Drugs / peficitinib
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 122 trials | ||||||
| Phase 1 | NCT04143477 | Dec 2019 → Dec 2020 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02760342 | May → Jun 2016 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02586194 | Dec 2015 → Sep 2016 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02603497 | Nov 2015 → Dec 2016 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02117505 | Apr → Jun 2014 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02141425 | Mar → Apr 2014 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02111317 | Oct → Nov 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01959399 | May → Jul 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01929577 | May → Aug 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01686217 | Jun → Jul 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01484964 | Sep → Oct 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01486017 | Sep 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01430078 | Sep → Oct 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01190670 | Jul → Sep 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01182077 | Jun → Jul 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01754805 | Jan → Mar 2010 | rheumatoid arthritis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01406132 | Dec 2009 → Jan 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01225224 | Nov 2009 → Mar 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01430065 | Jun 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01364987 | May → Jun 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01364974 | Jan → May 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01387087 | Jul → Nov 2008 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 26 trials · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT01959282 | Nov 2013 → May 2015 | ulcerative colitis | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT01711814 | Sep 2012 → Mar 2016 | rheumatoid arthritis | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01554696 | Jul 2012 → Feb 2014 | rheumatoid arthritis | Astellas Pharma Inc | Completed | Met primary |
| Phase 2 | NCT01565655 | Jun 2012 → Dec 2013 | rheumatoid arthritis | Astellas Pharma Global Development, Inc. | Completed | Met primary |
| Phase 2 | NCT01649999 | Mar 2012 → Jul 2013 | rheumatoid arthritis | Astellas Pharma Inc | Completed | Met primary |
| Phase 2 | NCT01096862 | Mar 2010 → Jul 2011 | psoriasis | Astellas Pharma Inc | Completed | Met primary |
| Phase 34 trials · 3 met primary | ||||||
| Phase 3 | NCT03660059 | Sep 2018 → Apr 2021 | rheumatoid arthritis | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT02308163 | Aug 2014 → Jan 2017 | rheumatoid arthritis | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT02305849 | Jul 2014 → Jun 2017 | rheumatoid arthritis | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT01638013 | Jun 2012 → Sep 2019 | rheumatoid arthritis | Astellas Pharma Inc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-03-26 | Astellas Pharma Inc | Regulatory Oral JAK Inhibitor Smyraf® Tablets Approved in Japan for the Treatment of Rheumatoid Arthritis (including prevention of structural joint damage) in Patients Who Have an Inadequate Response to Conventional Therapies astellas.com ↗
Oral JAK Inhibitor Smyraf® Tablets Approved in Japan for the Treatment of Rheumatoid Arthritis (including prevention of structural joint damage) in Patients Who Have an Inadequate Response to Conventional Therapies |
| 2018-05-31 | Astellas Pharma Inc | Regulatory Astellas Submits Application for Approval of Peficitinib for Rheumatoid Arthritis (Including Prevention of Structural Joint Damage) in Patients Who Have an Inadequate Response to Conventional Therapies in Japan astellas.com ↗
Astellas Submits Application for Approval of Peficitinib for Rheumatoid Arthritis (Including Prevention of Structural Joint Damage) in Patients Who Have an Inadequate Response to Conventional Therapies in Japan |
| 2018-02-08 | Astellas Pharma Inc | Results Astellas Announce Top-Line Results for Two Phase 3 Trials of Peficitinib in Rheumatoid Arthritis Patients with Inadequate Response to Existing Therapy astellas.com ↗
The primary endpoint of RAJ3, “ACR*120 response rate at Week 12 (percentage of patients with improvement of at least 20% in various rheumatoid arthritis endpoints)” was met. |
All press releases naming this drug 6 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | peficitinib | “Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects with Normal and Impaired Renal Function.” PMID 31729626 ↗ Feb 202014“Peficitinib, an Oral Janus Kinase Inhibitor, in Moderate-to-severe Ulcerative Colitis: Results From a Randomised, Phase 2 Study.” PMID 29917064 ↗ Nov 2018 |
| Known as | ASP-015K HYDROBROMIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137308 ↗ |
| Known as | ASP015K | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01364974 ↗ |
| Known as | JNJ-54781532 | “Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in one of the treatment periods.” NCT02117505 ↗ |
| Known as | PEFICITINIB HYDROBROMIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137308 ↗ |
| Action | Inhibit | “a novel Janus kinase inhibitor” PMID 25704750 ↗ Jun 2015 |
| Modality | Small molecule | — CHEMBL3137308 ↗ |
| Route | Oral | “a novel oral JAK inhibitor” PMID 25704750 ↗ Jun 2015 |
| Target | JAK1 | “moderate selectivity for JAK3 over JAK1 and JAK2 in enzyme assays” PMID 25704750 ↗ Jun 2015 |
| Target | JAK2 | “moderate selectivity for JAK3 over JAK1 and JAK2 in enzyme assays” PMID 25704750 ↗ Jun 2015 |
| Target | JAK3 | “moderate selectivity for JAK3 over JAK1 and JAK2 in enzyme assays” PMID 25704750 ↗ Jun 2015 |