ranitidine
Trade name: zantac
Approved
Jun 9, 1983
Ranitidine, a histamine H2-receptor antagonist, is now well established as a potent inhibitor of gastric acid secretion effective in the treatment and prophylaxis of gastrointestinal lesions aggravated by gastric acid secretion. — NCATS
Clinical trial activity
71 trials · 75 clinical orgs · 50 marketing orgs
Earliest trial started Jul 1, 1996 (NCT01538797)
Timeline
1980s
- Jun 9, 1983
Earliest FDA Approval
- Jun 9, 1983
GlaxoSmithKline — NDA Secondary Org
- Oct 19, 1984
Glaxo — First NDA Organization
- Oct 19, 1984
Glaxo — NDA Organization
- Oct 19, 1984
Teligent Pharmaceuticals — NDA Secondary Org
- Oct 19, 1984
Pharmaceutical Associates — Marketing Organization
- Oct 19, 1984
Pharmaceutical Associates — NDA Secondary Org
1990s
- Dec 19, 1995
Sanofi — NDA Secondary Org
- Dec 19, 1995
Sanofi — Marketing Organization
- Jan 1, 1996
Earliest Phase 1 Sponsor(trial)
- Jul 31, 1997
Ani Pharmaceuticals — Marketing Organization
- Aug 22, 1997
Mylan — Marketing Organization
- Aug 29, 1997
Boehringer Ingelheim — Marketing Organization
- Aug 29, 1997
Sandoz — Marketing Organization
- Aug 29, 1997
Novartis — Marketing Organization
- Sep 12, 1997
Apotex — Marketing Organization
- Oct 20, 1997
Watson Pharmaceuticals — Marketing Organization
- Nov 18, 1997
Actavis — Marketing Organization
- Jan 30, 1998
Ranbaxy — Marketing Organization
- Sep 30, 1998
Heritage Pharma — Marketing Organization
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
- Jan 28, 1999
Par Pharmaceuticals — Marketing Organization
- Jun 21, 1999
Contract Pharmacal — Marketing Organization
2000s
- Jan 14, 2000
Teva — Marketing Organization
- Jan 14, 2000
Sun Pharmaceuticals — Marketing Organization
- Jan 1, 2001
Earliest Phase 3 Sponsor(trial)
- Aug 30, 2002
Perrigo — Marketing Organization
- Aug 31, 2004
Sanofi-Aventis — NDA Secondary Org
- Nov 19, 2004
Bedford Pharmaceuticals — Marketing Organization
- Mar 2, 2005
West-Ward Pharmaceutical — Marketing Organization
- Jul 27, 2005
Dr. Reddy's Laboratories — Marketing Organization
- Feb 16, 2006
Hikma — Marketing Organization
- Feb 24, 2006
Wockhardt — Marketing Organization
- Sep 2, 2008
Amneal Pharmaceuticals — Marketing Organization
- Nov 19, 2008
Glenmark Pharmaceuticals — Marketing Organization
- May 26, 2009
Torrent Pharmaceuticals Limited — Marketing Organization
- Aug 27, 2009
Esteve Labs — Marketing Organization
2010s
- Jul 1, 2010
Lannett Company, Inc. — Marketing Organization
- Jul 28, 2010
Aurobindo Pharma — Marketing Organization
- Nov 15, 2010
ANDA Repository — Marketing Organization
- Nov 15, 2010
Tolmar Inc. — Marketing Organization
- Mar 22, 2011
Hi Tech Pharmaceuticals — Marketing Organization
- Mar 22, 2011
Akorn, Inc. — Marketing Organization
- Mar 22, 2011
Epic Pharma Llc — Marketing Organization
- Jun 13, 2011
Taro Pharmaceuticals — Marketing Organization
- Jun 28, 2011
Strides Pharma Science — Marketing Organization
- Sep 20, 2011
Nostrum Laboratories — Marketing Organization
- Feb 22, 2013
Zydus Discovery DMCC — Marketing Organization
- Nov 30, 2017
Acic Pharmaceuticals — Marketing Organization
- Aug 1, 2018
Vivimed Global — Marketing Organization
- Aug 20, 2018
Granules India — Marketing Organization
- Sep 27, 2018
Ajanta Pharma Ltd — Marketing Organization
- Nov 23, 2018
Novitium Pharma — Marketing Organization
- Jan 31, 2019
VKT Pharma — Marketing Organization
- Apr 5, 2019
Appco Pharma — Marketing Organization
- Aug 30, 2019
Unique Pharmaceuticals Ltd, India — Marketing Organization
- Aug 30, 2019
THINQ Pharma CRO Ltd. — Marketing Organization
Indications
Approved for
Studied for
- Anesthesia · Phase 4
- Aspirin · Phase 4
- Bacterial Infections · Phase 4
- Blood Protein Disorders · Phase 2
- Breast Neoplasms · Phase 2/Phase 3
- Carcinoma, Renal Cell · Phase 2
- Coronary Artery Disease · Phase 4
- Cough · Phase 3
- Critical Illness · Phase 4
- Diabetes Mellitus, Type 2 · Phase 1
- Drug Interactions · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Dyspepsia · Phase 4
- Esophageal Neoplasms · Phase 3
- Eustachian Tube · Phase 4
- Food-Drug Interactions · Phase 1
- Gastritis · Phase 4
- Head and Neck Neoplasms · Phase 2
- Healthy Volunteers · Phase 1/Phase 2
- Heart Failure · Phase 1
- Helicobacter pylori · Phase 2/Phase 3
- Hematologic Diseases · Phase 2
- Hemodynamics · Phase 4
- HIV Infections · Phase 2
- Hodgkin Disease · Phase 1
- Hypertension · Phase 1
- Hypertension, Pulmonary · Phase 1
- Hypotension, Orthostatic · Phase 1
- Immune System Diseases · Phase 2
- Infections · Phase 2
- Intestinal Pseudo-Obstruction · Phase 4
- Job Syndrome · Phase 2
- Kidney Failure, Chronic · Phase 2
- Laryngopharyngeal Reflux · Phase 4
- Leukemia · Phase 1
- Leukemia, Hairy Cell · Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 1
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Mastocytosis, Systemic · Phase 1
- Multiple Myeloma · Phase 3
- Multiple Sclerosis · Phase 3
- Multiple Sclerosis, Relapsing-Remitting · Phase 4
- Nausea · Phase 4
- Neoplasms · Phase 4
- Neoplasms by Histologic Type · Phase 2
- Neoplasms, Plasma Cell · Phase 2
- Neoplastic Cells, Circulating · Phase 2
- Pancreatic Neoplasms · Phase 4
- Paraproteinemias · Phase 2
- Pharmacokinetics · Phase 1
- Plasmacytoma · Phase 1
- Pneumonia, Ventilator-Associated · Phase 4
- Postoperative Pain · Phase 4
- Postpartum Hemorrhage · Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Prostatic Neoplasms · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 1
- Pure Autonomic Failure · Phase 1
- Stomach Ulcer · Phase 3
- Thyroid Neoplasms · Phase 1
- Ulcer · Phase 4
- Vomiting · Phase 4
- Voriconazole · Phase 1
Mechanism of action
- Histamine H2 receptorANTAGONIST
HRH2 antagonist
Approval history
- approvedJun 9, 1983
Chemistry & pharmacology
SMILES
CNC(NCCSCC1=CC=C(CN(C)C)O1)=C[N+]([O-])=O- Mol. weight
- 314.404 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Over the Counter
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- WikipediaAlbis ↗
- NCATS884KT10YB7 ↗
- ChEMBLCHEMBL2111286 ↗
- ChEMBLCHEMBL2110372 ↗
- ChEMBLCHEMBL1790041 ↗
- WikipediaRanitidine ↗
Also known as
- ah-19065
- ah-19065
- albis
- azanplus
- azantac
- azantac
- dumoran
- gavilast
- gavilast
- gavilast-p
- glaxosmithkline brand of ranitidine bismuth citrate
- glaxo wellcome brand of ranitidine bismuth citrate
- gr122311x
- gr 122311x
- gr-122311x
- gr-122311x
- gr-122311x
- histac
- pylorid
- pylorid
- pylorid
- raciran 150
- raciran 300
- ran
- ran
- raniberl
- ranicalm
- raniplex
- raniplex
- ranitic
- ranitic
- ranitidina
- ranitidina
- ranitidine
- ranitidine
- ranitidine
- ranitidine
- ranitidine
- ranitidine
- ranitidine
- ranitidine
- ranitidine
- ranitidine bismuth citrate
- ranitidine bismuth citrate
- ranitidine bismuth citrate
- ranitidine bismuth citrate
- ranitidine bismuth citrate
- ranitidine bismutrex
- ranitidine bismutrex
- ranitidine hcl
- ranitidine hcl
- ranitidine hcl
- ranitidine hydrochloride
- ranitidine hydrochloride
- ranitidine hydrochloride
- ranitidine hydrochloride
- ranitidinum
- ranitidinum
- ranitidne
- ranitil
- rantec
- rantidine
- rantidine
- ranzac
- tritec
- tritec
- tritec
- vivatak
- zaedoc 150
- zaedoc 300
- zantac
- zantac
- zantac
- zantac
- zantac
- zantac
- zantac
- zantac
- zantac 150
- zantac 150
- zantac 25
- zantac 25
- zantac 300
- zantac 300
- zantac 75
- zantac 75
- zantac 75 dissolve
- zantac 75 relief
- zantac 75 relief dissolve
- zenetac
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06143423 | Phase 1 | May 24, 2023 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT05298683 | Phase 2 | May 31, 2022 | Hellenic Society of Hematology, National Kapodistrian University of Athens, Sanofi |
| NCT04862585 | Phase 2/Phase 3 (Phase 3) | Oct 7, 2021 | Ohio State University |
| NCT04681105 | Phase 1 | Dec 30, 2020 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT04397445 | Phase 1 | Jun 30, 2020 | Food and Drug Administration, Spaulding Clinical Research Inc. |
| NCT04401020 | Phase 1 | Jun 30, 2020 | Sanofi |
| NCT04294459 | Phase 1/Phase 2 (Phase 2) | Mar 31, 2020 | Sanofi |
| NCT05338502 | Phase 1/Phase 2 (Phase 2) | Jul 8, 2019 | Eli Lilly, Loxo Oncology |
| NCT03301454 | Phase 2 | Sep 30, 2018 | University of Lille |
| NCT03583567 | Phase 4 | Sep 5, 2018 | Mahidol University |
| NCT03468777 | Phase 1 | Mar 6, 2018 | Johnson and Johnson |
| NCT03319667 | Phase 3 | Dec 7, 2017 | Sanofi |
| NCT03368664 | Phase 3 | Oct 24, 2017 | Genzyme, Sanofi |
| NCT02441673 | Phase 2 | Oct 1, 2017 | Lagos State Health Service Commission |
| NCT03145012 | Phase 4 | May 15, 2017 | Dalhousie University, Government of Canada, Government of Nova Scotia |
| NCT02999633 | Phase 2 | Mar 8, 2017 | Sanofi |
| NCT03050866 | Phase 2 | Feb 21, 2017 | Erasmus University Rotterdam, Sanofi |
| NCT02960555 | Phase 2 | Feb 8, 2017 | Sanofi, University of Texas at Houston |
| NCT02953210 | Phase 4 | Nov 1, 2016 | Faculdade de Ciências Médicas da Santa Casa de São Paulo, University of Sao Paulo |
| NCT03011463 | Phase 1 | Nov 1, 2016 | Dr. R. Pfleger Chemische Fabrik GmbH, University of Greifswald |
Organizations
Research & Development (75)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 12 | 6 | 4 | 2004 |
| AstraZeneca | For profit | 4 | 4 | 2 | 2001 |
| Boehringer Ingelheim | For profit | 3 | 3 | 1 | 2000 |
| National Institutes of Health (NIH) | Government | 3 | 0 | 3 | 2002 |
| University of Texas at Houston | Academic/Hospital | 3 | 3 | 2 | 2004 |
| Benazir Bhutto Hospital, Rawalpindi | Academic/Hospital | 2 | 2 | 1 | 2013 |
| Eisai | For profit | 2 | 2 | 1 | 2008 |
| Genzyme | For profit | 2 | 2 | 2 | 2014 |
| National Cancer Institute (NCI) | Government | 2 | 1 | 2 | 2002 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 2 | 2 | 2 | 1999 |
| Roche | For profit | 2 | 1 | 2 | 2004 |
| University of Sao Paulo | Academic/Hospital | 2 | 2 | 1 | 2011 |
| Yonsei University | Academic/Hospital | 2 | 1 | 1 | 2011 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Akdeniz University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Ardea Biosciences | For profit | 1 | 1 | 1 | 2013 |
| Azad University | Academic/Hospital | 1 | 1 | 1 | 2005 |
| City of Hope National Medical Center | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Cortice Biosciences, Inc. | For profit | 1 | 0 | 1 | 2011 |
Marketing (72)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Nov 15, 2010 |
| Acic Pharmaceuticals | For profit | MKTG | Nov 30, 2017 |
| Actavis | For profit | MKTG | Nov 18, 1997 |
| Actavis | For profit | SYN | Feb 21, 2007 |
| Ajanta Pharma Ltd | For profit | MKTG | Sep 27, 2018 |
| Akorn, Inc. | For profit | MKTG | Mar 22, 2011 |
| Amneal Pharmaceuticals | For profit | MKTG | Sep 2, 2008 |
| Amneal Pharmaceuticals | For profit | SYN | Oct 13, 2006 |
| Ani Pharmaceuticals | For profit | MKTG | Jul 31, 1997 |
| Ani Pharmaceuticals | For profit | SYN | Jul 31, 1997 |
| Apotex | For profit | MKTG | Sep 12, 1997 |
| Apotex | For profit | SYN | May 4, 2000 |
| Appco Pharma | For profit | MKTG | Apr 5, 2019 |
| Appco Pharma | For profit | SYN | Apr 5, 2019 |
| Aurobindo Pharma | For profit | MKTG | Jul 28, 2010 |
| Aurobindo Pharma | For profit | MKTG | Jul 28, 2010 |
| Bedford Pharmaceuticals | For profit | MKTG | Nov 19, 2004 |
| Boehringer Ingelheim | For profit | MKTG | Aug 29, 1997 |
| Contract Pharmacal | For profit | MKTG | Jun 21, 1999 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jul 27, 2005 |
| Dr. Reddy's Laboratories | For profit | SYN | Mar 28, 2000 |
| Epic Pharma Llc | For profit | MKTG | Mar 22, 2011 |
| Esteve Labs | For profit | MKTG | Aug 27, 2009 |
| Esteve Labs | For profit | SYN | Aug 27, 2009 |
| Glaxo | For profit | NDA | Oct 19, 1984 |
| GlaxoSmithKline | For profit | NDA2 | Jun 9, 1983 |
| GlaxoSmithKline | For profit | SYN | Mar 8, 1994 |
| Glenmark Pharmaceuticals | For profit | MKTG | Nov 19, 2008 |
| Granules India | For profit | MKTG | Aug 20, 2018 |
| Granules India | For profit | SYN | Aug 20, 2018 |
| Heritage Pharma | For profit | MKTG | Sep 30, 1998 |
| Heritage Pharma | For profit | MKTG | Sep 30, 1998 |
| Hi Tech Pharmaceuticals | For profit | MKTG | Mar 22, 2011 |
| Hikma | For profit | SYN | Mar 2, 2005 |
| Hikma | For profit | MKTG | Feb 16, 2006 |
| Lannett Company, Inc. | For profit | MKTG | Jul 1, 2010 |
| Mylan | For profit | MKTG | Aug 22, 1997 |
| Mylan | For profit | SYN | Jun 9, 2016 |
| Nostrum Laboratories | For profit | MKTG | Sep 20, 2011 |
| Novartis | For profit | MKTG | Aug 29, 1997 |
| Novitium Pharma | For profit | MKTG | Nov 23, 2018 |
| Par Pharmaceuticals | For profit | MKTG | Jan 28, 1999 |
| Perrigo | For profit | MKTG | Aug 30, 2002 |
| Perrigo | For profit | SYN | May 11, 2011 |
| Pharmaceutical Associates | For profit | MKTG | Sep 21, 2007 |
| Pharmaceutical Associates | For profit | MKTG | Oct 19, 1984 |
| Pharmaceutical Associates | For profit | NDA2 | Oct 19, 1984 |
| Ranbaxy | For profit | MKTG | Jan 30, 1998 |
| Sandoz | For profit | MKTG | Aug 29, 1997 |
| Sanofi | For profit | NDA2 | Dec 19, 1995 |
| Sanofi | For profit | MKTG | Dec 19, 1995 |
| Sanofi-Aventis | For profit | NDA2 | Aug 31, 2004 |
| Strides Pharma Science | For profit | MKTG | Jun 28, 2011 |
| Strides Pharma Science | For profit | SYN | Feb 22, 2018 |
| Sun Pharmaceuticals | For profit | MKTG | Jan 14, 2000 |
| THINQ Pharma CRO Ltd. | For profit | MKTG | Aug 30, 2019 |
| Taro Pharmaceuticals | For profit | MKTG | Jun 13, 2011 |
| Teligent Pharmaceuticals | For profit | NDA2 | Oct 19, 1984 |
| Teva | For profit | SYN | Jul 31, 1997 |
| Teva | For profit | MKTG | Jan 14, 2000 |
| Tolmar Inc. | For profit | MKTG | Nov 15, 2010 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | May 26, 2009 |
| Unique Pharmaceuticals Ltd, India | For profit | MKTG | Aug 30, 2019 |
| VKT Pharma | For profit | MKTG | Jan 31, 2019 |
| VKT Pharma | For profit | SYN | Jan 31, 2019 |
| Vivimed Global | For profit | MKTG | Aug 1, 2018 |
| Watson Pharmaceuticals | For profit | MKTG | Oct 20, 1997 |
| Watson Pharmaceuticals | For profit | SYN | Dec 19, 2005 |
| West-Ward Pharmaceutical | For profit | MKTG | Mar 2, 2005 |
| Wockhardt | For profit | MKTG | Feb 24, 2006 |
| Wockhardt | For profit | SYN | Dec 17, 1998 |
| Zydus Discovery DMCC | For profit | MKTG | Feb 22, 2013 |