Product Description
an orally administered, gut-selective pan-Janus kinase (JAK) inhibitor in development for the treatment of ulcerative colitis.Ê (Sourced from: https://investor.theravance.com/news-releases/news-release-details/theravance-biopharma-inc-announces-top-line-results-phase-2b)
Mechanisms of Action: JAK Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Theravance Biopharma
Company Location: GEORGE TOWN, GRAND CAYMAN E9 KY1-1104
Company CEO: Rick E Winningham
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Colitis, Ulcerative
Phase 2: Crohn Disease|Gastroparesis
Phase 1: Inflammatory Bowel Diseases|Healthy Volunteers|Colitis, Ulcerative
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| ACT 04/22 | N/A |
Completed |
Anemia, Iron-Deficiency |
2022-12-31 |
|||
| NCT04587713 | P1 |
Completed |
Inflammatory Bowel Diseases |
2020-12-24 |
88% |
2021-04-10 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| NCT03750565 | P1 |
Completed |
Inflammatory Bowel Diseases |
2019-02-13 |
12% |
2019-03-22 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
| NCT03555617 | P1 |
Completed |
Inflammatory Bowel Diseases |
2018-07-15 |
19% |
2019-03-22 |
Treatments |
| NCT02818686 | P1 |
Completed |
Colitis, Ulcerative |
2018-03-29 |
2020-09-09 |
Primary Endpoints |
|
| NCT03408470 | P1 |
Completed |
Inflammatory Bowel Diseases |
2018-02-21 |
61% |
2019-03-22 |
Treatments |
| NCT02657122 | P1 |
Completed |
Healthy Volunteers |
2016-04-01 |
2019-12-10 |
Primary Endpoints|Treatments |
|
| NCT04254549 | P2 |
Suspended |
Crohn Disease|Gastroparesis |
2025-04-08 |
2025-04-30 |
Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
|
| DIONE | P2 |
Terminated |
Crohn Disease |
2021-12-30 |
25% |
2022-01-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| Efficacy and Safety of TD-1473 in Crohnâs Disease | P2 |
Terminated |
Crohn Disease |
2021-02-10 |
25% |
2025-05-06 |
Treatments |
| NCT03920254 | P3 |
Terminated |
Colitis, Ulcerative |
2021-10-27 |
30% |
2021-11-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| RHEA | P3 |
Terminated |
Colitis, Ulcerative |
2021-10-20 |
26% |
2022-11-16 |
|
| Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | P3 |
Terminated |
Colitis, Ulcerative |
2021-09-01 |
26% |
2025-05-06 |
Treatments |
| TD-1473 LTS UC Study | P3 |
Terminated |
Colitis, Ulcerative |
2021-09-01 |
30% |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
03/28/2022 |
PubMed |
Gut-Selective Design of Orally Administered Izencitinib (TD-1473) Limits Systemic Exposure and Effects of Janus Kinase Inhibition in Nonclinical Species. |
|
02/01/2022 |
PubMed |
JAK inhibitors in crohn's disease: ready to go? |
|
11/25/2021 |
News Article |
Gastrointestinal Therapeutics Market Global Industry Trends, Share, Size and Forecast Report |
|
09/15/2021 |
News Article |
Theravance Biopharma, Inc. Announces Strategic Actions to Focus on Respiratory Disease Portfolio |
|
08/23/2021 |
News Article |
Theravance Biopharma, Inc. Announces Top-line Results from Phase 2b Dose-Finding Induction Study of Izencitinib in Patients with Ulcerative Colitis |
|
08/05/2021 |
News Article |
Gastrointestinal Therapeutics Market Size, Trends, Outlook, Opportunity |
|
09/01/2020 |
PubMed |
JAK selectivity: more precision less troubles. |