Subasumstat (TAK-981) Clinical Trials

Size	Price	Qty
5mg	USD 297
25mg	USD 777

Clinical Trials

Multiple clinical trials evaluate Subasumstat (TAK-981), a selective inhibitor of the SUMOylation cascade, across early-phase to Phase I/II studies sponsored primarily by industry entities including Takeda and Presage Biosciences. Targeting oncology indications such as advanced solid tumors, non-Hodgkin lymphoma, relapsed or refractory multiple myeloma, and head and neck cancer, these studies encompass completed, active not recruiting, and terminated recruitment statuses. Overall, these investigations aim to determine the safety, pharmacokinetics, and preliminary therapeutic efficacy of TAK-981, including combination regimens with pembrolizumab or rituximab.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04381650	COMPLETED	Advanced or Metastatic Solid Tumors	Takeda	2020-08-17	PHASE1; PHASE2
NCT05976334	TERMINATED	Solid Tumors	Takeda	2023-11-14	PHASE1
NCT03648372	TERMINATED	Neoplasms; Lymphoma; Hematologic Neoplasms	Takeda	2018-10-01	PHASE1; PHASE2
NCT04776018	TERMINATED	Relapsed and/or Refractory Multiple Myeloma (RRMM)	Takeda	2021-04-20	PHASE1; PHASE2
NCT04074330	TERMINATED	Lymphoma, Non-Hodgkin	Takeda	2019-10-15	PHASE1; PHASE2
NCT04065555	COMPLETED	Head and Neck Cancer	Presage Biosciences	2020-10-07	EARLY_PHASE1
NCT04381650	Active not recruiting	Advanced or Metastatic Solid Tumors	Takeda\|Takeda Development Center Americas Inc.	2020-08-17	Phase 1\|Phase 2
NCT04074330	Terminated	Lymphoma Non-Hodgkin	Takeda	2019-10-15	Phase 1\|Phase 2
NCT03648372	Terminated	Neoplasms\|Lymphoma\|Hematologic Neoplasms	Takeda	2018-10-01	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-12-10)

Check the Subasumstat (TAK-981) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Subasumstat (TAK-981) selectively binds to and inhibits the SUMOylation enzymatic cascade, thereby blocking the post-translational modification of target proteins essential for oncogenic signaling and cellular survival. This blockade triggers immune-activating and pro-apoptotic cellular pathways, providing antitumor efficacy relevant to the treatment of advanced solid tumors, non-Hodgkin lymphoma, and multiple myeloma.

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>).