Drugs / ipragliflozin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed type 1 diabetes mellitus 1 milestone | |||||
| Filed | Japan (PMDA) | Suglat | type 1 diabetes mellitus | 2018-01-11 | “Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of Selective SGLT2 Inhibitor Ipragliflozin L-Proline” astellas.com ↗ |
| Filed type 2 diabetes mellitus 1 milestone | |||||
| Filed | Japan (PMDA) | — | type 2 diabetes mellitus | — | “ipragliflozin L-proline (generic name; development code: ASP1941), a SGLT2 inhibitor for which Astellas has filed an application for approval in Japan.” astellas.com ↗ |
Trials 51
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 122 trials · 1 met primary | ||||||
| Phase 1 | NCT01972880 | Sep 2013 → Jan 2014 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01611363 | Oct 2011 → Feb 2012 | type 2 diabetes mellitus | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01611415 | Jul → Oct 2011 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01403818 | Jun → Aug 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01611428 | Jun → Jul 2011 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01373060 | Feb → Mar 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01674777 | Oct → Dec 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01232413 | Sep 2010 → Feb 2011 | — | Astellas Pharma Inc | Completed | Met primary |
| Phase 1 | NCT01187186 | May → Aug 2010 | liver disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01097681 | Feb → Jun 2010 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01099839 | Feb → Apr 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01104532 | Feb → Mar 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01302028 | Jan → Jun 2010 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01302158 | Dec 2009 → Apr 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01023945 | Nov 2009 → Mar 2010 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01088919 | Nov → Dec 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01302145 | Feb → Dec 2009 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01302132 | May → Oct 2008 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01678287 | Nov 2007 → Jan 2008 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01288898 | May 2007 → Mar 2008 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01121198 | Dec 2006 → Jul 2007 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01288885 | Nov 2006 → May 2007 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 25 trials · 2 met primary | ||||||
| Phase 2 | NCT02529449 | Sep 2015 → Mar 2016 | type 1 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT01117584 | Apr 2010 → Apr 2011 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT01071850 | Mar 2010 → Apr 2011 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | Met primary |
| Phase 2 | NCT00790660 | Oct 2008 → Mar 2009 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00621868 | Mar 2008 → Mar 2009 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | Met primary |
| Phase 318 trials · 1 met primary | ||||||
| Phase 3 | NCT03076112 | Apr 2017 → Jun 2022 | type 2 diabetes mellitus | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02897219 | Aug 2016 → Jul 2017 | type 1 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT02794792 | May 2016 → Mar 2017 | type 2 diabetes mellitus | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 3 | NCT02577003 | Nov 2015 → Nov 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02564211 | Oct 2015 → Mar 2017 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02452632 | Jun 2015 → Jan 2017 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01672762 | May 2012 → Apr 2013 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01514838 | Apr → Oct 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01505426 | Nov 2011 → Jan 2013 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01316094 | Jan 2011 → Nov 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01316107 | Jan 2011 → Oct 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01242202 | Oct 2010 → May 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01242228 | Oct 2010 → Jun 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01242215 | Sep 2010 → Apr 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01225081 | Sep 2010 → Apr 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01135433 | May 2010 → Nov 2011 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01054092 | Jan 2010 → Jul 2011 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01057628 | Jan → Nov 2010 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT03118713 | Apr 2017 → Dec 2018 | type 2 diabetes mellitus | Astellas Pharma Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02847091 | Jul 2016 → Nov 2017 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT02791035 | Jun 2016 → Mar 2017 | type 2 diabetes mellitus | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02875821 | Apr 2016 → Jun 2017 | NAFLD1 | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT02291874 | Oct 2014 → Jul 2016 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT02175784 | Mar 2014 → Mar 2015 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT02577016 Background | Nov 2015 → Nov 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 4 | NCT02528019 Comparator | Aug 2015 → Aug 2017 | — | Kurume University | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2018-12-21 | Astellas Pharma Inc | Regulatory Approval of Suglat® Tablets, Selective SGLT2 Inhibitor, for Additional Indication of type 1 diabetes mellitus and Additional dosage and administration in Japan astellas.com ↗
approval of selective SGLT2 inhibitor Suglat® Tablets (generic name: Ipragliflozin L-Proline , development code: ASP1941, "Suglat®") for the additional indication of type 1 diabetes mellitus and the additional dosage and administration has been obtained in Japan. |
| 2018-01-11 | Astellas Pharma Inc | Regulatory Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of Selective SGLT2 Inhibitor Ipragliflozin L-Proline for Patients with Type 1 Diabetes Mellitus in Japan astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas” ) and Kotobuki Pharmaceutical Co., Ltd. (President and CEO; Hiroshi Tomiyama, “Kotobuki”) today announced that Astellas submitted an application for the additional indication of the selective SGLT2 inhibitor Ipragliflozin L-Proline (generic name, brand name: “Suglat® Tablets, development code: ASP1941, “Ipragliflozin”) for the treatment of type 1 diabetes mellitus in Japan. |
| 2017-05-19 | Astellas Pharma Inc | Regulatory MSD submits application for approval of type-2 diabetes drug combining selective DPP-4 inhibitor and selective SGLT2 inhibitor astellas.com ↗
MSD submits application for approval of type-2 diabetes drug combining selective DPP-4 inhibitor and selective SGLT2 inhibitor |
| 2014-01-17 | Astellas Pharma Inc | Regulatory Approval of Suglat® Tablets, a Selective SGLT2 Inhibitor for Treatment of Type 2 Diabetes, in Japan astellas.com ↗
Suglat is the first SGLT2 inhibitor approved as a treatment for type 2 diabetes in Japan. |
All press releases naming this drug 5 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ipragliflozin | “Ipragliflozin (ASP1941) is a selective sodium glucose cotransporter 2 inhibitor in clinical development for the treatment of patients with type 2 diabetes mellitus (T2DM).” PMID 22795925 ↗ Jul 201229“Ipragliflozin (ASP1941) is a novel, selective inhibitor of the sodium-dependent glucose co-transporter 2, which is highly expressed in the proximal tubules of the kidneys.” PMID 21877761 ↗ Dec 2011 “Ipragliflozin, a potent, selective sodium glucose cotransporter 2 inhibitor, is in development for the treatment of type 2 diabetes mellitus.” PMID 23910665 ↗ Aug 2013 “Ipragliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM).” PMID 31606880 ↗ Oct 2019 “ipragliflozin (50-100mg daily)” NCT02528019 ↗ |
| Known as | ASP1941 | “Ipragliflozin (ASP1941) is a novel, selective inhibitor of the sodium-dependent glucose co-transporter 2, which is highly expressed in the proximal tubules of the kidneys.” PMID 21877761 ↗ Dec 201125“furosemide and ipragliflozin (ASP1941) in healthy volunteers.” NCT01611415 ↗ |
| Known as | Ipragliflozina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2018096 ↗ |
| Known as | Ipragliflozine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2018096 ↗ |
| Action | Inhibit | “Ipragliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor” PMID 31606880 ↗ Oct 20191“Sodium/glucose cotransporter 2 inhibitor” CHEMBL2018096 ↗ |
| Modality | Small molecule | — CHEMBL2018096 ↗ |
| Route | Oral | “once-daily oral ipragliflozin” PMID 25411597 ↗ Nov 2013 |
| Target | SLC5A2 | “Sodium/glucose cotransporter 2 inhibitor” CHEMBL2018096 ↗ |