Clinical Trials

Multiple clinical trials led by industry sponsors—including Dermavant Sciences, Alexion Pharmaceuticals, and Portola Pharmaceuticals—have evaluated cerdulatinib across Phase 1, Phase 2, and Phase 3 protocols. These studies targeted B-cell and T-cell hematological malignancies, such as chronic lymphocytic leukemia, follicular lymphoma, and peripheral T-cell lymphoma, as well as dermatological conditions like vitiligo. Trial recruitment statuses across these records include completed studies, withdrawn trials, and expanded access protocols.

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NCT04021082 WITHDRAWN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) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cerdulatinib is a potent dual inhibitor that selectively binds spleen tyrosine kinase and the Janus kinase family, thereby blocking downstream STAT phosphorylation and B-cell receptor signaling cascades. By inhibiting these key enzymatic pathways, cerdulatinib suppresses pro-survival signaling and induces apoptosis in malignant and inflammatory cells, mediating therapeutic efficacy in clinical conditions such as 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>).

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