Drugs / Tegaserod
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ZELNORM | — | 2004-08-21 – 2019-03-29 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Zelnorm | — | 2006-05-19 | europa.eu ↗ |
| Approved | US (FDA) | ZELNORM | — | 2002-07-24 | fda.gov ↗ |
Trials 25 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00142974 | May 2004 → Apr 2005 | — | Novartis | Terminated | No outcome recorded |
| Phase 2 | NCT00149851 | Jan 2004 → Jun 2005 | gastroesophageal reflux disease | Novartis | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00365820 | Jul 2006 → Apr 2007 | constipation disorder | Novartis | Terminated | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT00414024 | Feb → May 2007 | opioid-induced constipation | Novartis | Terminated | No outcome recorded |
| Phase 3 | NCT00399659 | Nov 2006 → Apr 2007 | opioid-induced constipation | Novartis | Terminated | No outcome recorded |
| Phase 3 | NCT00171457 | Apr 2005 → Sep 2006 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00171470 | Apr 2005 → Aug 2006 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00139568 | Feb → Oct 2005 | constipation disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00171431 | Nov 2004 → May 2006 | constipation disorder, irritable bowel syndrome | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00232102 | Sep 2004 → Aug 2006 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00232037 | Sep 2004 → Aug 2006 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00232089 | May 2004 → Jun 2006 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00141089 | Mar 2004 → Feb 2005 | constipation disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00232024 | Jan 2004 → May 2006 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00171483 | Jan 2004 → Apr 2005 | gastroesophageal reflux disease | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00171418 | Jun 2003 → Feb 2005 | gastroesophageal reflux disease | Novartis | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT00390975 | Jan → Mar 2007 | diabetes mellitus, gastroparesis | Novartis | Terminated | No outcome recorded |
| Phase 4 | NCT00348634 | Jul 2006 → Apr 2007 | constipation disorder | Novartis | Terminated | No outcome recorded |
| Phase 4 | NCT00171522 | May → Sep 2005 | constipation disorder | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00142987 | Apr 2004 → Jun 2005 | irritable bowel syndrome | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00149877 | Apr 2004 → Feb 2006 | constipation disorder | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00277550 | — | constipation disorder | Novartis | Withdrawn | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00563758 | Dec 2004 → Feb 2006 | constipation disorder | Hospital Authority, Hong Kong | Terminated | No outcome recorded |
| — | NCT00563615 | Nov 2004 → Oct 2006 | constipation disorder | Hospital Authority, Hong Kong | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00511771 | — | constipation disorder, irritable bowel syndrome | Novartis | No longer available | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tegaserod | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00149877 ↗24 |
| Known as | HTF919 | “Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists.” NCT00141089 ↗1“Tegaserod (HTF919) is an aminoguanidine indole compound” NCT00149877 ↗ |
| Known as | NSC-760425 | ChEMBL registry synonym — accepted as the source's own label CHEMBL76370 ↗ |
| Known as | SDZ-HTF-919 | ChEMBL registry synonym — accepted as the source's own label CHEMBL76370 ↗ |
| Known as | TEGASEROD MALEATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL76370 ↗ |
| Known as | Zelmac | ChEMBL registry synonym — accepted as the source's own label CHEMBL76370 ↗ |
| Known as | Zelnorm | ChEMBL registry synonym — accepted as the source's own label CHEMBL76370 ↗ |
| Action | Activate | “Serotonin 4 (5-HT4) receptor partial agonist” CHEMBL76370 ↗1“Activation of 5-HT4 receptors” NCT00139568 ↗ |
| Modality | Small molecule | “aminoguanidine indole compound” NCT00139568 ↗ |
| Route | Oral | “Given Orally” NCT00139568 ↗ |
| Target | HTR4 | “Serotonin 4 (5-HT4) receptor partial agonist” CHEMBL76370 ↗ |