 more trials

Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

Completed·Ppharmaand GmbH·Phase 1·NCT02740712·17 enrolled

Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer Subjects

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT01517399·28 enrolled

Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT01129388·72 enrolled

A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole

Completed·PPresidio Pharmaceuticals, Inc.·Phase 1·NCT01786382·24 enrolled

Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Completed· Amgen logo

Amgen·Phase 1·NCT05581992·14 enrolled

Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers

Completed·KKadmon Corporation, LLC·Phase 1·NCT03530995·73 enrolled

Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants

Completed·IInstitut de Recherches Internationales Servier (I.R.I.S.)·Phase 1·NCT07235748·28 enrolled

Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation

Completed· GSK logo

GSK·Phase 1·NCT00964106·87 enrolled

Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT01129375·72 enrolled

Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin

Completed·GGuangdong Raynovent Biotech Co., Ltd·Phase 1·NCT06031454·56 enrolled

Drug Interaction Study of CT1812 in Healthy Volunteers

Completed·CCognition Therapeutics·Phase 1·NCT03716427·16 enrolled

Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers

Completed·UUniversity of Sarajevo·Phase 1·NCT04198948·15 enrolled

Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults

Completed· GSK logo

GSK·Phase 1·NCT04425902·20 enrolled

Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)

Completed·GGrünenthal GmbH·Phase 1·NCT03979989·32 enrolled

Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris

Completed·BBausch & Lomb Incorporated·Phase 4·NCT02394340·20 enrolled

Tics15 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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06948006·32 enrolled

A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02492776·14 enrolled

A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT04959266·5 enrolled

Show 12 more trials

Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01159145·42 enrolled

Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Participants

Completed· Vertex Pharmaceuticals logo

Vertex Pharmaceuticals·Phase 1·NCT05635110·31 enrolled

Compare the Pharmacokinetics of Omeprazole, Rosiglitazone, and Desipramine When Administered With Avanafil in Healthy Male Subjects

Completed·VVIVUS LLC·Phase 1·NCT01415128·60 enrolled

Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01766050·45 enrolled

To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01813552·24 enrolled

Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib

Completed· Sanofi logo

Sanofi·Phase 1·NCT01539655·34 enrolled

A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

Completed· Amgen logo

Amgen·Phase 1·NCT05497557·16 enrolled

A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01392755·32 enrolled

A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881

Completed·AAgios Pharmaceuticals, Inc.·Phase 1·NCT04128787·36 enrolled

A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole

Completed·AAcerta Pharma BV·Phase 1·NCT04876807·36 enrolled

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)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03059303·72 enrolled

Luminal Fructose Kinetics (MARTINI Study)

Recruiting·—·Phase 2·NCT06539494·22 enrolled

Peptic ulcer6 trials

Ilaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients

Completed·LLivzon Pharmaceutical Group Inc.·Phase 3·NCT03362281·540 enrolled

DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers

Terminated·DDexa Medica Group·Phase 3·NCT02262169·32 enrolled

Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers

Completed·SSingapore General Hospital·Phase 3·NCT00519519·126 enrolled

Show 3 more trials

Oral Omeprazole in Bleeding Peptic Ulcer

Unknown status·—·Phase 1·NCT04170270·100 enrolled

IIaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients

Completed·LLivzon Pharmaceutical Group Inc.·Phase 2·NCT03362268·180 enrolled

High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding

Completed·CCasa Sollievo della Sofferenza IRCCS·Phase 3·NCT00374101·450 enrolled

Midazolam5 trials

Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05438303·59 enrolled

A Study to Investigate the Effect of Single and Repeated Oral Doses of ACT-539313 on What the Body Does to Flurbiprofen, Omeprazole, Midazolam in Healthy Subjects

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT05254548·22 enrolled

Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and Digoxin

Withdrawn· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02345304

Show 2 more trials

The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02254148·24 enrolled

Effects of PQ912 on the Pharmacokinetics of Midazolam and Omeprazole

Completed·VVivoryon Therapeutics N.V.·Phase 1·NCT02190708·18 enrolled

Clopidogrel5 trials

Clopidogrel Proton-Pump Inhibitors Study

Withdrawn·SSheba Medical Center·Phase 4·NCT01016717

Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01147588·149 enrolled

Ranitidin Versus Omeprazole in Patients Taking Clopidogrel

Completed·UUniversity of Sao Paulo General Hospital·Phase 4·NCT01896557·92 enrolled

Show 2 more trials

Platelet Inhibitory Effect of Clopidogrel in Patients Treated With Omeprazole, Pantoprazole, or Famotidine

Completed·TTel-Aviv Sourasky Medical Center·Phase 4·NCT00950339·63 enrolled

Impact of Omeprazole and Fluvoxamine on Platelet Response to Clopidogrel

Completed·HHadassah Medical Organization·Phase 1·NCT01269333·15 enrolled

100 more indications

Adult Subject4 trials

A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02957474·18 enrolled

A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03363815·56 enrolled

Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

Completed·SSpero Therapeutics·Phase 1·NCT04368585·20 enrolled

Show 1 more trial

A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT01489943·24 enrolled

Dyspepsia4 trials

Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia

Completed·RRenJi Hospital·Phase 4·NCT01851863·262 enrolled

Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

Terminated·CCasa Espirita Terra de Ismael·Phase 2·NCT01408849·4 enrolled

Endoscopic Tri-Modal Imaging to Distinguish Functional Dyspepsia From Reflux Disease

Completed·—·N/A·NCT02685150·157 enrolled

Show 1 more trial

Assessment and Management of Chronic Dyspepsia in Eastern Uganda

Completed·WWashington University School of Medicine·Phase 1·NCT04525664·376 enrolled

Drug Interactions4 trials

A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects

Completed·AAllist Pharmaceuticals, Inc.·Phase 1·NCT06162169·66 enrolled

A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05109390·72 enrolled

Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride

Completed·AAhon Pharmaceutical Co., Ltd.·Phase 1·NCT06822166·68 enrolled

Show 1 more trial

Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs

Completed·VViriom·Phase 1·NCT03709355·56 enrolled

Upper Gastrointestinal Bleeding3 trials

Effects of Different Omeprazole Dosing on Gastric pH in Non-variceal Upper Gastrointestinal Bleeding

Completed·MMedical University of Bialystok·Phase 4·NCT03980496·50 enrolled

Administration of High-Dose Intravenous Proton Pump Inhibitor for Upper Gastrointestinal Bleeding Prior to Endoscopy

Completed·—·Phase 4·NCT00164866·638 enrolled

Comparison of Oral Rabeprazole vs. iv Omeprazole in Mild to Moderate Nonvariceal Upper Gastrointestinal Bleeding

Unknown status·KKaohsiung Medical University Chung-Ho Memorial Hospital·Phase 4·NCT00861640·200 enrolled

Fasting Conditions3 trials

Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsules Under Fasting Conditions

Completed·—·Phase 1·NCT01045642·38 enrolled

Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions

Completed·—·Phase 1·NCT01170169·44 enrolled

Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions

Completed·XXspray Pharma AB·Phase 1·NCT05433896·17 enrolled

Gastric3 trials

A Study to Assess the Effect of Intragastric pH and Fasting on the Pharmacokinetics of Gefapixant (AF-219/MK-7264)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02229877·18 enrolled

Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01694706·15 enrolled

Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH

Completed·VVecta Ltd.·Phase 1·NCT00818870·60 enrolled

Adult3 trials

A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05319912·18 enrolled

A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05319899·18 enrolled

Study to Determine the Effects of Multiple-dose Omeprazole on the Single-dose Pharmacokinetics of Tipranavir (TPV) Coadministered With Ritonavir (RTV) in Healthy Adult Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02253875·15 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease

Completed·—·Phase 3·NCT01338077·195 enrolled

Efficacy and Safety of DLBS2411 in the Management of GERD

Terminated·DDexa Medica Group·Phase 3·NCT03367195·32 enrolled

Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS

Completed·AAboca Spa Societa' Agricola·Phase 4·NCT03238534·275 enrolled

Lymphoma3 trials

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

Completed·EEpizyme, Inc.·Phase 1·NCT03028103·32 enrolled

Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach

Unknown status·LLymphoma Trials Office·Phase 3·NCT00003617·200 enrolled

Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00003151·96 enrolled

Treatment3 trials

A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00259051·40 enrolled

Treatment in Patients With Globus: Psychoeducation, Anxiolytics or Proton Pump Inhibitors

Completed·MMahidol University·Phase 3·NCT03205228·40 enrolled

Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers

Completed·—··NCT03163680·295 enrolled

Back pain2 trials

Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial

Completed·NNorthwestern University·Phase 4·NCT02013427·82 enrolled

Placebo In Chronic Back Pain (Phase 2)

Completed·AApkar Apkarian·Phase 4·NCT02986334·94 enrolled

Atopic Dermatitis2 trials

Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic Dermatitis

Completed· Amgen logo

Amgen·Phase 1·NCT05891119·21 enrolled

Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4

Completed· LEO Pharma logo

LEO Pharma·Phase 1·NCT03556592·40 enrolled

Acute Coronary Syndrome2 trials

Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.

Terminated·IImperial College London·N/A·NCT04333407·320 enrolled

"Pharmacodynamic Comparison of Omeprazole Versus Pantoprazole on Platelet Reactivity in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy With New P2Y12 Inhibitors" -Trial dOPPLER-

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT02028234·150 enrolled

Clinical Trial2 trials

A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021

Completed·AAbbisko Therapeutics Co, Ltd·Phase 1·NCT06322706·36 enrolled

Comparing Omeprazole With Fluoxetine for Treatment of Non Erosive Reflux Disease and Its Subgroups: a Double-blind Placebo-controlled Clinical Trial

Completed·TTehran University of Medical Sciences·Phase 2/3·NCT01269788·144 enrolled

ART2 trials

Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05134350·10 enrolled

Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT04718181·131 enrolled

Gastric Ulcer2 trials

Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy

Completed·KKorea Otsuka International Asia Arab·Phase 4·NCT00272467·132 enrolled

Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

Completed· Otsuka logo

Otsuka·Phase 3·NCT01150162·129 enrolled

Metformin2 trials

Impact of OCT1 on Metformin Tolerance

Completed·NNHS Tayside·Phase 4·NCT02586636·61 enrolled

Effect of Omeprazole on Metformin

Completed·XXijing Hospital·Phase 1·NCT01711320·20 enrolled

Helicobacter Pylori Infection2 trials

The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children

Completed·—·N/A·NCT03165253·69 enrolled

Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians

Completed·HHelwan University·Phase 4·NCT06315478·60 enrolled

MPA2 trials

The Impact of Proton Pump Inhibitors on the Fecal Microbiome

Completed·MMayo Clinic·Phase 1·NCT01822977·15 enrolled

iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions

Completed·UUniversity of Zurich·Phase 4·NCT02552537·44 enrolled

Intravenous2 trials

Comparison of Intravenous Omeprazole to Ranitidine on Recurrent Bleeding After Endoscopic Treatment of Bleeding Ulcer

Withdrawn·KKeio University·Phase 4·NCT00247130

Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot

Completed·FFar Eastern Memorial Hospital·Phase 4·NCT02536989·40 enrolled

Aspirin2 trials

To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin

Completed·PPOZEN·Phase 1·NCT00442052·80 enrolled

A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin

Completed·PPOZEN·Phase 1·NCT00441519·80 enrolled

TED2 trials

Effect of Repeated Doses of YF476, Omeprazole and Placebo on Stomach Acidity in Healthy Volunteers

Completed·TTrio Medicines Ltd.·Phase 1·NCT01599858·49 enrolled

Risk of CYP2C19 Phenoconversion in Healthy Volunteers With Rapid, Normal, and Intermediate Predicted Metabolizers' Status

Unknown status·UUniversity Hospital, Geneva·Phase 1·NCT05264142·45 enrolled

Absorption2 trials

Does Omeprazole Decrease Intestinal Calcium Absorption?

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT00582972·23 enrolled

A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects

Completed·LLexicon Pharmaceuticals·Phase 1·NCT03302845·32 enrolled

Barrett's esophagus2 trials

Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?

Completed·MMayo Clinic·Phase 4·NCT01093755·30 enrolled

Argon Plasma Coagulation for Barrett's Esophagus

Completed·MMaria Sklodowska-Curie National Research Institute of Oncology·N/A·NCT04154748·71 enrolled

Esophagitis2 trials

Reflux Esophagitis Phase III Study (Initial Treatment)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00633932·602 enrolled

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

Completed· Boryung Pharmaceutical Co., Ltd logo

Boryung Pharmaceutical Co., Ltd·Phase 3·NCT01499368·495 enrolled

Gastroesophageal Reflux Disease2 trials

Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features

Terminated·—·Phase 4·NCT04028466·82 enrolled

Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis

Completed·KKhon Kaen University·Phase 1·NCT03561233·250 enrolled

Efficacy2 trials

Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

Completed·SSOFAR S.p.A.·N/A·NCT03793556·72 enrolled

EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN DYSPEPPSIA

Not yet recruiting·IInfan Industria Quimica Farmaceutica Nacional·Phase 3·NCT04069286·474 enrolled

Gastritis2 trials

A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis

Unknown status·—·Phase 4·NCT03908619·252 enrolled

Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis

Completed·UUniversity of Karachi·Phase 2·NCT04672018·240 enrolled

Duodenal Ulcer2 trials

Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 2)

Completed·LLivzon Pharmaceutical Group Inc.·Phase 2·NCT00953381·235 enrolled

Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 3)

Completed·LLivzon Pharmaceutical Group Inc.·Phase 3·NCT00952978·496 enrolled

Drug Metabolism2 trials

KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism

Completed·HHelsinki University Central Hospital·N/A·NCT06566794·12 enrolled

Drug Metabolism and Antidepressant

Unknown status·UUniversity Hospital, Geneva·N/A·NCT02438072·100 enrolled

Oral2 trials

A Study of Effect of Multiple Doses of LOXO-305 on the Pharmacokinetics of Single Oral Doses of CYP1A2, CYP2C9, CYP2C19 Substrates in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06215430·16 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03058419·16 enrolled

Fed1 trial

Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule Under Fed Conditions

Completed·—·Phase 1·NCT01045434·62 enrolled

Multiple Sclerosis1 trial

An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis

Completed· Biogen logo

Biogen·Phase 3·NCT01462318·133 enrolled

Head and Neck Cancer1 trial

A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

Completed·BBrooklyn ImmunoTherapeutics, LLC·Phase 2·NCT00210470·27 enrolled

Rheumatoid Arthritis1 trial

Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4

Completed·UUnknown Sponsor·Phase 1·NCT04246762·17 enrolled

Pancreatic Cancer1 trial

High Dose Omeprazole in Patients With Pancreatic Cancer

Recruiting·UUniversity of Oklahoma·Phase 1·NCT04930991·60 enrolled

Single Ascending Dose1 trial

A Study to Assess the Effects of Single Ascending Doses (SAD) of ASP8477, the Effect That Food Has on the Drug, and the Interaction Between ASP8477 and Omeprazole in Healthy Postmenopausal Females and Healthy Young Vasectomized Males

Completed· Astellas logo

Astellas·Phase 1·NCT02220777·72 enrolled

Age1 trial

Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination

Completed·TTobira Therapeutics, Inc.·Phase 1·NCT02684799·48 enrolled

Caffeine1 trial

A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT05067439·26 enrolled

Colonization1 trial

Gastric Acid Suppression and Probiotic Colonization

Completed·SStanford University·Phase 4·NCT03327051·39 enrolled

Growth1 trial

Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis

Completed·FFaculdade de Ciências Médicas da Santa Casa de São Paulo··NCT01389401·36 enrolled

Antibiotic-resistant Bacteria1 trial

Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy

Unknown status·SStephen Harbarth·Phase 2·NCT02472600·39 enrolled

Tonsillectomy1 trial

Anti-reflux Control to Decrease Post Tonsillectomy Pain

Terminated·AAscension Health·Phase 4·NCT01777854·6 enrolled

Critically Ill Patients1 trial

Single Dose Omeprazole Versus High Dose in High-risk Critically Ill Patients.

Completed·MMenoufia University·N/A·NCT03388463·110 enrolled

Pilot Study1 trial

Melatonin Associated to Acid Inhibition for Chemoprevention in Barret Esophagus: a Pilot Study

Completed·—·Phase 3·NCT01566474·80 enrolled

Reflux1 trial

Bronchial Hyper-responsiveness in Reflux Cough

Terminated·HHull University Teaching Hospitals NHS Trust·Phase 3·NCT00668317·5 enrolled

H Pylori Infection1 trial

High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT05342532·112 enrolled

MALT lymphoma1 trial

Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00002682·5 enrolled

Metastatic Head and Neck Cancer1 trial

A Phase II Trial of Proton Pump Inhibitors With Chemotherapy in Patients With Metastatic Head and Neck Cancer

Withdrawn·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT02013453

Neuropathy1 trial

The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Cancer Patients

Completed·AAya Mohamed Sadek Elsaid·Phase 3·NCT05680870·46 enrolled

Vulvar Intraepithelial Neoplasia1 trial

IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3

Terminated·UUniversity of Southern California·Phase 2·NCT03267680·10 enrolled

Ascorbic Acid1 trial

Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

Completed·IIndiana University·Phase 1·NCT04199624·11 enrolled

Idiopathic Pulmonary Fibrosis1 trial

Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)

Completed·NNewcastle-upon-Tyne Hospitals NHS Trust·Phase 2·NCT02085018·45 enrolled

Prevention1 trial

Ulcer Prevention Study in Post Gastric Bypass Patients

Completed·UUniversity of Missouri-Columbia·Phase 4·NCT00557349·40 enrolled

AML1 trial

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

Active, not recruiting· Sanofi logo

Sanofi·Phase 1·NCT06686628·23 enrolled

PK/PD1 trial

Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

Completed·SSeoul National University Hospital·Phase 1·NCT02299687·24 enrolled

EoE1 trial

EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

Unknown status·CClaire Daniels·Phase 4·NCT03781596·100 enrolled

HCV1 trial

Pharmacokinetic Study of the HCV Protease Inhibitor Bo-cePRevir and the Proton Pump Inhibitor OMeprazOle (PROMO)

Completed·RRadboud University Medical Center·Phase 1·NCT01470690·24 enrolled

Helicobacter Pylori1 trial

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

Unknown status·SSherief Abd-Elsalam·Phase 3·NCT02422706·120 enrolled

Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03864042·56 enrolled

Elderly Participants1 trial

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

Completed·KKaruna Therapeutics·Phase 1·NCT06605950·78 enrolled

Resistance1 trial

Tongue Exercises and Reflux Therapy for Upper Airway Resistance Syndrome

Withdrawn·WWest Side ENT·Phase 1·NCT00364481

Psoriasis1 trial

Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02397382·16 enrolled

Laryngomalacia1 trial

Laryngomalacia Study

Withdrawn·—·Phase 1·NCT01782560

Gut Microbiome1 trial

Factors Influencing the Human Gut Microbiome Profile in Multi-ethnic Groups of the Singapore Community (FAMES)

Completed·—·N/A·NCT02893709·36 enrolled

Elderly1 trial

GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects

Completed· GSK logo

GSK·Phase 1·NCT03457727·40 enrolled

Drug1 trial

Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02182336·23 enrolled

Systemic Inflammation1 trial

Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation in Older Adults

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT02844621·25 enrolled

Quality of Life1 trial

Quality of Life Validation in Laryngitis

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00641264·90 enrolled

Outcome1 trial

Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing

Terminated·MMatthias Schwab·Phase 4·NCT00537732·68 enrolled

Patients With Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors

Completed· Novartis logo

Novartis·Phase 1·NCT01596647·39 enrolled

Completed·TTorax Medical Incorporated·Phase 4·NCT02505945·152 enrolled

Impaired Renal Function1 trial

A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01275170·49 enrolled

Hypoalbuminemia1 trial

The Therapeutic Role of Intravenous Albumin Administration for Peptic Ulcer Bleeding Patients With Hypoalbuminemia

Completed·NNational Cheng-Kung University Hospital·Phase 4·NCT01822600·91 enrolled

Single Dose1 trial

A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05932277·22 enrolled

Pneumonia1 trial

Proton Pump Inhibitors and Risk of Community-acquired Pneumonia

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02555852·4,238,504 enrolled

Colorectal Cancer1 trial

Effect of G17DT in Patients With Stage II/III Colorectal Cancer

Completed·CCancer Advances Inc.·Phase 2·NCT02518373·22 enrolled

Methotrexate1 trial

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03131973·26 enrolled

Laryngopharyngeal Reflux1 trial

The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

Withdrawn·LLoma Linda University·Phase 4·NCT02123498

Safety and Efficacy1 trial

Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea

Completed·FForest Laboratories·Phase 3·NCT00559364·50 enrolled

Neoadjuvant Chemotherapy1 trial

Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy

Completed·KKathy Miller·Phase 2·NCT02595372·42 enrolled

Cystic Fibrosis1 trial

Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)

Completed·—·Phase 2·NCT03551691·19 enrolled

Crohn's Disease1 trial

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

Enrolling by invitation·MMedical University of Warsaw·Phase 2/3·NCT06719622·114 enrolled

Chronic Rhinosinusitis1 trial

Omeprazole 20 mg in Patients With Laryngopharyngeal reﬂux and Comorbid Chronic Rhinosinusitis

Completed·—·Phase 4·NCT03086070·60 enrolled

Type 1 Diabetes1 trial

The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Omeprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients

Withdrawn·PPerle Bioscience, Inc.·Phase 3·NCT01762644

Dysphagia1 trial

The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE

Unknown status·WWroclaw Medical University··NCT04803162·58 enrolled

Gastroparesis1 trial

Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis

Completed·UUniversity of Louisville·Phase 4·NCT00492622·12 enrolled

Prostate Cancer1 trial

Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

Recruiting·WWake Forest University Health Sciences·Phase 2·NCT04337580·50 enrolled

Heartburn1 trial

Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036)

Completed· Bayer logo

Bayer·Phase 4·NCT01587885·48 enrolled

Atorvastatin1 trial

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

Recruiting·NNational University Hospital, Singapore·Phase 4·NCT06690164·78 enrolled

Antibody1 trial

Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM

Withdrawn·TTiziana Life Sciences LTD·Phase 2·NCT03291249

Medication1 trial

Effect of Acid Suppression Medication on Pediatric Microbiome

Terminated·—·N/A·NCT02016820·7 enrolled

Granuloma1 trial

Efficacy Study of Botulinum Toxin (BOTOX) Injections to Treat Vocal Fold Granulomas

Withdrawn·—·Phase 2·NCT01678053

Ulcerative Colitis1 trial

A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03358706·28 enrolled

Trial1 trial

The Mechanism Versus PPI Trial

Recruiting·UUniversity of California, San Diego·Phase 4·NCT06999577·160 enrolled

Breast Disease1 trial

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

Not yet recruiting·NNational University Hospital, Singapore·Phase 4·NCT06943482·40 enrolled

Morbid Obesity1 trial

Study to Compare the Bioavailability of Omeprazole 20 mg Before and After Undergoing Surgery for Morbid Obesity

Completed·EEmilio Vargas Castrillón·Phase 4·NCT03378960·43 enrolled

Unspecified8 trials

Effect of a Proton Pump Inhibitor on Gleevec® in Healthy Volunteers

Completed·UUniversity of Pittsburgh·Phase 1·NCT00446004·15 enrolled

Prilosec Bioequivalence Study in Healthy Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01921920·54 enrolled

Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human

Completed·IInje University·Phase 1·NCT01570569·26 enrolled

Show 5 more trials

BAY73-4506 Probe Substrate Study

Completed· Bayer logo

Bayer·Phase 1·NCT01287598·41 enrolled

Relative Bioavailability Study of CC-292

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02433457·24 enrolled

Optimal Dosing of Omeprazole in Neonates

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT01657578·55 enrolled

Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Completed·PPT Kalbe Farma Tbk·N/A·NCT05849883·36 enrolled

AZD2066 Cocktail Study

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00930306·15 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 5, 1995

PRILOSEC

NDA NDA019810

Jun 20, 2003

PRILOSEC OTC

NDA NDA021229

Dec 4, 2007

OMEPRAZOLE

NDA NDA022032

Mar 20, 2008

PRILOSEC

NDA NDA022056

Dec 1, 2008

PRILOSEC

NDA NDA022056

Mar 3, 2010

PRILOSEC

NDA NDA022056

Sep 3, 2010

PRILOSEC

NDA NDA022056

Jan 20, 2011

PRILOSEC

NDA NDA022056

May 20, 2011

PRILOSEC

NDA NDA022056

Jun 30, 2011

PRILOSEC

NDA NDA022056

Jan 20, 2012

PRILOSEC

NDA NDA022056

Sep 28, 2012

PRILOSEC

NDA NDA022056

Oct 9, 2012

PRILOSEC

NDA NDA022056

May 15, 2013

PRILOSEC

NDA NDA022056

Feb 25, 2014

PRILOSEC

NDA NDA022056

Mar 27, 2014

PRILOSEC

NDA NDA022056

Dec 19, 2014

PRILOSEC

NDA NDA022056

Feb 3, 2016

PRILOSEC

NDA NDA022056

Oct 24, 2016

PRILOSEC

NDA NDA022056

Dec 19, 2016

PRILOSEC

NDA NDA022056

Jul 5, 2017

OMEPRAZOLE

NDA NDA209400

Jun 7, 2018

PRILOSEC

NDA NDA022056

Aug 21, 2018

PRILOSEC

NDA NDA022056

Nov 27, 2020

PRILOSEC

NDA NDA022056

Mar 4, 2022

PRILOSEC

NDA NDA022056

Jul 18, 2023

PRILOSEC

NDA NDA022056

Sources

References

[1]
ClinicalTrials.gov — 280 trial records for Omeprazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Prilosec drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Omeprazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Omeprazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022056). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Prilosec. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Dexcel Pharma Technologies Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Potassium-Transporting Atpase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: DDexcel Pharma Technologies Ltd.

Patent Landscape[6]

Patent Cliff

Jan 31, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12599565Jan 31, 2030

10835488Dec 8, 2036