Drugs / tirasemtiv
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT01709149 | Oct 2012 → Mar 2014 | amyotrophic lateral sclerosis | Cytokinetics | Completed | Missed primary |
| Phase 2 | NCT01486849 | Nov 2011 → Mar 2012 | amyotrophic lateral sclerosis | Cytokinetics | Completed | No outcome recorded |
| Phase 2 | NCT01378676 | Jun 2011 → Mar 2012 | amyotrophic lateral sclerosis | Cytokinetics | Completed | No outcome recorded |
| Phase 2 | NCT01268280 | Dec 2010 → Oct 2012 | generalized myasthenia gravis | Cytokinetics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01131013 | May 2010 → Mar 2011 | intermittent vascular claudication, peripheral arterial disease | Cytokinetics | Completed | No outcome recorded |
| Phase 2 | NCT01089010 | Mar → Nov 2010 | amyotrophic lateral sclerosis | Cytokinetics | Completed | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT02936635 | Oct 2016 → Oct 2018 | amyotrophic lateral sclerosis | Cytokinetics | Completed | No outcome recorded |
| Phase 3 | NCT02496767 | Sep 2015 → Mar 2017 | amyotrophic lateral sclerosis | Cytokinetics | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2017-12-08 | Cytokinetics | Results Cytokinetics Announces Presentation of Results From VITALITY-ALS at 28th International Symposium on ALS/MND cytokinetics.com ↗
VITALITY-ALS Did Not Meet Primary or Secondary Endpoints |
| 2017-11-30 | Cytokinetics | Results New Publication Summarizes Phase 1 Studies of CK-2127107 Showing Tolerability and Amplification of Skeletal Muscle Response to Nerve Activation cytokinetics.com ↗
Additionally, the results showed that CK-2127107 appeared more potent and produced a larger increase in force than tirasemtiv which was evaluated in a comparable study. |
| 2017-11-21 | Cytokinetics | Results Cytokinetics Announces Negative Results From VITALITY-ALS cytokinetics.com ↗
Phase 3 Clinical Trial of Tirasemtiv in Patients with ALS Did Not Meet Primary or Secondary Endpoints |
| 2016-12-09 | Cytokinetics | Results Cytokinetics Announces New Data Presented at the International Symposium on ALS/MND cytokinetics.com ↗
Baseline characteristics of patients enrolled in VITALITY-ALS are similar to those from BENEFIT-ALS and other recently conducted clinical trials in patients with ALS. |
| 2016-12-07 | Cytokinetics | Results Origent Data Sciences and Cytokinetics Present Analyses Demonstrating Baseline Data Predict Measures of Vital Capacity in Patients With ALS cytokinetics.com ↗
Origent Data Sciences, Inc. (Origent) and Cytokinetics, Inc. (Nasdaq:CYTK) today announced results from the first part of a research collaboration to refine and prospectively validate an Origent computer model to predict the course of ALS disease progression leveraging data from Cytokinetics’ clinical trials of tirasemtiv. |
| 2015-03-25 | Cytokinetics | Results Cytokinetics Announces Publication of Results from Phase II Trial of Tirasemtiv in Patients with Myasthenia Gravis cytokinetics.com ↗
This publication summarizes results from a Phase IIa "Evidence of Effect" or hypothesis-generating clinical trial which evaluated tirasemtiv in patients with generalized myasthenia gravis (MG). |
All press releases naming this drug 10 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tirasemtiv | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02496767 ↗ |
| Known as | CK-2017357 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01486849 ↗ |
| Action | Activate | “a novel small-molecule activator of the fast skeletal muscle troponin complex” PMID 24872402 ↗ May 2014 |
| Modality | Other / unclassified | “CK-2017357, an orally bioavailable fast skeletal muscle troponin activator” PMID 22591195 ↗ May 2012 |
| Route | Oral | “250 mg CK-2017357 in capsules administered as a single oral dose.” NCT01089010 ↗ |