TP-3654 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

Several Phase 1 and Phase 1/2 clinical trials sponsored by Sumitomo Pharma America Inc. evaluate the oral small-molecule agent TP-3654 across healthy volunteers, patients with myelofibrosis, and individuals with advanced solid tumors. These investigations aim to determine the compound's safety, pharmacokinetics, bioavailability, and preliminary pharmacodynamic responses. Recruitment status across these studies ranges from completed pharmacokinetic and food-effect trials to actively recruiting evaluations in targeted hematologic conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04176198	RECRUITING	Myelofibrosis	Sumitomo Pharma America, Inc.	2019-12-16	PHASE1; PHASE2
NCT07492355	COMPLETED	Myelofibroses	Sumitomo Pharma America, Inc.	2024-03-04	PHASE1
NCT06389955	COMPLETED	Healthy	Sumitomo Pharma America, Inc.	2023-05-22	PHASE1
NCT06389955	Completed	Healthy	Sumitomo Pharma America Inc.	2023-05-22	Phase 1
NCT03715504	COMPLETED	Advanced Solid Tumors	Sumitomo Pharma America, Inc.	2019-04-16	PHASE1
NCT04176198	Recruiting	Myelofibrosis	Sumitomo Pharma America Inc.	2019-12-16	Phase 1\|Phase 2
NCT03715504	Completed	Advanced Solid Tumors	Sumitomo Pharma America Inc.	2019-04-16	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-03)

Check the TP-3654 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TP-3654 is a selective second-generation PIM kinase inhibitor that binds PIM-1, PIM-2, and PIM-3 to disrupt downstream substrate phosphorylation, inhibiting cellular proliferation and promoting apoptotic pathway activation. This targeted inhibition of pro-survival PIM signaling underpins its therapeutic application in ongoing clinical trials for advanced solid tumors and myelofibrosis.

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>).