| Drug Name |
Tegaserod maleate |
| Drug ID |
BADD_D02139 |
| Description |
Novartis' brand name Zelnorm (tegaserod) had originally received approval from the US FDA in 2002 for the treatment of irritable bowel syndrome with constipation (IBS-C).[L5918,F4229] It was, however, voluntarily withdrawn from widespread use in the US market in 2007 after concerns arose over the possibility that tegaserod could potentially cause dangerous cardiovascular events in patients.[L5918,F4229] Since then, closer evaluations of the original data suggesting such cardiovascular risk have resulted in the limited reintroduction or 're-approval' of tegaserod for treatment of IBS-C specifically in female patients less than 65 years of age and whom are considered to be at a lower risk of a cardiovascular event than the broader population.[L5918,F4229] Zelnorm (tegaserod) by Sloan Pharma subsequently gained re-approval in April of 2019.[L5918] Nevertheless, tegaserod remains un-approved in certain regions.[F4226]
Despite the relative complications involved in its history of regulatory approval, ever since its first introduction in 2002 tegaserod remains the only therapy for IBS-C that possesses the unique mechanism of action of acting on serotonin-4 (5-HT(4)) receptors in smooth muscle cells and in the gastrointestinal wall to facilitate actions like esophageal relaxation, peristaltic gut movement, and natural secretions in the gut, among others.[L5918,A11044,A176762,F4229,F4223] |
| Indications and Usage |
Tegaserod is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C) [F4223, F4229]. The safety and effectiveness of tegaserod in men with IBS-C have not been established [F4223, F4229]. |
| Marketing Status |
approved; investigational; withdrawn |
| ATC Code |
A06AX06 |
| DrugBank ID |
DB01079
|
| KEGG ID |
D02730
|
| MeSH ID |
C105050
|
| PubChem ID |
135413539
|
| TTD Drug ID |
D00XWD
|
| NDC Product Code |
49706-1964 |
| UNII |
E5XNT3RF5A
|
| Synonyms |
tegaserod | tegaserod maleate | 5-methoxyindol-3-carboxaldehyde amino(pentylamino)methylenehydrazone hydrogen maleate | Zelnorm | Zelmac | SDZ HTF 919 | HTF 919 | SDZ HTF-919 |
