Drugs / Velusetrag
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01467726 | Nov 2011 → Jan 2012 | Alzheimer disease | Alfasigma S.p.A. | Completed | No outcome recorded |
| Phase 24 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT05724069 | Dec 2021 → Apr 2023 | chronic intestinal pseudoobstruction | Alfasigma S.p.A. | Completed | Missed primary |
| Phase 2 | NCT02267525 | Dec 2014 → Jun 2017 | gastroparesis | Theravance Biopharma | Completed | No outcome recorded |
| Phase 2 | NCT01718938 | Dec 2012 → Dec 2013 | gastroparesis | Theravance Biopharma | Completed | Met primary |
| Phase 2 | NCT00391820 | Oct 2006 → May 2007 | constipation disorder | Alfasigma S.p.A. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2017-08-02 | Theravance Biopharma | Results Theravance Biopharma Announces Positive Top-Line Results from Phase 2b Study of Velusetrag (TD-5108) in Patients with Gastroparesis theravance.com ↗ |
| 2016-12-06 | Theravance Biopharma | Regulatory Theravance Biopharma Receives FDA Fast Track Designation for Velusetrag (TD-5108) for Idiopathic and Diabetic Gastroparesis theravance.com ↗
Theravance Biopharma, Inc. ( NASDAQ : TBPH) (" Theravance Biopharma " or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-08-02 | Theravance Biopharma | Theravance Biopharma Announces Positive Top-Line Results from Phase 2b Study of Velusetrag (TD-5108) in Patients with Gastroparesis theravance.com ↗ |
| 2016-12-06 | Theravance Biopharma | Theravance Biopharma Receives FDA Fast Track Designation for Velusetrag (TD-5108) for Idiopathic and Diabetic Gastroparesis theravance.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Velusetrag | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02267525 ↗ |
| Known as | TD-5108 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00391820 ↗ |
| Known as | Velusetrag hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL2087337 ↗ |
| Known as | VELUSETRAG HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2087337 ↗ |
| Action | Activate | “5-hydroxytryptamine type 4 receptor agonist” PMID 33811761 ↗ Apr 20211“Serotonin 4 (5-HT4) receptor agonist” CHEMBL2087337 ↗ |
| Modality | Small molecule | — CHEMBL2087337 ↗ |
| Route | Oral | “received oral velusetrag (5, 15 or 30 mg) or placebo once daily for 7 days each.” PMID 33811761 ↗ Apr 2021 |
| Target | HTR4 | “Serotonin 4 (5-HT4) receptor agonist” CHEMBL2087337 ↗ |