nizatidine
Trade name: axid
Approved
Apr 12, 1988
Nizatidine, chemically N-[2-[[[2- [(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N’ -methyl-2-nitro-1,1-ethenediamine, is a histamine H2-receptor antagonist. Nizatidine reduced gastric acid secretion for up to 8 h suggesting that this compound could be used in with a once or twice daily dosage regime. Nizatidine was rapidly and well-absorbed orally, was widely distributed in tissues and the majority of the dose was excreted in the urine within 24 h. Nizatidine is indicated for duodenal and gastric ulcer as well as for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to gastroesophageal reflux disease. — NCATS
Clinical trial activity
9 trials · 13 clinical orgs · 13 marketing orgs
Earliest trial started Feb 1, 2003 (NCT00486005)
Timeline
1980s
- Apr 12, 1988
SmithKline Beecham — Earliest FDA Approval
- Apr 12, 1988
SmithKline Beecham — NDA Secondary Org
- Apr 12, 1988
SmithKline Beecham — NDA Organization
1990s
- May 9, 1996
Pfizer — NDA Secondary Org
- May 9, 1996
GlaxoSmithKline — Marketing Organization
- May 9, 1996
GlaxoSmithKline — NDA Secondary Org
2000s
- Jul 5, 2002
Epic Pharma Llc — Marketing Organization
- Jul 5, 2002
Mylan — Marketing Organization
- Jul 5, 2002
Sandoz — Marketing Organization
- Jul 8, 2002
Ani Pharmaceuticals — Marketing Organization
- Jul 9, 2002
Watson Pharmaceuticals — Marketing Organization
- Jan 23, 2003
Apotex — Marketing Organization
- Jan 1, 2004
Dr. Reddy's Laboratories — Earliest Phase 1 Sponsor(trial)
- May 25, 2004
Braintree Laboratories — NDA Secondary Org
- Sep 15, 2005
Dr. Reddy's Laboratories — Marketing Organization
- Jan 1, 2006
Braintree Laboratories — Earliest Phase 3 Sponsor(trial)
- Nov 18, 2009
Amneal Pharmaceuticals — Marketing Organization
2010s
- Jul 15, 2011
Glenmark Pharmaceuticals — Marketing Organization
Indications
Approved for
Mechanism of action
- Histamine H2 receptorANTAGONIST
HRH2 antagonist
Approval history
- approvedApr 12, 1988
Chemistry & pharmacology
SMILES
CNC(=C[N+](=O)[O-])NCCSCc1csc(CN(C)C)n1- Mol. weight
- 331.47 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Over the Counter
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3183075 ↗
- WikipediaNizatidine ↗
- NCATSP41PML4GHR ↗
- ChEMBLCHEMBL653 ↗
Also known as
- axid
- axid
- axid
- axid ar
- axid ar
- ly-139037
- ly-139037
- naxidine
- nizatidina
- nizatidina
- nizatidine
- nizatidine
- nizatidine
- nizatidine
- nizatidine
- nizatidine
- nizatidine
- nizatidine
- nizatidine
- nizatidine
- nizatidine
- nizatidinum
- nizatidinum
- nizaxid
- zinga 150
- zinga 300
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05072938 | Phase 4 | Nov 30, 2021 | Daewoong Pharmaceutical Co. LTD. |
| NCT03509831 | Phase 1 | Nov 2, 2017 | Inha University, Kukje Pharma |
| NCT02232308 | Phase 1 | Jul 1, 2014 | Mayo Clinic, National Center for Research Resources (NCRR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT02703896 | Phase 4 | Jan 1, 2012 | King Saud University |
| NCT01409395 | Phase 1 | Sep 1, 2011 | National Institute of General Medical Sciences (NIGMS), University of California, San Francisco |
| NCT00373334 | Phase 3 | Aug 1, 2006 | Braintree Laboratories |
| NCT01161940 | Phase 1 | Jul 1, 2004 | Dr. Reddy's Laboratories, Lambda Therapeutic Research Ltd |
| NCT01161927 | Phase 1 | Jul 1, 2004 | Dr. Reddy's Laboratories, Lambda Therapeutic Research Ltd |
| NCT00486005 | Phase 4 | Feb 1, 2003 | Eli Lilly |
Organizations
Research & Development (13)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Dr. Reddy's Laboratories | For profit | 2 | 2 | 1 | 2004 |
| Lambda Therapeutic Research Ltd | For profit | 2 | 0 | 1 | 2004 |
| Braintree Laboratories | For profit | 1 | 1 | 1 | 2006 |
| Daewoong Pharmaceutical Co. LTD. | For profit | 1 | 1 | 1 | 2021 |
| Eli Lilly | For profit | 1 | 1 | 1 | 2003 |
| Inha University | Academic/Hospital | 1 | 0 | 1 | 2017 |
| King Saud University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Kukje Pharma | For profit | 1 | 1 | 1 | 2017 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2014 |
| National Center for Research Resources (NCRR) | Government | 1 | 0 | 1 | 2014 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 1 | 0 | 1 | 2014 |
| National Institute of General Medical Sciences (NIGMS) | Government | 1 | 0 | 1 | 2011 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 2011 |
Marketing (17)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Amneal Pharmaceuticals | For profit | MKTG | Nov 18, 2009 |
| Ani Pharmaceuticals | For profit | MKTG | Jul 8, 2002 |
| Ani Pharmaceuticals | For profit | SYN | Jul 8, 2002 |
| Apotex | For profit | MKTG | Jan 23, 2003 |
| Braintree Laboratories | For profit | NDA2 | May 25, 2004 |
| Dr. Reddy's Laboratories | For profit | MKTG | Sep 15, 2005 |
| Epic Pharma Llc | For profit | MKTG | Jul 5, 2002 |
| Epic Pharma Llc | For profit | SYN | Jul 5, 2002 |
| GlaxoSmithKline | For profit | MKTG | May 9, 1996 |
| GlaxoSmithKline | For profit | NDA2 | May 9, 1996 |
| Glenmark Pharmaceuticals | For profit | MKTG | Jul 15, 2011 |
| Mylan | For profit | MKTG | Jul 5, 2002 |
| Pfizer | For profit | NDA2 | May 9, 1996 |
| Sandoz | For profit | MKTG | Jul 5, 2002 |
| SmithKline Beecham | For profit | NDA2 | Apr 12, 1988 |
| SmithKline Beecham | For profit | NDA | Apr 12, 1988 |
| Watson Pharmaceuticals | For profit | MKTG | Jul 9, 2002 |