Tapotoclax (AMG-176) Clinical Trials

Size	Price	Qty
1mg	USD 590

Clinical Trials

Multiple Phase 1 clinical trials sponsored by pharmaceutical entities, including Amgen and AbbVie, have evaluated Tapotoclax (AMG-176) as monotherapy and in combination with azacitidine or venetoclax. These studies assessed safety, tolerability, pharmacokinetics, and pharmacodynamics across various hematologic malignancies, including acute myeloid leukemia, higher-risk myelodysplastic syndrome, chronic myelomonocytic leukemia, non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, and relapsed or refractory multiple myeloma. Notably, all recorded Phase 1 clinical trials for this compound currently hold a recruitment status of terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02675452	TERMINATED	Relapsed or Refractory Multiple Myeloma; Relapsed or Refractory Acute Myeloid Leukemia	Amgen	2016-06-13	PHASE1
NCT05209152	TERMINATED	Higher Risk Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia	Amgen	2022-11-14	PHASE1
NCT03797261	TERMINATED	Acute Myeloid Leukemia; Non-Hodgkin's Lymphoma; Diffuse Large B-cell Lymphoma	AbbVie	2019-03-18	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-07-09)

Check the Tapotoclax (AMG-176) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tapotoclax (AMG-176) selectively binds to myeloid cell leukemia 1 (MCL1) with a Ki of 0.13 nM, blocking its interaction with pro-apoptotic proteins and disrupting downstream anti-apoptotic survival biochemistry. This targeted disruption triggers mitochondrial-mediated apoptosis in dysregulated hematopoietic cells, providing the biological foundation for evaluating AMG-176 in clinical trials for hematologic malignancies such as acute myeloid leukemia, multiple myeloma, and myelodysplastic syndrome.

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>).