Drugs / SIPAGLADENANT
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT04342273 | Mar → Sep 2020 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04190654 | Nov 2019 → Mar 2020 | — | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04070495 | Aug → Nov 2019 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04147910 | Aug → Oct 2019 | — | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03970798 | May → Jul 2019 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03830528 | Feb → Oct 2019 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT03703570 | Sep 2018 → Apr 2020 | Parkinson disease | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 2 | NCT02939391 | Sep 2016 → Nov 2017 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-10-21 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Positive Phase 2b Results for KW-6356 in Patients with Parkinson's Disease kyowakirin.com ↗
The study result met its primary endpoint as the change in the KW-6356 group was greater than in the placebo group with a statistically significant difference. |
| 2018-08-20 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Results of Early Phase 2 Trial of KW-6356 for Parkinson's Disease at IAPRD kyowakirin.com ↗
Changes from baseline in MDS-UPDRS part III scores were -4.76 in the high-dose KW-6356 group (95% CI, -6.55 to -2.96), -5.37 in the low-dose KW-6356 group (95% CI, -7.25 to -3.48), and -3.14 (95% CI, -4.97 to -1.30) in the placebo group, with both KW-6356 groups showing a greater reduction in score compared with the placebo group. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-10-21 | Kyowa Kirin, Inc. | Kyowa Kirin Announces Positive Phase 2b Results for KW-6356 in Patients with Parkinson's Disease kyowakirin.com ↗ |
| 2018-08-20 | Kyowa Kirin, Inc. | Kyowa Hakko Kirin Announces Results of Early Phase 2 Trial of KW-6356 for Parkinson's Disease at IAPRD kyowakirin.com ↗ |
| 2010-10-05 | Kyowa Kirin, Inc. | Kyowa Hakko Kirin to enter licensing agreement with Lundbeck for A2a antagonist KW-6356 kyowakirin.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SIPAGLADENANT | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314441 ↗ |
| Known as | KW-6356 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04342273 ↗ |
| Action | Inhibit | “KW-6356 is a novel selective adenosine A2A receptor antagonist/inverse agonist.” PMID 37948832 ↗ Oct 2023 |
| Modality | Small molecule | — CHEMBL5314441 ↗ |
| Route | Oral | “6 mg/day) orally administered as monotherapy for 12 weeks” PMID 37948832 ↗ Oct 2023 |
| Target | ADORA2A | “Adenosine A2a receptor inverse agonist” CHEMBL5314441 ↗ |