Osunprotafib (ABBV-CLS-484) Clinical Trials

Size	Price	Qty
1mg	USD 570
5mg	USD 1,670

Clinical Trials

Multiple clinical trials sponsored by Calico Life Sciences LLC are evaluating osunprotafib (ABBV-CLS-484) in patients with advanced solid tumors, including locally advanced or metastatic malignancies. The development program features a recruiting Phase I trial assessing the drug's safety and efficacy as monotherapy and in combination regimens. Additionally, an expanded access protocol with an unspecified phase status is currently available for patient care in this early-stage oncology research.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04777994	RECRUITING	Advanced Solid Tumor Cancer	Calico Life Sciences LLC	2021-03-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-04)

Check the Osunprotafib (ABBV-CLS-484) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Osunprotafib is a sub-nanomolar inhibitor that selectively targets protein tyrosine phosphatase non-receptor type 1 (PTPN1) and protein tyrosine phosphatase non-receptor type 2 (PTPN2), suppressing their catalytic dephosphorylation of critical signaling mediators such as signal transducer and activator of transcription (STAT) proteins. Blockade of PTPN1 and PTPN2 downstream signaling restores immune cell activation and enhances interferon-gamma sensitivity within the tumor microenvironment, promoting potent immune-mediated destruction of advanced solid tumor cells.

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>).