Birinapant (TL32711) Clinical Trials

Size	Price	Qty
5mg	USD 370
50mg	USD 970

Clinical Trials

Multiple clinical trials spanning Phase 1 to Phase 2 have evaluated birinapant as monotherapy and in combination with agents like azacitidine and pembrolizumab across hematologic malignancies and solid tumors, including acute myeloid leukemia, myelodysplastic syndrome, epithelial ovarian cancer, and head and neck squamous cell carcinoma. Sponsored by pharmaceutical entities such as TetraLogic Pharmaceuticals and Medivir, as well as government and academic institutions like the National Cancer Institute, these studies reflect varied recruitment statuses including completed, active not recruiting, terminated, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04553692	TERMINATED	Solid Tumor; Colorectal Cancer; Non Hodgkin Lymphoma; Sarcoma; Chondrosarcoma; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia; Acute Myeloid Leukemia	IGM Biosciences, Inc.	2020-09-23	PHASE1
NCT03803774	ACTIVE_NOT_RECRUITING	Locally Recurrent Head and Neck Squamous Cell Carcinoma; Nasopharyngeal Squamous Cell Carcinoma; Sinonasal Squamous Cell Carcinoma	National Cancer Institute (NCI)	2019-09-25	PHASE1
NCT02587962	TERMINATED	Solid Tumors	Medivir	2017-08-04	PHASE1; PHASE2
NCT02756130	WITHDRAWN	High Grade Fallopian Tube Serous Adenocarcinoma; High Grade Ovarian Serous Adenocarcinoma; Primary Peritoneal High Grade Serous Adenocarcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma	Jonsson Comprehensive Cancer Center	2018-08-01	PHASE1; PHASE2
NCT02147873	TERMINATED	Myelodysplastic Syndrome (MDS); Chronic Myelomonocytic Leukemia (CMML)	TetraLogic Pharmaceuticals	2014-06	PHASE2
NCT01940172	COMPLETED	Relapsed Epithelial Ovarian Cancer; Relapsed Primary Peritoneal Cancer; Relapsed Fallopian Tube Cancer	TetraLogic Pharmaceuticals	2013-11	PHASE1
NCT01828346	COMPLETED	Myelodysplastic Syndrome	TetraLogic Pharmaceuticals	2013-06	PHASE1; PHASE2
NCT02288208	TERMINATED	Hepatitis B	TetraLogic Pharmaceuticals	2014-11	PHASE1
NCT01486784	TERMINATED	Acute Myelogenous Leukemia	Abramson Cancer Center at Penn Medicine	2011-11	PHASE1; PHASE2
NCT01681368	TERMINATED	Epithelial Ovarian Cancer; Peritoneal Neoplasms; Fallopian Tube Neoplasms	National Cancer Institute (NCI)	2012-08-15	PHASE2
NCT01188499	COMPLETED	Cancer	TetraLogic Pharmaceuticals	2010-10	PHASE1; PHASE2
NCT01766622	WITHDRAWN	Ovarian Neoplasms; Ovarian Cancer; Fallopian Tube Neoplasms; Fallopian Tube Cancer	National Institutes of Health Clinical Center (CC)	2012-11-30	PHASE2
NCT01681368	Terminated	Epithelial Ovarian Cancer\|Peritoneal Neoplasms\|Fallopian Tube Neoplasms	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2012-08-15	Phase 2
NCT00993239	COMPLETED	Cancer	TetraLogic Pharmaceuticals	2009-11	PHASE1
NCT01486784	Terminated	Acute Myelogenous Leukemia	Abramson Cancer Center at Penn Medicine	2011-11	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-03-28)

Check the Birinapant (TL32711) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Birinapant functions as a SMAC mimetic that high-affinity binds cellular inhibitor of apoptosis protein 1 (cIAP1), triggering rapid cIAP degradation and uninhibiting downstream caspase activation to drive cell apoptosis. This reactivation of programmed cell death restores chemo-sensitivity and suppresses tumor growth, underlying its clinical investigation for conditions such as acute myeloid leukemia, myelodysplastic syndrome, and ovarian cancer.

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>).