Drugs / Nizatidine
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | AXID AR | — | 1998-04-01 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | AXID | — | 1991-07-26 – 1993-09-21 | fda.gov ↗ |
| Approved | US (FDA) | AXID | — | 1988-04-12 | fda.gov ↗ |
Trials 6 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03509831 | Nov 2017 → Jan 2018 | gastritis | Kukje Pharma | Unknown | No outcome recorded |
| Phase 1 | NCT02232308 | Jul → Sep 2014 | gastroparesis | Adil Bharucha | Completed | No outcome recorded |
| Phase 1 | NCT01409395 | Sep 2011 → Mar 2013 | — | University of California, San Francisco | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00373334 | Aug 2006 → Feb 2008 | dyspepsia, gastroesophageal reflux disease | Braintree Laboratories | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02703896 | Jan 2012 | lung disorder | King Saud University | Completed | No outcome recorded |
| Phase 4 | NCT00486005 | Feb → Oct 2003 | schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05072938 Comparator | Sep 2021 → Dec 2022 | gastritis | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nizatidine | “Group N (nizatidine 150 mg)” NCT02703896 ↗6“Nizatidine Monotherapy” NCT05072938 ↗ |
| Known as | Acinon | ChEMBL registry synonym — accepted as the source's own label CHEMBL3183075 ↗ |
| Known as | axid | “nizatidine (axid)” NCT00373334 ↗ |
| Known as | Axid ar | ChEMBL registry synonym — accepted as the source's own label CHEMBL3183075 ↗ |
| Known as | LY 139037 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3183075 ↗ |
| Known as | Nizatidina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3183075 ↗ |
| Known as | NSC-759289 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3183075 ↗ |
| Known as | Zinga 150 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3183075 ↗ |
| Known as | Zinga 300 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3183075 ↗ |
| Action | Inhibit | “nizatidine may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of metformin” NCT01409395 ↗1“Histamine H2 receptor antagonist” CHEMBL3183075 ↗ |
| Modality | Small molecule | — CHEMBL3183075 ↗ |
| Route | Oral | “Subjects will be given a single oral dose of 850 mg of metformin and a single oral dose of 600 mg of nizatidine” NCT01409395 ↗ |
| Target | HRH2 | “Histamine H2 receptor antagonist” CHEMBL3183075 ↗ |