Last reviewed · How we verify
NCT04676529
Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis
Phase 1, PHASE2 trial testing PXS-5505 in Myelofibrosis in 43 participants. Completed in 9 July 2025.
9 July 2025
Quick facts
| Lead sponsor | Syntara |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 18 February 2021 |
| Primary completion | 9 July 2025 |
| Estimated completion | 9 July 2025 |
| Sites | 23 locations across Taiwan, United States, Australia, South Korea |
Drugs / interventions tested
- PXS-5505 — full drug profile →
Conditions studied
- Myelofibrosis — all drugs for Myelofibrosis →
Sponsor
Syntara — full company profile →
Who can join
18 and older, any sex, with Myelofibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will be an open-label phase 1/2a study to evaluate the safety and tolerability of PXS-5505 in patients with primary, postpolycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting extracellular matrix stiffness and mechanotransducers to improve cancer therapy.
Jiang Y, Zhang H, Wang J, Liu Y, et al · · 2022 · cited 342× · PMID 35331296 · DOI 10.1186/s13045-022-01252-0 -
A first-in-class pan-lysyl oxidase inhibitor impairs stromal remodeling and enhances gemcitabine response and survival in pancreatic cancer.
Chitty JL, Yam M, Perryman L, Parker AL, et al · · 2023 · cited 99× · PMID 37640930 · DOI 10.1038/s43018-023-00614-y -
Myelofibrosis.
Passamonti F, Mora B. · · 2023 · cited 82× · PMID 36416738 · DOI 10.1182/blood.2022017423 -
Extracellular matrix stiffness: mechanisms in tumor progression and therapeutic potential in cancer.
Zhang M, Zhang B. · · 2025 · cited 69× · PMID 40211368 · DOI 10.1186/s40164-025-00647-2 -
Matrix stiffness affects tumor-associated macrophage functional polarization and its potential in tumor therapy.
Xiong J, Xiao R, Zhao J, Zhao Q, et al · · 2024 · cited 39× · PMID 38246995 · DOI 10.1186/s12967-023-04810-3 -
Pan-Lysyl Oxidase Inhibitor PXS-5505 Ameliorates Multiple-Organ Fibrosis by Inhibiting Collagen Crosslinks in Rodent Models of Systemic Sclerosis.
Yao Y, Findlay A, Stolp J, Rayner B, et al · · 2022 · cited 36× · PMID 35628342 · DOI 10.3390/ijms23105533 -
Lysyl Oxidase Family Proteins: Prospective Therapeutic Targets in Cancer.
Wang W, Wang X, Yao F, Huang C. · · 2022 · cited 32× · PMID 36293126 · DOI 10.3390/ijms232012270 -
Exploring Extracellular Matrix Crosslinking as a Therapeutic Approach to Fibrosis.
Lloyd SM, He Y. · · 2024 · cited 20× · PMID 38474402 · DOI 10.3390/cells13050438
Verify or expand the search:
- PubMed search for NCT04676529
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Myelofibrosis
Currently open trials in the same condition.
- NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
- NCT06781099 — Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis · NA · recruiting
- NCT07362225 — MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myel · recruiting
- NCT07342712 — Clinical Trail to Evaluate the Effect of Long-term Treatment With Gecacitinib on Myelofibrosis and Gene Mutation Levels · active not recruiting
- NCT06533813 — Clinical Epidemiology in Contemporary Patients With Myelofibrosis. · recruiting
Other Syntara trials
Trials by the same sponsor.
- NCT05904717 — Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder · Phase 2 · active not recruiting
- NCT04183517 — A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04676529 (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 Syntara
- Last refreshed: 24 August 2025
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/NCT04676529.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing