Tasisulam Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Several clinical trials sponsored by Eli Lilly and Company evaluated tasisulam (LY573636) as a single agent or combination therapy across Phase 1 and Phase 2 stages. These studies investigated the drug in conditions including advanced solid tumors, acute myeloid leukemia, essential thrombocythemia, metastatic renal cell cancer, and soft tissue sarcoma. Most investigations, including Phase 1 combination studies and a Phase 2 trial in soft tissue sarcoma, are completed, whereas a Phase 1 pharmacokinetic interaction trial was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01209832	Terminated	Advanced Cancer	Eli Lilly and Company	2010-09	Phase 1
NCT01214668	Completed	Solid Tumors	Eli Lilly and Company	2009-01	Phase 1
NCT00718159	Completed	Acute Myeloid Leukemia\|Essential Thrombocythemia	Eli Lilly and Company	2008-08	Phase 1
NCT01258348	Completed	Metastatic Renal Cell Cancer	Eli Lilly and Company	2008-07	Phase 1
NCT01215916	Completed	Solid Tumors	Eli Lilly and Company	2008-02	Phase 1
NCT00490451	Completed	Sarcoma Soft Tissue	Eli Lilly and Company	2007-08	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tasisulam acts as an antitumor small molecule that triggers apoptosis through the intrinsic mitochondrial apoptotic pathway, leading to mitochondrial membrane permeabilization and activation of downstream executioner caspases. This cascade promotes programmed cell death in proliferating malignant cells, thereby inhibiting neoplastic progression in clinical conditions such as soft tissue sarcoma, renal cell carcinoma, and acute myeloid leukemia.

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>).