Clinical Trials

Gusacitinib (ASN-002) has been evaluated across multiple Phase 1, Phase 2, and combined Phase 1/2 clinical trials for dermatological and autoimmune conditions, including atopic dermatitis, chronic hand dermatitis, basal cell carcinoma, basal cell nevus syndrome, systemic lupus erythematosus, and healthy volunteer safety assessments. Sponsored by commercial entities like Asana BioSciences and Ascend Biopharmaceuticals, as well as government institutions such as the National Institute of Arthritis and Musculoskeletal and Skin Diseases, these studies span recruitment statuses ranging from completed to suspended, withdrawn, or pending.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06238531 WITHDRAWN
Systemic Lupus Erythematosus
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 2025-01-22 PHASE1
NCT03208296 SUSPENDED
Basal Cell Carcinoma in Basal Cell Nevus Syndrome
Ascend Biopharmaceuticals Ltd
 2017-12-01 PHASE1; PHASE2
NCT06238531 Not yet recruiting
Systemic Lupus Erythematosus
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|National Institutes of Health Clinical Center (CC)
 2024-05-15 Phase 1
NCT04416516 COMPLETED
Basal Cell Carcinoma; Basal Cell Nevus Syndrome
Ascend Biopharmaceuticals Ltd
 2020-07-16 PHASE2
NCT04416516 Completed
Basal Cell Carcinoma|Basal Cell Nevus Syndrome
Ascend Biopharmaceuticals Ltd
 2020-07-16 Phase 2
NCT03728504 COMPLETED
Chronic Hand Dermatitis
Asana BioSciences
 2019-01-03 PHASE2
NCT03654755 TERMINATED
Atopic Dermatitis
Asana BioSciences
 2018-09-29 PHASE2
NCT03531957 COMPLETED
Atopic Dermatitis
Asana BioSciences
 2018-07-05 PHASE2
NCT03641573 COMPLETED
Healthy Volunteer
Asana BioSciences
 2018-10-11 PHASE1
NCT03641573 Completed
Healthy Volunteer
Asana BioSciences
 2018-10-11 Phase 1
NCT02440685 TERMINATED
Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Cancer; Neoplasm; Tumor; Lymphoma, Malignant; Lymphoma, B-cell; Lymphoma, Non-Hodgkin; B-Cell Chronic Lymphocytic Leukemia; B-Cell Leukemia, Chronic; B-Lymphocytic Leukemia, Chronic; Chronic Lymphocytic Leukemia; Leukemia, Lymphocytic, Chronic; Leukemia, Lymphocytic, Chronic, B Cell; Myelofibrosis; Chronic Idiopathic Myelofibrosis; Idiopathic Myelofibrosis; Lymphoma, T Cell, Peripheral; Peripheral T-Cell Lymphoma; T-Cell Lymphoma, Peripheral
Asana BioSciences
 2015-05 PHASE1; PHASE2
NCT03208296 Suspended
Basal Cell Carcinoma in Basal Cell Nevus Syndrome
Ascend Biopharmaceuticals Ltd
 2017-12-01 Phase 1|Phase 2
NCT03139981 COMPLETED
Dermatitis, Atopic; Dermatitis Eczema; Dermatitis, Eczematous
Asana BioSciences
 2017-04-12 PHASE1
NCT02550678 COMPLETED
Basal Cell Nevus Syndrome; Skin Neoplasm; Nodular Basal Cell Carcinoma of Skin
Ascend Biopharmaceuticals Ltd
 2015-09 PHASE1; PHASE2
NCT03139981 Completed
Dermatitis Atopic|Dermatitis Eczema|Dermatitis Eczematous
Asana BioSciences
 2017-04-12 Phase 1
NCT02853643 COMPLETED
Healthy Volunteers
Asana BioSciences
 2016-07 PHASE1
NCT02853643 Completed
Healthy Volunteers
Asana BioSciences
 2016-07 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-03-13)

Check the Gusacitinib (ASN-002) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gusacitinib acts as a dual inhibitor of spleen tyrosine kinase (SYK) and Janus kinases (JAK), binding to their ATP-catalytic domains to prevent downstream STAT protein phosphorylation and pro-inflammatory signal transduction. This inhibition halts cytokine-driven immune cell activation and pathological signaling, providing therapeutic potential against inflammatory and neoplastic diseases such as atopic dermatitis, chronic hand dermatitis, and basal cell carcinoma.

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.