Cerdulatinib (PRT062070) hydrochloride Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 447

Clinical Trials

Multiple clinical trials sponsored by industry entities including Dermavant Sciences, Alexion Pharmaceuticals, and Portola Pharmaceuticals have evaluated cerdulatinib across Phase 1 through Phase 3. The investigated indications encompass dermatological conditions like vitiligo alongside hematologic malignancies, including relapsed or refractory chronic lymphocytic leukemia, B-cell non-Hodgkin lymphoma, and peripheral T-cell lymphoma. Recruitment statuses across these studies range from completed trials to withdrawn protocols and expanded access programs.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04021082	WITHDRAWN	Peripheral T-Cell Lymphoma (PTCL NOS); Nodal Lymphomas of T Follicular Helper (TFH); Follicular T-cell Lymphoma (FTCL); AITL; ALCL; HSTCL; EATL I,II; MEITL, EATL Type II; Nasal Lymphoma	Portola Pharmaceuticals	2019-11-15	PHASE2; PHASE3
NCT01994382	COMPLETED	Follicular Lymphoma (FL/Indolent NHL); Aggressive NHL (a NHL); Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL); T-cell Lymphoma (PTCL and CTCL); B-cell Non Hodgkin Lymphoma (NHL)	Alexion Pharmaceuticals, Inc.	2013-08-30	PHASE1; PHASE2
NCT04103060	COMPLETED	Vitiligo	Dermavant Sciences GmbH	2019-09-27	PHASE2
NCT04103060	Completed	Vitiligo	Dermavant Sciences GmbH\|Dermavant Sciences Inc.	2019-09-27	Phase 2
NCT01994382	Completed	Follicular Lymphoma (FL/Indolent NHL)\|Aggressive NHL (a NHL)\|Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)\|T-cell Lymphoma (PTCL and CTCL)\|B-cell Non Hodgkin Lymphoma (NHL)	Alexion Pharmaceuticals Inc.\|Portola Pharmaceuticals	2013-08-30	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2023-02-21)

Check the Cerdulatinib (PRT062070) hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cerdulatinib functions as a potent dual inhibitor of Spleen Tyrosine Kinase and Janus Kinases (JAK1, JAK2, JAK3, and TYK2), binding these targets to block downstream STAT protein phosphorylation and disrupt oncogenic intracellular signaling cascades. By suppressing cellular proliferation and survival in dysregulated lymphocytes and immune cells, this targeted biochemical blockade provides the mechanistic basis for clinical evaluation in non-Hodgkin lymphoma, chronic lymphocytic leukemia, and vitiligo.

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>).