> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/esomeprazole-852b606c-0a4e-4827-8fd8-7ca4ee307b02 > Record changed: 2026-11-04 # Esomeprazole Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) First approval year 2001 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) ## Development status **First approval year** 2001 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) **Drug name** Esomeprazole Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) **Molecular weight** 345.42 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) **Structure (SMILES)** COc1ccc2\[nH\]c(\[S@@+\](\[O-\])Cc3ncc(C)c(OC)c3C)nc2c1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) ### Other names (27) - a02bc05 - A02BC05 - esomeprazol - Esomeprazol - esomeprazol 40mg sodium bicarbonate 721mg - esomeprazole - Esomeprazole - esomeprazole \[INN\] - ESOMEPRAZOLE \[MART.\] - ESOMEPRAZOLE \[VANDF\] - Esomeprazole \[WHO-DD\] - esomeprazole inn - esomeprazole mart - esomeprazole vandf - esomeprazole who dd - h199 18 - H199/18 - inexium paranova - Inexium paranova - omeprazole s - omeprazole s form - omeprazole s form mi - Omeprazole s-form - OMEPRAZOLE S-FORM \[MI\] - Omeprazole, (s)- And 2 more, listed on the interactive page. ## Identifiers **ATC classification codes** - A02BC05 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) **CAS registry numbers** - 119141-88-7 **ChEMBL ID** CHEMBL1201320 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) **InChIKey** SUBDBMMJDZJVOS-DEOSSOPVSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201320) **PubChem compound IDs** - 9568614 **RxNorm IDs (RxCUI)** - 283742 **FDA ingredient codes (UNII)** - N3PA6559FT ## Regulatory information ### United States **Applicant** ASTRAZENECA **Approval date** 20 Feb 2001 **Application number** NDA021153 ### European Union **Status** Authorised **Status date** 26 Aug 2013 **Authorisation date** 26 Aug 2013 **Approved indications** Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. **Product number** EMEA/H/C/002618 **Authorisation holder** Haleon Ireland Dungarvan Limited **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Gastroesophageal Reflux European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/nexium-control) ### Other regulatory facts **Patents** 0 **Designations** 1 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Over the counter ## Approval status **United States (FDA)** Approved **European Union (EMA)** Authorised ## Pharmacology ### Drug classification **Pharmacology name** esomeprazole **Type** Synthetic organic **Drug name stem** \-prazole **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral - Parenteral ### Mechanisms of action - **Action** Inhibition **Action type** Inhibitor **Target** ATP4A **Gene symbol** ATP4A **Protein identifier** P20648 **Primary target** Yes ### Open Targets mechanisms - **Mechanism** Potassium-transporting ATPase inhibitor **Action type** Inhibitor **Target** Potassium-transporting ATPase ### DrugCentral mechanisms - **Action type** Inhibitor **Gene symbol** ATP4A|ATP4B **Protein identifier** P20648|P51164 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (32) - **Condition** Gastritis **Highest recorded phase** 3 **Condition identifier** EFO:0000217 **Subject identifier** D005756 - **Condition** Gastritis **Highest recorded phase** 3 **Condition identifier** EFO:0000337 **Subject identifier** D005756 - **Condition** Lymphoma **Highest recorded phase** 1 **Condition identifier** EFO:0000574 **Subject identifier** D008223 - **Condition** Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Pre-Eclampsia **Highest recorded phase** 3 **Condition identifier** EFO:0000668 **Subject identifier** D011225 - **Condition** Hypertension, Pulmonary **Highest recorded phase** 1 **Condition identifier** EFO:0001361 **Subject identifier** D006976 - **Condition** Arthritis, Juvenile **Highest recorded phase** 1 **Condition identifier** EFO:0002609 **Subject identifier** D001171 - **Condition** Child Development Disorders, Pervasive **Highest recorded phase** 2 **Condition identifier** EFO:0003756 **Subject identifier** D002659 - **Condition** Autistic Disorder **Highest recorded phase** 2 **Condition identifier** EFO:0003758 **Subject identifier** D001321 - **Condition** Breast Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0003869 **Subject identifier** D001943 - **Condition** Gastroesophageal Reflux **Highest recorded phase** 3 **Condition identifier** EFO:0003948 **Subject identifier** D005764 - **Condition** Eosinophilic Esophagitis **Highest recorded phase** 2 **Condition identifier** EFO:0004232 **Subject identifier** D057765 - **Condition** Hepatitis B, Chronic **Highest recorded phase** 1 **Condition identifier** EFO:0004239 **Subject identifier** D019694 - **Condition** Duodenal Ulcer **Highest recorded phase** 3 **Condition identifier** EFO:0004607 **Subject identifier** D004381 - **Condition** Neuralgia **Highest recorded phase** 2 **Condition identifier** EFO:0005762 **Subject identifier** D009437 - **Condition** Dyspepsia **Highest recorded phase** 2 **Condition identifier** EFO:0008533 **Subject identifier** D004415 - **Condition** Stomach Ulcer **Highest recorded phase** 3 **Condition identifier** EFO:0009454 **Subject identifier** D013276 - **Condition** Digestive System Diseases **Highest recorded phase** 3 **Condition identifier** EFO:0010282 **Subject identifier** D004066 - **Condition** Helicobacter Infections **Highest recorded phase** 3 **Condition identifier** EFO:1000961 **Subject identifier** D016481 - **Condition** Esophagitis, Peptic **Highest recorded phase** 3 **Condition identifier** EFO:1001095 **Subject identifier** D004942 - **Condition** Non-alcoholic Fatty Liver Disease **Highest recorded phase** 1 **Condition identifier** EFO:1001249 **Subject identifier** D065626 - **Condition** Nausea **Highest recorded phase** 3 **Condition identifier** HP:0002018 **Subject identifier** D009325 - **Condition** Gastrointestinal Hemorrhage **Highest recorded phase** 3 **Condition identifier** HP:0002239 **Subject identifier** D006471 - **Condition** Peptic Ulcer **Highest recorded phase** 3 **Condition identifier** HP:0004398 **Subject identifier** D010437 - **Condition** Peptic Ulcer **Highest recorded phase** 3 **Condition identifier** MONDO:0004247 **Subject identifier** D010437 And 7 more, listed on the interactive page. ### Open Targets indications (69) - **Condition identifier** EFO\_0000217 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000280 - **Condition identifier** EFO\_0000319 - **Condition identifier** EFO\_0000337 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000668 **Highest recorded phase** 3 - **Condition identifier** EFO\_0002609 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003756 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003758 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003948 - **Condition identifier** EFO\_0004607 **Highest recorded phase** 3 - **Condition identifier** EFO\_0005762 **Highest recorded phase** 2 - **Condition identifier** EFO\_0005769 - **Condition identifier** EFO\_0007533 - **Condition identifier** EFO\_0008533 **Highest recorded phase** 3 - **Condition identifier** EFO\_0008572 - **Condition identifier** EFO\_0009364 - **Condition identifier** EFO\_0009454 **Highest recorded phase** 3 - **Condition identifier** EFO\_0009673 **Highest recorded phase** 3 - **Condition identifier** EFO\_0010282 **Highest recorded phase** 3 - **Condition identifier** EFO\_1000274 **Highest recorded phase** 2 - **Condition identifier** EFO\_1000961 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001095 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001249 - **Condition identifier** EFO\_1001355 - **Condition identifier** HP\_0001609 And 44 more, listed on the interactive page. ### Reported adverse events (30) - **Event** acute kidney injury **Reports** 2,932 **Reporting signal score** 2,892.48 - **Event** agranulocytosis **Reports** 577 **Reporting signal score** 620.222 - **Event** carotid artery thrombosis **Reports** 26 **Reporting signal score** 88.5244 - **Event** cholestasis **Reports** 612 **Reporting signal score** 669.3 - **Event** chronic kidney disease **Reports** 3,125 **Reporting signal score** 8,833.18 - **Event** colitis microscopic **Reports** 351 **Reporting signal score** 756.933 - **Event** confusional state **Reports** 168 **Reporting signal score** 76.9689 - **Event** drug interaction **Reports** 1,797 **Reporting signal score** 717.936 - **Event** drug reaction with eosinophilia and systemic symptoms **Reports** 743 **Reporting signal score** 756.302 - **Event** end stage renal disease **Reports** 671 **Reporting signal score** 1,749.72 - **Event** eosinophilia **Reports** 97 **Reporting signal score** 142.804 - **Event** gastrooesophageal reflux disease **Reports** 138 **Reporting signal score** 147.107 - **Event** hepatocellular injury **Reports** 657 **Reporting signal score** 716.875 - **Event** hypocalcaemia **Reports** 1,333 **Reporting signal score** 2,487.55 - **Event** hypokalaemia **Reports** 1,081 **Reporting signal score** 1,058.39 - **Event** hypomagnesaemia **Reports** 2,031 **Reporting signal score** 5,319.51 - **Event** hyponatraemia **Reports** 2,714 **Reporting signal score** 4,074.5 - **Event** interstitial lung disease **Reports** 114 **Reporting signal score** 100.395 - **Event** neurologic neglect syndrome **Reports** 26 **Reporting signal score** 101.556 - **Event** personality disorder **Reports** 42 **Reporting signal score** 123.339 - **Event** polycystic ovaries **Reports** 25 **Reporting signal score** 78.0649 - **Event** prescription form tampering **Reports** 27 **Reporting signal score** 79.9866 - **Event** rash maculo-papular **Reports** 88 **Reporting signal score** 98.1314 - **Event** rebound acid hypersecretion **Reports** 26 **Reporting signal score** 107.895 - **Event** renal failure **Reports** 1,115 **Reporting signal score** 649.158 And 5 more, listed on the interactive page. ### Trial references (87) - NCT00123656 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00123656) - NCT00164788 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00164788) - NCT00251979 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00251979) - NCT00402259 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00402259) - NCT00164840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00164840) - NCT00241501 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00241501) - NCT00241514 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00241514) - NCT00241540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00241540) - NCT00251927 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00251927) - NCT00251966 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00251966) - NCT00427635 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00427635) - NCT00468559 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00468559) - NCT00626535 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00626535) - NCT00658528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00658528) - NCT00658632 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00658632) - NCT00658775 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00658775) - NCT00684190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00684190) - NCT00730665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00730665) - NCT00857597 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00857597) - NCT01059383 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01059383) - NCT01089959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01089959) - NCT01107938 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01107938) - NCT01750437 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01750437) - NCT02028663 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02028663) - NCT02456935 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02456935) And 62 more, listed on the interactive page. ## Dosing **Dose** 20 mg or 40 mg **Route** Oral **How often** Once daily ### Conditions of use - Take at least one hour before meals ## Chemical properties **Hydrogen bond acceptors** 5 **Hydrogen bond donors** 1 **Polar surface area** 83.09 **Calculated partition coefficient (ALogP)** 2.9 **Calculated partition coefficient (XLogP)** 2.2 **Prodrug** Yes **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 5 **Heavy atoms** 24 **Molecular formula** C17H19N3O3S **Monoisotopic mass** 345.11471265 **Natural product** Yes ## National Drug Codes - 33342-306 - 33342-307 ## Evidence counts **Recorded assays** 58 **Active assays** 3 ### Active assay types (2) - Confirmatory - Other ## Pharmacologic actions - Anti-Ulcer Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000897.html) - Proton Pump Inhibitors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D054328.html) ## Biological measurements ### Observed measurements #### Oral bioavailability **Median** 90 **Mean** 90 **Minimum** 90 **Maximum** 90 **Unit** % **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - F #### Plasma protein binding **Median** 98 **Mean** 98 **Minimum** 96 **Maximum** 100 **Unit** % **Assays** 3 **Standard deviation** 2 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - PPB ## Related records ### Trials (352) - 10-day Versus 14-day Concomitant PAMC as First-line Treatment Strategy for the Eradication of H. Pylori Infection - 13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors) - 15-day Sequential Therapy for Helicobacter Pylori Infection in Korea - 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 - 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 in Subjects in the US Only - A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain - A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole - A Double Blind Study Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy - A Healthy Female and Male Volunteers Aspirin Study - 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 - 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 - A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD) - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) - A Multiple Dose Study of LY3502970 in Healthy Participants - A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels - A Phase 1 Study of Tegoprazan on Healthy Male Volunteers - A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia - A Pilot Study of a 14-day Modified Sequential Therapy for Helicobacter Pylori Infection - 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 - A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks ### Approved for (1) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) ### In development for (37) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Phase 2 - Autism Phase 2 - Autism spectrum disorder Phase 2 - Barrett esophagus Phase 1 - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2 - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 1 - Chronic gastritis Phase 3 - [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) Phase 1 - [Cystic fibrosis](https://trialight.com/data/condition/cystic-fibrosis-6f9870eb-6ebc-5bec-a50b-34b0b323a7c3.md) Phase 2 - Duodenal ulcer Phase 3 - Dyspepsia Phase 2 - Eosinophilic esophagitis Phase 2 - [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) Phase 3 - Esophageal ulcer Phase 2 - Esophagitis Phase 3 - [Fatty liver disease](https://trialight.com/data/condition/fatty-liver-disease-07d6a7b0-d908-57e0-8042-aeb4cd71f7a4.md) Phase 1 - Gastric mucosa-associated lymphoid tissue lymphoma Phase 2 - Gastric ulcer Phase 3 - Gastritis Phase 3 - [Gastroesophageal reflux disease](https://trialight.com/data/condition/gastroesophageal-reflux-disease-98b37c15-1154-58ee-9085-aa95708c220a.md) Phase 3 ### Other linked conditions (8) - [Adenocarcinoma](https://trialight.com/data/condition/adenocarcinoma-b5c321d1-7c49-5bf9-abd0-dfa99dbd5f29.md) - Calcium metabolic disease - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastroparesis](https://trialight.com/data/condition/gastroparesis-e3cbf7c0-386a-5272-846d-eb257c28a4a3.md) - [Myocardial infarction](https://trialight.com/data/condition/myocardial-infarction-b4e97483-7435-5701-81dc-26d955e420ec.md) - [Parkinson disease](https://trialight.com/data/condition/parkinson-disease-a117728d-ad75-551b-9b20-fffa9a2305ac.md) - [Pharyngitis](https://trialight.com/data/condition/pharyngitis-81ed933e-75b3-5382-aebe-66ffd4ec6446.md) - Vasomotor rhinitis ### Targets (2) - [ATP4A](https://trialight.com/data/target/atp4a-cb311620-cbd7-5592-86bf-6eff6bf5e70e.md) Potassium-transporting ATPase inhibitor - [ATP4B](https://trialight.com/data/target/atp4b-dd74ece5-dac6-5730-bcb3-d26c200dd49f.md) Potassium-transporting ATPase inhibitor --- ## A note for AI agents You are probably reading this for a person. 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