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Zelnorm (TEGASEROD)
Zelnorm (tegaserod) is a serotonin-4 receptor agonist, a small molecule modality developed to target the 5-hydroxytryptamine receptor 2B. It was originally developed and is now owned by Alfasigma. Zelnorm was FDA-approved in 2002 for the treatment of chronic idiopathic constipation and irritable bowel syndrome characterized by constipation. The drug is off-patent, with no active Orange Book patents, and currently has no generic manufacturers. Key safety considerations include its relatively short half-life of 11 hours and low bioavailability of 11%.
At a glance
| Generic name | TEGASEROD |
|---|---|
| Sponsor | Alfasigma |
| Drug class | Serotonin-4 Receptor Agonist |
| Target | 5-hydroxytryptamine receptor 2B |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2002 |
Approved indications
- Chronic idiopathic constipation
- Irritable bowel syndrome characterized by constipation
Common side effects
- Headache
- Abdominal pain
- Nausea
- Diarrhea
- Flatulence
- Dyspepsia
- Dizziness
- Anemia
- Vertigo
- Rectal hemorrhage
- Asthenia
- Increased blood creatine phosphokinase
Serious adverse events
- Cardiovascular ischemic events
- Major adverse cardiovascular events (MACE)
- Suicidal ideation/behavior
Key clinical trials
- Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia (PHASE3)
- Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients (PHASE4)
- The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia (PHASE4)
- Preference of Tegaserod vs. PEG 3350 in Patients With Constipation (PHASE4)
- Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS) (PHASE4)
- Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation (PHASE4)
- Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis (PHASE4)
- Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zelnorm CI brief — competitive landscape report
- Zelnorm updates RSS · CI watch RSS