Drugs / Lansoprazole
Lansoprazole
also known as
Prevacid · Lansoprazole (generic name) · Takepron · Takepron OD · A-65006 · AD-2121 · AG-1749 · Agopton · +22 more
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | PREVACID | — | 1996-04-08 – 2008-10-28 | fda.gov ↗ |
| Approved | US (FDA) | PREVACID | — | 1995-05-10 | fda.gov ↗ |
Trials 109 · started per year
today
US approved 1995
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04400136 | Jul 2020 → Jul 2021 | Barrett esophagus, gastroesophageal reflux disease | University of Roma La Sapienza | Unknown | No outcome recorded |
| Phase 121 trials · 3 met primary | ||||||
| Phase 1 | NCT06025773 | Sep 2023 → Apr 2024 | gastroesophageal reflux disease | Addpharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05050188 | Jun → Sep 2021 | esophagitis | Jiangsu Carephar Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04453189 | Jul → Sep 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03710434 | Nov 2018 → Apr 2019 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03488186 | Jul → Oct 2018 | — | First Affiliated Hospital of Zhejiang University | Completed | No outcome recorded |
| Phase 1 | NCT03488173 | Apr → Jul 2018 | — | First Affiliated Hospital of Zhejiang University | Completed | No outcome recorded |
| Phase 1 | NCT03468777 | Mar → Jul 2018 | — | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT03059303 | Feb → Apr 2017 | — | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT02334501 | Aug → Oct 2014 | — | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01820104 | Mar → May 2013 | — | Xijing Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02022280 | Mar 2013 → May 2014 | — | Stanford University | Completed | No outcome recorded |
| Phase 1 | NCT01147588 | May 2010 → May 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00942175 | Dec 2009 → Jun 2010 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT00952913 | Aug → Oct 2009 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00458614 | Jun 2006 → Apr 2007 | cystic fibrosis | Arkansas Children's Hospital Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT00864396 | Jul 2005 → May 2008 | upper respiratory tract disorder | University of California, Davis | Completed | No outcome recorded |
| Phase 1 | NCT00174928 | May → Aug 2005 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT00220818 | Jan → Jul 2005 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT01045967 | May → Jun 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT01046253 | Jan 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT01046084 | Aug → Sep 2003 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01946971 | Sep 2013 → Jul 2014 | gastroesophageal reflux disease | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 210 trials · 2 missed | ||||||
| Phase 2 | NCT07076914 | Oct 2025 → Jan 2028 expected | non-small cell lung carcinoma, small cell lung carcinoma | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05055128 | Aug 2021 → Sep 2022 | esophagitis | Cinclus Pharma Holding AB | Completed | No outcome recorded |
| Phase 2 | NCT04531475 | Jan → Oct 2020 | peptic esophagitis | Jiangsu Sinorda Biomedicine Co., Ltd | Completed | Missed primary |
| Phase 2 | NCT02387203 | Jan 2015 → Dec 2024 overdue | pseudomyxoma peritonei | Mercy Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02388581 | Dec 2014 → Dec 2017 | gastric diffuse large B-cell lymphoma | National Health Research Institutes, Taiwan | Unknown | No outcome recorded |
| Phase 2 | NCT01778101 | Jan → May 2013 | gastroesophageal reflux disease | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01279252 | Jul 2011 → Jan 2015 | chronic lymphocytic leukemia/small lymphocytic lymphoma | King's College Hospital NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT01155284 | Aug 2010 → May 2014 | type 1 diabetes mellitus | Sanford Health | Completed | Missed primary |
| Phase 2 | NCT01037452 | Dec 2009 → Jan 2010 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00837759 | Feb 2009 → Mar 2011 | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Terminated | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07337655 | Oct 2026 → Sep 2030 expected | — | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT00789061 | Aug 2006 → Mar 2008 | hearing loss disorder | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 323 trials · 7 met primary · 3 missed | ||||||
| Phase 3 | NCT06284876 | Jul 2024 → Aug 2026 overdue | peptic ulcer disease | Il-Yang Pharm. Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT04965298 | Jun 2021 → Feb 2026 overdue | idiopathic pulmonary fibrosis | Norfolk and Norwich University Hospitals NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 3 | NCT03015610 | Oct 2017 → Jan 2024 | asthma, gastroesophageal reflux disease | Jason Lang, M.D., M.P.H. | Completed | Missed primary |
| Phase 3 | NCT03317223 | Oct 2017 → Jan 2019 | Helicobacter pylori infectious disease | HK inno.N Corporation | Completed | Met primary |
| Phase 3 | NCT03050307 | Apr 2017 → Feb 2020 | gastric ulcer | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03050359 | Apr 2017 → Mar 2019 | duodenal ulcer | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02873702 | Dec 2016 → Oct 2017 | esophagitis | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT02557932 | Sep 2015 → Dec 2018 | Helicobacter pylori infectious disease, hereditary gastric cancer | National Cancer Center, Korea | Completed | Met primary |
| Phase 3 | NCT02388737 | Apr 2015 → Dec 2018 | esophagitis | Takeda | Completed | Met primary |
| Phase 3 | NCT01762657 | Sep 2014 → Sep 2015 | type 1 diabetes mellitus | Perle Bioscience, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01505127 | Jan 2012 → Jun 2013 | Helicobacter pylori infectious disease | Takeda | Completed | Met primary |
| Phase 3 | NCT01481844 | Nov 2011 → Dec 2014 | — | Soroka University Medical Center | Completed | Met primary |
| Phase 3 | NCT01182597 | Aug 2010 → Aug 2013 | peptic ulcer disease | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01131026 | Jun 2010 → Aug 2011 | Helicobacter pylori infectious disease | Deva Holding A.S. | Completed | No outcome recorded |
| Phase 3 | NCT01061437 | Jun 2009 → Jul 2011 | Helicobacter pylori infectious disease | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 3 | NCT00762359 | May 2007 → Nov 2008 | duodenal ulcer, gastric ulcer | Takeda | Terminated | Met primary |
| Phase 3 | NCT00787254 | Apr 2007 → May 2009 | duodenal ulcer, gastric ulcer | Takeda | Completed | Met primary |
| Phase 3 | NCT00701259 | Jan → Aug 2007 | — | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00390390 | Jun 2006 → Jan 2007 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00389948 | Jun 2006 → Jan 2007 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00324974 | Jun 2006 → May 2007 | gastroesophageal reflux disease | Takeda | Completed | Missed primary |
| Phase 3 | NCT00175032 | Jul 2003 → Jul 2004 | osteoarthritis, peptic ulcer disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00149084 | Apr 2003 → ? | Helicobacter pylori infectious disease, duodenal ulcer, gastric ulcer, gastritis | Hamamatsu University | Unknown | No outcome recorded |
| Phase 440 trials · 3 met primary · 3 missed | ||||||
| Phase 4 | NCT07611162 | May 2026 → May 2030 expected | gastroesophageal reflux disease | University of Mons | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07344506 | May 2025 → May 2026 overdue | Helicobacter pylori infectious disease | Dow University of Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT05624229 | Oct 2023 → Dec 2025 overdue | esophageal varices with bleeding | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05711810 | Jan 2023 | Orthocoronavirinae infectious disease, myocarditis | Yang I. Pachankis | Completed | No outcome recorded |
| Phase 4 | NCT04713670 | Mar 2021 → Dec 2025 overdue | Helicobacter pylori infectious disease | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04660461 | Feb 2020 → Jun 2021 | pseudoxanthoma elasticum (inherited or acquired) | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Unknown | No outcome recorded |
| Phase 4 | NCT04248335 | Jul 2018 → Dec 2024 | gastroesophageal reflux disease, metabolic dysfunction-associated steatotic liver disease | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 4 | NCT03524833 | May 2018 → Jan 2019 | Helicobacter pylori infectious disease | Mackay Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03273634 | May 2017 → May 2018 | cardiac rhythm disease | Jordan Collaborating Cardiology Group | Completed | No outcome recorded |
| Phase 4 | NCT03130452 | Dec 2016 → Jan 2019 | Helicobacter pylori infectious disease | Inje University | Completed | No outcome recorded |
| Phase 4 | NCT02794844 | Jul 2016 → Jan 2017 | gastroesophageal reflux disease | Nemours Children's Clinic | Completed | No outcome recorded |
| Phase 4 | NCT02759393 | Oct 2015 → Jul 2017 | gastroesophageal reflux disease | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02278081 | Jan 2015 → Jan 2016 | gastroesophageal reflux disease, rhinitis | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| Phase 4 | NCT02958046 | Jan 2014 → May 2015 | gastroesophageal reflux disease | Neutec Ar-Ge San ve Tic A.Ş | Completed | No outcome recorded |
| Phase 4 | NCT01906879 | Jun 2013 → Dec 2017 | Helicobacter pylori infectious disease | National Taiwan University Hospital | Unknown | Met primary |
| Phase 4 | NCT01888237 | May 2013 → Aug 2014 | dyspepsia, gastritis | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT01607918 | Feb 2012 → Dec 2013 | — | National Taiwan University Hospital | Unknown | Missed primary |
| Phase 4 | NCT01537055 | Feb 2012 → Dec 2015 | — | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02703896 | Jan 2012 | lung disorder | King Saud University | Completed | No outcome recorded |
| Phase 4 | NCT01512953 | Jan 2011 → Aug 2012 | coronary artery disorder | Università degli Studi di Ferrara | Unknown | No outcome recorded |
| Phase 4 | NCT01082029 | Mar 2010 → Jun 2014 | otitis media with effusion | Hamilton Health Sciences Corporation | Completed | No outcome recorded |
| Phase 4 | NCT01040455 | Dec 2009 → Dec 2013 | dyspepsia | National Taiwan University Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01042184 | Dec 2009 → Feb 2012 | Helicobacter pylori infectious disease | National Taiwan University Hospital | Completed | Met primary |
| Phase 4 | NCT00472186 | Jun 2008 → Feb 2011 | — | Boston Children's Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00663897 | May 2008 → Jul 2009 | dyspepsia | Lotung Poh-Ai Hospital | Completed | Missed primary |
| Phase 4 | NCT01404832 | Oct 2007 → May 2010 | eosinophilic esophagitis, gastroesophageal reflux disease | Dallas VA Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00442013 | Mar 2007 → Apr 2011 | asthma | Johns Hopkins University | Completed | Missed primary |
| Phase 4 | NCT00444145 | Mar 2007 → Mar 2009 | gastroesophageal reflux disease, laryngeal disorder | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00410592 | Oct 2006 → May 2007 | gastroesophageal reflux disease | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT00369265 | Aug 2006 → Nov 2009 | upper respiratory tract disorder | American Institute for Voice and Ear Research | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT00467571 | Mar 2006 → Sep 2008 | Helicobacter pylori infectious disease, autoimmune thrombocytopenic purpura | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT00237068 | Mar 2006 → Dec 2009 | asthma | Emory University | Unknown | No outcome recorded |
| Phase 4 | NCT00352261 | Jan 2006 → Apr 2007 | Barrett esophagus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00239551 | Oct 2005 → Oct 2006 | gastric ulcer | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00220909 | Sep 2005 → Jan 2006 | — | Temple University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00230516 | Sep 2005 → Feb 2006 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00625274 | Jun → Nov 2004 | dyspepsia, gastroesophageal reflux disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00204373 | Mar 2003 → Dec 2010 | Zollinger-Ellison syndrome, multiple endocrine neoplasia | Charles Mel Wilcox, MD | Completed | No outcome recorded |
| Phase 4 | NCT01135368 | Jun 2002 → Sep 2008 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT00299845 | — | gastroesophageal reflux disease | Osaka University | Withdrawn | No outcome recorded |
| Phase not applicable11 trials | ||||||
| — | NCT06778824 | Apr 2024 → Dec 2026 expected | gastroesophageal reflux disease | Hualien Tzu Chi General Hospital | Recruiting | No outcome recorded |
| — | NCT05899842 | Jun 2023 → Feb 2028 expected | achalasia | Nîmes University Hospital | Recruiting | No outcome recorded |
| — | NCT05926804 | Aug 2022 → Oct 2026 expected | Helicobacter pylori infectious disease | Miguel O'Ryan Gallardo | Recruiting | No outcome recorded |
| — | NCT03859102 | Dec 2018 → Oct 2019 | aneurysm or dilatation of ascending aorta, aortic valve disorder, cardiac valvular defect, coronary artery disorder +2 | James Cook University Hospital | Unknown | No outcome recorded |
| — | NCT02788591 | Aug 2015 → Jun 2021 | gastroesophageal reflux disease | LCMC Health | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01568944 | Mar 2012 → Sep 2014 | chronic periodontitis | Augusta University | Completed | No outcome recorded |
| — | NCT01139645 | Oct 2009 → Jul 2010 | calcium metabolic disease | American University of Beirut Medical Center | Completed | No outcome recorded |
| — | NCT00546117 | Oct 2007 → Dec 2009 | otitis media with effusion | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT00211614 | Jul → Sep 2006 | gastroesophageal reflux disease, obstructive sleep apnea syndrome | MetroHealth Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00274339 | Dec 2005 → Jun 2008 | upper respiratory tract disorder | Hodge, Kenneth M., M.D. | Unknown | No outcome recorded |
| — | NCT00215787 | Sep 2005 → Sep 2008 | gastroesophageal reflux disease, nasal cavity polyp | Head and Neck Surgery Associates | Completed | No outcome recorded |
| Comparator or background therapy111 trials | ||||||
| Phase 1 | NCT04729101 Comparator | Jan → Jun 2021 | — | Phathom Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 1 | NCT03487562 Background | Apr 2018 → Jan 2019 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT03120273 Comparator | May → Aug 2017 | — | First Affiliated Hospital of Zhejiang University | Unknown | No outcome recorded |
| Phase 1 | NCT02892409 Comparator | Sep 2016 → Apr 2017 | Helicobacter pylori infectious disease | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02625259 Background | Jan → May 2016 | neoplasm | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Show all 111 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2025-10-15 | HK inno.N Corporation | Results HK inno.N Presents Clinical Results of Novel GERD Drug ‘K-CAB’ for H. pylori Eradication at UEGW inno-n.com ↗
K-CAB Achieves Over 80% Eradication Rates Across All Dose Groups, Demonstrating Superior Therapeutic Efficacy |
| 2025-04-07 | Cinclus Pharma Holding AB | Results New scientific article highlights good healing results for Cinclus Pharma's drug candidate linaprazan glurate for the treatment of eGERD cincluspharma.com ↗
The healing rate for patients with moderate to severe eGERD was 93 percent, which was 50 percentage points higher than the treatment with lansoprazole. |
| 2023-10-16 | Cinclus Pharma Holding AB | Results Cinclus Pharma's phase II eGERD study in two presentations at UEG cincluspharma.com ↗
For Cinclus Pharma's primary patient population, patients with moderate to severe eGERD, the highest four-week healing rate in a linaprazan glurate dosing group was 89%, compared to 38% in the lansoprazole group. |
| 2022-11-28 | HK inno.N Corporation | Results HK inno.N presents K-CAB big data hepatotoxicity inno-n.com ↗
The study showed that K-CAB had a 27% lower risk of hepatotoxicity compared to six competitor PPI drugs. |
| 2022-11-04 | Cinclus Pharma Holding AB | Results Cinclus Pharma announces positive topline results from the LEED phase II eGERD study cincluspharma.com ↗
For patients with moderate to severe eGERD, LA grade C/D, the highest four-week healing rate in a linaprazan glurate dosing group was 89%, compared to 38% in the lansoprazole group. |
| 2018-11-29 | Zydus Lifesciences Limited | Regulatory Zydus receives approvals from the USFDA for Lansoprazole Tablets and Linagliptin tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Lansoprazole delayed release orally disintegrating tablets (US RLD - Prevacid), 15 mg and 30 mg and tentative approval for Linagliptin tablets (US RLD- Tradjenta), 5 mg. |
| 2017-10-02 | Lannett Company, Inc. | Regulatory Lannett Receives Two FDA Approvals For Lansoprazole Delayed-Release Capsules USP, One Each For Full Prescription And OTC investorroom.com ↗
The company also announced that it received FDA approval of its ANDA for Lansoprazole Delayed-Release Capsules USP, 15 mg (OTC), the bioequivalent to the reference listed drug, Prevacid® 24HR Delayed-Release Capsules, 15 mg, of GlaxoSmithKline. |
| 2014-03-24 | Takeda | Regulatory Takeda Announces the New Drug Application Approval of TAKELDA ® Combination Tablets, the Fixed Dose Combination of TAKEPRON ® and Low-Dose Aspirin, in Japan takeda.com ↗
Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the New Drug Application of TAKELDA ® Combination Tablets [a fixed dose combination (FDC) of low-dose aspirin and TAKEPRON ® (generic name: lansoprazole) for peptic ulcers]. |
| 2013-09-14 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval for generic Prevacid® sunpharma.com ↗
the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Applications (A NDA) for generic version of Prevacid ®, Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg. |
| 2013-02-21 | Kyowa Kirin, Inc. | Regulatory Pasetocin® and Sawacillin®: Approval for Additional Indication for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitors and either Clarithromycin or Metronidazole kyowakirin.com ↗
has been approved by Japan's Ministry of Health, Labour and Welfare. |
| 2013-02-21 | Eisai Inc. | Regulatory Helicobacter pylori Gastritis Approved as Additional Indication in Japan for Helicobacter pylori Eradication by Triple Therapy with Proton Pump Inhibitor eisai.com ↗ |
| 2012-09-17 | Wockhardt | Regulatory WOCKHARDT LAUNCHES GENERIC VERSION OF ANTI – ULCER DRUG PREVACID® wockhardt.com ↗
Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 15mg and 30 mg delayed release capsules of Lansoprazole, which is used in treatment of peptic ulcers. |
| 2012-08-31 | Tanabe Pharma Corporation | Regulatory Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole tanabe-pharma.com ↗
Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole |
| 2012-08-31 | Eisai Inc. | Regulatory Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole eisai.com ↗
they have submitted a joint application * to Japan’s Ministry of Health, Labour and Welfare seeking approval of Helicobacter pylori (“ H. pylori ”) gastritis as an additional indication |
| 2012-05-18 | Perrigo Company | Regulatory Perrigo Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules perrigo.com ↗
Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Lansoprazole capsules (15 mg). |
| 2010-10-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Launch of Generic Prevacid® SoluTab in the United States tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of Takeda's Prevacid® (lansoprazole) SoluTab. |
| 2010-06-18 | Tanabe Pharma Corporation | Regulatory Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors tanabe-pharma.com ↗
they have received approval from the Japanese Ministry of Health, Labor and Welfare for additional indications for Helicobacter pylori (“H. pylori”) eradication by concomitant therapy |
| 2010-06-18 | Eisai Inc. | Regulatory Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors eisai.com ↗ |
| 2009-11-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Final Approval For Generic Prevacid® Delayed-Release Capsules tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor Prevacid® (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg. |
| 2009-10-01 | Eisai Inc. | Regulatory Application Submitted for Additional Indications for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors eisai.com ↗ |
| 2008-01-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Generic Prevacid® Delayed-Release Capsules tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of TAP Pharmaceutical's gastric-acid pump inhibitor, Prevacid® (Lansoprazole) Delayed-release Capsules, 15 mg and 30 mg. |
| 2007-08-24 | Eisai Inc. | Regulatory Approval of an additional dosage and administration for secondary eradication of Helicobacter pylori for proton pump inhibitors in Japan eisai.com ↗ |
All press releases naming this drug 28 releases
Evidence & citations 34 cited values
Every value below carries the sentence it was read from. 222 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lansoprazole | “Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40...” NCT00978016 ↗212“sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe...” NCT01418300 ↗ “All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium...” NCT02637557 ↗ “Participants will receive lansoprazole once daily in fasted condition on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on...” NCT04453189 ↗ “Administration of naproxen 250 mg twice and lansoprazole 30 mg daily for prevention of gastropathy induced by stress or a nonsteroidal anti-inflammatory drug (NSAID) in...” NCT04325633 ↗ “A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn” NCT00389948 ↗ “Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month.” NCT00729339 ↗ “Eligible patients were randomised to receive LAL: levofloxacin (750 mg once a day), amoxicillin (1000 mg twice a day) and lansoprazole (30 mg twice a day) for 7 days” PMID 20427390 ↗ May 2010 “Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days” NCT05371249 ↗ “triple therapy:a 10-day course of a Lansoprazole (proton pump inhibitor )combined with amoxicillin (2 × 1 g daily) and clarithromycin (2 × 500 mg daily).(trio)” NCT03654781 ↗ “Bismuth 300 mg (4 times a day), lansoprazole 30 mg (twice a day), metronidazole 500 mg (3 times a day), and tetracycline 500 mg (4 times a day) for 10 days” NCT02112214 ↗ |
| Known as | A-65006 | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | AD-2121 | “AD-2121 (Lansoprazole 15 mg), Oral, Capsule” NCT06025773 ↗ |
| Known as | AG-1749 | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Agopton | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | LAN | “group two received lansoprazole (LAN) 60 mg p.o. bid for only one week before starting each of cycle” PMID 33394214 ↗ Jan 2021 |
| Known as | Lansoprazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Lansoprazole (generic name) | “Lansoprazole (generic name)” NCT01046084 ↗ |
| Known as | Lansoprazole component of prevpac | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Lansoprazole is marketed as Prevacid. | “Lansoprazole is marketed as Prevacid.” NCT00204373 ↗ |
| Known as | lansoprazole or Prevacid | “lansoprazole or Prevacid” NCT00467571 ↗ |
| Known as | Lansoprazole Teva | “Pembrolizumab, immune modulatory cocktail composed of Vitamin D, Lansoprazole Teva, Cyclophosphamide and Aspirine, radiation and Curcumin” NCT03192059 ↗ |
| Known as | Lansoprazole: Prevacid | “Lansoprazole: Prevacid” NCT01061437 ↗ |
| Known as | Lansox | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Lanzoprazole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01139645 ↗ |
| Known as | Lanzor | “1/3 of the patients are taking Lanzor (Lanzoprazole) 30 mg once daily” NCT01139645 ↗ |
| Known as | Limpidex | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | NSC-758638 | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Ogast | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Ogastoro | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Opiren | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Prevacid | “The proposed study is a randomized controlled trial in which children with nasal obstruction will be randomized to receive either antireflux medication lansoprazole (prevacid)...” NCT02278081 ↗12“iv esomeprazole (Nexium® ) offers better intragastric acid suppression than iv lansoprazole (Prevacid ®” NCT00230516 ↗ “Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.” NCT01005719 ↗ “Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast” NCT00903448 ↗ “proton pump inhibitors (ppi; Prevacid, Nexium).” NCT02794844 ↗ “Lansoprazole (Prevacid)” NCT00546117 ↗ “Lansoprazole (Prevacid)” NCT00211614 ↗ |
| Known as | Prevacid 24 hr | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Prevacid delayed release | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Prevacid is the brand name for this drug | “Prevacid is the brand name for this drug” NCT00215787 ↗ |
| Known as | Prevacid iv | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Prevacid solutab | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Prevonco | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Known as | Takepron | “lansoprazole(takepron)-based bismuth quadruple therapy for 14 days (BQ-L14)” NCT04713670 ↗ |
| Known as | Takepron OD | “oral lansoprazole (Takepron OD 30 mg, Takeda Co. Ltd, Tokyo, Japan) once daily before breakfast for 8 weeks” NCT03418337 ↗1“Lansoprazole (Takepron OD) 30mg q12h PO” NCT01182597 ↗ |
| Known as | Zoton | ChEMBL registry synonym — accepted as the source's own label CHEMBL480 ↗ |
| Action | Inhibit | “Lansoprazole ( i.e., proton pump inhibitor)” NCT00237068 ↗ |
| Modality | Other / unclassified | “a proton pump inhibitor” PMID 19183157 ↗ Apr 2009 |
| Route | Oral | “Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.” NCT00174928 ↗ |