Clinical Trials

Sumitomo Pharma America Inc. has sponsored several clinical trials evaluating the safety, pharmacokinetics, and efficacy of itacnosertib (TP-0184). A Phase 1 study in patients with advanced solid tumors completed recruitment. Meanwhile, a Phase 1/2 trial investigating the treatment for anemia in adult patients with myelodysplastic syndromes was terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04623996 Terminated
Anemia in Myelodysplastic Syndromes
Sumitomo Pharma America Inc.
 2020-12-28 Phase 1|Phase 2
NCT03429218 Completed
Advanced Solid Tumors
Sumitomo Pharma America Inc.
 2018-07-10 Phase 1

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

Check the Itacnosertib (TP-0184) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Itacnosertib (TP-0184) acts as a potent small-molecule inhibitor of the bone morphogenetic protein (BMP) type 1 receptor ALK2 (ACVR1), blocking downstream BMP receptor signaling and downregulating hepcidin expression. By preventing hepcidin-mediated suppression of iron availability and disrupting BMP-driven oncogenic signals, this mechanism aims to alleviate systemic anemia in myelodysplastic syndromes and inhibit tumor progression in advanced solid tumors.

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.