PIM447 (LGH447) Hydrochloride Clinical Trials

Size	Price	Qty
2mg	USD 197
5mg	USD 370

Clinical Trials

Sponsored by Novartis Pharmaceuticals, PIM447 (LGH447) has been evaluated across several clinical trials investigating its safety, tolerability, and preliminary efficacy as monotherapy or in combination with other targeted agents. These Phase 1 and Phase 1b dose-escalation studies encompassed diverse hematologic conditions, including relapsed and refractory multiple myeloma, acute myeloid leukemia, high-risk myelodysplastic syndrome, and myelofibrosis. All of these clinical investigations have achieved completed status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02370706	COMPLETED	Myelofibrosis	Novartis Pharmaceuticals	2015-05-21	PHASE1
NCT01456689	COMPLETED	Multiple Myeloma	Novartis Pharmaceuticals	2012-04-25	PHASE1
NCT02078609	COMPLETED	AML and High Risk MDS	Novartis Pharmaceuticals	2014-03-20	PHASE1
NCT02160951	COMPLETED	Multiple Myeloma	Novartis Pharmaceuticals	2014-09	PHASE1
NCT02144038	COMPLETED	Relapsed and Refractory Multiple Myeloma	Novartis Pharmaceuticals	2014-07-23	PHASE1
NCT02160951	Completed	Multiple Myeloma	Novartis Pharmaceuticals\|Novartis	2014-09	Phase 1
NCT02078609	Completed	AML and High Risk MDS	Novartis Pharmaceuticals\|Novartis	2014-03-20	Phase 1
NCT01456689	Completed	Multiple Myeloma	Novartis Pharmaceuticals\|Novartis	2012-04-25	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-02-09)

Check the PIM447 (LGH447) Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PIM447 Hydrochloride is a potent pan-PIM kinase inhibitor that selectively binds to and inhibits PIM1, PIM2, and PIM3 kinases with picomolar affinity, thereby blocking downstream pro-survival signaling cascades and protein translation pathways. This enzymatic inhibition induces apoptosis and suppresses cell proliferation, providing therapeutic relevance for treating hematologic malignancies such as multiple myeloma and acute myeloid leukemia.

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>).