Data updated: May 26, 2026
KONVOMEP (omeprazole)
Gastrointestinal
Approved 2022-08-30
Konvomep combines omeprazole and sodium bicarbonate to help adults manage specific gastrointestinal issues. It treats active benign gastric ulcers over a short-term period of four to eight weeks. Additionally, healthcare providers use it to reduce the risk of upper gastrointestinal bleeding in patients who are critically ill.
Source: FDA Label • AZURITY
How KONVOMEP Works
This medication works by inhibiting the H+/K+ ATPase enzyme system, often called the proton pump, located on the surface of gastric parietal cells. By targeting this system, it blocks the final step of acid production in the stomach. This process effectively reduces both basal and stimulated gastric acid secretion regardless of the initial stimulus.
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2022-08-30
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION
KONVOMEP Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2022 to 2022
What KONVOMEP Treats
2 indicationsKONVOMEP is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastric Ulcer
- Gastrointestinal Bleeding
Source: FDA Label
KONVOMEP Competitive Set
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MoA expansion candidates
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Indication competitors
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Drugs Similar to KONVOMEP
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
154 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05646862 INAVO121 | WO43919 2022-502322-41-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy |
| NCT07214662 | GO46057 | Ph 1 | recruiting | A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer |
| NCT06686628 | INT18404 U1111-1303-3406, 2024-513495-17 | Ph 1 | completed | An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates |
| NCT02783040 results posted | 1346.22 2015-001371-41 | Ph 1 | completed | Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin |
| NCT07223671 | CA127-1088 | Ph 1 | completed | Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants |
| NCT06562907 | GS-US-506-6610 | Ph 1 | recruiting | Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM) |
| NCT07235748 | S095032-230 | Ph 1 | completed | Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants |
| NCT05444556 results posted | 18413 J2J-MC-JZLI | Ph 1 | completed | A Study of Imlunestrant (LY3484356) in Female Healthy Participants |
| NCT04840888 results posted | 18204 J2J-MC-JZLD | Ph 1 | completed | A Study of LY3484356 in Healthy Female Participants |
| NCT02950259 results posted | 16-126B IRX-2 2016-B | Ph 1 | completed | Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) |
| NCT06494761 results posted | 1479-0014 2023-510263-35-00, U1111-1301-9035 | Ph 1 | completed | A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body |
| NCT07156201 | ABS1230-1001 | Ph 1 | recruiting | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ABS-1230 Given Orally Compared With Placebo in Healthy Participants Aged 18 to 55 Years |
| NCT07149415 | 296HV104 | Ph 1 | completed | A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55 |
| NCT05468164 results posted | 17752 J2G-MC-JZJQ, LOXO-RET-18015 | Ph 1 | completed | A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants |
| NCT05680870 | MS.22.12.2244.R1 | Ph 3 | completed | The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Cancer Patients |
| NCT06383338 PEGASUS | PEGASUS 2023/ETH01954 | Ph 1 | recruiting | A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma. |
| NCT06948006 | D9441C00003 | Ph 1 | completed | 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 |
| NCT06605950 | CN012-0030 | Ph 1 | completed | 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 |
| NCT05487235 | GO43712 2021-006479-40 | Ph 1 | completed | A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors |
| NCT07037888 Keto | 16671 | Ph 4 | recruiting | Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective Double-Blinded Randomized Controlled Trial |
| NCT06279234 | C4001002 NCT06279234 | Ph 1 | completed | A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus |
| NCT03267680 results posted | 5GYN-16-2 NCI-2017-01402, 5GYN-16-2 | Ph 2 | terminated | IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3 |
| NCT06162169 | JAB-21822-1010 | Ph 1 | completed | A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects |
| NCT05581992 | 20190320 | Ph 1 | completed | Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants |
| NCT03556592 | LP0162-1342 2018-000534-35 | Ph 1 | completed | Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4 |
| NCT06322706 | ABSK021-105 | Ph 1 | completed | A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021 |
| NCT06822166 | ET-26-HCL-CP-006 | Ph 1 | completed | Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride |
| NCT02638116 | CR108106 2015-005015-32, PCI-32765CLL1005 | Ph 1 | completed | A Drug Interaction Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults |
| NCT01499368 results posted | LAF-BR-CT-302 | Ph 3 | completed | 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 |
| NCT05134350 results posted | LOXO-BTK-20014 J2N-OX-JZNH | Ph 1 | completed | Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants |
| NCT05599828 | 20200199 | Ph 1 | completed | A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants |
| NCT05981365 results posted | GBT440-0122 C5341029 | Ph 1 | completed | Voxelotor CYP and Transporter Cocktail Interaction Study |
| NCT05338502 results posted | 17574 J2G-OX-JZJL, LOXO-RET-19075 | Ph 1 | completed | Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants |
| NCT03864042 results posted | ARRAY-818-103 C4221003, 2019-001036-66 | Ph 1 | completed | Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors |
| NCT04246762 results posted | CL04041026 | Ph 1 | completed | 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 |
| NCT05067439 results posted | B7451092 | Ph 1 | completed | A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants |
| NCT06031454 | RAY1216-23-05 | Ph 1 | completed | Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin |
| NCT05635110 | VX22-548-013 | Ph 1 | completed | Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Participants |
| NCT02609386 INSPIRE results posted | IRX-2 2015-A | Ph 2 | completed | IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity |
| NCT05497557 results posted | 20220024 | Ph 1 | completed | A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers |
| NCT04028466 | RP 19-007 | Ph 4 | terminated | Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features |
| NCT05932277 | CN007-1000 | Ph 1 | completed | A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants |
| NCT05852769 | IM038-022 | Ph 1 | completed | A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants |
| NCT05319912 results posted | WTX101-102 CA13895 | Ph 1 | completed | A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults |
| NCT05319899 results posted | WTX101-101 CA12887 | Ph 1 | completed | A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults |
| NCT03531762 results posted | MS200095_0039 2017-002832-18 | Ph 1 | completed | Effect of a Proton Pump Inhibitor on the PK of Tepotinib |
| NCT03028103 results posted | EZH-105 | Ph 1 | completed | 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 |
| NCT02740712 DDI | CO-338-044 | Ph 1 | completed | Pharmacokinetic Drug-Drug Interaction Study of Rucaparib |
| NCT04718181 | BP42066 | Ph 1 | completed | Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants |
| NCT02013427 results posted | STU00080585 R01AT007987-01A1 | Ph 4 | completed | Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial |
Showing 50 of 154 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KONVOMEP FDA Label Details
Indications & Usage
FDA Label (PDF)KONVOMEP is indicated for the treatment of Gastric Ulcer; Gastrointestinal Bleeding.
View full patent landscape →
8 OB patents · 2 families ·
22 international docs across 6 countries
KONVOMEP Patents & Exclusivity
Latest Patent: Mar 2040
Patents (8 active)
US11771686
Expires Mar 1, 2040
US11911473
Expires Jul 16, 2039
US12440566
Expires Jul 16, 2039
US12329752
Expires Jul 16, 2039
US10751333
Expires Jul 16, 2039
US11103492
Expires Jul 16, 2039
US11633478
Expires Jul 16, 2039
US12042539
Expires Jul 16, 2039
Source: FDA Orange Book
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Patent Timeline
- • Cliff: 2040
- • 9 active patents
Trial Analysis
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Competitive Landscape
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.