Numerous clinical trials evaluate losmapimod across Phase 1 to Phase 3 studies, ranging from early safety evaluations in healthy subjects to advanced efficacy assessments in target clinical populations. The candidate has been investigated for facioscapulohumeral muscular dystrophy, chronic obstructive pulmonary disease, focal segmental glomerulosclerosis, COVID-19, acute coronary syndrome, and cardiovascular disease. Driven by major industry and academic sponsors—such as Fulcrum Therapeutics, GlaxoSmithKline, and Cambridge University Hospitals NHS Foundation Trust—these studies encompass completed, active not recruiting, and terminated statuses, including Phase 2 muscular dystrophy and Phase 3 COVID-19 evaluations.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05397470 | TERMINATED | Facioscapulohumeral Muscular Dystrophy (FSHD) |
Fulcrum Therapeutics |
2022-06-16 | PHASE3 |
| NCT04264442 | TERMINATED | Facioscapulohumeral Muscular Dystrophy (FSHD) |
Fulcrum Therapeutics |
2020-02-13 | PHASE2 |
| NCT04004000 | TERMINATED | Facioscapulohumeral Muscular Dystrophy 1 |
Fulcrum Therapeutics |
2019-08-23 | PHASE2 |
| NCT05002231 | COMPLETED | Healthy Adult Subjects |
Fulcrum Therapeutics |
2021-08-19 | PHASE1 |
| NCT04511819 | TERMINATED | COVID-19 |
Fulcrum Therapeutics |
2020-08-28 | PHASE3 |
| NCT04003974 | COMPLETED | Facioscapulohumeral Muscular Dystrophy (FSHD) |
Fulcrum Therapeutics |
2019-08-09 | PHASE2 |
| NCT04264442 | Active not recruiting | Facioscapulohumeral Muscular Dystrophy (FSHD) |
Fulcrum Therapeutics |
2020-02-13 | Phase 2 |
| NCT04004000 | Active not recruiting | Facioscapulohumeral Muscular Dystrophy 1 |
Fulcrum Therapeutics |
2019-08-23 | Phase 2 |
| NCT04003974 | Completed | Facioscapulohumeral Muscular Dystrophy (FSHD) |
Fulcrum Therapeutics |
2019-08-09 | Phase 2 |
| NCT02299375 | COMPLETED | Pulmonary Disease, Chronic Obstructive |
GlaxoSmithKline |
2014-12-09 | PHASE2 |
| NCT02000440 | COMPLETED | Glomerulosclerosis, Focal Segmental |
GlaxoSmithKline |
2014-07-01 | PHASE2 |
| NCT02145468 | COMPLETED | Acute Coronary Syndrome |
GlaxoSmithKline |
2014-06-03 | PHASE3 |
| NCT02000440 | Completed | Glomerulosclerosis Focal Segmental |
GlaxoSmithKline |
2014-07-01 | Phase 2 |
| NCT01541852 | COMPLETED | Chronic Obstructive Pulmonary Disease |
Cambridge University Hospitals NHS Foundation Trust |
2012-06 | PHASE2 |
| NCT01756495 | COMPLETED | Acute Coronary Syndrome |
GlaxoSmithKline |
2013-01-10 | PHASE1 |
| NCT01648192 | COMPLETED | Acute Coronary Syndrome |
GlaxoSmithKline |
2012-07-24 | PHASE1 |
| NCT01218126 | COMPLETED | Pulmonary Disease, Chronic Obstructive |
GlaxoSmithKline |
2010-11-04 | PHASE2 |
| NCT01039961 | COMPLETED | Cardiovascular Disease |
GlaxoSmithKline |
2010-02-02 | PHASE1 |
| NCT00633022 | COMPLETED | Atherosclerosis |
GlaxoSmithKline |
2008-06-02 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-11-10)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).