Drugs / Idalopirdine
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT03307993 | Sep 2017 → Feb 2018 | Alzheimer disease | H. Lundbeck A/S | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02436486 | May → Aug 2015 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT02340195 | Jan → Sep 2015 | Alzheimer disease | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT02231450 | Jul 2014 → Mar 2015 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT02122692 | Mar → Jun 2014 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT02019394 | Dec 2013 → Feb 2014 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT01975779 | Jul → Oct 2013 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT01019421 | Dec 2009 → Dec 2011 | Alzheimer disease | H. Lundbeck A/S | Completed | Met primary |
| Phase 2 | NCT00810667 | Nov 2008 → Jan 2010 | schizophrenia | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 34 trials · 3 missed | ||||||
| Phase 3 | NCT02079246 | Apr 2014 → Jul 2017 | Alzheimer disease | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT02006654 | Mar 2014 → Jan 2017 | Alzheimer disease | H. Lundbeck A/S | Completed | Missed primary |
| Phase 3 | NCT02006641 | Feb 2014 → Dec 2016 | Alzheimer disease | H. Lundbeck A/S | Completed | Missed primary |
| Phase 3 | NCT01955161 | Oct 2013 → Jul 2016 | Alzheimer disease | H. Lundbeck A/S | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2016-09-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Headline conclusions from the phase III study of idalopirdine (Lu AE58054) for cognitive symptoms associated with Alzheimer's disease otsuka.co.jp ↗
Idalopirdine, co-developed with Lundbeck, did not meet its primary efficacy endpoint in the study. |
| 2016-07-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Idalopirdine granted Fast Track Designation by U.S. Food and Drug Administration (FDA) otsuka-us.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational agent idalopirdine for the treatment of mild to moderate Alzheimer’s disease. |
| 2013-07-17 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Phase II clinical data show statistically significant improvement for Lu AE58054 as add-on to donepezil, versus donepezil alone, on cognitive symptoms of Alzheimer's diseaseLundbeck and Otsuka present data at Alzheimer’s Association International Conference 2013*1 otsuka.co.jp ↗
The phase II clinical study demonstrated that treatment with Lu AE58054 as add-on to donepezil for six months improved cognitive performance in patients with moderate Alzheimer's disease.*1 |
All press releases naming this drug 5 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | idalopirdine | “We assessed the effect on cognitive performance of Lu AE58054 (idalopirdine), a selective 5-HT6 receptor antagonist, in donepezil-treated patients with moderate Alzheimer's disease.” PMID 25297016 ↗ Oct 2014 |
| Known as | Idalopirdina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3286580 ↗ |
| Known as | Lu AE58054 | “Idalopirdine (Lu AE58054) 60 mg” NCT02079246 ↗7“Idalopirdine (Lu AE58054) 60 mg” NCT02340195 ↗ |
| Known as | LY-483518 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3286580 ↗ |
| Known as | SGS-518 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3286580 ↗ |
| Action | Inhibit | “Serotonin 6 (5-HT6) receptor antagonist” CHEMBL3286580 ↗1“selective 5-HT6 antagonist” NCT00810667 ↗ |
| Modality | Small molecule | — CHEMBL3286580 ↗ |
| Route | Oral | “twice daily oral dose (60 mg BID: total dose 120 mg/day)” NCT00810667 ↗ |
| Target | HTR6 | “Serotonin 6 (5-HT6) receptor antagonist” CHEMBL3286580 ↗ |