Drugs / Ranitidine
Ranitidine
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (8) | US (FDA) | ZANTAC 300 | — | 1985-06-28 – 1999-10-29 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | ZANTAC 75 | — | 1998-06-08 – 1999-03-08 | fda.gov ↗ |
| Label expansion | US (FDA) | ZANTAC | — | 1990-08-13 | fda.gov ↗ |
| Approved | US (FDA) | ZANTAC 300 | — | 1983-06-09 | fda.gov ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials · 1 missed | ||||||
| Phase 1 | NCT04397445 | Jun → Jul 2020 | — | Food and Drug Administration (FDA) | Completed | Missed primary |
| Phase 1 | NCT05338502 | Jul → Sep 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03468777 | Mar → Jul 2018 | — | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT01908257 | Jul → Sep 2013 | — | Ardea Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01734759 | Nov 2012 → Jan 2013 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT01539655 | Feb → Sep 2012 | medullary thyroid gland carcinoma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01392755 | Jul → Sep 2011 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02195804 | May → Jun 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02966665 | Sep 2008 → Aug 2030 expected | chronic obstructive pulmonary disease, heart failure, pulmonary arterial hypertension | D. Walter Wray | Recruiting | No outcome recorded |
| Phase 1 | NCT00223691 | Mar 2002 → Jan 2017 | autonomic nervous system disorder, orthostatic hypotension | Vanderbilt University | Completed | Mixed |
| Phase 1 | NCT02170792 | Feb → Mar 2001 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02172417 | Jul → Nov 2000 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01538797 | Jul → Aug 1996 | peptic esophagitis | Trio Medicines Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00000964 | ? → Oct 1990 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05922358 | Sep 2023 → Sep 2025 overdue | digestive system neoplasm | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT01601522 | Feb 2012 → Sep 2021 | food allergy | Hamilton Health Sciences Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00527878 | Sep 2007 → Jun 2011 | hyper-IgE syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00405119 | May 2006 → Mar 2007 | gastroesophageal reflux disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00002106 | — | HIV infectious disease | Glaxo Wellcome | Completed | No outcome recorded |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT00668317 | Sep 2006 → Sep 2009 | — | Hull University Teaching Hospitals NHS Trust | Terminated | No outcome recorded |
| Phase 3 | NCT00401752 | Mar 2006 → Nov 2008 | gastric ulcer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00131248 | Apr 2004 → Mar 2008 | gastroesophageal reflux disease | The University of Texas Health Science Center, Houston | Completed | Missed primary |
| Phase 3 | NCT00161200 | Dec 2002 → Oct 2006 | Barrett esophagus | University of Medicine and Dentistry of New Jersey | Terminated | No outcome recorded Stop: Enrollment |
| Phase 48 trials · 1 missed | ||||||
| Phase 4 | NCT03920306 | Apr 2019 → Sep 2024 | gastrocutaneous syndrome | University of British Columbia | Completed | No outcome recorded |
| Phase 4 | NCT03583567 | Sep 2018 → Mar 2019 | hyperheparinemia | Mahidol University | Completed | Missed primary |
| Phase 4 | NCT03145012 | May → Oct 2018 | cancer | Nova Scotia Health Authority | Completed | No outcome recorded |
| Phase 4 | NCT02570529 | Oct 2015 → Oct 2017 | pancreatic ductal adenocarcinoma | Yonsei University | Withdrawn | No outcome recorded |
| Phase 4 | NCT02197143 | Mar 2013 → Jul 2014 | dyspepsia | Pamukkale University | Completed | No outcome recorded |
| Phase 4 | NCT02703896 | Jan 2012 | lung disorder | King Saud University | Completed | No outcome recorded |
| Phase 4 | NCT01896557 | Oct 2011 → Jun 2013 | coronary artery disorder | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02123498 | ? → May 2015 | eustachian tube disorder, gastroesophageal reflux disease | Loma Linda University | Withdrawn | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT03518463 | Jun → Jul 2017 | pregnancy disorder | Mbarara University of Science and Technology | Completed | No outcome recorded |
| — | NCT02733640 | Oct 2012 → May 2015 | platelet aggregation, spontaneous | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| — | NCT00585351 | Jan 2007 → Jan 2008 | stroke disorder | University of Iowa | Completed | No outcome recorded |
| — | NCT00247715 | Oct 2003 → Jan 2007 | dyspepsia | Radboud University Medical Center | Completed | No outcome recorded |
| Comparator or background therapy32 trials | ||||||
| Phase 1 | NCT04681105 Background | Nov 2020 → Aug 2025 | B-cell acute lymphoblastic leukemia, CD4+/CD56+ hematodermic neoplasm, Hodgkins lymphoma, T-cell acute lymphoblastic leukemia +4 | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03011463 Comparator | Nov 2016 → Mar 2017 | — | Dr. R. Pfleger Chemische Fabrik GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01682408 Comparator | Sep → Dec 2012 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01017198 Background | Nov 2009 → Aug 2010 | cancer | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01042704 Background | Feb 2008 → Jan 2011 | plasma cell myeloma | Robert Redner, MD | Completed | No outcome recorded |
| Phase 1/2 | NCT04294459 Background | Jun 2020 → May 2022 | immune system disorder | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT05298683 Background | May 2022 → Nov 2025 | impaired renal function disease, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Unknown | No outcome recorded |
| Phase 2 | NCT02441673 Comparator | Oct 2018 → Jan 2019 | benign shuddering attacks | Lagos State Health Service Commission | Unknown | No outcome recorded |
| Phase 2 | NCT03301454 Background | Aug 2018 → Jul 2022 | esophageal squamous cell carcinoma | Centre Oscar Lambret | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02999633 Background | Mar → Nov 2017 | T lymphoblastic leukemia/lymphoma, precursor T-cell acute lymphoblastic leukemia | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01953536 Background | Apr 2014 → Nov 2016 | breast neoplasm | Endocyte | Withdrawn | No outcome recorded |
| Phase 2 | NCT01332630 Background | Aug 2011 → Apr 2017 | breast cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00030992 Background | Feb 2002 → Jan 2009 | renal cell carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2/3 | NCT04862585 Comparator | Oct 2021 → Jun 2024 | breast carcinoma in situ, female breast carcinoma | Ohio State University Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT03368664 Background | Oct 2017 → May 2021 | multiple sclerosis | Genzyme, a Sanofi Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00838526 Comparator | Aug 2008 → Jul 2009 | gastroesophageal reflux disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00839306 Comparator | Aug 2008 → Aug 2009 | gastroesophageal reflux disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00633412 Comparator | Feb 2001 → Mar 2003 | active peptic ulcer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00633672 Comparator | Feb 2001 → Oct 2003 | active peptic ulcer disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02953210 Background | Nov 2016 | neuropathy, painful, paralytic ileus | Federal University of São Paulo | Unknown | No outcome recorded |
| Phase 4 | NCT02441894 Background | Apr 2015 → Feb 2016 | prostate cancer | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT02205489 Background | Oct 2014 → Apr 2016 | relapsing-remitting multiple sclerosis | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT01737840 Comparator | Oct 2012 → Jan 2013 | dyspepsia | Akdeniz University | Completed | No outcome recorded |
| Phase 4 | NCT00930670 Comparator | Jun 2009 → Dec 2011 | coronary artery disorder | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Completed | No outcome recorded |
| Phase 4 | NCT00247130 Comparator | Oct 2005 → Jul 2007 | active peptic ulcer disease | Keio University | Withdrawn | No outcome recorded |
| Phase 4 | NCT00702871 Comparator | Mar 2005 → Apr 2006 | — | Maulana Azad Medical College | Completed | No outcome recorded |
| Phase 4 | NCT00590928 Comparator | Jul 2004 → Jun 2006 | — | Medical University of Vienna | Completed | No outcome recorded |
| — | NCT02700087 Comparator | Feb 2016 → Feb 2017 | gastroesophageal reflux disease, laryngeal disorder | Stanford University | Withdrawn | No outcome recorded |
| — | NCT02288923 Comparator | Mar 2015 → Jul 2018 | osteoarthritis, knee | Royal Devon and Exeter NHS Foundation Trust | Completed | No outcome recorded |
| — | NCT02169856 Background | Jul 2013 → Feb 2014 | — | Benazir Bhutto Hospital, Rawalpindi | Completed | No outcome recorded |
| — | NCT02162134 Background | Jan 2013 → Feb 2014 | ileus | Benazir Bhutto Hospital, Rawalpindi | Completed | No outcome recorded |
| — | NCT01209455 Comparator | Jan → Jul 2011 | poisoning | University of Edinburgh | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2011-05-16 | Perrigo Company | Regulatory Perrigo Announces FDA Final Approval for Ranitidine 150 - Generic Equivalent to Zantac 150® 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 for over-the-counter (OTC) Ranitidine 150 (regular and cool mint), a generic version of Zantac 150®. |
| 2009-02-26 | Wockhardt | Regulatory Wockhardt to launch generic version of ulcer drug Ranitidine syrup in the US market wockhardt.com ↗
Wockhardt received final approval from the United States Food & Drug Administration (US FDA) for marketing the alcohol-free syrup containing 15mg/ml Ranitidine hydrochloride, which is used for ulcers and hyperacidity. |
All press releases naming this drug 28 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 67 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ranitidine | “Oral anti-reflux therapy of either Pantoprazole 20-40mg PO OD, or Ranitidine 5-10mg/kg/day PO divided twice daily or 150mg PO BID, for either 4 weeks or until gastrocutaneous...” NCT03920306 ↗64“usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment” NCT03301454 ↗ “Suggested medications included ranitidine 150 mg PC BID or omeprazole 20 mg PO QD or equivalent.” NCT01042704 ↗ “Antacid premedication is permitted using ranitidine, metoclopramide or proton pump inhibitors.” NCT02288923 ↗ “Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid” NCT01601522 ↗ “Albis® is a newly developed drug comprised of ranitidine, bismuth and sucralfate.” NCT02570529 ↗ “cimetidine 300 mg IV or ranitidine 50 mg IV 30 to 60 minutes prior to paclitaxel.” NCT01953536 ↗ “Take orally (cetirizine 10 mg bid, dexamethasone 8 mg bid, ranitidine 150 mg bid” NCT05922358 ↗ “the effect of an antacid (ranitidine) on the pharmacokinetics of 450 mg BIIB021” NCT01017198 ↗ “* H2 receptor blockers: famotidine 4 mg, ranitidine 7.5 mg” NCT01734759 ↗ “Group Z (ranitidine 150 mg)” NCT02703896 ↗ |
| Known as | Ranitidine Hydrochloride | “Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®)” NCT02195804 ↗1“Drug: Ranitidine Hydrochloride” NCT02953210 ↗ |
| Known as | Ranitidine hydrochloride ODT | “Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint)” NCT02195804 ↗ |
| Known as | Zantac | “This study will examine the safety and effectiveness of ranitidine (Zantac) in patients with Hyper-IgE recurrent infection syndrome” NCT00527878 ↗ |
| Known as | ZantacÒ | “Ranitidine (ZantacÒ) 150 mg twice daily” NCT00161200 ↗ |
| Action | Inhibit | “Ranitidine suppresses gastric acid output” NCT00000964 ↗ |
| Route | Intravenous | “will receive one dose intravenously of ranitidine in distilled water” NCT00000964 ↗ |