PRT062607 (P505-15) HCl Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 570

Clinical Trials

The clinical evaluation of PRT062607 (BIIB057) for inflammatory disease management consists of a clinical trial sponsored by Biogen. This multicenter, randomized, dose-ranging Phase II investigation aimed to evaluate the safety, tolerability, and efficacy of the compound in patients with rheumatoid arthritis, but it was prematurely withdrawn without generating completed human efficacy outcomes. Consequently, no active or recruiting clinical trials currently exist for PRT062607 across any therapeutic indication.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01652937	Withdrawn	Rheumatoid Arthritis	Biogen	2012-08	Phase 2

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

Check the PRT062607 (P505-15) HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PRT062607 HCl is a highly potent and selective spleen tyrosine kinase (Syk) inhibitor that blocks intracellular Syk phosphorylation and disrupts downstream B-cell receptor and Fc receptor-mediated biochemical signaling pathways. By suppressing immune cell activation and inflammatory cytokine release, this targeted enzymatic inhibition reduces synovial inflammation and tissue damage, addressing the pathophysiology underlying rheumatoid arthritis.

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>).