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Also known as Nolpitantium besylate
Nolpitantium · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| Nolpitantium besylate | DRUG | - |
Inclusion Criteria: * Age at least 18 years * Ulcerative colitis of at least 6 months duration * Patient's ulcerative colitis should remain active while taking 5-ASA or sulfasalazine for at least 4 week * If taking corticosteroids, dose must be stable for at least 2 weeks prior to enrollment and no...
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Nolpitantium is an investigational small molecule developed by Sanofi for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It has been studied in a Phase 2 clinical trial in adults with ulcerative colitis. It is not approved for any indication and remains in clinical development.
Nolpitantium is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 2 clinical program evaluating the drug in ulcerative colitis. No other developer or partnership for this asset has been disclosed.
Nolpitantium is in Phase 2 development. Its single clinical trial, NCT00232258, was a Phase 2 study in ulcerative colitis that has been completed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
Nolpitantium has been evaluated in one clinical trial, NCT00232258, titled a double-blind, placebo-controlled efficacy and safety study of Nolpitantium besylate in patients with ulcerative colitis. The Phase 2 trial enrolled 307 adults, was randomized and double-blind, and is now completed. It ran across sites in Argentina, Belgium, Brazil, Canada, Chile, Czechia, Estonia, Hungary, Italy, Russia, Singapore, South Africa, Spain and Sweden.
Yes, Nolpitantium besylate is the besylate salt form of Nolpitantium and is the name used in its clinical trial. The two names refer to the same investigational drug, which Sanofi studied in ulcerative colitis under the trial identifier NCT00232258.