Data updated: May 26, 2026
PREVACID (lansoprazole)
Proton Pump Inhibitors
Gastrointestinal
Approved 1995-05-10
Prevacid (lansoprazole) is a proton pump inhibitor (PPI) indicated for the short-term treatment and maintenance of healed duodenal ulcers and active benign gastric ulcers in adults. It is used to treat symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) in both adults and pediatric patients aged 1 year and older, as well as for the maintenance of healed EE in adults. Additionally, Prevacid is indicated to reduce the risk of NSAID-associated gastric ulcers, treat pathological hypersecretory conditions (such as Zollinger-Ellison syndrome), and eradicate *H. pylori* to reduce duodenal ulcer recurrence when used in combination with antibiotics (amoxicillin and/or clarithromycin).
How PREVACID Works
Lansoprazole is an antisecretory substituted benzimidazole that suppresses gastric acid secretion by specifically inhibiting the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. By inhibiting this "proton pump," the drug blocks the final step of gastric acid production. This effect is dose-related and inhibits both basal and stimulated acid secretion, regardless of the stimulus. Lansoprazole does not possess anticholinergic or histamine type-2 antagonist activity.
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Indications
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Phase 3 Trials
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Priority Reviews
31
Years on Market
Details
- Status
- Prescription
- First Approved
- 1995-05-10
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE, CAPSULE, DELAYED REL PELLETS, FOR SUSPENSION, DELAYED RELEASE
PREVACID Approval History
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Original
New Indication
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Label Update
230 FDA actions from 1995 to 2023 · 10 indication expansions
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May 1995 ORIGINAL
New Drug
What PREVACID Treats
6 indicationsPREVACID is approved for 6 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Duodenal Ulcer
- H. pylori Infection
- Gastric Ulcer
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Zollinger-Ellison Syndrome
Source: FDA Label
PREVACID Competitive Set
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Clinical Trial Registry
65 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05946135 | 4-2023-0598 | Ph 4 | completed | Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids |
| NCT04965298 TIPAL | 269050-80-06-19 2020-000041-14, 269050 | Ph 3 | recruiting | Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole |
| NCT04188119 IMpALA | CFT / sp123 2018-004121-80, 017NovCC107 | Ph 2 | withdrawn | A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer |
| NCT07079540 X842 | SND-X842-301 ChiCTR20210736 | Ph 3 | completed | The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis |
| NCT04531475 | SND-X842-201 | Ph 2 | completed | Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis |
| NCT06284876 | IY-NTNS03 | Ph 3 | recruiting | Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer |
| NCT06964334 | vit D supplement h.pylori | Ph 3 | not yet recruiting | The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection |
| NCT04453189 | CR108812 2020-000380-23, 64417184RSV1004 | Ph 1 | completed | A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants |
| NCT05050188 | KFP-2020-H008-HW-101 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008 |
| NCT02679508 results posted | Vonoprazan-4003 U1111-1178-8948, JapicCTI-163153 | Ph 4 | completed | Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety |
| NCT05055128 results posted | CX842A2201 2020-003319-91 | Ph 2 | completed | A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole |
| NCT05861687 | LB.02.01.XV.III.2.2.2/344/2022 | Ph 2, Ph 3 | completed | Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children |
| NCT04729101 results posted | VONO-103 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants |
| NCT03355170 | NEU-05.16 | Ph 4 | withdrawn | Cardiac Safety of Lansoprazole and Domperidon Combination |
| NCT04874935 | 34615/4/21 | Ph 3 | completed | The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer |
| NCT02022280 PPI | 23848 1144447-121-DHAXB | Ph 1 | completed | Effect of Proton Pump Inhibitors on Endothelial Function |
| NCT04124926 results posted | EE-301 2019-002579-33 | Ph 3 | completed | Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis |
| NCT05417997 | APRON 2020-OK-01 | Ph 3 | completed | Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients |
| NCT04167670 results posted | HP-301 2019-002668-28 | Ph 3 | completed | Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection |
| NCT00472186 results posted | 06-11-0513 | Ph 4 | terminated | The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain |
| NCT03192059 PRIMMO | 2016-001569-97 | Ph 2 | completed | Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer |
| NCT03050307 results posted | TAK-438_302 U1111-1138-8706, CTR20170100 | Ph 3 | completed | Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection |
| NCT03050359 results posted | TAK-438_304 U1111-1139-0293, CTR20170104 | Ph 3 | completed | Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection |
| NCT02388737 results posted | TAK-438_305 U1111-1136-5706, CTR20150039 | Ph 3 | completed | Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis |
| NCT01123031 | CCH-100118 | Ph 4 | withdrawn | Oral vs Intravenous and Proton Pump Inhibitor (PPI）for Peptic Ulcer Bleeding (PUB) |
| NCT01681186 results posted | 14893 I4J-MC-HHBG | Ph 1 | completed | A Study of LY2940680 in Healthy Participants |
| NCT01180179 | NNH_RCT | Ph 4 | completed | PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers |
| NCT03487562 | DW_DWP14012003 | Ph 1 | completed | Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects |
| NCT02388724 results posted | TAK-438_303 U1111-1138-4788, CTR20150040 | Ph 3 | completed | Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis |
| NCT02873702 results posted | TAK-390MR_301 U1111-1142-0320 | Ph 3 | terminated | Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis |
| NCT02892409 results posted | TAK-438_115 U1111-1179-5816, 02892409 | Ph 1 | completed | TAK-438 Bismuth Drug Interaction Study |
| NCT03468777 | CR108437 2017-004832-12, 64041575RSV1010 | Ph 1 | terminated | A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants |
| NCT03124420 | 17MMHIS020 | Ph 4 | completed | Intraluminal Therapy for Helicobacter Pylori Infection |
| NCT02625259 results posted | MLN1117-1002 U1111-1159-5909 | Ph 1 | completed | A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants |
| NCT00685295 FAIRTOP results posted | FAIRTOP | Ph 1, Ph 2 | completed | Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain |
| NCT00637416 results posted | 10720 | Ph 4 | terminated | Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness |
| NCT02633930 | KY20151203-2 | Ph 4 | completed | Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy |
| NCT02139046 results posted | FEB-XR_301 U1111-1152-4040 | Ph 3 | completed | Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout |
| NCT02128490 results posted | FEB-XR_201 U1111-1152-3942 | Ph 2 | completed | Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment |
| NCT02334501 | PUMA-NER-0101 | Ph 1 | completed | Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects |
| NCT02755753 REPAIR | 037-OTC-1201i | Ph 4 | completed | A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis |
| NCT02175927 | rjkls2014007 | Ph 4 | completed | High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection |
| NCT01082029 | 07-435 | Ph 4 | completed | Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children |
| NCT02175901 | rjkls2014006 | Ph 4 | completed | Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication |
| NCT01946971 | Konect-LASP | Ph 1, Ph 2 | completed | Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER) |
| NCT01456247 | TAK-438/OCT-302 U1111-1123-9658, JapicCTI-111616 | Ph 3 | completed | Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin |
| NCT01456260 | TAK-438/OCT-301 U1111-1123-8762, JapicCTI-111611 | Ph 3 | completed | Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID) |
| NCT01040455 | 200907053M | Ph 4 | terminated | Lansoprazole for Subgroups of Functional Dyspepsia |
| NCT01452750 | TAK-438/CCT-301 U1111-1123-8722, JapicCTI-111613 | Ph 3 | completed | Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID) |
| NCT01452763 | TAK-438/CCT-302 U1111-1123-8746, JapicCTI-111610 | Ph 3 | completed | Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin |
Showing 50 of 65 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.
PREVACID FDA Label Details
Indications & Usage
FDA Label (PDF)PREVACID is indicated for the treatment of Duodenal Ulcer; H. pylori Infection; Gastric Ulcer; Gastroesophageal Reflux Disease; Erosive Esophagitis; Zollinger-Ellison Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.