Long-term Safety and Tolerability
Primary
· Baseline to Week 34 (time the study was terminated prematurely)
Incidence of treatment-emergent adverse events
| Group | Value | 95% CI |
|---|---|---|
| Reldesemtiv | 39 |
Last reviewed · How we verify
NCT05442775
A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
Terminated
Phase 3
Results posted
Last updated 13 August 2024
What this trial tests
Phase 3 trial testing Reldesemtiv in Amyotrophic Lateral Sclerosis in 71 participants. Terminated before completion.
Timeline
4 August 2022
Primary endpoint
7 June 2023
7 June 2023
7 June 2023
Quick facts
| Lead sponsor | Cytokinetics |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 71 |
| Start date | 4 August 2022 |
| Primary completion | 7 June 2023 |
| Estimated completion | 7 June 2023 |
| Sites | 41 locations across Italy, Netherlands, Belgium, Sweden, Ireland, Canada, Australia, United States |
Drugs / interventions tested
- Reldesemtiv — full drug profile →
Conditions studied
- Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
Sponsor
Cytokinetics — full company profile →
Who can join
18 and older, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Long-term Effect of Reldesemtiv on ALSFRS-R Functional Outcomes
Secondary
· Baseline to Week 32 (last timepoint before study was terminated prematurely)
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total scores. ALSFRS-R total score range is from 0 to 48. A score of 48 reflects normal function.
Week 12
| Group | Value | 95% CI |
|---|---|---|
| Reldesemtiv | 29.5 | ± 9.04 |
Week 24
| Group | Value | 95% CI |
|---|---|---|
| Reldesemtiv | 27.4 | ± 11.86 |
Week 32
| Group | Value | 95% CI |
|---|---|---|
| Reldesemtiv | 26.6 | ± 13.96 |
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 34 weeks (time the study was terminated prematurely). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Reldesemtiv
Serious: 11/71 (15%)
Deaths: 5/71
Serious adverse events (13 terms)
| Reaction | System | Reldesemtiv |
|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Assisted suicide | Psychiatric disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Pneumoperitoneum | Gastrointestinal disorders | — |
| Klebsiella urinary tract infection | Infections and infestations | — |
| Metapneumovirus infection | Infections and infestations | — |
| Pneumonia aspiration | Infections and infestations | — |
| Septic shock | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Stress cardiomyopathy | Cardiac disorders | — |
| Tibia fracture | Injury, poisoning and procedural complications | — |
Other adverse events (5 terms — click to expand)
| Reaction | System | Reldesemtiv |
|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Nausea | Gastrointestinal disorders | — |
Most-reported serious reactions: Respiratory failure, Assisted suicide, Abdominal pain, Gastric ulcer haemorrhage, Lower gastrointestinal haemorrhage, Pneumoperitoneum, Klebsiella urinary tract infection, Metapneumovirus infection.
Data from ClinicalTrials.gov NCT05442775 adverse events section.
Sponsor's own description
The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY 5031 (also known as COURAGE-ALS)
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Identification of human metabolites of fast skeletal troponin activators Tirasemtiv and Reldesemtiv for doping control purposes.
Euler L, Deinert K, Wagener F, Walpurgis K, et al · · 2025 · cited 7× · PMID 39138120 · DOI 10.1002/dta.3786 -
Sarcopenia and Muscle Aging: Updated Insights into Molecular Mechanisms and Translational Therapeutics.
Nguyen TT, Dao T, Nguyen HT, Park JH, et al · · 2026 · cited 1× · PMID 41674227 · DOI 10.3803/enm.2025.2656 -
Large Language Models for Clinical Trial Protocol Assessments.
Shin E, Bhat AG, Ramanathan M. · · 2026 · PMID 41121745 · DOI 10.1002/cpt.70096
Verify or expand the search:
- PubMed search for NCT05442775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Reldesemtiv
Trials testing the same drug.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05442775 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cytokinetics
- Last refreshed: 13 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05442775.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing