OT-82 Clinical Trials

Size	Price	Qty
5mg	USD 337
25mg	USD 970

Clinical Trials

Sponsored by Oncotartis Inc., multiple Phase I clinical trials evaluate the safety, dosing regimens, and preliminary efficacy of OT-82 in patients with relapsed or refractory lymphomas, including Non-Hodgkin, B-cell, T-cell, follicular, peripheral T-cell, and Hodgkin subtypes. These early-stage studies assess the drug's therapeutic potential across these hematologic malignancies. Currently, registry records list the recruitment status for these trials as unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03921879	UNKNOWN	Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, T-Cell; Lymphoma, Follicular; Lymphoma, Peripheral T-Cell; Lymphoma, Hodgkin	Oncotartis, Inc.	2019-07-29	PHASE1
NCT03921879	Unknown status	Lymphoma\|Lymphoma Non-Hodgkin\|Lymphoma B-Cell\|Lymphoma T-Cell\|Lymphoma Follicular\|Lymphoma Peripheral T-Cell\|Lymphoma Hodgkin	Oncotartis Inc.	2019-07-29	Phase 1

(data from https://clinicaltrials.gov, updated on 2020-10-23)

Check the OT-82 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

OT-82 functions as a potent inhibitor of nicotinamide phosphoribosyltransferase (NAMPT), blocking the rate-limiting enzyme in the NAD+ salvage biosynthesis pathway and causing rapid depletion of intracellular NAD+ levels. This metabolic disruption induces severe energetic stress and selective cytotoxicity in susceptible cells, suppressing cell proliferation and providing a strong therapeutic rationale for targeting hematologic malignancies such as lymphoma.

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>).