Drugs / Reldesemtiv
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03065959 | Jun 2017 → Oct 2018 | — | Astellas Pharma Global Development, Inc. | Terminated | No outcome recorded |
| Phase 23 trials · 2 missed | ||||||
| Phase 2 | NCT03160898 | Jul 2017 → Mar 2019 | amyotrophic lateral sclerosis | Cytokinetics | Completed | Missed primary |
| Phase 2 | NCT02662582 | Jun 2016 → Jun 2018 | chronic obstructive pulmonary disease | Astellas Pharma Global Development, Inc. | Completed | Missed primary |
| Phase 2 | NCT02644668 | Jan 2016 → May 2018 | spinal muscular atrophy | Cytokinetics | Completed | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT05442775 | Aug 2022 → Jun 2023 | amyotrophic lateral sclerosis | Cytokinetics | Terminated | No outcome recorded |
| Phase 3 | NCT04944784 | Aug 2021 → Jul 2023 | amyotrophic lateral sclerosis | Cytokinetics | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2023-12-07 | Cytokinetics | Results Cytokinetics Presents Results From COURAGE-ALS at the 34th International Symposium on ALS/MND cytokinetics.com ↗
Treatment with reldesemtiv for 24 weeks had no effect on the primary efficacy endpoint measure of change from baseline up to Week 24 in the ALS Functional Rating Scale Revised (ALSFRS-R) (joint rank test p=0.11). |
| 2023-03-31 | Cytokinetics | Results Cytokinetics Announces COURAGE-ALS Met Criteria for Futility at Second Interim Analysis cytokinetics.com ↗
Given these results, study conduct in COURAGE-ALS will be concluding. |
| 2022-12-08 | Cytokinetics | Results Cytokinetics Presents Data at the Virtual 33rd International Symposium on ALS/MND cytokinetics.com ↗
Analysis from FORTITUDE-ALS Shows Predicted Survival Risk Score Strongly Correlated with Decline in ALSFRS-R |
| 2021-12-10 | Cytokinetics | Results Cytokinetics Announces Data From Its ALS Program Presented at the 32nd International Symposium on ALS/MND cytokinetics.com ↗
Majority of Initial Patients Enrolled in COURAGE-ALS Show Intended Middle to Fast Disease Progression Phenotype at Baseline |
| 2020-12-14 | Cytokinetics | Results Cytokinetics Announces Data and Trial Design Presented at the International Symposium on ALS/MND cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data relating to the impact of patient characteristics on treatment effect in FORTITUDE-ALS, the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS), were presented at the 31st International Symposium on ALS/MND. |
| 2020-03-04 | Cytokinetics | Regulatory Cytokinetics Granted European Orphan Designation for Reldesemtiv for the Treatment of Amyotrophic Lateral Sclerosis cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation to reldesemtiv for the treatment of amyotrophic lateral sclerosis (ALS). |
| 2019-12-18 | Cytokinetics | Regulatory Cytokinetics Granted Orphan Drug Designation for Reldesemtiv for the Treatment of Amyotrophic Lateral Sclerosis cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to reldesemtiv for the treatment of amyotrophic lateral sclerosis (ALS). |
| 2019-12-05 | Cytokinetics | Results Cytokinetics Announces New Results Presented at the International Symposium on ALS/MND cytokinetics.com ↗
Among the post-hoc analyses presented were results of subgroup analyses describing the effect of reldesemtiv with and without use of Radicava® (edaravone) and/or Rilutek® (riluzole) and the interaction between quality of life and depression in the placebo group. |
| 2019-10-04 | Cytokinetics | Results Cytokinetics Announces Presentation of Additional Analyses From FORTITUDE-ALS at the 18th Annual NEALS Meeting cytokinetics.com ↗
Faster Progressing Patients Who Received Reldesemtiv in the Trial Demonstrated Statistically Significant Differences in the Decline in ALSFRS-R Total Score |
| 2019-07-23 | Cytokinetics | Regulatory Cytokinetics Granted European Orphan Designation for Reldesemtiv for the Treatment of Spinal Muscular Atrophy cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation to reldesemtiv for the potential treatment of spinal muscular atrophy (SMA). |
| 2019-06-28 | Cytokinetics | Results Cytokinetics Announces Preclinical Data For Reldesemtiv Presented at the 2019 Annual Cure SMA Conference cytokinetics.com ↗
Two Studies Show Addition of Reldesemtiv to SMN-Directed Treatment Increases Muscle Force in Mouse Model of Spinal Muscular Atrophy |
| 2019-05-05 | Cytokinetics | Results Cytokinetics Announces Results of FORTITUDE-ALS, a Phase 2 Clinical Trial of Reldesemtiv in Patients With ALS, Presented at American Academy of Neurology Annual Meeting cytokinetics.com ↗
FORTITUDE-ALS did not achieve statistical significance for a pre-specified dose-response relationship in its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing (p=0.11). |
| 2019-01-22 | Cytokinetics | Regulatory Cytokinetics Announces Receipt of FDA Feedback Regarding Reldesemtiv in Patients With SMA cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it has received feedback from the U.S. Food and Drug Administration (FDA) that the Six Minute Walk Test (6MWT) is an acceptable primary efficacy endpoint for a potential registration program for reldesemtiv in patients with spinal muscular atrophy (SMA) who have maintained ambulatory function. |
| 2018-12-10 | Cytokinetics | Results Cytokinetics Announces New Data Presented at the International Symposium on ALS/MND cytokinetics.com ↗
Baseline characteristics of patients enrolled in FORTITUDE-ALS are similar to those of other recent large clinical trials in ALS, including BENEFIT-ALS and VITALITY-ALS. |
| 2018-06-16 | Cytokinetics | Results Cytokinetics Announces Data From Phase 2 Clinical Study of Reldesemtiv in Patients With Spinal Muscular Atrophy Presented at the 2018 Annual Cure SMA Conference cytokinetics.com ↗
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced data from the Phase 2 clinical study of reldesemtiv in patients with spinal muscular atrophy (SMA) were presented in an oral presentation by John W. Day, M.D., Ph.D., Professor of Neurology and Pediatrics (Genetics), Stanford University, at the 2018 Annual Cure SMA Conference in Dallas. |
All press releases naming this drug 35 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | reldesemtiv | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03065959 ↗ |
| Known as | CK-2127107 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297600 ↗ |
| Action | Activate | “a fast skeletal muscle troponin activator” PMID 34218726 ↗ Jul 2021 |
| Modality | Small molecule | — CHEMBL4297600 ↗ |
| Route | Oral | “Granules for oral suspension” NCT02644668 ↗ |