Drugs / IZENCITINIB
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT04587713 | Oct → Dec 2020 | inflammatory bowel disease | Theravance Biopharma | Completed | No outcome recorded |
| Phase 1 | NCT03750565 | Nov 2018 → Feb 2019 | inflammatory bowel disease | Theravance Biopharma | Completed | No outcome recorded |
| Phase 1 | NCT03555617 | Jun → Jul 2018 | inflammatory bowel disease | Theravance Biopharma | Completed | No outcome recorded |
| Phase 1 | NCT03408470 | Jan → Feb 2018 | inflammatory bowel disease | Theravance Biopharma | Completed | No outcome recorded |
| Phase 1 | NCT02818686 | Oct 2016 → Mar 2018 | ulcerative colitis | Theravance Biopharma | Completed | No outcome recorded |
| Phase 1 | NCT02657122 | Dec 2015 → Apr 2016 | — | Theravance Biopharma | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT03920254 | Jul 2020 → Oct 2021 | ulcerative colitis | Theravance Biopharma | Terminated | No outcome recorded |
| Phase 2/3 | NCT03758443 | Mar 2019 → Oct 2021 | ulcerative colitis | Theravance Biopharma | Terminated | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03635112 Comparator | Nov 2018 → Dec 2021 | Crohn disease | Theravance Biopharma | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2021-08-23 | Theravance Biopharma | Results Theravance Biopharma, Inc. Announces Top-line Results from Phase 2b Dose-Finding Induction Study of Izencitinib in Patients with Ulcerative Colitis theravance.com ↗
The study did not meet its primary endpoint of change in the total Mayo score or the key secondary endpoint of clinical remission at week 8, relative to placebo. |
| 2020-04-20 | Theravance Biopharma | Results Theravance Biopharma Announces Peer-Reviewed Publication Highlighting TD-1473 Program in the Journal of Crohn's and Colitis theravance.com ↗
The manuscript, which was published in the Journal of Crohn's and Colitis , highlights a broad collection of data demonstrating minimal systemic drug exposure, local target engagement, and trends toward reduced markers of ulcerative colitis disease activity following TD-1473 administration versus placebo. |
| 2019-05-21 | Theravance Biopharma | Results Theravance Biopharma Reports Data from Phase 1b Study of TD-1473 in Oral Presentation at Digestive Disease Week (DDW) 2019 theravance.com ↗
Presented data demonstrated that four weeks of TD-1473 treatment produced signals of clinical, histologic, and biomarker activity, suggesting the achievement of localized target engagement in patients with moderately-to-severely active ulcerative colitis (UC). |
| 2019-05-14 | Theravance Biopharma | Results Theravance Biopharma Announces Data from Phase 1b Study of TD-1473 to be Featured in Oral Presentation at Digestive Disease Week (DDW) 2019 theravance.com ↗
These findings demonstrate signals of clinical and biomarker activity for TD-1473 suggesting localized target engagement, as well as minimal systemic exposure and no evidence of systemic immunosuppression or infections. |
| 2018-10-22 | Theravance Biopharma | Results Theravance Biopharma Reports Data from TD-1473 Phase 1b Four-Week Study in Oral Late-Breaker Presentation at UEG Week 2018 theravance.com ↗ |
| 2017-08-08 | Theravance Biopharma | Results Theravance Biopharma Reports Encouraging Data from First Cohort of Patients in Phase 1b Clinical Trial of TD-1473 in Ulcerative Colitis theravance.com ↗ |
| 2017-02-17 | Theravance Biopharma | Results Theravance Biopharma Presents Positive Clinical Data on TD-1473 at the 12th Congress of the European Crohn's and Colitis Organization theravance.com ↗
Newly presented data demonstrated that no moderate, severe or serious treatment emergent adverse events (TEAEs) were reported in subjects dosed with TD-1473, and no TEAEs of any severity led to study discontinuation. |
All press releases naming this drug 12 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IZENCITINIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650343 ↗ |
| Known as | TD-1473 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03920254 ↗ |
| Action | Inhibit | “TD-1473 exhibited potent pan-JAK inhibitory activity in vitro.” PMID 32161949 ↗ Sep 2020 |
| Modality | Small molecule | — CHEMBL4650343 ↗ |
| Route | Oral | “The study drug (TD-1473 or placebo) will be administered orally as a single dose.” NCT02657122 ↗ |