TP-1454 Clinical Trials

Size	Price	Qty
5mg	USD 157
25mg	USD 470

Clinical Trials

Multiple Phase 1 clinical trials sponsored by industry sponsor Sumitomo Pharma America, Inc. evaluate the early-phase clinical development of orally administered TP-1454 in patients with advanced solid tumors and anal cancer. These evaluations include a first-in-human, open-label, dose-escalation study designed to characterize the safety profile, pharmacokinetics, and pharmacodynamics of the therapeutic. Across these clinical trials, recruitment status is recorded as both actively recruiting and completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04328740	COMPLETED	Advanced Solid Tumor; Anal Cancer	Sumitomo Pharma America, Inc.	2020-07-08	PHASE1
NCT04328740	Recruiting	Advanced Solid Tumor\|Anal Cancer	Sumitomo Pharma America Inc.	2020-07-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-05-01)

Check the TP-1454 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TP-1454 functions as a potent activator of pyruvate kinase M2 (PKM2) with an AC50 of 10 nM in biochemical assays, destabilizing immunosuppressive T-regulatory cells to restore functional anti-tumor immune responses. By reversing immune evasion within the tumor microenvironment, this therapeutic agent promotes targeted destruction of malignant cells in clinical indications such as advanced solid tumors and anal cancer.

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>).