Zasocitinib Clinical Trials

Size	Price	Qty
1mg	USD 327
5mg	USD 970

Clinical Trials

Multiple clinical trials sponsored by Takeda evaluate zasocitinib (TAK-279) across Phase 1, Phase 2, and Phase 3 stages, with statuses spanning completed, recruiting, and not yet recruiting. Phase 1 studies assess safety, drug-drug interactions, and pharmacokinetics in healthy volunteers and individuals with renal impairment. Mid- and late-stage trials evaluate clinical efficacy in autoimmune and inflammatory conditions, including plaque psoriasis, psoriatic arthritis, palmoplantar psoriasis, hidradenitis suppurativa, nonsegmental vitiligo, Crohn's disease, and ulcerative colitis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07250802	RECRUITING	Plaque Psoriasis	Takeda	2025-12-04	PHASE3
NCT06764615	RECRUITING	Crohn's Disease; Ulcerative Colitis	Takeda	2025-05-28	PHASE2
NCT07286058	RECRUITING	Psoriatic Arthritis	Takeda	2026-03-11	PHASE3
NCT07403968	RECRUITING	Crohn's Disease	Takeda	2026-08-13	PHASE2
NCT07244263	RECRUITING	Hidradenitis Suppurativa	Takeda	2026-01-26	PHASE2
NCT07108283	RECRUITING	Nonsegmental Vitiligo	Takeda	2025-11-03	PHASE2
NCT07752108	NOT_YET_RECRUITING	Palmoplantar Psoriasis	Takeda	2026-09-01	PHASE3
NCT06671496	RECRUITING	Psoriatic Arthritis	Takeda	2025-03-10	PHASE3
NCT06671483	RECRUITING	Psoriatic Arthritis	Takeda	2025-03-03	PHASE3
NCT06973291	COMPLETED	Plaque Psoriasis	Takeda	2025-07-09	PHASE3
NCT06793943	COMPLETED	Healthy Volunteers	Takeda	2025-01-23	PHASE1
NCT06111547	Not yet recruiting	Healthy Volunteers	Takeda	2024-05-30	Phase 1
NCT06290050	Recruiting	Healthy Volunteers	Takeda	2024-03-29	Phase 1
NCT06108544	Recruiting	Plaque Psoriasis	Takeda	2023-11-06	Phase 3
NCT06088043	Recruiting	Plaque Psoriasis	Takeda	2023-11-06	Phase 3
NCT05992155	Recruiting	Renal Impairment\|Healthy Volunteers	Takeda	2023-09-27	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zasocitinib functions as a selective tyrosine kinase 2 (TYK2) inhibitor that binds to TYK2, thereby blocking receptor-associated transphosphorylation and downstream signal transducer and activator of transcription (STAT) protein activation mediated by interleukin-12, interleukin-23, and type I interferons. By inhibiting these signaling cascades, the compound suppresses pathogenic T-cell activation and cytokine release, leading to reduced tissue inflammation and clinical efficacy in conditions studied in trials, such as plaque psoriasis, psoriatic arthritis, and Crohn's disease.

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>).