Nexium

(esomeprazole)

ApprovedSmall molecule

Esomeprazole reduces stomach acid to treat heartburn, acid reflux, and ulcers. It helps protect the stomach lining and allows it to heal.[2] Nexium is currently approved and in use across 47 indications[4].[1]

Nexium is one of 669 small molecule programs targeting Hemorrhage. It is currently in Approved.

Indications

293

Total Trials

Active Trials

668

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HemorrhageApproved

Laryngeal DiseaseApproved

Autism Spectrum DisorderApproved

Gastrointestinal DiseaseApproved

Chronic GastritisApproved

Gastric Mucosa-Associated Lymphoid Tissue LymphomaApproved

Helicobacter Pylori Infectious DiseaseApproved

Peptic EsophagitisApproved

Juvenile Idiopathic ArthritisApproved

CirrhosisActive, not recruiting

HemorrhageApproved

Approved

Laryngeal DiseaseApproved

Approved

Autism Spectrum DisorderApproved

Approved

Gastrointestinal DiseaseApproved

Approved

Chronic GastritisApproved

Approved

Gastric Mucosa-Associated Lymphoid Tissue LymphomaApproved

Approved

Helicobacter Pylori Infectious DiseaseApproved

Approved

Peptic EsophagitisApproved

Approved

Juvenile Idiopathic ArthritisApproved

Approved

CirrhosisApproved

Active, not recruiting

Showing 10 of 46 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Nexium

DDexcel Pharma Technologies Ltd.

Approved

1 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Persantine

Boehringer Ingelheim

Preclinical

1 9

Luvox

SSolvay Pharmaceuticals

Preclinical

1 10

Catapres

Boehringer Ingelheim

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Gastroesophageal Reflux Disease

NCT07268820

Q4 2026

Post-ApprovalNot yet recruiting

Healing

NCT07312370

Q1 2028

Post-ApprovalRecruiting

Cirrhosis

NCT04448028

Q3 2028

Post-ApprovalRecruiting

Peptic Ulcer

NCT05582174

Clinical

Trials by Indication[1]

Gastroesophageal Reflux Disease12 trials

Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00660660·276 enrolled

An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00242736·350 enrolled

Heartburn, Gastroesophageal Reflux Disease

Recruiting·IIncheon St.Mary's Hospital·Phase 4·NCT07268820·160 enrolled

Show 9 more trials

Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 2·NCT03184324·211 enrolled

An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00629564·60 enrolled

Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

Completed· Eisai logo

Eisai·Phase 3·NCT00658775·1,069 enrolled

Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

Completed· Eisai logo

Eisai·Phase 3·NCT00658528·1,061 enrolled

Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients

Completed·LLivzon Pharmaceutical Group Inc.·Phase 3·NCT02860624·550 enrolled

Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients

Unknown status·LLivzon Pharmaceutical Group Inc.·Phase 2·NCT01107938·330 enrolled

Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease

Completed·OOnconic Therapeutics Inc.·Phase 2·NCT04282954·188 enrolled

Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 3·NCT03736369·263 enrolled

Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance

Completed·—·N/A·NCT01079884·18 enrolled

Esophagitis10 trials

Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Completed·HHK inno.N Corporation·Phase 2·NCT02028663·206 enrolled

A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00641602·1,000 enrolled

Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

Not yet recruiting·IIndonesia University·Phase 4·NCT06720610·216 enrolled

Show 7 more trials

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01669811·1,398 enrolled

Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis

Completed·SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.·Phase 3·NCT03615677·261 enrolled

Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy

Completed·—·Phase 4·NCT01874535·408 enrolled

Study to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis

Completed·YYuhan Corporation·Phase 2·NCT01538849·154 enrolled

JP-1366 20mg Versus Esomeprazole 40mg in Patients With Erosive Esophagitis

Completed·OOnconic Therapeutics Inc.·Phase 3·NCT05443984·300 enrolled

Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM

Recruiting·—·N/A·NCT06955520·300 enrolled

Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Completed·HHK inno.N Corporation·Phase 3·NCT03006874·302 enrolled

Peptic ulcer9 trials

A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00251979·1,312 enrolled

Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Withdrawn·LLotung Poh-Ai Hospital·Phase 4·NCT00881413

Oral vs Intravenous and Proton Pump Inhibitor (PPI）for Peptic Ulcer Bleeding (PUB)

Withdrawn·—·Phase 4·NCT01123031

Show 6 more trials

Compare Efficacy of Gastric Acid Suppression by Oral and Intravenous Administration of Esomeprazole in Patients With Peptic Ulcer

Unknown status·—·Phase 4·NCT00471029·20 enrolled

Effect of Second-look Endoscopy on Peptic Ulcer Rebleeding in Patients With Early Resumption of Antiplatelet Agents

Terminated·TThe University of Hong Kong·N/A·NCT02840929·2 enrolled

PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

Recruiting·—·Phase 4·NCT05582174·594 enrolled

Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer

Completed·KKaohsiung Veterans General Hospital.·Phase 2·NCT01138969·165 enrolled

Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00441727·2,426 enrolled

Long-term Oral Esomeprazole for Prevention of Peptic Ulcer Rebleeding in High-risk Patients

Completed·HHsiu-Chi Cheng·Phase 4·NCT02456012·268 enrolled

Tics8 trials

A Study to Evaluate the Effects of Food and Esomeprazole on the Pharmacokinetics of Crizotinib in a Coated Microsphere Formulation.

Completed· Pfizer logo

Pfizer·Phase 1·NCT03137134·18 enrolled

A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants

Completed·IInsmed Incorporated·Phase 1·NCT05826574·32 enrolled

Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety

Completed·IIl-Yang Pharm. Co., Ltd.·Phase 1·NCT01820143·40 enrolled

Show 5 more trials

A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT04156646·16 enrolled

A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole

Completed· Astellas logo

Astellas·Phase 1·NCT02128893·24 enrolled

Safety, Tolerability, and Pharmacokinetics of TAK-438 in Healthy Western Male Subjects, Preliminary Food Effect Analysis, and an Ethnic Comparison With Japanese Subjects

Completed· Takeda logo

Takeda·Phase 1·NCT02141698·73 enrolled

Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers

Completed·SSeoul National University Hospital·Phase 1·NCT04568772·19 enrolled

Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers

Completed·SSeoul National University Hospital·Phase 1·NCT04942652·13 enrolled

Efficacy and Safety7 trials

Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00427635·32 enrolled

Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT06514274·558 enrolled

Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00730665·81 enrolled

Show 4 more trials

Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection

Not yet recruiting·SShicai Ye·Phase 4·NCT06526455·196 enrolled

Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment

Active, not recruiting·XXijing Hospital of Digestive Diseases·Phase 4·NCT06523764·208 enrolled

A Multi-center, Double-blinding, Parallel and Positive-controlled Phase III Clinical Trial for Efficacy and Safety Evaluation of Ilaprazole Sodium for Injection on Prevention of Stress Ulcer Bleeding

Completed·LLivzon Pharmaceutical Group Inc.·Phase 3·NCT05841394·449 enrolled

Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole

Not yet recruiting·HHospital General de México Dr. Eduardo Liceaga·Phase 4·NCT06318104·160 enrolled

78 more indications

Helicobacter Pylori Eradication7 trials

Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04558502·339 enrolled

Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

Completed·KKing Faisal Specialist Hospital & Research Center·N/A·NCT02884713·55 enrolled

Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05742568·124 enrolled

Show 4 more trials

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT02296021·612 enrolled

Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Completed·—·Phase 3·NCT06162949·242 enrolled

Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05237115·600 enrolled

Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication

Unknown status·—·Phase 3·NCT06811207·300 enrolled

Oral7 trials

Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)

Completed· Takeda logo

Takeda·Phase 3·NCT02037477·20 enrolled

A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.

Completed· Roche logo

Roche·Phase 1·NCT02023125·42 enrolled

Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil

Completed· United Therapeutics logo

United Therapeutics·Phase 1·NCT00963027·30 enrolled

Show 4 more trials

A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants

Completed· Incyte logo

Incyte·Phase 1·NCT07018635·63 enrolled

Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH4808 After Oral Administration in Healthy Male Subjects

Completed·YYuhan Corporation·Phase 1·NCT01007019·134 enrolled

Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects

Completed·HHK inno.N Corporation·Phase 1·NCT01473173·59 enrolled

A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants

Completed· Takeda logo

Takeda·Phase 1·NCT03083639·52 enrolled

Helicobacter Pylori6 trials

Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02935010·382 enrolled

Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

Completed·SShanghai Jiao Tong University School of Medicine·N/A·NCT04879992·413 enrolled

Doxycycline for Helicobacter Pylori Rescue Treatment

Recruiting·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05874570·368 enrolled

Show 3 more trials

High Dose of Amoxicillin and Metronidazole Plus Bismuth For Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03557437·216 enrolled

The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

Unknown status·HHuazhong University of Science and Technology·N/A·NCT05189444·672 enrolled

Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

Unknown status·RRabin Medical Center·Phase 3·NCT04652284·300 enrolled

Adult6 trials

A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult Participants

Completed·CCerevel Therapeutics, LLC·Phase 1·NCT06366243·20 enrolled

A Study Comparing Different Formulations of LY3410738 in Healthy Adult Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06181084·60 enrolled

A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults

Completed· Bayer logo

Bayer·Phase 1·NCT05061563·14 enrolled

Show 3 more trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant

Completed· Incyte logo

Incyte·Phase 1·NCT06213818·137 enrolled

A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy

Completed·TTheriva Biologics, Inc.·Phase 1/2·NCT02473640·15 enrolled

Bioequivalence Study of Esomeprazole 20 Milligram (mg) Delayed-Release Capsules in Healthy Adult Participants

Completed·HHALEON·Phase 1·NCT05265247·61 enrolled

Interaction4 trials

A Study of Interaction of Zasocitinib (TAK-279) With Other Medicines in Healthy Adults

Completed· Takeda logo

Takeda·Phase 1·NCT06793943·78 enrolled

Drug Interaction Study Between AZD3355 and Nexium

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00684190·30 enrolled

Study to Evaluate the Interaction Between Aspirin and Nexium

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01199328·34 enrolled

Show 1 more trial

Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00676117·30 enrolled

Dyspepsia4 trials

Nexium Dyspepsia/AST

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00251992·1,200 enrolled

Rebamipide in Combination With Esomeprazole in the Management of Asian Patients With Functional Dyspepsia

Unknown status·UUniversity of Malaya·Phase 4·NCT02134405·200 enrolled

Nexium Dyspepsia/AST

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00251914·1,500 enrolled

Show 1 more trial

BRAVO Study for Functional Dyspepsia

Completed·—·Phase 4·NCT01349413·130 enrolled

Intravenous4 trials

A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain

Completed·PPamukkale University·Phase 4·NCT02197143·286 enrolled

Phase 1 Pharmacokinetics of Intravenous Nexium in Children

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00474019·42 enrolled

Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02157376·343 enrolled

Show 1 more trial

A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole

Terminated·—·Phase 2·NCT00164788·7 enrolled

Heartburn4 trials

Efficacy of Esomeprazole in Patients With Frequent Heartburn

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01370525·340 enrolled

Efficacy of Esomeprazole in Patients With Frequent Heartburn

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01370538·341 enrolled

To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT01397084·107 enrolled

Show 1 more trial

To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT01249651·101 enrolled

Helicobacter Pylori Infection4 trials

Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection

Unknown status·TTechnische Universität Dresden·Phase 3·NCT00455806·132 enrolled

A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

Completed· Takeda logo

Takeda·Phase 3·NCT04198363·510 enrolled

Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children

Completed·FFinni Kollins·Phase 2/3·NCT05861687·51 enrolled

Show 1 more trial

Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection （SHARE2301）

Unknown status·YYanqing Li·N/A·NCT05870683·368 enrolled

Randomized3 trials

A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia

Completed·UUniversity of Oxford·Phase 3·NCT00357682·2,557 enrolled

Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00626262·60 enrolled

A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00625274·100 enrolled

Prevention3 trials

Ulcer Prevention II

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00629928·800 enrolled

AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers

Completed· AbbVie logo

AbbVie·Phase 1·NCT00325715·150 enrolled

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00595517·395 enrolled

Preeclampsia3 trials

Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia

Unknown status·—·N/A·NCT03717701·120 enrolled

Metformin and Esomeprazole For Preterm Pre-eclampsia

Unknown status·CChristiana Care Health Services·Phase 1·NCT05232994·38 enrolled

Esomeprazole in Treatment of Early Onset Preeclampsia (ESOPE Trial)

Completed·—·Phase 2/3·NCT03213639·205 enrolled

Treatment3 trials

The Effect of Lifestyle-Adjustments Prior to Medical Treatment on the Effect of Medical Treatment in Reflux Patients

Completed· AstraZeneca logo

AstraZeneca··NCT00524251·990 enrolled

Proton Pump Inhibitor Treatment Stop

Completed·OOdense University Hospital·Phase 4·NCT00120315·171 enrolled

On Demand Treatment of Reflux Disease

Completed·NNorwegian University of Science and Technology·Phase 4·NCT00184522·82 enrolled

Gastric Ulcer3 trials

A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00633672·400 enrolled

Prevention of Gastric Ulcers

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00629512·504 enrolled

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00633412·400 enrolled

ESS3 trials

A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant

Completed· Pfizer logo

Pfizer·Phase 1·NCT06275841·12 enrolled

Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01494402·77 enrolled

A Double Blind Study Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

Unknown status·TTaipei Medical University·Phase 4·NCT01275937·65 enrolled

Gastrointestinal3 trials

Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00241540·808 enrolled

Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00241553·276 enrolled

Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00241527·556 enrolled

GERD3 trials

Study Using Esomeprazole as a Diagnostic Test for GERD in Patients With NCCP

Completed·NNational University Hospital, Singapore·N/A·NCT00786695·60 enrolled

Symptom Adapted Therapy in GERD Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00343161·441 enrolled

Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00444275·3,029 enrolled

Barrett's esophagus2 trials

Barrett's Esophagus - 315 - 3 Way Cross Over

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00637988·32 enrolled

An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00352261·80 enrolled

First-line Treatment2 trials

Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02732249·66 enrolled

Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

Completed·SShandong University·Phase 4·NCT05431075·406 enrolled

Drug Interactions2 trials

A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults

Completed·AAssembly Biosciences·Phase 1·NCT04142762·80 enrolled

Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects

Completed·BBridge Biotherapeutics, Inc.·Phase 1·NCT04138836·48 enrolled

Asthma2 trials

Adult Asthmatics and Acid Reflux

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00628953·1,400 enrolled

Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00317044·961 enrolled

Trial2 trials

Nexium RESPONSE Trial

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00318968·1,000 enrolled

PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena

Unknown status·ZZealand University Hospital·Phase 4·NCT00526006

Helicobacter2 trials

Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT04678492·658 enrolled

Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT03609892·658 enrolled

MPA2 trials

A Study in Healthy People to Compare Two Different Tablets of BI 685509 and to Test How Food and Esomeprazole Influence the Amount of BI 685509 in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06193811·16 enrolled

A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole

Completed·AAddpharma Inc.·Phase 1·NCT03980756·88 enrolled

ART2 trials

A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04468815·24 enrolled

A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants

Completed· Bayer logo

Bayer·Phase 1·NCT06378658·21 enrolled

Double-blind2 trials

Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00644735·750 enrolled

Active Control, Double-blind, Double-dummy, Parallel-group, Randomized Study to Assess the Effect of VECAM 40/300, Administered at Bedtime, vs. Esomeprazole 20 mg, Administered 30-60 Min. Before Dinner, on Daytime and Nighttime GERD Symptoms

Completed·VVecta Ltd.·Phase 2·NCT01059383·52 enrolled

Bismuth Quadruple Therapy2 trials

Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.

Unknown status·XXijing Hospital of Digestive Diseases·Phase 4·NCT06603688·548 enrolled

Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment

Recruiting·YYongquan Shi·Phase 4·NCT07139366·1,248 enrolled

Second-line Treatment2 trials

Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT01792700·648 enrolled

Sequential Versus Quadruple Therapy in the Second-line Treatment

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03208426·240 enrolled

AIN2 trials

Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01667575·180 enrolled

Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy

Unknown status·SSir Run Run Shaw Hospital·Phase 4·NCT02894268·300 enrolled

Gastric2 trials

Study of Intragastric pH Profile After 5 Days Pantoprazole 40 mg iv Followed by Oral Esomeprazole 40 mg po or Oral Pantoprazole 40 mg po

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00206050·40 enrolled

Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00410592·90 enrolled

Gastric Acid2 trials

Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients

Completed·UUniversity of Kansas Medical Center·Phase 2·NCT00222131·73 enrolled

The Effect of Protein on Calcium Absorption and Gastric Acid Production

Completed·YYale University·Phase 4·NCT00719160·12 enrolled

H Pylori Infection2 trials

Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection

Unknown status·NNational Institute of Public Health, Slovenia··NCT06216639·2,000 enrolled

Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03555526·320 enrolled

Clopidogrel2 trials

Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects

Unknown status·HHK inno.N Corporation·Phase 1·NCT06164834·48 enrolled

Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants

Completed·HHK inno.N Corporation·Phase 1·NCT03814642·25 enrolled

Rescue Therapy for Helicobacter Pylori1 trial

Rescue Therapy for Helicobacter Pylori Eradication Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT04531059·368 enrolled

Laryngopharyngeal Reflux1 trial

Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux

Completed·UUniversity Hospital, Bordeaux·N/A·NCT01854970·30 enrolled

Non-Allergic Rhinitis1 trial

Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial

Completed·UUniversity of Texas Southwestern Medical Center·N/A·NCT00745849·43 enrolled

Nausea1 trial

Nexium Study To Suppress Nausea During Chemotherapy

Terminated·BBaylor Breast Care Center·Phase 3·NCT00206440·43 enrolled

Infusion1 trial

Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA

Completed· Sanofi logo

Sanofi·Phase 4·NCT02205489·58 enrolled

SLE1 trial

The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 4·NCT06283381·40 enrolled

Peptic Ulcer Disease1 trial

Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT04432233·60 enrolled

Granuloma1 trial

Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas

Withdrawn·VVanderbilt University·Phase 3·NCT00567658

Allergy1 trial

Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03708848·112 enrolled

Thyroid Associated Ophthalmopathy1 trial

The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy

Completed·MMedical University of Vienna·Phase 3·NCT01579539·18 enrolled

Chronic Gastritis1 trial

Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT01119768·305 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

Outcome1 trial

Examine National Characteristics & Outcome Measures of GERD Patients Using the PPI Acid Suppression Symptom (PASS) Test for Response

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00392002·2,000 enrolled

Bariatric Surgery1 trial

Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00608712·140 enrolled

Function1 trial

Gastric Functions & Proton Pump Inhibitor( PPI) Study

Completed·—·Phase 4·NCT00951431·155 enrolled

TED1 trial

HEARD (Long Term) Study - Histology of the Esophagus in Acid-Related Disease

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00243724·350 enrolled

Psoriasis1 trial

Proton Pump Inhibitors Use in Patients With Psoriasis

Withdrawn·EEMS·Phase 4·NCT02624544

Duodenal Ulcer1 trial

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00542789·343 enrolled

Intraoperative Bleeding1 trial

The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

Completed·XXijing Hospital of Digestive Diseases·N/A·NCT02730533·74 enrolled

Medication1 trial

Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT01015729·30 enrolled

Reflux Episodes1 trial

Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy

Completed·WWalter Reed National Military Medical Center·N/A·NCT01710800·41 enrolled

Critically Ill Patients1 trial

Gastric pH in Critically Ill Patients

Completed·MMedical University of Vienna·Phase 4·NCT00590928·75 enrolled

Acid Reflux1 trial

Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD

Unknown status·SSouthern Arizona VA Health Care System·Phase 2/3·NCT01089959·20 enrolled

Gastro-oesophageal Reflux Disease1 trial

The Use of Proton Pump Inhibitor for the Treatment of Non-erosive Gastro-oesophageal Reflux Disease in Chinese Population

Unknown status·HHospital Authority, Hong Kong·N/A·NCT00516971·200 enrolled

MPR1 trial

Esomeprazole in PPI Failures - IMPROVE

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00272701·450 enrolled

Homeostasis1 trial

Effect of Dexlansoprazole on Bone Homeostasis

Completed· Takeda logo

Takeda·Phase 1·NCT01216293·115 enrolled

Stricture1 trial

Study of Proton Pump Inhibitors (PPI) to Prevent Strictures After Gastric Bypass Surgery

Withdrawn·WWeill Medical College of Cornell University·Phase 4·NCT00361985

Sepsis1 trial

Esomeprazole to Reduce Organ Failure in Sepsis

Completed·UUniversità Vita-Salute San Raffaele·Phase 3·NCT03452865·300 enrolled

Gastritis1 trial

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

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

Bone pain1 trial

Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy

Not yet recruiting·—·Phase 2·NCT06903585·385 enrolled

Phase 11 trial

A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

Unknown status·HHK inno.N Corporation·Phase 1·NCT03530228·44 enrolled

Resistance1 trial

Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.

Unknown status·—·Phase 4·NCT04090021·304 enrolled

Adolescent1 trial

Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00241501·140 enrolled

Head and Neck Cancer1 trial

Evaluation of Esomeprazole in Treating Gastro-esophageal Reflux Disease (GERD) in Head and Neck Cancer Patients Exposed to Radiation Therapy

Terminated·DDouglas Trask·N/A·NCT00222079·40 enrolled

Reflux1 trial

vMII for Measurement of Oesophageal Bolus Transport and Reflux

Terminated·GGuy's and St Thomas' NHS Foundation Trust·N/A·NCT00604942·140 enrolled

Gastric Emptying1 trial

Esomeprazole and Gastric Emptying of Beer

Completed·HHeidelberg University·Phase 4·NCT00472550·16 enrolled

Total Knee Arthroplasty1 trial

The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty

Completed·RRothman Institute Orthopaedics·N/A·NCT04003350·216 enrolled

Pilot Study1 trial

Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment

Completed· Pfizer logo

Pfizer·Phase 4·NCT02708355·55 enrolled

Healing1 trial

Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing

Not yet recruiting·LLanZhou University·Phase 4·NCT07312370·120 enrolled

Side Effects1 trial

The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep

Completed·TThomas Jefferson University·Phase 4·NCT00225238·500 enrolled

Intensive Care Unit1 trial

Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit

Completed·FFar Eastern Memorial Hospital·Phase 4·NCT00633035·60 enrolled

Cirrhosis1 trial

Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

Recruiting·UUniversitätsklinikum Hamburg-Eppendorf·Phase 4·NCT04448028·476 enrolled

Clinical Trial1 trial

Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)

Completed·YYuhan Corporation·Phase 2·NCT01750437·149 enrolled

First-line1 trial

The Efficacy of 10-day and 14-day Bismuth-based Quadruple Therapy in First-line H. Pylori Eradication

Enrolling by invitation·NNational Cheng-Kung University Hospital·Phase 4·NCT04527055·312 enrolled

Unspecified8 trials

The Effect of Esomeprazole and Fundoplication on Airways

Completed·TTampere University Hospital·Phase 3·NCT00994708

Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib

Completed· Takeda logo

Takeda·Phase 1·NCT01844583·55 enrolled

Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice

Unknown status·GGlostrup University Hospital, Copenhagen·Phase 4·NCT00363701·150 enrolled

Show 5 more trials

Validation of RDQ Questionnaire

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00291746·350 enrolled

A Study in Healthy Men to Test Whether Esomeprazole Influences the Amount of BI 3000202 in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06419660·15 enrolled

A Study of IBI351 in Healthy Subjects

Completed· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT05688124·24 enrolled

PPI Test in GP Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00318084·100 enrolled

13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)

Completed·MMeridian Bioscience, Inc.·Phase 4·NCT00825630·123 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 20, 2001

NEXIUM

NDA NDA021153

Mar 31, 2005

NEXIUM IV

NDA NDA021689

Feb 27, 2008

NEXIUM

NDA NDA022101

Dec 15, 2011

NEXIUM

NDA NDA021957

Mar 28, 2014

NEXIUM 24HR

NDA NDA204655

Nov 23, 2015

NEXIUM 24HR

NDA NDA207920

Oct 20, 2020

ESOMEPRAZOLE MAGNESIUM

NDA NDA214278

Sources

References

[1]
ClinicalTrials.gov — 293 trial records for esomeprazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nexium drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — esomeprazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for esomeprazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214278). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Nexium. 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

Dec 8, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10076494Dec 8, 2036