MIK665 (S64315) Clinical Trials

Size	Price	Qty
1mg	USD 170
5mg	USD 490

Clinical Trials

Multiple clinical trials evaluate MIK665 (S64315) in hematologic malignancies, including acute myeloid leukemia, multiple myeloma, myelodysplastic syndrome, diffuse large B-cell lymphoma, and non-Hodgkin lymphoma. These Phase I and Phase I/II studies, sponsored by major pharmaceutical organizations including Novartis Pharmaceuticals and Institut de Recherches Internationales Servier, assess safety, tolerability, pharmacokinetics, and preliminary activity as monotherapies or combination treatments. Recruitment statuses across these evaluations encompass completed, active but not recruiting, and terminated studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04702425	TERMINATED	Non-Hodgkin Lymphoma (NHL); Acute Myeloid Leukemia (AML); Multiple Myeloma (MM)	Novartis Pharmaceuticals	2021-06-23	PHASE1
NCT04629443	COMPLETED	Acute Myeloid Leukaemia	Institut de Recherches Internationales Servier	2021-02-17	PHASE1; PHASE2
NCT03672695	COMPLETED	Acute Myeloid Leukaemia	Institut de Recherches Internationales Servier	2018-11-28	PHASE1
NCT04702425	Active not recruiting	Non-Hodgkin Lymphoma (NHL)\|Acute Myeloid Leukemia (AML)\|Multiple Myeloma (MM)	Novartis Pharmaceuticals\|Novartis	2021-06-23	Phase 1
NCT04629443	Active not recruiting	Acute Myeloid Leukaemia	Institut de Recherches Internationales Servier\|ADIR a Servier Group company\|Servier	2021-02-17	Phase 1\|Phase 2
NCT02979366	COMPLETED	Acute Myeloid Leukaemia (AML); Myelodysplastic Syndrome (MDS)	Institut de Recherches Internationales Servier	2017-03-15	PHASE1
NCT02992483	COMPLETED	Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma	Novartis Pharmaceuticals	2017-07-12	PHASE1
NCT02992483	Completed	Multiple Myeloma (MM) Lymphoma Large B-Cell Diffuse (DLBCL) Lymphoma	Novartis Pharmaceuticals\|Novartis	2017-07-12	Phase 1
NCT02979366	Completed	Acute Myeloid Leukaemia (AML)\|Myelodysplastic Syndrome (MDS)	Institut de Recherches Internationales Servier\|ADIR a Servier Group company\|Servier	2017-03-15	Phase 1

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

Check the MIK665 (S64315) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MIK665 (S64315) selectively binds to the anti-apoptotic protein myeloid cell leukemia-1 (Mcl-1) with a Ki of 1.2 nM, effectively neutralizing its ability to sequester pro-apoptotic BH3-only proteins. This targeted inhibition restores the intrinsic apoptotic pathway and promotes mitochondrial outer membrane permeabilization, driving programmed cell death to suppress tumor burden in Mcl-1-dependent hematologic malignancies such as acute myeloid leukemia 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>).