Clinical Trials

Multiple clinical trials have been completed across Phase 1, Phase 2, Phase 3, and unassigned phase designs, studying conditions such as knee osteoarthritis, chronic myeloid leukemia, postmenopausal osteoporosis, and pharmacokinetics in healthy volunteers. These fully recruited studies include Phase 2 investigations in leukemia and Phase 3 trials for bone disorders. Sponsorship is shared among academic and network entities, including the University of British Columbia and the Canadian Arthritis Network, alongside pharmaceutical sponsors such as Pfizer, Amgen, and Bionos Biotech S.L.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05722158 COMPLETED
Healthy Volunteers
Bionos Biotech S.L.
2023-08-01
NCT02157948 COMPLETED
Postmenopausal Osteoporosis
Amgen
2014-05 PHASE3
NCT02053753 COMPLETED
Healthy Volunteer
Amgen
2014-02 PHASE1
NCT01241812 Completed
Knee Osteoarthritis
University of British Columbia|Canadian Arthritis Network
2010-10 Not Applicable
NCT00261846 Completed
Chronic Myeloid Leukemia
Pfizer
2006-01-18 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-01-05)

Check the CP2 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CP2 selectively binds to and inhibits JmjC histone demethylases KDM4A and KDM4C, preventing the enzymatic removal of methyl groups from methylated histone residues to alter chromatin structure and disrupt oncogenic transcription. By blocking demethylase-dependent epigenetic remodeling and cellular proliferation, this targeted inhibition provides therapeutic relevance in hyperproliferative conditions such as chronic 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>).

Note: Technical data last updated: Sep 1, 2026.