Clinical Trials

Multiple clinical trials evaluate this investigational agent across Phase 1, combined Phase 1/2, and Phase 2 protocols targeting myelofibrosis—including primary, post-polycythemia vera, and post-essential thrombocythemia subtypes—acute myeloid leukemia, indolent systemic mastocytosis, and solid tumors or blood cancers in the context of COVID-19. Predominantly sponsored by industry entities such as Telios Pharma Inc. and Kartos Therapeutics Inc., these evaluations currently span recruiting, active but non-recruiting, and completed statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05280509 Recruiting
Myelofibrosis|Primary Myelofibrosis|Post-PV MF|Post-ET Myelofibrosis
Telios Pharma Inc.
 2022-06-09 Phase 1|Phase 2
NCT04669067 Active not recruiting
Acute Myeloid Leukemia
Telios Pharma Inc.|Kartos Therapeutics Inc.
 2021-03-31 Phase 1|Phase 2
NCT04640532 Recruiting
Myelofibrosis|Post-PV MF|Post-ET Myelofibrosis|Primary Myelofibrosis
Kartos Therapeutics Inc.|Telios Pharma Inc.
 2020-11-17 Phase 1|Phase 2
NCT04655118 Recruiting
Myelofibrosis|Indolent Systemic Mastocytosis
Telios Pharma Inc.
 2020-10-22 Phase 2
NCT04419623 Completed
COVID-19|Sars-CoV2|Cancer|Solid Tumor|Carcinoma|Blood Cancer
Telios Pharma Inc.
 2020-07-09 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the M7583 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

M7583 binds irreversibly to the ATP-binding pocket of Bruton's tyrosine kinase (BTK), thereby blocking autophosphorylation and suppressing downstream B-cell receptor signaling pathways essential for oncogenic cellular proliferation. Inhibiting this signaling cascade promotes apoptosis and blocks malignant tumor growth, providing a therapeutic rationale for treating hematologic conditions such as myelofibrosis and acute myeloid leukemia in clinical settings.

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>).

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Note: Technical data last updated: Sep 1, 2026.